A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)
Phase: PHASE3
Conditions: Multiple Myeloma
Sponsor: GlaxoSmithKline

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TITLE PAGE 
Protocol Title: A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the 
Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and 
Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone 
(PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8) 
Protocol Number: 207499 Amendment 4 
Compound Number: GSK2857916 (Belantamab Mafodotin) 
Brief Title: A Phase III Study of Belantamab Mafodotin plus Pomalidomide and 
Dexamethasone vs. Pomalidomide, Bortezomib and Dexamethasone in Participants with 
RRMM 
Study Phase: Phase 3 
Acronym: DREAMM 8  
Sponsor Name and Legal Registered Address: 
GlaxoSmithKline Research & Development Limited 
980 Great West Road 
Brentford 
Middlesex, TW8 9GS 
UK 
Regulatory Agency Identifying Numbers: 
Registry 
ID 
EudraCT 
2018-004354-21 
EU CT 
2023-506877-37-00 
IND 
119333 
Medical Director Name and Contact Information can be found in the Study 
Reference Manual 
Sponsor Signatory: 
Brandon Kremer, MD, PhD 
Senior Group Director, Clinical Development, 
Clinical Development Lead 
Belantamab Mafodotin Program 
Approval Date: 28 Sep 2023 
©2023 GSK group of companies or its licensor. All rights reserved. Unauthorized 
copying or use of this information is prohibited. 

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PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE 
DOCUMENT HISTORY 
Document 
Date 
Document Identifier 
Amendment 04 
28 Sep 2023 
TMF-16737343 
Amendment 03 
23 Feb 2023 
TMF-15201205 
Amendment 02 
12 Jul 2022 
TMF-14683895 
Amendment 01 
20 Apr 2021 
TMF-12460807 
Original Protocol 
16 Apr 2020 
2018N381008_00 
Amendment 4: 28 Sep 2023 
Where this Protocol Amendment applies: 
Protocol Amendment 4 applies to all participants in all countries and all sites. 
Overall Rationale for the Amendment 4: 
The overall rationale for this protocol amendment is to delay the timing of the Primary 
PFS analysis, allowing for a longer duration of follow up and increasing OS data maturity 
at the time of Primary PFS analysis. Consequently, an interim analysis has been included 
prior to the Primary PFS analysis to allow for the opportunity to test for efficacy early. 
The delayed Primary PFS analysis and additional interim analysis for PFS result in an 
increase in the targeted number of PFS events and modified multiplicity strategy. 
Additional details regarding planned OS interim analyses have been included.  
Updated sections of pharmacokinetics and pharmacodynamics in humans; updated 
benefit:risk assessment to align with the changes made in current belantamab mafodotin 
Investigator Brochure (IB); administrative updates were made to add clarification and/or 
remove discrepancies. 
All changes are listed in table below. 

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Section # and Name 
Description of Change 
Brief Rationale 
Headers, cover page, and 
Protocol Amendment 
Summary of Changes 
Table 
 
 
 
 
 
Headers and cover page were updated with new 
document number; added an EU CT study number 
for EU CTR submission; and revised sponsor name 
from GSK to GlaxoSmithKline 
Protocol Amendment Summary of Changes Table 
section was created and populated to include details 
and rationale for this amendment 
Editorial changes to align 
with the GSK’s standard 
protocol template 
Throughout 
 
 
Administrative updates to add clarification and/or 
remove discrepancies 
Editorial changes were made 
for accuracy, clarity, 
conformity, flow, and 
typographical error 
corrections 
Section 1.1 Synopsis and 
Section 3 Objectives and 
Endpoints 
Details of endpoint definitions expanded in alignment 
with definitions in Section 9. 
Clarification 
Section 1.1 Synopsis 
Section 6.1 Study 
Intervention(s) 
Administered 
Clarification of definitions of experimental arm (B-Pd, 
Arm A) and active comparator arm (PVd, Arm B). 
Clarification 
Section 1.3 Schedule of 
Activities 
Clarification of disease evaluations of sample 
collection and immunofixation test in Table 1 and 
Table 2. 
PD confirmation based on laboratory parameters 
must be performed from a different blood or ‘urine’ 
collection. 
Serum immunofixation must be performed each time 
that M-protein is not quantifiable by SPEP (0 g/dL). 
Urine immunofixation must be performed each time 
that M-protein is not quantifiable by UPEP 
(0 mg/24 h) AND SPEP (0 g/dL). 
Clarification 
Section 1.3 Schedule of 
Activities 
Addition of a footnote in Table 1 and Table 2 for the 
frequency of Pregnancy Prevenstion Counselling 
after EoT. It must be performed in WOCBP at the 
EoT visit and at least 4 weeks following 
discontinuation of pomalidomide treatment, 
whichever comes last. 
Clarification 
Section 2.3 Human 
Experience with 
Belantamab Mafodotin 
Updated with results from ongoing DREAMM 
studies. 
Updated and added newly 
available information from 
the current IB. 
Section 2.4 Benefit:Risk 
Assessment 
Update of Risk Assessment table to reflect current 
information from the belantamab mafodotin program. 
Updated information from 
the current IB. 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 3 Objectives and 
Endpoints and deletion of 
Section 10.1.11 Third 
Parties and Sub-
Contractors 
Deleted footnote regarding list of third parties and 
sub-contractors with cross-reference to now deleted 
Section 10.1.11. 
Deleted Section 10.1.11 
Third Parties and Sub-
Contractors to avoid the 
necessity of protocol 
amendment due to vendor 
name change only.  
Section 6.4 Study 
Intervention Compliance 
Deleted "intravenously" for dose administration of 
bortezomib. 
Correction of typographical 
error. 
Section 7.2 7.2 Participant 
Withdrawal from the Study 
Added “treatment” after the study.  
Participants who are withdrawn from the study 
TREATMENT because of AEs/SAEs must be clearly 
distinguished from participants who are withdrawn 
for other reasons. Investigator will follow participants 
who are withdrawn from the study TREATMENT due 
to an AE/SAE until the event is resolved or 
considered clinically stable. 
As there is no way a 
physician will follow up with 
the participant after they 
have withdrawn from the 
study/consent, protocol 
wording amended to 
withdrawn from the study 
TREATMENT instead of 
withdrawn from 
study/consent.  
Section 7.3 Lost to Follow-
up 
Added “directly” in below sentence  
Sponsor personnel will not be DIRECTLY involved in 
any attempts to collect vital status information. 
Clarification 
Section 8 Study 
Assessments and 
Procedures 
Added “Inclusion/exclusion criteria will be assessed 
during screening until enrollment. A participant is 
considered enrolled when the investigator or 
designee has confirmed, through the eligibility form, 
that all eligibility criteria have been met. Any interval 
change in the participant's clinical course (e.g., 
laboratory values, concomitant medications, clinical 
condition) between enrollment and the first dose of 
investigational product that could impact the ability of 
the participant to safely receive their first dose 
should be jointly discussed between the investigator 
and medical monitor prior to dosing”. 
Deleted reticulocyte count from Table 24 List of 
Clinical Laboratory Assessments.  
Clarification of management 
of safety before the first 
study drug dose. 
Reticulocyte count deleted 
because not included in any 
planned analyses. 
Section 8.2.7 Pregnancy 
Testing (WOCBP Only) 
Clarifying documentation requirement of the 
pregnancy prevention program.  
Ensure counselling is completed and documented as 
required by applicable pregnancy prevention 
program. 
Clarification 
Section 9.1 Statistical 
Hypotheses 
Section focused on hypotheses to be tested only. 
Removed reference to statistical assumptions and 
significance level for testing. Reordered endpoints to 
align with multiplicity strategy. 
The inclusion of an interim 
analysis changes the 
multiplicity strategy, details 
were previously included in 
multiple places and are more 
appropriate to include in 
Section 9.2 and 9.3.  

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Section # and Name 
Description of Change 
Brief Rationale 
Section 9.2 Multiple 
Comparisons and 
Multiplicity 
Modified multiplicity strategy, acknowledging the 
importance of OS as a key secondary endpoint and 
accommodating the group sequential design. Further 
details to be provided in the SAP. 
Inclusion of interim analyses 
and modified multiplicity 
strategy. 
Section 9.3 Sample Size 
Determination 
Sample size for PFS revised. Subsections for key 
secondary endpoints removed.  
To permit a longer follow up, 
increase OS data maturity at 
the time of Primary PFS 
analysis/IA3 and account for 
PFS interim analysis for 
efficacy (IA1). Subsections 
for key secondary endpoints 
provided no additional value.  
The decision to revise 
sample size was 
independent of the planned 
sample size re-estimation 
per Section 9.3.2. 
Section 9.5.1 Efficacy 
Analyses 
Flexible wording added when defining subgroup 
analyses and stratum size.  
Removed redundant information that is defined in 
other sections of the protocol or clarified in the SAP. 
Removed reference to significance level for testing 
and added clarification of p-values and confidence 
intervals to be produced. 
Removed reference to 2L analysis. 
OS definition revised so that “Participants who are 
alive will be censored at the date last known alive” 
instead of at date of last contact. 
 
To align with intent of 
analyses and provide 
sufficient information. 
To avoid repetition. 
Multiplicity strategy is 
defined in Section 9.2 and 
will be clarified in the SAP. 
A separate 2L analysis will 
no longer be performed due 
to increased follow-up for all 
participants. 
Intent of OS analysis has not 
changed, but wording 
clarified to allow the use of 
public records if applicable 
per local laws. 
Section 9.6 Interim 
Analyses 
Interim analyses for efficacy included. 
Tables of Stopping Boundaries for Interim Analysis 
for PFS Efficacy added. 
IA for harm (IA1) details clarified. 
Additional OS analyses considered. 
Added text to clarify that delegate(s) who are not 
involved in the study conduct may be unblinded for 
performing population PK and PKPD dataset 
preparation in support of planned analyses and PK 
display review. All other personnel will remain 
blinded to aggregate data by treatment group until 
database lock. 
Interim analyses added to 
allow the opportunity to test 
for efficacy early. 
Given the revised targeted 
number of PFS events, 
clarified IA1 as this was 
planned under previous 
protocol assumptions and 
sample size. 
If requested, additional OS 
analyses may be required. 
To allow for sufficient time to 
prepare and conduct 
planned analyses. 
Section 9.6.1 Independent 
Data Monitoring Committee 
Section restructured and multiple interim analyses 
considered for IDMC review. 
Addition of interim analyses 
for efficacy. 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 9.6.2 Sequence of 
Interim and Other Planned 
Analyses 
IA for harm (IA1) details clarified. 
Interim analyses for efficacy included. 
Primary PFS analysis/IA3 and final analysis events 
and timing modified.  
2L analysis removed. 
Given the revised targeted 
number of PFS events, 
clarified IA1 as this was 
planned under previous 
protocol assumptions and 
sample size. 
Interim analyses added to 
allow the opportunity to test 
for efficacy early. 
Primary PFS analysis/IA3 
and final analysis events and 
timing modified to permit a 
longer follow up and 
increase OS data maturity. 
2L analysis is redundant with 
the increased follow up for 
Primary PFS analysis/IA3. 
Section 10.1.4 Recruitment 
Strategy 
Added section to clarify study recruitment 
To align with EU CTR 
transition. 
Section 10.1.11 Study and 
Site Start and Closure 
Addition of First Act of Recruitment. 
Updated study/site termination. 
To align with EU CTR 
transition.  
Section 10.2.5 Reporting of 
Serious Adverse Events to 
GSK or Designee 
Removed SAE coordinator. 
The role was eliminated. 
Section 10.4 Appendix 4: 
Required Actions, Follow-
up Assessments, and 
Study Treatment 
Rechallenge Guidelines 
Corrected footnote 2 to clarify that ALT ≥3×ULN. 
Added "3" due to 
typographical error in 
previous amendments. 
Section 10.9 Appendix 9: 
Progression-Free Survival 
Event and Censoring Rules 
Clarifications added to table and footnotes 2, 3, and 
5. 
Clarification 
Section 10.14 
Abbreviations, Trademarks 
and Definitions of Terms 
Addition of definitions of specialized terms in clinical 
study. 
Clarification 

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TABLE OF CONTENTS 
PAGE 
TITLE PAGE ................................................................................................................... 1 
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ..................................... 2 
1. 
PROTOCOL SUMMARY ........................................................................................ 15 
1.1. 
Synopsis ..................................................................................................... 15 
1.2. 
Study Schema ............................................................................................ 22 
1.3. 
Schedule of Activities (SoA) ........................................................................ 23 
2. 
INTRODUCTION .................................................................................................... 38 
2.1. 
Study Rationale .......................................................................................... 38 
2.2. 
Background ................................................................................................ 40 
2.2.1. 
Clinical Management of Multiple Myeloma and 
Relapsed/Refractory Multiple Myeloma ........................................ 40 
2.2.1.1. 
Pomalidomide in Combination with 
Dexamethasone (Pd) for Relapsed/Refractory 
Multiple Myeloma Treatment ...................................... 40 
2.2.1.2. 
Pomalidomide Plus Bortezomib and 
Dexamethasone (PVd) for Relapsed/Refractory 
Multiple Myeloma Treatment ...................................... 41 
2.2.2. 
Role of B-Cell Maturation Antigen in Multiple Myeloma ................ 41 
2.2.3. 
Antibody-Drug Conjugate Belantamab Mafodotin ........................ 42 
2.2.4. 
Nonclinical Pharmacology of Belantamab Mafodotin ................... 43 
2.3. 
Human Experience with Belantamab Mafodotin .......................................... 44 
2.3.1. 
Studies with Belantamab Mafodotin Monotherapy ....................... 44 
2.3.2. 
Safety .......................................................................................... 45 
2.3.3. 
Pharmacokinetics and Pharmacodynamics in Humans ................ 47 
2.3.4. 
Study 209418: Belantamab mafodotin in combination with 
pomalidomide and dexamethasone ............................................. 49 
2.4. 
Benefit:Risk Assessment ............................................................................ 49 
2.4.1. 
Summary of Risk Assessment for the Combination 
Therapy of B-Pd (Arm A) ............................................................. 51 
2.4.2. 
Benefit Assessment ..................................................................... 55 
2.4.3. 
Overall Benefit:Risk Conclusion ................................................... 55 
3. 
OBJECTIVES AND ENDPOINTS ........................................................................... 56 
4. 
STUDY DESIGN .................................................................................................... 59 
4.1. 
Overall Design ............................................................................................ 59 
4.2. 
Scientific Rationale for Study Design .......................................................... 60 
4.3. 
Justification for Dose .................................................................................. 63 
4.3.1. 
Belantamab Mafodotin Dose ........................................................ 63 
4.3.2. 
Pomalidomide Dose ..................................................................... 64 
4.3.3. 
Bortezomib Dose ......................................................................... 64 
4.3.4. 
Dexamethasone Dose ................................................................. 64 
4.4. 
End of Study Definition ............................................................................... 65 
5. 
STUDY POPULATION ........................................................................................... 66 
5.1. 
Inclusion Criteria ......................................................................................... 66 

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5.2. 
Exclusion Criteria ........................................................................................ 69 
5.3. 
Lifestyle Considerations .............................................................................. 71 
5.4. 
Screen Failures........................................................................................... 72 
6. 
STUDY INTERVENTION ........................................................................................ 73 
6.1. 
Study Intervention(s) Administered ............................................................. 73 
6.1.1. 
Treatment Arm A Dosing Schedule .............................................. 74 
6.1.2. 
Treatment Arm B Dosing Schedule .............................................. 74 
6.1.3. 
Belantamab Mafodotin ................................................................. 75 
6.1.3.1. 
Belantamab Mafodotin Pre/Post-Medication ............... 75 
6.1.3.2. 
Corneal Supportive Care Guidelines .......................... 76 
6.1.3.3. 
Ocular Prophylaxis for Treatment Arm A .................... 77 
6.1.4. 
Pomalidomide .............................................................................. 77 
6.1.4.1. 
Dosing for Participants with Hepatic 
Impairment ................................................................. 78 
6.1.4.2. 
Dosing for Participants with Renal Impairment ........... 78 
6.1.5. 
Bortezomib .................................................................................. 78 
6.1.5.1. 
Dose Calculation ........................................................ 79 
6.1.5.2. 
Dosing for Participants with Hepatic 
Impairment ................................................................. 79 
6.1.5.3. 
Dosing for Participants with Renal Impairment ........... 79 
6.1.6. 
Dexamethasone........................................................................... 79 
6.2. 
Preparation/Handling/Storage/Accountability .............................................. 80 
6.3. 
Measures to Minimize Bias: Randomization and Blinding ........................... 80 
6.3.1. 
Interactive Response Technology System ................................... 80 
6.3.2. 
Stratification ................................................................................. 81 
6.4. 
Study Intervention Compliance ................................................................... 81 
6.5. 
Concomitant Therapy.................................................................................. 82 
6.5.1. 
Permitted Concomitant Therapies ................................................ 82 
6.5.2. 
Prohibited Concomitant Therapies ............................................... 83 
6.6. 
Dose Modification and Delay ...................................................................... 84 
6.6.1. 
Guidance on Dose Delays for Treatment Arm A (B-Pd) ............... 84 
6.6.2. 
Guidance on Dose Delays for Treatment Arm B (PVd) ................ 85 
6.7. 
Dose Reductions Due to Toxicity ................................................................ 87 
6.7.1. 
Guidance on Dose Reductions in Treatment Arm A (B-Pd) .......... 87 
6.7.2. 
Guidance on Dose Reductions in Treatment Arm B (PVd) ........... 95 
6.8. 
Continued Access to Study Intervention after the Final Analysis and 
the End of the Study ................................................................................... 98 
6.8.1. 
Continued Access to Study Intervention After Final 
Analysis Data Cut-off prior to EOS ............................................... 99 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ................................................................... 100 
7.1. 
Discontinuation of Study Intervention ........................................................ 100 
7.1.1. 
Liver Chemistry Stopping Criteria .............................................. 101 
7.1.1.1. 
Study Intervention Restart or Rechallenge after 
Liver Stopping Criteria Are Met ................................. 103 
7.1.2. 
Corneal Event Stopping Criteria ................................................. 104 
7.1.3. 
Infusion-Related Reactions Stopping Criteria ............................. 104 
7.1.3.1. 
Belantamab Mafodotin .............................................. 104 
7.1.4. 
Allergic Reactions and Anaphylactic Reactions Stopping 
Criteria ....................................................................................... 104 

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7.2. 
Participant Withdrawal from the Study ...................................................... 104 
7.3. 
Lost to Follow-Up ...................................................................................... 106 
8. 
STUDY ASSESSMENTS AND PROCEDURES ................................................... 106 
8.1. 
Efficacy Assessments ............................................................................... 109 
8.1.1. 
Response Evaluation ................................................................. 110 
8.1.2. 
Minimal Residual Disease Assessment and PET/CT 
Imaging ...................................................................................... 110 
8.2. 
Safety Assessments ................................................................................. 111 
8.2.1. 
Physical Examinations ............................................................... 111 
8.2.2. 
ECOG Performance Status ........................................................ 111 
8.2.3. 
Vital Signs .................................................................................. 112 
8.2.3.1. 
Vital Sign Measurement ........................................... 112 
8.2.4. 
Electrocardiogram ...................................................................... 112 
8.2.5. 
Clinical Safety Laboratory Assessments .................................... 112 
8.2.6. 
Ophthalmic Assessments .......................................................... 113 
8.2.6.1. 
Treatment Arm A: B-Pd ............................................ 114 
8.2.6.2. 
Treatment Arm B: PVd ............................................. 114 
8.2.7. 
Pregnancy Testing (WOCBP Only) ............................................ 114 
8.2.8. 
Management of Hepatitis B+ Participants .................................. 115 
8.3. 
Adverse Events and Serious Adverse Events ........................................... 116 
8.3.1. 
Time Period and Frequency for Collecting AE and SAE 
Information ................................................................................. 116 
8.3.2. 
Method of Detecting AEs and SAEs ........................................... 118 
8.3.3. 
Follow-Up of AEs and SAEs ...................................................... 118 
8.3.4. 
Regulatory Reporting Requirements for SAEs ........................... 118 
8.3.5. 
Pregnancy ................................................................................. 118 
8.3.6. 
Cardiovascular and Death Events .............................................. 119 
8.3.7. 
Adverse Events of Special Interest ............................................ 119 
8.4. 
Treatment of Overdose ............................................................................. 119 
8.5. 
Pharmacokinetics ..................................................................................... 120 
8.5.1. 
Belantamab Mafodotin Pharmacokinetic Sample 
Collection ................................................................................... 120 
8.5.2. 
Belantamab Mafodotin Pharmacokinetic Sample Analysis ......... 122 
8.5.3. 
Pomalidomide Pharmacokinetic Sample Collection and 
Analysis ..................................................................................... 122 
8.5.4. 
Bortezomib and Dexamethasone ............................................... 123 
8.6. 
Belantamab Mafodotin Immunogenicity .................................................... 123 
8.7. 
Pharmacodynamics .................................................................................. 124 
8.8. 
Genetics ................................................................................................... 124 
8.9. 
Biomarkers ............................................................................................... 124 
8.9.1. 
Soluble B-Cell Maturation Antigen ............................................. 125 
8.9.2. 
Tumor-Related Biomarkers ........................................................ 127 
8.9.3. 
RNA Transcriptome Research ................................................... 128 
8.10. 
Patient-Reported Outcomes...................................................................... 128 
8.10.1. 
Patient-Reported Outcomes Version of the Common Term 
Criteria for Adverse Events (PRO-CTCAE) ................................ 129 
8.10.2. 
Health-Related Quality of Life .................................................... 129 
8.10.2.1. European Organization for Research and 
Treatment of Cancer Quality of Life 
Questionnaire 30-Item Core Module (EORTC 
QLQ-C30) ................................................................. 129 

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8.10.2.2. European Organization for Research and 
Treatment of Cancer 20-item Multiple Myeloma 
Module (EORTC QLQ-MY20) and the Item 
Library 52 (EORTC IL52; the Disease 
Symptoms Domain of the EORTC QLQ-MY20) ........ 129 
8.10.2.3. EuroQol Questionnaire (EQ-5D-3L) .......................... 130 
8.10.2.4. Functional Assessment of Cancer Therapy – 
General Population (FACT-GP5) .............................. 130 
8.10.2.5. Patient Global Impression Items ............................... 130 
8.10.3. 
Ocular Surface Disease Index ................................................... 130 
8.11. 
Non-protocol Specified Healthcare Resource Utilization ........................... 131 
9. 
STATISTICAL CONSIDERATIONS ...................................................................... 132 
9.1. 
Statistical Hypotheses............................................................................... 132 
9.1.1. 
Primary Endpoint ....................................................................... 132 
9.1.2. 
Key Secondary Overall Survival Endpoint .................................. 132 
9.1.3. 
Key Secondary Duration of Response Endpoint ........................ 132 
9.1.4. 
Key Secondary Minimal Residual Disease Negativity 
Endpoint .................................................................................... 132 
9.2. 
Multiple Comparisons and Multiplicity ....................................................... 132 
9.3. 
Sample Size Determination ...................................................................... 133 
9.3.1. 
Primary Endpoint ....................................................................... 133 
9.3.2. 
Sample Size Re-Estimation ....................................................... 134 
9.4. 
Populations for Analyses .......................................................................... 134 
9.5. 
Statistical Analyses ................................................................................... 135 
9.5.1. 
Efficacy Analyses ....................................................................... 135 
9.5.2. 
Safety Analyses ......................................................................... 140 
9.5.3. 
Pharmacokinetic Analyses ......................................................... 141 
9.5.4. 
Pharmacokinetic/Pharmacodynamic Analyses ........................... 142 
9.5.5. 
Other Analyses .......................................................................... 142 
9.6. 
Interim Analyses ....................................................................................... 143 
9.6.1. 
Independent Data Monitoring Committee ................................... 147 
9.6.2. 
Sequence of Interim and Other Planned Analyses ..................... 147 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ............................................................................................. 148 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations .......................................................................................... 148 
10.1.1. 
Regulatory and Ethical Considerations ...................................... 148 
10.1.2. 
Financial Disclosure ................................................................... 148 
10.1.3. 
Informed Consent Process ........................................................ 149 
10.1.4. 
Recruitment Strategy ................................................................. 149 
10.1.5. 
Data Protection .......................................................................... 149 
10.1.6. 
Committee Structure .................................................................. 150 
10.1.7. 
Publication Policy ....................................................................... 150 
10.1.8. 
Dissemination of Clinical Study Data ......................................... 151 
10.1.9. 
Data Quality Assurance ............................................................. 151 
10.1.10. Source Documents .................................................................... 152 
10.1.11. Study and Site Start and Closure ............................................... 153 
10.2. 
Appendix 2: Adverse Events: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting ..................................... 154 
10.2.1. 
Definition of Adverse Event ........................................................ 154 

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10.2.2. 
Definition of Serious Adverse Event ........................................... 154 
10.2.3. 
Definition of Cardiovascular Events ........................................... 156 
10.2.4. 
Recording and Follow-Up of Adverse Events and Serious 
Adverse Events.......................................................................... 156 
10.2.5. 
Reporting of Serious Adverse Events to GSK or Designee ........ 157 
10.3. 
Appendix 3: Contraceptive Guidance and Collection of Pregnancy 
Information ................................................................................................ 159 
10.3.1. 
Definitions .................................................................................. 159 
10.3.2. 
Contraception Guidance ............................................................ 160 
10.3.3. 
Collection of Pregnancy Information .......................................... 160 
10.4. 
Appendix 4: Liver Safety: Required Actions, Follow-up 
Assessments, and Study Treatment Rechallenge Guidelines ................... 162 
10.4.1. 
Liver Safety Drug Restart or Rechallenge Guidelines ................ 164 
10.4.1.1. Rechallenge Following Liver Stopping Events 
that are Possibly Related to Study Treatment ........... 165 
10.4.1.2. Restart Following Transient Resolving Liver 
Stopping Events NOT Related to Study 
Treatment ................................................................. 166 
10.5. 
Appendix 5: Genetics ................................................................................ 168 
10.6. 
Appendix 6: Eastern Cooperative Oncology Group (ECOG) 
Functional Status ...................................................................................... 169 
10.7. 
Appendix 7: Modified Diet in Renal Disease Formula................................ 170 
10.8. 
Appendix 8: New York Heart Association Classification ............................ 171 
10.9. 
Appendix 9: Progression-Free Survival Event and Censoring Rules ......... 172 
10.10. Appendix 10: Country Specific Requirements ........................................... 174 
10.11. Appendix 11: Eye Care Specialist’s Qualifications and 
Requirements ........................................................................................... 175 
10.12. Appendix 12: Home Healthcare and Telemedicine Approaches ................ 176 
10.13. Appendix 13: Data Management/Monitoring: ............................................ 179 
10.14. Appendix 14: List of Abbreviations, Trademarks, and Definitions of 
Terms ....................................................................................................... 180 
10.15. Appendix 15: Protocol Amendment History ............................................... 189 
11. REFERENCES ..................................................................................................... 206 
 

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LIST OF TABLES 
PAGE 
Table 1 
Treatment Arm A - Belantamab Mafodotin in Combination with 
Pomalidomide and Dexamethasone (B-Pd) ............................................ 23 
Table 2 
Treatment Arm B – Pomalidomide Plus Bortezomib and 
Dexamethasone (PVd) ........................................................................... 29 
Table 3 
Bone Marrow Aspirate and/or Biopsy and tissue sample 
Collection (Treatment Arm A and Treatment Arm B) .............................. 35 
Table 4 
Additional procedures for Participants with positive serology for 
HBV at Baseline ..................................................................................... 36 
Table 5 
Additional schedule of procedures: HCV+ Participants ........................... 37 
Table 6 
Adequate Organ System Function Based on Safety 
Assessments .......................................................................................... 67 
Table 7 
Hepatitis B criteria .................................................................................. 70 
Table 8 
Study Treatment(s) Administered ........................................................... 73 
Table 9 
Prophylactic Measures for Corneal Toxicity Associated with 
Belantamab Mafodotin ........................................................................... 77 
Table 10 
Dose Delays for B-Pd in Treatment Arm A ............................................. 85 
Table 11 
Dose Delays for PVd in Treatment Arm B .............................................. 86 
Table 12 
Belantamab Mafodotin Dose Levels for Corneal Toxicities 
Management: Treatment Arm A ............................................................. 88 
Table 13 
Dose Modifications Guidelines for Belantamab Mafodotin 
Treatment-Related Adverse Events........................................................ 89 
Table 14 
General Dose Modification and Management Guidelines for 
Drug-Related Adverse Events Not Otherwise Specified ......................... 92 
Table 15 
KVA Scale and Dose Modification Guidelines for Belantamab 
Mafodotin Treatment-Related Corneal Events Based on KVA 
Scale ...................................................................................................... 93 
Table 16 
Permitted Dose Reductions for Pomalidomide ....................................... 95 
Table 17 
Permitted Dose Reductions for Dexamethasone in Arm A ..................... 95 
Table 18 
Permitted Dose Reductions for Pomalidomide ....................................... 95 
Table 19 
Dose Modifications Guidelines for Hematologic and Other 
Toxicities associated with Pomalidomide Plus Dexamethasone ............. 96 

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Table 20 
Permitted Dose Reductions for Dexamethasone in Arm B ..................... 97 
Table 21 
Dose Modifications Guidelines for Dexamethasone-Related AEs ........... 97 
Table 22 
Permitted Dose Reductions for Bortezomib in Arm B ............................. 97 
Table 23 
Dose Modification Guidelines for Hematologic and Other 
Toxicities Associated with Bortezomib Plus Dexamethasone in 
Arm B ..................................................................................................... 98 
Table 24 
List of Clinical Laboratory Assessments ............................................... 108 
Table 25 
Dose Modification Table for HBV+ Participants .................................... 116 
Table 26 
Enhanced PK Collection Schedule ....................................................... 121 
Table 27 
Standard PK Collection Schedule ........................................................ 121 
Table 28 
PK Sampling Schedule for Pomalidomide in Arm A .............................. 123 
Table 29 
Treatment Arm A sBCMA Blood Collections, Associated with the 
Enhanced PK Collection Schedule ....................................................... 125 
Table 30 
Treatment Arm A sBCMA Blood Collections, Associated with the 
Standard PK Collection Schedule ........................................................ 127 
Table 31 
Treatment Arm B sBCMA Blood Collection (Approximately 100 
Participants) ......................................................................................... 127 
Table 32 
Statistical Analytical Methods: Efficacy ................................................. 137 
Table 33 
Statistical Analytical Methods: Safety ................................................... 141 
Table 34 
Summary of Planned Interim Analyses ................................................. 143 
Table 35 
Stopping Boundaries for Interim Analysis for Harm (based on 
139 targeted PFS events) .................................................................... 145 
Table 36 
Boundary Crossing Probabilities for Harm at the Interim Analysis 
Under a Range of Underlying True Hazard Ratios ............................... 145 
Table 37 
Stopping Boundaries for Interim Analyses for PFS Efficacy 
(based on 173 targeted PFS events) .................................................... 146 
Table 38 
Details of Planned Analyses ................................................................. 147 
 

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LIST OF FIGURES 
PAGE 
Figure 1 
Schematic of Study Structure ................................................................. 22 
Figure 2 
Mechanism of Action of Belantamab Mafodotin ...................................... 43 
Figure 3 
Summary of Dosing Schedule for Treatment Arm A (B-Pd) .................... 74 
Figure 4 
Summary of Dosing Schedule for Treatment Arm B (PVd) ..................... 75 
Figure 5 
Liver Stopping and Monitoring Event Algorithm .................................... 102 
Figure 6 
Liver Monitoring Event Algorithm with Continued Therapy for 
ALT≥3×ULN but <8×ULN ..................................................................... 103 
 

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1. 
PROTOCOL SUMMARY 
1.1. 
Synopsis 
Protocol Title:  
A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and 
Safety of Belantamab Mafodotin in Combination with Pomalidomide and 
Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone 
(PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8) 
Brief Title:  
A Phase III Study of Belantamab Mafodotin plus Pomalidomide and Dexamethasone vs. 
Pomalidomide, Bortezomib, and Dexamethasone in Participants with RRMM 
Rationale: 
Multiple myeloma (MM) is a heterogeneous disease characterized by the clonal 
proliferation of plasma cells. A variety of drugs and combination treatments have been 
evaluated and were found effective in treating MM. These include immunomodulatory 
agents and proteasome inhibitors (PIs) that form the backbone of treatment regimens 
across all treatment lines.  
The treatment paradigm of relapsed/refractory multiple myeloma (RRMM) is rapidly 
evolving with an increasing use of lenalidomide-based therapy as frontline treatment and 
pomalidomide in subsequent lines of therapy. Pomalidomide is an immunomodulatory 
drug with a similar structure to thalidomide and lenalidomide that binds to cereblon 
(CRBN). It is approved when administered with low-dose dexamethasone (pomalidomide 
in combination with dexamethasone; Pd) in the United States (US), European Union 
(EU), and a number of other countries worldwide for patients with RRMM who have 
received at least 2 prior therapies, including both lenalidomide and bortezomib and have 
demonstrated disease progression at last therapy. The Pd combination improved median 
progression-free survival (mPFS) for about 2 months over dexamethasone alone in 
patients with lenalidomide-resistant MM (4.0 vs. 1.9; hazard ratio [HR] 0.49; 95% 
confidence interval [CI]: 0.40, 0.61; p<0.001). The combination regimens of 
daratumumab or elotuzumab with Pd were also approved in the US for RRMM in 
patients who have been previously treated with at least 2 prior therapies including 
lenalidomide and a proteasome inhibitor. 
With the increasing use of lenalidomide in first-line either in combination with other anti-
myeloma drugs or as maintenance therapy after autologous stem cell transplant (ASCT), 
pomalidomide is also emerging as a second-line regimen for the treatment of RRMM. 
The combination of pomalidomide with twice-weekly bortezomib injected 
subcutaneously (SC) and low-dose dexamethasone (pomalidomide plus bortezomib and 
dexamethasone; PVd) given in 21-day cycles (i.e., every 3 weeks [q3w]) showed 
significantly improved clinical activity in a randomized Phase III trial (OPTIMISMM 
Study, N=559) in patients previously treated with lenalidomide and 1 to 3 prior lines of 
therapy. PVd reduced the risk of progression and death by 39% compared with 

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bortezomib plus dexamethasone (Vd) (HR: 0.61; 95% CI: 0.49, 0.77, p<0.0001) with a 
mPFS of 11.2 (vs. 7.1) months and an overall response rate (ORR) of 82% (vs. 50%), 
including 15.7% stringent complete response (sCR)/complete response (CR), 37% very 
good partial response (VGPR), and 29.5% partial response (PR). The safety profile was 
consistent with known toxicities associated with other immunomodulators, PIs, and 
dexamethasone combination regimens, mostly comprising myelosuppression, infections, 
and neuropathy. Based on these findings, PVd has been approved in the EU for the 
treatment of patients with at least 1 prior lines of therapy including lenalidomide. It is 
anticipated that the combination of PVd will become a standard of care (SoC) option for 
second line treatment of RRMM in other countries/regions.  
Belantamab mafodotin is a humanized immunoglobulin G1 (IgG1) antibody-drug 
conjugate (ADC) that binds specifically to B-cell maturation antigen (BCMA), a target 
restricted to B-cells at later stages of differentiation, and expressed on tumor cells of all 
patients with MM. Efficacy and safety results from the first-time-in-human (FTIH) Study 
BMA117159 (DREAMM-1) have demonstrated that belantamab mafodotin administered 
as single agent at the 3.4 mg/kg q3w has the potential to be an effective treatment option 
with a novel mechanism of action (MOA) for patients with RRMM. However, a 
significant number of patients required dose delays and dose reductions to manage 
adverse events (AEs); most common AEs include thrombocytopenia and corneal events. 
In the pivotal Phase II Study 205678 (DREAMM-2), belantamab mafodotin was further 
evaluated as monotherapy in RRMM patients at doses of 2.5 mg/kg and 3.4 mg/kg q3w 
and demonstrated meaningful clinical activity in patients with heavily pretreated RRMM. 
While both 2.5 and 3.4 mg/kg dose levels have a positive benefit:risk profile, the 2.5 
mg/kg dose had a lower incidence of adverse events, less frequent dose delays and 
reductions, and with similar efficacy as the 3.4 mg/kg dose as measured by ORR, and 
therefore belantamab mafodotin monotherapy was approved by regulatory authorities at 
2.5 mg/kg as an intravenous infusion once every 3 weeks in patients with RRMM. 
Nonclinical data with belantamab mafodotin suggest significant added benefit (efficacy 
and survival) when combined with pomalidomide and/or dexamethasone in an 
established MM xenograft model. We hypothesize that the combination of belantamab 
mafodotin with Pd may result in significant additive or synergistic effects with acceptable 
toxicity profiles, establishing new global standard of care (SoC) regimens. 
Belantamab mafodotin at multiple dose levels in combination with Pd every 4 weeks 
(q4w) is being evaluated for safety and efficacy in patients with RRMM in an ongoing 
Phase I/II study conducted by the Myeloma Canada Research Network (MCRN 007 or 
Study 209418).  
The present study is evaluating whether the combined activity of belantamab mafodotin 
at 2.5 mg/kg in Cycle 1 (C1) and 1.9 mg/kg in Cycle 2 onwards (C2+) when administered 
in combination with Pd could potentially translate into clinically meaningful benefits 
compared to PVd in RRMM participants who are progressing on or after treatment with a 
lenalidomide-containing regimen. 

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Primary and Secondary Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
To compare the efficacy of B-Pd with that of PVd in 
participants with RRMM 
• Progression-Free Survival (PFS), defined as the 
time from randomization until the earliest date of PD 
based on IRC-assessment per IMWG criteria, or 
death due to any cause. 
Key Secondary 
To further compare the efficacy of B-Pd with that of PVd 
in participants with RRMM 
• Overall Survival (OS), defined as the interval of time 
from randomization to the date of death due to any 
cause. 
• Duration of Response (DoR), defined as the time 
from first documented evidence of PR or better until 
progressive disease (PD) or death due to any 
cause. Response will be based on IRC-assessment 
per IMWG criteria. 
• MRD negativity rate, defined as the percentage of 
participants who achieve MRD negative status (as 
assessed by NGS at 10-5 threshold) at least once 
during the time of confirmed CR or better response 
based on IRC-assessment per IMWG. 

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Objectives 
Endpoints 
Secondary 
To further assess the efficacy of B-Pd in terms of other 
efficacy outcomes in participants with RRMM 
• Overall Response Rate (ORR), defined as the 
percentage of participants with a confirmed partial 
response (PR) or better (i.e., PR, VGPR, CR, and 
sCR) based on IRC-assessment per IMWG criteria. 
• Complete Response Rate (CRR), defined as the 
percentage of participants with a confirmed 
complete response (CR) or better (i.e., CR and 
stringent complete respone (sCR) based on IRC-
assessment per IMWG criteria. 
• Very Good Partial Response (VGPR) or better rate, 
defined as the percentage of participants with a 
confirmed VGPR or better (i.e., VGPR, CR, and 
sCR) based on IRC-assessment per IMWG criteria. 
• Time to Best Response (TTBR), defined as the 
interval of time between the date of randomization 
and the earliest date of achieving best response 
among participants with a confirmed PR or better 
based on IRC-assessment per IMWG. 
• Time to Response (TTR), defined as the time 
between the date of randomization and the first 
documented evidence of response (PR or better) 
among participants who achieve a response (i.e., 
confirmed PR or better) based on IRC-assessment 
per IMWG. 
• Time to Progression (TTP), defined as the time from 
randomization until the earliest date of PD based on 
IRC-assessment per IMWG criteria, or death due to 
PD. 
• PFS2, defined as time from randomization to 
disease progression (investigator-assessed 
response) after initiation of new anti-myeloma 
therapy or death from any cause, whichever is 
earlier. If disease progression after new anti-
myeloma therapy cannot be measured, a PFS 
event is defined as the date of discontinuation of 
new anti-myeloma therapy, or death from any 
cause, whichever is earlier. 
To evaluate the safety and tolerability of B-Pd 
• Incidence of AEs and changes in laboratory 
parameters  
• Ocular findings on ophthalmic exam 
To describe the exposure to belantamab mafodotin after 
infusion  
• Plasma concentrations of belantamab mafodotin, 
and cys-mcMMAF 
To evaluate the PK of pomalidomide in combination with 
belantamab mafodotin and dexamethasone, in a subset 
of participants 
• Derived PK parameter values, as data permit 
To assess ADAs against belantamab mafodotin 
• Incidence and titers of ADAs against belantamab 
mafodotin 

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Objectives 
Endpoints 
To evaluate the safety and tolerability of belantamab 
mafodotin based on self-reported symptomatic adverse 
effects when administered in combination with 
pomalidomide and dexamethasone 
• Maximum post-baseline PRO-CTCAE score for 
each item attribute 
To evaluate and compare changes in symptoms and 
HRQoL 
• Change from baseline in HRQoL as measured by 
EORTC QLQ-C30, EORTC QLQ-MY20* and 
EORTC IL52*  
Abbreviations: ADA=Anti-drug antibody; AE=adverse event; B-Pd=Belantamab mafodotin in combination with 
pomalidomide and dexamethasone; CR=complete response; CRR=complete response rate; cys-mcMMAF=Cysteine 
maleimidocaproyl monomethyl auristatin F; DoR=duration of response; EORTC IL52=European Organisation for 
Research and Treatment of Cancer Item Library 52; EORTC QLQ C30=European Organisation for Research and 
Treatment of Cancer Quality of Life Questionnaire 30 item core module; EORTC QLQ MY20=European Organisation 
for Research and Treatment of Cancer Quality of Life Questionnaire 20-item Multiple Myeloma Module; 
HRQoL=Health-related Quality of Life; MRD=Minimal Residual Disease; NGS=next generation sequencing; 
ORR=Overall Response Rate; OS=Overall Survival; PFS=Progression-free Survival; PFS2=progression-free survival 
on subsequent line of therapy; PR=partial response; PRO CTCAE=Patient Reported Outcomes version of the 
Common Terminology Criteria for Adverse Events; PK=Pharmacokinetic(s); PVd=pomalidomide plus bortezomib and 
dexamethasone; RRMM=Relapsed/refractory multiple myeloma; sCR=Stringent Complete Response; TTBR=time to 
best response; TTP=Time to Disease Progression; TTR=Time to Response; VGPR=Very Good Partial Response. 
*EORTC IL52 applies to participants enrolled under the original protocol; EORTC QLQ-MY20 applies to participants 
enrolled under protocol amendment 1. 
Overall Design: 
This study will evaluate the efficacy and safety of belantamab mafodotin in combination 
with pomalidomide and dexamethasone (B-Pd) compared with PVd in participants with 
RRMM previously treated with lenalidomide and at least 1 prior line of therapy. 
Disclosure Statement:  
This study is a parallel group study with 2 treatment arms and no masking.  
Number of Participants: 
Approximately 375 participants in Phase III will be screened to achieve approximately 
300 participants randomized in a 1:1 ratio between the 2 arms. 
If the number of participants required by local regulatory agencies is not recruited within 
the planned recruitment target, enrollment may continue in separate cohorts until the 
country enrollment requirements are met, as required by local regulatory bodies, have 
been reached. Additional participants that are enrolled in separate cohorts will not be 
included in the analysis portion of the study planned for the marketing application. 
However, these additional participants will be included in country-specific supplemental 
analyses, as detailed in the country-specific Statistical Analysis Plan (SAP). 
Intervention Groups and Duration: 
Following Screening, participants will be stratified based on the number of prior lines of 
therapy (1 vs. 2 /3 vs. ≥4), prior bortezomib treatment (yes or no) and  prior anti-CD38 
treatment (yes or no), and centrally randomized in a 1:1 ratio to Treatment Arm A or 

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Treatment Arm B. No more than 50% of participants with 2 or more prior lines of 
treatment will be enrolled. It is anticipated that no more than 15% of participants will be 
enrolled in with 4 or more prior lines of treatment. No cross-over between 2 study arms 
will be allowed.  
Experimental Arm/Treatment Arm A (B-Pd): belantamab mafodotin 2.5 mg/kg in 
C1 and 1.9 mg/kg in C2+  (IV), pomalidomide 4 mg, and dexamethasone 40 mg, q4w 
In Treatment Arm A, belantamab mafodotin will be administered intravenously (IV) at a 
single dose of 2.5 mg/kg on Day 1 (D1) of Cycle 1 and 1.9 mg/kg in Cycle 2 and beyond 
(2+)  of every 28-day cycle (q4w). Pomalidomide will be taken orally 4 mg per day on 
Days 1-21 of each 28-day cycle. Dexamethasone will be administered orally at a dose of 
40 mg per day on Days 1, 8, 15, and 22 of each 28-day cycle. For participants who are 
>75 years old or have comorbidities or are intolerant to dexamethasone 40 mg, 
dexamethasone may be administered at the lower dose of 20 mg in Arm A at the 
discretion of the investigator. 
Active Comparator Arm/Treatment Arm B (PVd): Pomalidomide 4 mg, bortezomib 
1.3 mg/m2, and dexamethasone 20 mg, q3w  
In Treatment Arm B, pomalidomide will be administered PO at 4 mg daily on Days 1 to 
14 of each 21-day cycle (i.e., q3w), with bortezomib injected SC at 1.3 mg/m2 on Days 1, 
4, 8, and 11 of each 21-day cycle for Cycles 1 through 8 and on Days 1 and 8 of each 21-
day cycle for Cycles 9 and beyond (Cycles 9+). Dexamethasone will be administered PO 
at a dose of 20 mg on the day of and day after bortezomib, q3w or on Days 1, 2, 4, 5, 8, 9, 
11, and 12 for Cycles 1 through 8, and then on Days 1, 2, 8, and 9 for Cycles 9+. For 
participants who are >75 years old or have comorbidities or are intolerant to 
dexamethasone 20 mg, dexamethasone may be administered at the lower dose of 10 mg 
on the day of and day after bortezomib in Arm B at the discretion of the investigator. 
Treatment will continue in both arms until progressive disease (PD), death, unacceptable 
toxicity, start of a new anti-myeloma therapy, withdrawal of consent, or end of the study, 
whichever occurs first. Dose delays or reductions may be required following potential 
drug-associated toxicities. Participants will be followed for PD and overall survival (OS). 
End of Study Definition 
The final analysis data cut-off (DCO) is defined as 5 years from Last Participant First 
Visit (LPFV), or when all participants have died, withdrawn consent or have been lost to 
follow-up, whichever occurs first. The final analysis DCO represents the end of data 
collection. Following the final analysis, DREAMM-8 will move into the Post Analysis 
Continued Treatment (PACT) phase where the study remains open to provide continued 
access to treatment for study participants who are continuing to derive clinical benefit. At 
that time, the collection of new data for participants who no longer receive study 
treatment will stop entirely and the clinical trial database will be closed. Participants in 
survival follow-up will be considered to have completed the study. Those participants 
still benefiting from study drug in the opinion of their treating physician may continue to 
receive study drug and only SAEs, AEs leading to treatment discontinuation, overdose 
and pregnancy cases, and pre-specified ocular data will be reported directly to GSK.  

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End of study is defined as the end of the safety follow-up following the last participant 
last dose i.e. the completion of the PACT phase. 
Data Monitoring/Other Committee: Yes, refer to Section 10.1.6 

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1.2. 
Study Schema 
Figure 1 
Schematic of Study Structure 
 
Abbreviations: PD=progressive disease; RRMM=relapsed/refractory multiple myeloma. 
* Stratification: Prior lines of treatment (1 vs. 2 / 3 vs. ≥4), prior bortezomib treatment (yes or no) and prior anti-CD38 treatment (yes or no) . No more than 50% of participants with 2 or 
more prior lines of treatment will be enrolled. It is anticipated that no more than 15% of participants will be enrolled with 4 or more prior lines of treatment. No cross-over will be allowed. 
† SC administration of bortezomib only 
‡ Reduce the dose level of dexamethasone by half if age >75 years or have comorbidities or are intolerant to 40 mg dose in Arm A or 20 mg dose in Arm B, respectively. 

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1.3. 
Schedule of Activities (SoA) 
Table 1 
Treatment Arm A - Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) 
Screening assessments do not need to be repeated on C1D1 if conducted within 72 hours of C1D1 dosing, unless otherwise specified. Study treatment should be initiated within 72 hours after 
treatment allocation. 
Precise timing of treatment cycles may vary due to treatment delays, but participants must still visit for efficacy assessments regularly, regardless of when they receive treatment. The schedule for 
efficacy assessments is q4w. These are referred to as ‘fixed visits’ or ‘weeks visits’ and should be scheduled from C1D1. 
Assessments scheduled on days of dosing should be done prior to drug administration unless otherwise specified. All assessments should be carried out even if a participant is not dosed except for 
the following: vital signs, weight, pregnancy test, PK (with the exception of C2D1), and ADA.  
The End of Treatment (EoT) Visit will occur within 30 days from the last cycle or prior to initiation of new anti-MM treatment, whichever occurs first. AEs and SAEs will be collected up to at least 70 days 
after the last dose, either via phone or a follow-up visit.  
The progression-free survival (PFS) Follow-up Visit, (for participants who discontinue study treatment for a reason other than PD) should be conducted q4w (±3 days) until confirmed PD, death, 
unacceptable toxicity, start of a new anti-myeloma therapy, withdrawal of consent, or end of the study, whichever occurs first. 
The overall survival (OS) Follow-up Visit will be performed in all participants who come off treatment completely. Participants will be followed for survival and subsequent anti-myeloma therapy by chart 
review, phone, or any form of communication every 12 weeks (±14 days) until the final analysis. Record the participant’s survival status and whether subsequent treatment for disease was given. 
Participant does not need to attend the site. An exception is participants who have ocular symptoms at EoT who will be followed up for ocular examinations and OSDI questionnaire.  
PACT Phase: Participants who continue to receive study treatment during the PACT phase will be monitored and receive follow-up care in accordance with standard local clinical practice. Assessments 
will revert to the standard of care at a participant’s particular study site and only SAEs, AEs leading to discontinuation of study treatment, overdoses, prespecified ocular data (Arm A only), and 
pregnancies will be reported directly to the Sponsor via paper forms (see Section 4.4, Section 6.7 and Section 8.3.1). For participant discontinuing treatment in the PACT phase, no end of treatment 
visit is required. 
 
Procedure 
 
Screening 
On Treatment 
Follow-up 
 
Cycle / Visit 
C1 
 
C2 Onward 
Fixed Visits 
q4w (Starting 
at Week 5) 
EoT 
Visit 
PFS 
Follow-up 
Visit 
OS 
Follow-up 
Visit26 
C2 
Onward 
C2 
Only 
C3 Onward 
Day 
 
D1 
D8, 15, 22 
D1 
D8, 15, 22 
D15 
Window 
-28 
days 
±3 days (except D8, 15, and 22) 
±14 days 
Informed Consent1 
X 
 
 
 
 
 
 
 
 
 
Baseline Demographics 
X 
 
 
 
 
 
 
 
 
 
Medical/Disease History and Characteristics 
X 
 
 
 
 
 
 
 
 
 
Body Weight 
X 
X 
 
X 
 
 
 
X 
 
 
Height 
X 
 
 
 
 
 
 
 
 
 

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Procedure 
 
Screening 
On Treatment 
Follow-up 
 
Cycle / Visit 
C1 
 
C2 Onward 
Fixed Visits 
q4w (Starting 
at Week 5) 
EoT 
Visit 
PFS 
Follow-up 
Visit 
OS 
Follow-up 
Visit26 
C2 
Onward 
C2 
Only 
C3 Onward 
Day 
 
D1 
D8, 15, 22 
D1 
D8, 15, 22 
D15 
Window 
-28 
days 
±3 days (except D8, 15, and 22) 
±14 days 
Safety 
ECOG Performance Status 
X 
X 
 
X 
 
 
 
X 
X 
 
AEs/SAEs 
 
AEs/SAEs will be collected from the start of study treatment until at least 70 days following EoT, regardless of initiation of new anti-
myeloma therapy. SAEs related to study participation or any GSK product are collected from time of consent up to and including 
any follow-up. 
Concomitant Medications 
Concomitant medications will be collected, as reported by the participant or through participant 
medical record review. 
 
 
Physical Examination2 
X 
X 
 
X 
 
 
 
X 
X 
 
Ocular Examination3 
X 
X3 
 
X 
 
 
 
X 
X3 
X3 
Vital Signs (BP, Heart Rate, Body Temperature)4,5 
X 
X 
 
X 
 
 
 
X 
 
 
12-Lead ECG6 
X 
As clinically indicated 
 
Laboratory Assessments7 
Hematology5,8 
X 
X  
X 
X  
X 
X 
 
X 
X 
 
Clinical Chemistry8 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
HbA1c 
As clinically indicated 
eGFR9 
X 
X 
 
X 
 
 
 
X 
 
 
Urinalysis (Dipstick) OR Spot Urine 
(Albumin/Creatine Ratio)10 
X 
X 
 
X 
 
 
 
X 
 
 
HbsAg, HbcAb, Hep C Ab, Hep C RNA11 
X 
 
 
 
 
 
 
 
 
 
Pregnancy Test for WOCBP12 
X 
X 
 
X 
 
 
 
X 
X 
X 
Disease Evaluations: Baseline disease assessments completed within 28 days (30 days for imaging) of C1D1 do not need to be repeated on C1D1. For participants who are discontinuing 
IP due to PD, confirmation based on laboratory parameters must be performed from a different blood or urine collection preferably within 14 days of the original date of the disease 
progression, preferably before institution of any new anti-myeloma therapy. This may be performed at the EoT Visit. 
β2 Microglobulin 
X 
 
 
 
 
 
 
 
 
 
SPEP (Serum Protein Electrophoresis) 
X 
X 
 
 
 
 
X 
X 
X 
 
UPEP (Urine Protein Electrophoresis on 24-hour 
Collected Urine)  
X 
X 
 
 
 
 
X 
X 
X 
 
Serum Kappa Lambda Free LC, FLC Ratio 
X 
X 
 
 
 
 
X 
X 
X 
 
Serum Immunofixation 
X 
Serum immunofixation must be performed each time that M-protein is not quantifiable by SPEP (0 g/dL) 
Urine immunofixation must be performed each time that M-protein is not quantifiable by UPEP (0 mg/24 h) AND 
SPEP (0 g/dL). 
 
Urine Immunofixation 
X 
 
Ca2+ Corrected for Albumin (Serum) 
X 
X 
 
 
 
 
X 
X 
X 
 
lgG, lgM, lgA 
X 
X 
 
 
 
 
X 
X 
X 
 

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Procedure 
 
Screening 
On Treatment 
Follow-up 
 
Cycle / Visit 
C1 
 
C2 Onward 
Fixed Visits 
q4w (Starting 
at Week 5) 
EoT 
Visit 
PFS 
Follow-up 
Visit 
OS 
Follow-up 
Visit26 
C2 
Onward 
C2 
Only 
C3 Onward 
Day 
 
D1 
D8, 15, 22 
D1 
D8, 15, 22 
D15 
Window 
-28 
days 
±3 days (except D8, 15, and 22) 
±14 days 
lgD/lgE13 
X 
X 
 
 
 
 
X 
X 
X 
 
Imaging for Extramedullary Disease14 
X 
X 
 
 
 
 
q12w for 1 year then as clinically indicated 
 
Skeletal Survey15 
X 
X 
As clinically indicated 
 
Response Assessment by IMWG16 
 
 
 
 
 
 
X 
X 
X 
 
PET/CT upon Achieving MRD Negativity by NGS 
 
To be performed once and within 42 days of receiving MRD negative result (by NGS). In participants who achieved CR or better 
response by the time MRD negative result received. 
Bone Marrow Assessments 
BM Biopsy or Aspirate for BCMA Expression and 
Biomarker Research 
 
 
 
Please refer to Table 3 for detailed schedule for BM collection procedures at all timepoints, including Screening 
BM Aspirate for FISH Testing 
BM Biopsy and/or Aspirate for Disease Assessment 
BM Aspirate for MRD Testing 
BM Biopsy to Confirm sCR by IHC 
Optional BM Sample at PD 
Treatments Administered 
Supportive Medications 
 
Belantamab mafodotin: Premedication should be considered in any participant who 
experienced an IRR at the first or any subsequent infusion.  
Pomalidomide: Thromboprophylaxis recommended for the duration of treatment with 
pomalidomide based on an assessment of the participant’s underlying risk factors and 
local prescribing information 
 
 
 
Belantamab Mafodotin17 
 
Day 1 of every 28-day cycle  
 
 
 
Pomalidomide18 
 
Days 1 – 21 of every 28-day cycle 
 
 
 
Dexamethasone19 
 
Days 1, 8, 15, and 22 of every 28-day cycle 
 
 
 
Pregnancy Prevention Counselling 
X 
X 
 
X 
 
 
 
X27 
X27 
X27 
Ocular Supportive Care for Belantamab Mafodotin 
Preservative-free Artificial Tears 
 
Administered in each eye at least 4-8 times daily beginning on C1D1 until EoT. In the event of ocular 
symptoms (i.e., dry eyes), the use of artificial tears may be increased up to every 2 hours, as needed. 
 
 
Cooling Eye Masks 
 
Apply cooling eye masks as long as tolerated, up to 4 hours 
 
 
Health Outcomes20 
PRO-CTCAE 
 
X 
 
 
 
 
X 
X 
 
 
EORTC QLQ-C30 
 
X 
 
 
 
 
X 
X 
X21 
X22 
EORTC IL5224 
 
X 
 
 
 
 
X 
X 
X21 
X22 

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Procedure 
 
Screening 
On Treatment 
Follow-up 
 
Cycle / Visit 
C1 
 
C2 Onward 
Fixed Visits 
q4w (Starting 
at Week 5) 
EoT 
Visit 
PFS 
Follow-up 
Visit 
OS 
Follow-up 
Visit26 
C2 
Onward 
C2 
Only 
C3 Onward 
Day 
 
D1 
D8, 15, 22 
D1 
D8, 15, 22 
D15 
Window 
-28 
days 
±3 days (except D8, 15, and 22) 
±14 days 
EORTC QLQ-MY2025 
 
X 
 
 
 
 
X 
X 
X21 
X22 
EQ-5D-3L 
 
X 
 
 
 
 
X (q8w) 
X 
X21 
X22 
PGIS 
 
X 
 
 
 
 
X 
X 
X21 
 
PGIC 
 
 
 
 
 
 
X 
X 
X21 
 
FACT-GP5 
 
X 
 
 
 
 
X 
X 
 
 
OSDI23 
 
X 
 
 
 
 
X23 
X 
X23 
X23 
HCRU 
 
X 
 
 
 
 
X 
 
 
 
PK and ADA 
PK 
 
On-treatment standard and enhanced PK sampling schedule can be 
found in Section 8.5.1 and Section 8.5.3 
 
X  
 
 
ADA 
 
On-treatment ADA sampling schedule can be found in Section 8.6 
 
X 
 
 
Biomarkers 
Soluble BCMA 
X 
On-treatment standard and enhanced sBCMA sampling schedules can be found in Section 8.9.1 
 
 
Genetics 
Optional Genetic Sample 
 
X 
To be taken at C1D1 from participants who consent to genetic research after randomization. May be 
taken at another visit if not taken at C1D1. 
 
Other Follow-Up 
Safety Follow-up Phone Call 
 
 
 
 
 
 
 
 
 
X 
Subsequent Anti-MM Treatment 
 
 
 
 
 
 
 
 
X 
X 
Abbreviations: ADA=anti-drug antibody; AE=adverse event; BCMA=B-cell maturation antigen; BM=bone marrow; BP=blood pressure; C=Cycle; CBC=complete blood count; CR=complete response; 
CT=computed tomography; D=Day; ECG=electrocardiogram; ECOG=Eastern Cooperative Oncology Group; eGFR=estimated glomerular filtration rate; EOI=end of infusion; EORTC IL52=European 
Organization for Research and Treatment of Cancer Item Library 52; EORTC QLQ-C30=European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item core module; 
EORTC QLQ-MY20=European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 20-item Multiple Myloma Module; EoT=End of Treatment; EQ-5D-3L=European Quality of 
Life 5 Dimensions 3 Level Scale; FACT-GP5=Functional Assessment of Cancer Therapy – General Population; FISH=fluorescence-in-situ hybridization; FLC=free light chain; HbA1c=hemoglobin A1c; 
HbcAb=Hepatitis B core antibody; HbsAg=Hepatitis B surface antigen; Hep C Ab=Hepatitis C antibody; Hep C RNA=Hepatitis C ribonucleic acid; HCRU=Healthcare Resource Utilization; ICF=Informed 
Consent Form; Ig=immunoglobulin.; IHC=immunohistochemistry; IMWG=International Myeloma Working Group; IP=Investigational Product; IRR=infusion-related reaction; LC=light chain; MDRD=Modified 
Diet in Renal Disease; MM=Multiple myeloma; MRD=Minimal Residual Disease; MRI=magnetic resonance imaging; NGS=Next-Generation Sequencing; OS=Overall Survival; OSDI=Ocular Surface 
Disease Index; PD=progressive disease; PET/CT=positron emission tomography/computed tomography; PFS=progression-free survival; PGIC=Patient Global Impression of Change, PGIS=Patient Global 
Impression of Severity, PK=Pharmacokinetic(s); PRO=patient-reported outcome; PRO-CTCAE=Patient-Reported Outcomes version of the Common Term Criteria for Adverse Events; q12w=every 12 
weeks; q4w=every 4 weeks; q8w=every 8 weeks; SAE=serious adverse event; sBCMA=soluble B-cell maturation antigen; sCR=stringent complete response; SOI=Start of Infusion; SPEP=Serum Protein 
Electrophoresis; SRM=Study Reference Manual; UPEP=Urine Protein Electrophoresis; VGPR=Very Good Partial Response; WOCBP=Woman of Childbearing Potential. 
1. 
ICF must be signed before any study-specific assessments are performed; the day the informed consent form is signed will be counted as Day 1 and the screening window of 28 days will initiate on 
this Day 1 as well. Assessments performed as standard of care prior to signing consent need not be repeated if done within the appropriate screening window. A separate informed consent required 

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for optional samples. For optional samples, a blood sample will be taken at C1D1. The blood sample may be collected at another visit if not taken at C1D1. A redraw can be requested if the sample is 
not availableor of insufficient quality to perform the analysis. 
2. 
Physical examination assessments are listed in Section 8.2.1. Physical examination must be within 72 hours prior to first dose of study drugs to be administered in that cycle. 
3. 
C1D1 ocular examination does not need to be repeated if within 28 days of Screening examination. On treatment ocular examinations to be performed q4w, prior to dosing, up to the 6th dose of 
belantamab mafodotin. Ocular examination shall be performed up to 5 days prior to dosing. After the 6th dose of belantamab mafodotin, if there have been no significant ocular exam findings, 
symptoms or vision changes up to and including the 6th dose, the frequency of ocular examinations may be decreased to every 3 months until EoT. In case of persistent or newly developed ocular 
symptoms or vision changes, participants will have further ocular examinations, at least every cycle, until resolution (to Grade 1 or baseline) or more frequently as clinically indicated by the eye care 
specialist. See Section 8.2.6 and for full details of ophthalmic examination procedures. Participants in PFS follow-up will only have ocular examinations if they had signs or symptoms at EoT or as 
clinically indicated. 
4. 
At the first dose of belantamab mafodotin, vital signs must be assessed within 30 minutes prior to SOI, 15 minutes after SOI, (±10 minutes), within 15 minutes after EOI, and at 1 hour (±10 minutes) 
after EOI. On subsequent doses of belantamab mafodotin, vital signs must be assessed within 30 minutes prior to SOI and within 15 minutes after EOI. Vital signs should be measured after resting 
for at least 5 minutes. On days when vital sign time points align with blood sampling time points, it is recommended that vital signs be assessed prior to blood samples being drawn. On days when 
vital signs are measured multiple times, temperature does not need to be repeated unless clinically indicated.  
5. 
Hematology and vital signs must be repeated prior to each dose of belantamab mafodotin treatment.  
6. 
Single ECG at Screening..  
7. 
All laboratory assessments with values considered clinically significantly abnormal during participation in the study and up to at least 70 days after the last dose of study treatment should be repeated 
until the values return to normal or baseline. Refer to Table 24 for a comprehensive list of laboratory assessments. If laboratory assessments are completed within 72 hours prior to the first dose, 
these assessments need not be repeated on C1D1. 
8. 
Hematology (CBC) and clinical chemistry should be performed weekly for the first 2 cycles (i.e., D1, 8, 15, and 22 for 8 weeks) and as clinically indicated; thereafter, CBC and clinical chemistry 
laboratory assessments should be performed on D1 and 15 of every 28-day cycle for C3+ and prior to every belantamab mafodotin administration. Testing may be performed up to 72 hours prior to 
administration of study treatment. Results must be evaluated prior to treatment administration. 
9. 
eGFR as calculated by Modified Diet in Renal Disease (MDRD) formula (Section 10.7). 
10. Urine dipstick may be used to assess for presence of urine protein. Albumin/creatinine ratio needs to be done in any participant with urine dipstick result of ≥1+ at Screening or ≥2+ On Treatment, or 
with positive protein if urine dipstick protein quantification is not available. Albumin/creatinine will be performed at a local laboratory. If local testing is not available, then central testing will be 
performed (first void). 
11.  Hepatitis B virus DNA testing will be done to determine a participant’s eligibility if HBcAb and/or HBsAg is positive. Hepatitis C virus RNA testing will be done to determine participant eligibility if 
Hepatitis C Ab-positive. This will be performed at a local laboratory or, if not available, then at a central laboratory. For additional procedures during Screening and upon enrolment for participants 
who have a history of Hepatitis B and/or Hepatitis C, please refer to Table 4 and Table 5, respectively. 
12. Perform only in women of childbearing potential (WOCBP), see Appendix 3 for definition. A serum pregnancy test must be performed at Screening. Two negative serum pregnancy tests must be 
obtained prior to initiating treatment; the first test should be performed within 10-14 days of C1D1, but the second must be performed within 24 hours of C1D1. After the first dose, pregnancy test will 
be done weekly during the first month, then every cycle thereafter (or every 2 weeks in females with irregular menses). Subsequent pregnancy test on dosing days may be either serum or urine test. 
Each pregnancy test must be performed within 24 hours prior to dosing. Final pregnancy test (serum or urine) must be performed in WOCBP at the EoT Visit and at 2 weeks (in females with irregular 
menses) and 4 weeks following treatment discontinuation, and repeated at least 70 days after last dose. Follow-up pregnancy assessment by phone (for WOCBP only) should be performed 4 months 
after the last dose of belantamab mafodotin. 
13. Only in participants with IgD/IgE myeloma.  
14. Imaging is only required for participants with extramedullary disease by either CT, MRI, or PET/CT. Screening assessment may be performed up to 30 days prior to C1D1. Subsequently imaging 
should be performed every 12 weeks within the first 12 months (at Weeks 13, 25, 37, and 49, 7 days); thereafter only if clinically indicated, per local guidance. The same modality should be used 
throughout the study as was done at Baseline. Selected target lesion should be measured and followed over time. Plasmacytoma measurements should be taken from the CT portion of the PET/CT, 
MRI scans, or dedicated CT scans, where applicable. For participants with only skin involvement, skin lesions should be measured with a ruler. Measurement of tumor size will be determined by the 
sum of the products of the maximal perpendicular diameters of measured lesions. Digital copies of all scans must be maintained at investigator site as source document. Participants undergoing 
PET/CT should have all blood samples taken before the PET/CT is performed.  

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For participants with PD due to extramedullary disease, confirmation scans are not required. The laboratory assessments do not need to be repeated if the extramedullary disease is the only site of 
progression. If the last radiographic assessment occurred ≥8 weeks prior to the participant’s withdrawal from study treatment, and PD has NOT been documented, a new assessment for 
extramedullary disease should be obtained at EoT. If participant continues in PFS follow-up, perform scans for extramedullary disease as clinically indicated. Optional tissue sample from 
extramedullary tumor may be collected at PD (Table 3). 
15. Imaging of bones for lytic lesions by method aligned with institutional guidance (e.g., X-ray, CT, or MRI). Survey results within 30 days prior to C1D1 date are acceptable. At later cycles, repeat as 
clinically indicated, or if worsening clinical symptoms suggest PD, by the same method used as at Screening. Sites shall maintain an archive of all study-related images/scans as source 
documentation. 
16. Response to treatment will be assessed q4w (±3 days) regardless of dosing, based on laboratory assessments and imaging (if applicable), using IMWG criteria [Kumar, 2016]. 
17. Belantamab mafodotin 2.5 mg/kg will be administered on Day 1 of Cycle 1 and 1.9 mg/kg in Day 1 of C2 onwards every 28-day cycle as an IV infusion over at least 30 minutes (see Pharmacy Manual 
for details). A window of ±3 days is acceptable for administration of study treatment after C1D1. Refer to Section 6.6.1 and Section 6.7.1 for instructions on dose delays and dose modification 
guidelines.  
18. Pomalidomide 4 mg PO daily on Days 1-21 of each 28-day cycle to be taken after the 1hr rest period after belantamab mafodotin. Platelet count must be ≥50,000 per L to initiate new cycle. Refer to 
Section 6.6.1 and Section 6.7.1 for instructions on dose delays and dose modification guidelines.  
19. Dexamethasone 40 mg PO on Days 1, 8, 15, and 22 of every 28-day cycle. For participants who are >75 years, have comorbidities, or are intolerant to 40 mg, the dose of dexamethasone can be 
reduced to 20 mg in Arm A. Refer to Section 6.6.1 and Section 6.7.1 for instructions on dose delays and dose modification guidelines. On days where only pomalidomide and dexamethasone are 
taken at home, they should be taken in the morning approximately at the same time each day. On belantamab mafodotin dosing days, dexamethasone should be administered 1 to 3 hours prior to 
the first administration of belantamab mafodotin. Participant diaries will be used to keep a record of self-administered oral study treatment(s) at home. 
20. PRO-CTCAE, EORTC QLQ-C30, EORTC QLQ-MY20, EORTC IL52, FACT-GP5, PGIS, and PGIC, should be collected q4w regardless of treatment and at EoT. EQ-5D3L should be collected q8w 
regardless of treatment and at EoT. All PROs should be administered prior to any assessments being performed and prior to results being provided to the participant. PRO collection will start at C1D1 
with the exception of the PGIC which will start at Week 5. 
21. EORTC QLQ-C30, EORTC QLQ-MY20, EORTC IL52, EQ-5D-3L, PGIS, and PGIC will be administered q8w after EoT whilst in PFS follow-up.  
22. EORTC QLQ-C30, EORTC QLQ-MY20, EORTC IL52, and EQ-5D-3L should be administered at 12, 24, and 48 weeks in the OS follow-up. For participants in OS follow-up not attending the site, they 
can be administered via a phone call in an interview format. 
23. OSDI should be collected prior to any treatment administration on C1D1, then q4w up to Week 21 and thereafter q8w post Week 21 until EoT. Participants in Arm A with no ocular signs at the EoT 
ocular assessment will have no further OSDI collection. Participants in Arm A with ocular signs at the EoT ocular assessment will have OSDI collected q12w until resolution to Grade 1 or baseline or 
more frequently as clinically indicated by the eye care specialist. For participants in OS follow-up not attending the site, they can be administered via a phone call in an interview format. 
24. Only applicable for participants enrolled under the original protocol. 
25. Only applicable for participants enrolled under protocol amendment 1. 
26. GSK may request that updated survival data be collected on all treated/randomized participants outside the protocol window noted in the SoA. At the time of the request, the site will determine 
survival status for each participant by the method agreed with the participant, unless the participant has withdrawn consent for survival follow up. Where permitted, data from publically available death 
registers will be used for participants withdrawn from study or lost to follow-up prior to death.  
27. Final Pregnancy Prevention Counselling must be performed in WOCBP at the EoT visit and/or at least 4 weeks following discontinuation of pomalidomide treatment, whichever comes last. 

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Table 2 
Treatment Arm B – Pomalidomide Plus Bortezomib and Dexamethasone (PVd) 
Screening assessments do not need to be repeated on C1D1 if conducted within 72 hours of C1D1 dosing, unless otherwise specified. Study treatment should be initiated within 72 hours after 
treatment allocation. 
Precise timing of treatment cycles may vary due to treatment delays, but participants must still visit for efficacy assessments regularly, regardless of when they receive treatment. The schedule for 
efficacy assessments is q4w. These are referred to as ‘fixed visits’ or ‘weeks visits’ and should be scheduled from C1D1. 
Assessments scheduled on days of dosing should be done prior to drug administration unless otherwise specified. All assessments should be carried out even if a participant is not dosed except for 
the following: vital signs, weight, and pregnancy test.  
The end of treatment (EoT) Visit will occur within 30 days from the last cycle or prior to initiation of new anti-MM treatment, whichever occurs first. AEs and SAEs will be collected up to at least 70 days 
after the last dose, either via phone or a follow-up visit.  
The progression-free survival (PFS) Follow-up Visit (for participants who discontinue study treatment for a reason other than PD) should be conducted q4w (±3 days) until confirmed PD, death, 
unacceptable toxicity, start of a new anti-myeloma therapy, withdrawal of consent, or end of the study, whichever occurs first. 
The overall survival (OS) Follow-up Visit will be performed in all participants who come off treatment completely. Participants will be followed for survival and subsequent anti-myeloma therapy by chart 
review, phone, or any form of communication every 12 weeks (±14 days) until the final analysis. Record the participant’s survival status and whether subsequent treatment for disease was given. 
Participant does not need to attend the site.  
PACT Phase: Participants who continue to receive study treatment during the PACT phase will be monitored and receive follow-up care in accordance with standard local clinical practice. Assessments 
will revert to the standard of care at a participant’s particular study site and only SAEs, AEs leading to discontinuation of study treatment, overdoses, prespecified ocular data (Arm A only), and 
pregnancies will be reported directly to the Sponsor via paper forms (see Section 4.4, Section 6.7 and Section 8.3.1). For participant discontinuing treatment in the PACT phase, no end of treatment 
visit is required. 
 
Procedure 
Screening 
On Treatment 
Follow-up 
Cycle / Visit 
C1-8 
C9 Onward 
Fixed Visits 
q4w Starting 
Week 5 
EoT Visit 
PFS Follow-Up 
Visit 
OS 
Follow-Up 
Visit26 
Day 
D1 
D4, 8, 11 
D1 
D8 
Window 
-28 days 
±3 days (except D4, 8, and 11) 
±14 days 
Informed Consent1 
X 
 
 
 
 
 
 
 
 
Baseline Demographics 
X 
 
 
 
 
 
 
 
 
Medical/Disease History and Characteristics 
X 
 
 
 
 
 
 
 
 
Body Weight 
X 
X 
 
X 
 
 
X 
 
 
Height 
X 
 
 
 
 
 
 
 
 
Safety 
ECOG Performance Status 
X 
X 
 
X 
 
 
X 
X 
 
AEs/SAEs 
 
AE/SAEs will be collected from the start of study treatment until at least 70 days following EoT, regardless of initiation of new anti-
myeloma therapy. SAEs related to study participation or any GSK product are collected from time of consent up to and including 
any follow-up. 
Concomitant Medications 
Concomitant medications will be collected, as reported by the participant or through participant medical record review. 
 

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Procedure 
Screening 
On Treatment 
Follow-up 
Cycle / Visit 
C1-8 
C9 Onward 
Fixed Visits 
q4w Starting 
Week 5 
EoT Visit 
PFS Follow-Up 
Visit 
OS 
Follow-Up 
Visit26 
Day 
D1 
D4, 8, 11 
D1 
D8 
Window 
-28 days 
±3 days (except D4, 8, and 11) 
±14 days 
Physical Examination2 
X 
X 
 
X 
 
 
X 
X 
 
Ocular Examination3 
X 
X3 
 
X 
 
 
X 
 
 
Vital Signs (BP, Heart Rate, Body Temperature)4,5 
X 
X 
 
X 
 
 
X 
 
 
12-Lead ECG6 
X 
As clinically indicated 
 
Laboratory Assessments7 
Hematology5,8 
X 
X 
X 
X 
X 
 
X 
X 
 
Clinical Chemistry8 
X 
X 
X 
X 
X 
 
X 
X 
 
HbA1c 
As clinically indicated 
 
eGFR9 
X 
X 
 
X 
 
 
X 
 
 
Urinalysis (Dipstick) OR Spot Urine 
(Albumin/Creatinine Ratio)10 
X 
X 
 
X 
 
 
X 
 
 
HbsAg, HbcAb, Hep C Ab, Hep C RNA11 
X 
 
 
 
 
 
 
 
 
Pregnancy Test for WOCBP12 
X 
X 
 
X 
 
 
X 
X 
X 
Disease Evaluations: Baseline disease assessments completed within 28 days (30 days for imaging) of C1D1 do not need to be repeated on C1D1. The efficacy assessments need to be 
completed q4w starting Week 5. For participants who are discontinuing IP due to PD, confirmation based on laboratory parameters must be performed from a different blood or urine 
collection preferably within 14 days of the original date of the PD, preferably before institution of any new anti-MM therapy. This may be performed at the EoT Visit. 
β2 Microglobulin 
X 
 
 
 
 
 
 
 
 
SPEP (Serum Protein Electrophoresis) 
X 
X 
(C1D1) 
 
 
 
X 
X 
X 
 
UPEP (Urine Protein Electrophoresis on 24-hour 
Collected Urine)  
X 
X 
(C1D1) 
 
 
 
X 
X 
X 
 
Serum Kappa Lambda Free LC, FLC Ratio 
X 
X 
(C1D1) 
 
 
 
X 
X 
X 
 
Serum Immunofixation 
X 
Serum immunofixation must be performed each time that M-protein is not quantifiable by SPEP (0 g/dL) 
Urine immunofixation must be performed each time that M-protein is not quantifiable by UPEP (0 mg/24 h) AND 
SPEP (0 g/dL). 
 
Urine Immunofixation 
X 
Ca2+ Corrected for Albumin (Serum) 
X 
X 
(C1D1) 
 
 
 
X 
X 
X 
 
lgG, lgM, lgA 
X 
X 
(C1D1) 
 
 
 
X 
X 
X 
 
lgD/lgE13 
X 
X 
(C1D1) 
 
 
 
X 
X 
X 
 
Imaging for Extramedullary Disease14 
X 
X 
(C1D1) 
 
 
 
q12w for 1 year then as clinically indicated 
 

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Procedure 
Screening 
On Treatment 
Follow-up 
Cycle / Visit 
C1-8 
C9 Onward 
Fixed Visits 
q4w Starting 
Week 5 
EoT Visit 
PFS Follow-Up 
Visit 
OS 
Follow-Up 
Visit26 
Day 
D1 
D4, 8, 11 
D1 
D8 
Window 
-28 days 
±3 days (except D4, 8, and 11) 
±14 days 
Skeletal Survey15 
X 
X 
(C1D1) 
 
As clinically indicated 
 
Response Assessment by IMWG16 
 
 
 
 
 
X 
X 
X 
 
PET/CT upon Achieving MRD Negativity by NGS 
 
To be performed once and within 42 days of receiving MRD negative result (by NGS). In participants who achieved CR or better 
response by the time MRD negative result received. 
Bone Marrow Assessments 
Please refer to Table 3 for detailed schedule for BM collection procedures at all timepoints, including Screening 
BM Biopsy or Aspirate for BCMA Expression and 
Biomarker Research 
BM Aspirate for FISH Testing 
BM Biopsy and/or Aspirate for Disease 
Assessment 
BM Aspirate for MRD Testing 
BM Biopsy to Confirm sCR by IHC 
Optional BM Sample at PD  
Treatments Administered 
Supportive Medications 
 
Bortezomib: Antiviral prophylaxis recommended for the duration of treatment with bortezomib 
in accordance with local prescribing information. 
Pomalidomide: Thromboprophylaxis recommended for the duration of treatment with 
pomalidomide based on an assessment of the participant’s underlying risk factors and local 
prescribing information. 
 
 
Pomalidomide17 
 
Days 1 –14 of each 21-day cycle 
 
 
Bortezomib18 
 
Cycles 1-8: Days 1, 4, 8, and 11 of each 21-day cycle, 
Cycle 9+: Day 1 and 8 of each 21-day cycle 
 
 
Dexamethasone19 
 
Cycles 1-8: Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle 
Cycle 9+: Days 1,2 ,8, and 9 of each 21-day cycle 
 
 
Pregnancy Prevention Counselling 
X 
X 
 
X 
 
 
X27 
X27 
X27 
Health Outcomes20 
PRO-CTCAE 
 
X 
 
 
 
X 
X 
 
 
EORTC QLQ-C30 
 
X 
 
 
 
X 
X 
X21 
X22 
EORTC IL5224 
 
X 
 
 
 
X 
X 
X21 
X22 
EORTC QLQ-MY2025 
 
X 
 
 
 
X 
X 
X21 
X22 
EQ-5D-3L 
 
X 
 
 
 
X (q8w) 
X 
X21 
X22 
PGIS 
 
X 
 
 
 
X 
X 
X21 
 
PGIC 
 
 
 
 
 
X 
X 
X21 
 

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Procedure 
Screening 
On Treatment 
Follow-up 
Cycle / Visit 
C1-8 
C9 Onward 
Fixed Visits 
q4w Starting 
Week 5 
EoT Visit 
PFS Follow-Up 
Visit 
OS 
Follow-Up 
Visit26 
Day 
D1 
D4, 8, 11 
D1 
D8 
Window 
-28 days 
±3 days (except D4, 8, and 11) 
±14 days 
FACT-GP5 
 
X 
 
 
 
X 
X 
 
 
OSDI23 
 
X 
 
 
 
X 
X23 
 
 
HCRU 
 
X 
 
 
 
X 
 
 
 
Biomarkers 
Soluble BCMA 
X 
sBCMA sampling schedule can be found in Section 8.9.1 
 
 
Optional Genetics  
 
Optional Genetic Sample 
 
X 
To be taken at C1D1 from participants who consent to genetic research after randomization. May be 
taken at another visit if not taken at C1D1. 
 
Other Follow-Up 
Safety Follow-up Phone Call 
 
 
 
 
 
 
 
 
X 
Subsequent Anti-MM Treatment 
 
 
 
 
 
 
 
X 
X 
Abbreviations: AE=adverse event; BCMA=B-cell maturation antigen; BM=bone marrow; BP=blood pressure; C=Cycle; CR=complete response; CT=computed tomography; D=Day; 
ECG=electrocardiogram; ECOG=Eastern Cooperative Oncology Group; eGFR=estimated glomerular filtration rate; EORTC IL52=European Organization for Research and Treatment of Cancer Item 
Library 52; EORTC QLQ-C30=European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item core module; EORTC-QLQ-MY20 = European Organisation for 
Research and Treatment of Cancer Quality of Life Questionnaire 20-item Multiple Myeloma Module; EoT=End of Treatment; EQ-5D-3L=European Quality of Life 5 Dimensions 3 Level Scale; 
FACT-GP5=Functional Assessment of Cancer Therapy – General Population; FISH=fluorescence-in-situ hybridization; FLC=free light chain; HbA1c=hemoglobin A1c; HbcAb=hepatitis B core antibody; 
HbsAg=hepatitis B surface antigen; Hep C Ab=Hepatitis C antibody; Hep C RNA=Hepatitis C ribonucleic acid; HCRU=Healthcare Resource Utilization; ICF=Informed Consent Form; Ig=immunoglobulin.; 
IHC=immunohistochemistry; IMWG=International Myeloma Working Group; IP=Investigational Product; LC=light chain; MDRD=Modified Diet in Renal Disease; MM=multiple myeloma; MRD=Minimal 
Residual Disease; MRI=Magnetic Resonance Imaging; NGS=next-generation sequencing; OS=Overall Survival; OSDI=Ocular Surface Disease Index; PD=progressive disease; PET/CT=positron emission 
tomography/computed tomography; PFS=progression-free survival; PGIC=Patient Global Impression of Change, PGIS=Patient Global Impression of Severity; PRO=patient-reported outcome; PRO-
CTCAE=Patient-Reported Outcomes version of the Common Term Criteria for Adverse Events; PVd=pomalidomide plus bortezomib and dexamethasone; q12w=every 12 weeks; q4w=every 4 weeks; 
q8w=every 8 weeks; QTcF=QT interval corrected using Fridericia’s formula; SAE=serious adverse event; sBCMA=soluble B-cell maturation antigen; sCR=stringent complete response; SPEP=serum 
protein electrophoresis; UPEP=Urine Protein Electrophoresis; VGPR=Very Good Partial Response; WOCBP=Woman of Childbearing Potential. 
1. 
ICF must be signed before any study-specific assessments are performed; the day the informed consent form is signed will be counted as Day 1 and the screening window of 28 days will initiate on 
this Day 1 as well. Assessments performed as standard of care prior to signing consent need not be repeated if done within the appropriate screening window. A separate informed consent required 
for optional samples. For optional samples, a blood sample will be taken at C1D1. The blood sample may be collected at another visit if not taken at C1D1. A redraw can be requested if the sample is 
not available of insufficient quality to perform the analysis.  
2. 
Physical examination assessments are listed in Section 8.2.1. Physical examination must be within 72 hours prior to first dose of study drugs to be administered in that cycle. 
3. 
C1D1 ocular examination does not need to be repeated if within 28 days of the Screening examination. On treatment ocular examinations to be performed every 6 months (± 4 weeks window) or as 
clinically indicated and at the EoT. See Section 8.2.6 for full details of ophthalmic examination procedures 
4. 
Vital signs must be assessed within 30 minutes before and within 15 minutes after each dose of bortezomib. Vital signs should be measured after resting for at least 5 minutes.  
5. 
Hematology and vital signs must be repeated prior to each dose of PVd treatment.  
6. 
Single ECG at Screening  

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7. 
All laboratory assessments with values considered clinically significantly abnormal during participation in the study up to at least 70 days after the last dose of study treatment should be repeated until 
the values return to normal or baseline. Refer to Table 24 for a comprehensive list of laboratory assessments. If laboratory assessments are completed within 72 hours prior to the first dose, these 
assessments need not be repeated on C1D1.  
8. 
Hematology and clinical chemistry must be repeated prior to each dose of bortezomib on D1, 4, 8, and 11 of each 21-day cycle for C1 to 8 and then on D1 and 8 of each 21-day cycle for C9+. If 
laboratory assessments are completed within 72 hours prior to the first dose, these assessments need not be repeated on C1D1. Results must be evaluated prior to treatment administration. Refer to 
Table 24 for a comprehensive list of laboratory assessments. 
9. 
eGFR as calculated by Modified Diet in Renal Disease (MDRD) formula (Section 10.7). 
10. Urine dipstick may be used to assess for presence of urine protein. Albumin/creatinine ratio needs to be done in any participant with urine dipstick result of ≥1+ at Screening or ≥2+ On Treatment, or 
with positive protein if urine dipstick protein quantification is not available. Albumin/creatinine will be performed at a local laboratory. If local testing is not available, then central testing will be 
performed (first void). 
11. Hepatitis B virus DNA testing will be done to determine a participant’s eligibility if HBcAb and/or HBsAg is positive. Hepatitis C virus RNA testing will be done to determine participant eligibility if 
Hepatitis C Ab-positive. This will be performed at a local laboratory or, if not available, then at a central laboratory. For additional procedures during Screening and upon enrolment for participants 
who have a history of Hepatitis B and/or Hepatitis C, please refer to Table 4 and Table 5, respectively. 
12. Perform only in women of childbearing potential (WOCBP), see Appendix 3 for definition. A serum pregnancy test must be performed at Screening. Two negative serum pregnancy tests must be 
obtained prior to initiating treatment; the first test should be performed within 10-14 days of C1D1, but the second must be performed within 24 hours of C1D1. After the first dose, pregnancy test will 
be done weekly during the first month, then every cycle thereafter (or every 2 weeks in females with irregular menses). Subsequent pregnancy test on dosing days may be either serum or urine test. 
Each pregnancy test must be performed within 24 hours prior to dosing. Final pregnancy test (serum or urine) must be performed in WOCBP at the EoT Visit and at 2 weeks (in females with irregular 
menses) and 4 weeks following treatment discontinuation, and repeated at least 70 days after last dose. Follow-up pregnancy assessment by phone (for WOCBP only) should be performed 7 months 
after the last dose of bortezomib. 
13. Only in participants with IgD/IgE myeloma.  
14. Imaging is only required for participants with extramedullary disease by either CT, MRI, or PET/CT. Screening assessment may be performed up to 30 days prior to C1D1. Subsequent imaging 
should be performed every 12 weeks within the first 12 months (at Weeks 13, 25, 37, and 49, 7 days); thereafter only if clinically indicated, per local guidance. The same modality should be used 
throughout the study as was done at Baseline. Selected target lesion should be measured and followed over time. Plasmacytoma measurements should be taken from the CT portion of the PET/CT, 
MRI scans, or dedicated CT scans, where applicable. For participants with only skin involvement, skin lesions should be measured with a ruler. Measurement of tumor size will be determined by the 
sum of the products of the maximal perpendicular diameters of measured lesions. Digital copies of all scans must be maintained at investigator site as source document. Participants undergoing 
PET/CT should have all blood samples taken before the PET/CT is performed. 
For participants with PD due to extramedullary disease, confirmation scans are not required. The laboratory assessments do not need to be repeated if the extramedullary disease is the only site of 
progression. If the last radiographic assessment occurred ≥8 weeks prior to the participant’s withdrawal from study treatment, and PD has NOT been documented, a new assessment for 
extramedullary disease should be obtained at EoT. If participant continues in PFS follow-up, perform scans for extramedullary disease as clinically indicated. Optional tissue sample from 
extramedullary tumor may be collected at PD (Table 3). 
15. Imaging of bones for lytic lesions by method aligned with institutional guidance (e.g., X-ray, CT, or MRI). Survey results within 30 days prior to C1D1 date are acceptable. At later cycles, repeat as 
clinically indicated, or if worsening clinical symptoms suggest PD, by the same method used as at Screening. Sites shall maintain an archive of all study-related images/scans as source 
documentation. 
16. Response to treatment will be assessed q4w (±3 days) regardless of dosing, based on laboratory assessments and imaging (if applicable), using IMWG criteria [Kumar, 2016]. 
17. Pomalidomide administration 4 mg PO daily on Days 1-14 of each 21-day cycle. Platelet count must be ≥50,000 per L to initiate a new cycle. Refer to Section 6.6.2 and Section 6.7.2 for instructions 
on dose delays and dose modification guidelines.  
18. Bortezomib 1.3 mg/m2 (SC only). Bortezomib administered on Days 1, 4, 8, and 11 of every 21-day cycle in Cycles 1 to 8 and then on Days 1 and 8 of every 21-day cycle in Cycles 9 and beyond 
(C9+). Refer to Section 6.6.2 and Section 6.7.2 for instructions on dose delays and dose modification guidelines.  
19. Dexamethasone 20 mg PO will be given on D1, 2, 4, 5, 8, 9, 11 and 12 of every 21-day cycle for C1 to 8 and on D1, 2, 8 and 9 of each 21-day cycle for C9+. For participants who are >75 years, have 
comorbidities, or are intolerant to 20 mg, the dose of dexamethasone can be reduced to 10 mg in Arm B. Refer to Section 6.6.2 and Section 6.7.2 for instructions on dose delays and dose 

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modification guidelines. On days where only pomalidomide and dexamethasone are taken at home, they should be taken in the morning approximately at the same time each day. Participant diaries 
will be used to keep record of self-administered oral study treatment(s) at home. 
20. PRO-CTCAE, EORTC QLQ-C30, EORTC QLQ-MY20 EORTC IL52, FACT-GP5, PGIS, and PGIC should be collected q4w regardless of treatment and at EoT. EQ-5D3L should be collected q8w 
regardless of treatment and at EoT. All PROs should be administered prior to any assessments being performed and prior to results being provided to the participant. PRO collection will start at C1D1 
with the exception of the PGIC which will start at Week 5. 
21. EORTC QLQ-C30, EORTC QLQ-MY20, EORTC IL52, EQ-5D-3L, PGIS, and PGIC will be administered q8w after EoT whilst in PFS follow-up. 
22. EORTC QLQ-C30, EORTC QLQ-MY20, EORTC IL52 and EQ-5D-3L should be administered at 12, 24, and 48 weeks in the OS follow-up. For participants in OS follow-up not attending the site, they 
can be administered via a phone call in an interview format. 
23. OSDI should be collected prior to any treatment administration on C1D1, then q4w up to Week 21 and thereafter q8w weeks post Week 21 until EoT, and at EoT. EQ-5D-3L should be administered 
q8w on treatment. During PFS/OS follow-up, there will be no collection of OSDI in Arm B.  
24. Only applicable for participants enrolled under the original protocol. 
25. Only applicable for participants enrolled under protocol amendment 1. 
26. GSK may request that updated survival data be collected on all treated/randomized participants outside the protocol window noted in the SoA. At the time of the request, the site will determine 
survival status for each participant by the method agreed with the participant, unless the participant has withdrawn consent for survival follow up. Where permitted, data from publically available death 
registers will be used for participants withdrawn from study or lost to follow-up prior to death. 
27. Final Pregnancy Prevention Counselling must be performed in WOCBP at the EoT visit and/or at least 4 weeks following discontinuation of pomalidomide treatment, whichever comes last. 

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Table 3 
Bone Marrow Aspirate and/or Biopsy and tissue sample Collection (Treatment Arm A and Treatment Arm B) 
Timepoint  
BM biopsy and/or 
aspirate for disease 
assessmenta,d 
BM aspirate for 
FISH testinga,e 
BM aspirate for MRD 
testingb,f 
BM biopsy or aspirate for BCMA 
expression and biomarker 
researchb,g 
Optional BM biopsy or aspirate or 
tissue sample at PD for BCMA 
expression and biomarker 
researchb,h 
Screening 
Xc 
X 
X 
X 
 
VGPR or better 
 
 
X 
 
 
CR/sCR 
Xd 
 
X 
 
 
Suspected PD, 
only if PD is not otherwise 
evident  
Xc 
 
 
 
 
At PD 
 
 
 
 
X 
BCMA = B-cell maturation antigen; BM = bone marrow; CR = complete response; DNA = deoxyribonucleic acid; FISH = fluorescence in situ hybridization; EMD = extramedullary diseases; MRD = Minimal 
Residual Disease; PD = Progressive disease; RNA = ribonucleic acid; sCR = Stringent Complete Response; VGPR = Very Good Partial Response.  
a. 
These assessments will be performed at a local laboratory. 
b. 
These assessments will be performed at a central laboratory.  
c. 
For Disease assessment: BM aspirate and/or biopsy as per institutional practice. 
d. 
For sCR in participants achieving a CR, a bone marrow core biopsy is required to confirm sCR by IHC for absence of clonal cells. Only 1 bone marrow procedure required for CR 
and sCR assessment. If IHC testing cannot be performed at a local lab, the samples can be sent to the central lab. 
e. 
FISH testing to be performed locally at least for: t(4;14), t(14;16), amp(1q), del(1p) and del(17p13). If participant is known to have tested positive for t(4;14) or t(14;16) on previous 
tests, FISH for those translocations does not need to be repeated and results from previous tests are acceptable regardless of when those tests were performed. For amp(1q), 
del(1p) and del(17p13), FISH results from samples taken within 60 days prior to first dose are acceptable. If testing cannot be performed at a local lab, the samples can be sent to 
the central lab.  
f. 
MRD sample to be collected at the time of first achieving confirmed response of VGPR or better (i.e. achieving CR without prior VGPR), and repeated every 6 months (±1 month) 
until PD. In case of deepening of response from VGPR to CR, MRD sample should be collected at the time of CR assessment and then repeated every 6 months until PD.  
g. 
BM core biopsy or aspirate samples are collected at Screening for BCMA expression and biomarker research. When medically feasible and consistent with institutional practice, a 
BM core biopsy is the preferred samples for these exploratory analyses. If a BM biopsy is not obtainable, then an aspirate should be collected for BCMA expression and biomarker 
research. Any remaining biopsy and/or aspirate sample may be used for biomarker research (which may include, but not be limited to, immune cell characterization and/or profiling 
and/or DNA/RNA analyses). 
h. 
Optional BM (core biopsy or aspirate) or tissue sample (if from extramedullary tumor, BM sample is not required in case of EMD relapse) for BCMA expression and biomarker 
research may be collected at PD. When medically feasible and consistent with institutional practice, BM core biopsy is the preferred sample to be collected for BCMA expression 
and biomarker research at PD. If BM biopsy is not obtainable, then an aspirate may be collected for BCMA expression and biomarker research. Any remaining biopsy and/or 
aspirate sample may be used for biomarker research (which may include, but not be limited to immune cell characterization and/or profiling and/or DNA/RNA analyses). Separate 
consent is required for this optional sample at PD. 

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Table 4 
Additional procedures for Participants with positive serology for HBV at Baseline 
HBV Study 
Assessments 
During Screening /Prior to 
starting treatment 
During Treatment 
EoT 
 
Notes 
HBV related Liver 
Imaging3 
X1 
X1 
X1 
1. 
Liver imaging (specific test per standard of care at 
local institution) in HBsAg+ participants to rule-
out/identify cirrhosis, focal hepatic lesions, and/or 
biliary abnormalities at baseline. Repeat imaging at 
one year after starting treatment if still on treatment 
and twice yearly thereafter as long as participant 
remains on study treatment or as clinically 
indicated. 
2. 
HBV-DNA testing prior to the start of belantamab 
mafodotin and subsequently every 3 months, or if 
LFT elevations requiring increased monitoring or 
stopping criteria occurs, or for any clinical suspicion 
of hepatitis reactivation. 
3. 
For HBsAg+ participants, appropriate antiviral 
treatment per local guidance (e.g. tenofovir or 
entecavir) is started before starting belantamab 
mafodotin, continues through to completion of 
belantamab mafodotin therapy and should not be 
stopped unless advised by local hepatology or 
virology services.. 
4. 
Only for Japan: HBsAg+ participants only 
HBV-DNA testing 
X2 
X2 
X2 
Prevention of HBV 
reactivation 
X3 
X3 
X3 
HBeAg and HBeAb 
testing 
X4 
 
 
HBeAg = Hepatitis B e antgen; HBeAb = Hepatitis B e antibody; HBsAg = Hepatitis B surface antigen; HBV = Hepatitis B; LFT = Liver Function Test 
Please refer to Section 8.2.8 for management of participants with positive serology for HBV. 

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Table 5 
Additional schedule of procedures: HCV+ Participants 
HCV Study Assessments 
During Screening 
/Prior to starting 
treatment 
During Treatment 
Post Treatment 
Notes 
HCV-RNA testing 
X1 
X1 
 
1. HCV- RNA testing prior to the start of belantamab mafodotin and 
subsequently every 3 months, or if LFT elevations requiring increased 
monitoring or stopping criteria occurs, or for any clinical suspicion of 
hepatitis reactivation. 
2. Antiviral treatment should be given to participants with HCV before 
enrolment using an 8 (to 12) week antiviral treatment course with 
curative intent per local guidance. Hep C RNA should be negative at 4 
weeks washout period post anti-HCV therapy prior to enrolment. 
Treatment of active HCV  
X2 
 
 
HCV= Hepatitis C virus; LFT = Liver Function Test 

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2. 
INTRODUCTION 
2.1. 
Study Rationale 
Multiple myeloma (MM) is a heterogeneous disease characterized by the clonal 
proliferation of plasma cells. A variety of drugs and combination treatments have been 
evaluated and found effective in treating MM [NCCN, 2018; Moreau, 2017]. These 
include immunomodulatory agents and proteasome inhibitors (PIs) that form the 
backbone of treatment regimens across all treatment lines. Combining active agents with 
lenalidomide plus dexamethasone or bortezomib plus dexamethasone (Vd) treatment can 
yield improved patient outcomes with acceptable toxicity profiles, establishing new 
global standard of care (SoC) regimens [Raza, 2017; Palumbo, 2016; Reeder, 2009; 
Richardson, 2010]. 
Lenalidomide is widely used in first-line either in combination with other anti-myeloma 
drugs or as maintenance therapy after autologous stem cell transplant (ASCT). 
Pomalidomide, an immunomodulatory drug with a similar structure to thalidomide and 
lenalidomide, that binds to cereblon (CRBN), is also emerging as a regimen in 
subsequent settings. Pomalidomide when administered with low-dose dexamethasone 
(pomalidomide in combination with dexamethasone; Pd) is approved by the United States 
Food and Drug Administration and European Medicines Agency (EMA) for patients with 
relapsed/refractory multiple/myeloma (RRMM) who have received at least 2 prior 
therapies including lenalidomide and bortezomib and have demonstrated disease 
progression after their last therapy. Pd improved median progression-free survival 
(mPFS) for about 2 months over dexamethasone alone in patients with lenalidomide-
resistant MM (4.0 vs. 1.9; hazard ratio [HR] 0.49; 95% confidence interval [CI]: 0.40, 
0.61; p<0.001). The combination regimens of daratumumab or elotuzumab with Pd were 
also approved in the United States (US) for RRMM in patients who have been previously 
treated with at least 2 prior therapies including lenalidomide and a PI [POMALYST 
USPI, 2019; Darzalex USPI, 2018; Empliciti, 2018].  
The combination of pomalidomide with twice-weekly bortezomib injected 
subcutaneously (SC) and low-dose dexamethasone (PVd) given in 21-day cycles (q3w) 
showed significantly improved clinical activity in a randomized Phase III trial 
(OPTIMISMM Study, n=559) in patients previously treated with lenalidomide and 1 to 3 
prior lines of therapy [San Miguel, 2013; Paludo, 2017; Richardson, 2019]. PVd reduced 
the risk of progression and death by 39% compared with bortezomib and dexamethasone 
(Vd) (HR: 0.61; 95% CI: 0.49, 0.77, p<0.0001) with a mPFS of 11.2 (vs. 7.1) months and 
an overall response rate (ORR) of 82% (vs. 50%), including 15.7% sCR/CR, 37% VGPR, 
and 29.5% PR.  The safety profile was consistent with known toxicities associated with 
other immunomodulators, PIs, and dexamethasone combination regimens, mostly 
comprising myelosuppression, infections and neuropathy. Based on these findings, PVd 
has been approved in the EU for treatment of patients with at least 1 prior line of therapy 
including lenalidomide. It is anticipated that the combination of PVd will become a SoC 
option for second-line (2L) treatment of RRMM in other countries/regions as well. 
Belantamab mafodotin, a humanized immunoglobulin G1 (IgG1) antibody-drug 
conjugate (ADC) that targets B-cell maturation antigen (BCMA), has demonstrated 

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strong single-agent activity in two clinical studies (DREAMM-1 and DREAMM-2) 
conducted in heavily pre-treated patients with RRMM [Trudel, 2018; Trudel, 2019; 
Lonial, 2020]. Based on the results from the pivotal Phase II Study 205678 (DREAMM-
2), belantamab mafodotin was approved by regulatory authorities at 2.5 mg/kg as an 
intravenous (IV) infusion once every 3 weeks in patients with RRMM. 
Nonclinical data demonstrated that the activity of belantamab mafodotin is enhanced by 
lenalidomide in cultured myeloma cell lines and patient myeloma cells [Tai, 2014; Tai, 
2015]. Additional, nonclinical data with belantamab mafodotin suggest significant added 
benefit (efficacy and survival) when combined with pomalidomide and/or dexamethasone 
in an established MM xenograft model [GSK Document Number RPS-CLIN-051778, IB 
V11, 2023]. 
Belantamab mafodotin at multiple dose levels in combination with Pd q4w is being 
evaluated for safety and efficacy in patients with RRMM in an ongoing Phase I/II study 
conducted by the Myeloma Canada Research Network (MCRN 007 or Study 209418, see 
Section 2.3.4).  The Sponsor performed an analysis for an abstract submission (cut-off 
date of 01 February 2020). A total of 18 patients were included in this report, of which 
11 patients received belantamab mafodotin at 1.92 mg/kg dose level, and 7 patients at 
2.5 mg/kg dose level.  Preliminary data showed that the B-Pd combination at both dose 
levels resulted in early signs of clinical activity, and the observed safety profile of B-Pd 
was consistent with the safety profile of belantamab mafodotin and 
pomalidomide/dexamethasone. 
Responses obtained in the belantamab mafodotin 2.5 mg/kg cohort were deep and rapid, 
with PR or VGPR responses achieved within the first 2 cycles. However,  all 7 patients 
treated in the belantamab mafodotin 2.5 mg.kg cohort experienced Grade 2 or 3 ocular 
toxicities within 2 cycles of therapy, requiring dose interruptions or dose reductions of 
belantamab mafodotin from 2.5 mg/kg to 1.92 mg/kg q4w. Despite these dose 
modifications, all 7 patients achieved deep responses (best overall response 6 VGPR and 
1 sCR). 
The dose cohort of 1.92 mg/kg q4w was better tolerated with less frequent dose 
interruptions of belantamab mafodotin. However, the efficacy observed thus far (4 SD, 
2 PR and 4 VGPR) appears inferior than the efficacy observed in the dose cohort of 
2.5 mg/kg q4w. 
We hypothesize that the combination of belantamab mafodotin with Pd may result in 
significant additive or synergistic effects, which could potentially translate into better 
benefits compared to PVd in RRMM participants who are progressing on or after the 
treatment with a lenalidomide-containing regimen.  While there is some overlap in the 
pattern of identified toxicities (primarily hematologic), the safety and tolerability of this 
combination will be further explored in this randomized trial. This study will evaluate the 
efficacy and safety of belantamab mafodotin at 2.5 mg/kg in C1 q4w and 1.9 mg/kg in 
C2+ q4w when administered in combination with Pd versus PVd q3w in participants with 
RRMM. 

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Further information on the effects of belantamab mafodotin is available in the 
Investigator’s Brochure (IB) [GSK Document Number RPS-CLIN-051778, IB V11, 
2023] 
2.2. 
Background 
2.2.1. 
Clinical Management of Multiple Myeloma and 
Relapsed/Refractory Multiple Myeloma  
MM is an incurable malignancy that accounts for 1.8% of all new cancers and 13% of all 
hematologic malignancies [SEER CSR, 2015]. Worldwide, approximately 103,000 new 
cases are diagnosed annually [Cowan, 2018] and in the United States (US), 32,110 new 
cases and 12,960 deaths are estimated to occur in 2019 [Siegel, 2019].  
A variety of drugs and combination treatments have been evaluated and found effective 
in treating MM [Moreau, 2017; Fonseca, 2017; NCCN, 2018]. However, most, if not all, 
patients treated with currently approved treatment regimens inevitably relapse and require 
subsequent treatments [Moreau, 2015; Jagannath, 2008, Richardson, 2003, Richardson, 
2006]. 
Bortezomib is approved in the US, EU and a number of other countries worldwide for the 
treatment of MM and is the most frequently used PI [VELCADE USPI, 2019 ; 
VELCADE SmPC, 2021]. Bortezomib is often given in combination with dexamethasone 
as this has been shown to result in improved ORRs in MM [Kropff, 2005; Kroemer, 
2013; Dimopoulos, 2015]. Multiple studies have demonstrated that adding a third agent 
to bortezomib/dexamethasone leads to improved patient outcomes, with acceptable safety 
profiles [Paludo, 2017; Palumbo, 2016; Raza, 2017; Reeder, 2009; Richardson, 2010]. 
European Society for Medical Oncology and National Comprehensive Cancer Network 
guidelines recommend triplet combination regimens as the induction therapy for fit 
patients with MM eligible for ASCT, and as the increasingly preferred therapy for 
RRMM patients [Moreau, 2017; NCCN, 2018]. 
Immunomodulatory agents are an important cornerstone of treatment for patients with 
RRMM, including lenalidomide and more recently pomalidomide. The treatment 
paradigm of relapsed MM is rapidly evolving with increasing use of lenalidomide-based 
therapy as frontline treatment and pomalidomide in subsequent settings.  
2.2.1.1. 
Pomalidomide in Combination with Dexamethasone (Pd) for 
Relapsed/Refractory Multiple Myeloma Treatment 
Pd is approved by in the US, EU and a number of other countries for patients with 
RRMM who have received at least 2 prior therapies including both lenalidomide and 
bortezomib and have demonstrated disease progression on their last therapy 
[POMALYST USPI, 2019; Imnovid SmPC, 2019].  
The combination regimen of Pd has been previously studied in patients with relapsed or 
refractory MM to lenalidomide and bortezomib in the Phase III trial MM-003, which 
compared Pd with high-dose dexamethasone (HD) [San Miguel, 2013]. The median OS 
was significantly longer with Pd than with HD alone (12.7 vs. 8.1 months; HR: 0.74; 

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p=0.0285). Pd improved the mPFS by about 2 months over HD alone in patients with 
lenalidomide-resistant MM (4.0 vs. 1.9; HR 0.49; 95% CI: 0.40, 0.61; p<0.001). An ORR 
of 31% was achieved with Pd (CR: 1%; VGPR: 5%; PR: 26%). The most common Grade 
3 to 4 hematological AEs were neutropenia (48% vs. 16%), anemia (33% vs. 37%), and 
thrombocytopenia (22% vs. 26%). Serious adverse events (SAEs; defined as fatal, life-
threatening, requiring hospitalization or resulting in disability or incapacity) occurred in 
61% and 53% of participants in the Pd and HD groups, respectively. The most common 
cause of death in both groups was progression of disease (68% vs. 64%), with the second 
most common cause being infection (10% vs. 19%). Treatment-related AEs leading to 
death were seen in 4% and 5% participants, respectively. The combination regimens of 
daratumumab or elotuzumab with Pd were also approved in the US for RRMM in 
patients who have been previously treated with at least 2 prior therapies including 
lenalidomide and a PI [POMALYST USPI, 2019; Darzalex USPI, 2018; Empliciti USPI, 
2018]. 
2.2.1.2. 
Pomalidomide Plus Bortezomib and Dexamethasone (PVd) for 
Relapsed/Refractory Multiple Myeloma Treatment 
Lenalidomide is widely used in first-line either in combination with other anti-myeloma 
drugs or as maintenance therapy after ASCT. Pomalidomide is also emerging as a 
second-line regimen for the treatment of RRMM. PVd (pomalidomide with twice-weekly 
bortezomib injected SC and low-dose dexamethasone) given in 21-day cycles (i.e., q3w) 
showed significantly improved clinical activity in a randomized Phase III trial 
(OPTIMISMM Study, N=559) in patients previously treated with lenalidomide and 1 to 3 
prior lines of therapy [San Miguel, 2013; Paludo, 2017; Richardson, 2019]. PVd reduced 
the risk of progression and death by 39% compared with Vd (HR: 0.61; 95% CI: 0.49, 
0.77, p<0.0001) with mPFS of 11.2 (vs. 7.1) months and an ORR of 82% (vs. 50%), 
including 15.7% sCR/CR, 37% VGPR, and 29.5% PR. The safety profile was consistent 
with known toxicities associated with other immunomodulators, PIs, and dexamethasone 
combination regimens, mostly comprising myelosuppression, infections, and neuropathy. 
Based on these clinical results [Richardson, 2019], PVd has received the endorsement 
from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and has 
been approved by EMA for treatment of RRMM patients with at least 1 prior line of 
therapy. It is anticipated that the combination of PVd will become a SoC option for 
second-line treatment of RRMM in other countries/regions as well.  
2.2.2. 
Role of B-Cell Maturation Antigen in Multiple Myeloma 
B-cell maturation antigen (BCMA), also designated as tumor necrosis factor receptor 
superfamily member 17 (TNFRSF17), is expressed on the surface of normal and 
malignant B lymphocytes at later stages of differentiation [Novak, 2004]. Ligands 
targeting BCMA such as B cell-activating factor (BAFF, TNFSF13B) along with a 
proliferation-inducing ligand (APRIL, TNFSF13) activate cell proliferation pathways and 
upregulate anti-apoptotic proteins in MM cell lines [Bellucci, 2005; Moreaux, 2004]. 
Mice deficient for BCMA are viable, have normal B-cell development, and exhibit 
normal humoral responses [Belnoue, 2008; Jiang, 2011; Usmani, 2013; Varfolomeev, 
2004]. BCMA is widely expressed on malignant plasma cells in MM and to a lesser 
degree in other B-cell malignancies [Tai, 2015; Tai, 2006]. The restricted expression 

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profile of BCMA to B cells at later stages of differentiation, and the expression on tumor 
cells of all patients with MM (GSK internal data) make it a very good target for a 
therapeutic antibody with direct cell killing activity, which is expected to have limited off 
target effects [Tai, 2015]. Soluble BCMA (sBCMA) is present in the serum of MM 
patients, and its levels have been shown to associate with response to therapy and OS 
[San Miguel, 2013; Sanchez, 2012].  
BCMA has been validated as a therapeutic target in MM in nonclinical studies [Tai, 
2014; Tai, 2015], and more recently in the clinic, where notable results were 
demonstrated with chimeric antigen T-cell therapy (CAR-T) [Cohen, 2016; Ormhøj, 
2017], and with belantamab mafodotin monotherapy in heavily pre-treated MM patients 
[Trudel, 2018; Trudel, 2019; Lonial, 2020].  
2.2.3. 
Antibody-Drug Conjugate Belantamab Mafodotin 
Belantamab mafodotin is a humanized immunoglobulin G1 (IgG1) antibody-drug 
conjugate (ADC) that binds specifically to BCMA and competes with its natural ligands: 
APRIL and BAFF. The parent antibody (belantamab) is produced in an afucosylated 
form to enhance antibody-dependent cellular cytotoxicity (ADCC) and is conjugated to 
the microtubule inhibitor monomethyl auristatin-F (MMAF), resulting in an ADC 
molecule. In addition, when MM cells expressing BCMA are exposed to belantamab 
mafodotin, immunogenic cell death (ICD) markers are induced. Exposure of dendritic 
cells to tumor cells undergoing ICD is expected to result in an antigen-specific T-cell 
response, enhancing the patient’s own immune response against the MM tumor. The 
inhibition of BCMA-dependent signaling has also been demonstrated in vitro, but it is 
uncertain if it contributes to in vivo anti-tumor activity due to the lower concentrations 
achievable in humans (Figure 2).  
Altogether, these mechanisms enable belantamab mafodotin to deliver potent anti-tumor 
activity by targeting both dividing and non-dividing tumor cells. These mechanisms of 
action (MoAs) clearly differentiate belantamab mafodotin from existing approved 
treatments for MM [GSK Document Number RPS-CLIN-051778, IB V11, 2023].  

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Figure 2 
Mechanism of Action of Belantamab Mafodotin 
 
Abbreviations: ADC=antibody drug conjugate; ADCC/ADCP=antibody-dependent cellular cytotoxicity/antibody-
dependent cellular phagocytosis; BCMA=B-cell maturation antigen. 
2.2.4. 
Nonclinical Pharmacology of Belantamab Mafodotin 
Anti-tumor activity has been observed for belantamab mafodotin in vitro and in vivo. In 
vitro, belantamab mafodotin demonstrated both ADC and ADCC against all MM cell 
lines tested, including those with low BCMA expression, and against primary multiple 
myeloma samples. Further, belantamab mafodotin activity was demonstrated under 
conditions designed to mimic the human target cells and microenvironment in the bone 
marrow, including in the presence of physiological concentrations of BCMA ligands, in 
the presence of shed BCMA (sBCMA), at a large range of BCMA expression levels, and 
at concentrations of belantamab mafodotin hypothesized to be achievable in humans. 
Monotherapy treatment with belantamab mafodotin significantly inhibited tumor growth 
in xenograft models of female mice bearing human MM NCI-H929, OPM2, and 
MM1Sluc cells [GSK Document Number RPS-CLIN-051778, IB V11, 2023].  
Previous work has demonstrated that combining belantamab mafodotin with existing 
myeloma therapies can enhance the apoptotic and ADCC activities in MM cell lines and 
MM patient samples [Tai, 2014; Tai, 2015]. 
Additional studies have been performed to evaluate the anti-tumor activity of belantamab 
mafodotin in combination with bortezomib, pomalidomide and/or dexamethasone in 
2 established MM xenograft mouse models. Belantamab mafodotin had significant tumor 
growth inhibition efficacy and provided survival advantage when administered to the 
OPM-2 and MOLP-8 MM xenograft models as a monotherapy. Belantamab mafodotin 
combination therapy with pomalidomide or bortezomib provided additional benefit 
compared to each single agent by significantly increasing survival in both mouse models. 
In the OPM-2 model, belantamab mafodotin combination therapy with bortezomib also 
led to significant increases in tumor growth inhibition. Combining belantamab mafodotin 

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with dexamethasone in double or triple combinations did not provide significant added 
benefit when compared to single agents or double combinations, respectively [GSK 
Document Number RPS-CLIN-051778, IB V11, 2023]. 
2.3. 
Human Experience with Belantamab Mafodotin  
2.3.1. 
Studies with Belantamab Mafodotin Monotherapy 
Belantamab mafodotin has demonstrated strong single-agent activity in 2 clinical studies 
conducted in heavily pre-treated participants with RRMM (Trudel, 2018; Trudel 2019; 
Lonial, 2020). 
In the FTIH study BMA117159 (NCT02064387, DREAMM-1), as of 27 February 2019 
safety cut-off, a total of 73 participants with RRMM received at least 1 dose of 
belantamab mafodotin (Trudel, 2018; Trudel, 2019). The administration schedule was 
once q3w IV. Final data from BMA117159 demonstrated a manageable safety profile 
with thrombocytopenia and corneal events being the most frequently reported AEs. 
Thirty-eight (38) patients were treated in the dose-escalation Part 1 and 35 patients in the 
dose-expansion Part 2 at the 3.4 mg/kg. The majority of patients (29/38 [76%] in Part 1 
and 20/35 [57%] in Part 2) had received 5 or more prior lines of therapy. All patients in 
Part 2 experienced at least 1 AE. The most common events occurring in 30% of patients 
were corneal events, thrombocytopenia (including the preferred term platelet count 
decreased), nausea, fatigue, anemia, and aspartate aminotransferase increased. In Part 2, 
Grade 3 to 4 AEs were reported in 29/35 patients (83%) and SAEs were reported in 17/35 
(49%) patients. The most common SAEs were lung-associated infections, pneumonia, 
pyrexia, and infusion-related reaction (IRR). 
Thrombocytopenia/platelet count decreased was reported in a total of 40/70 patients 
(55%) in the All-Patients Treated (APT), and 22/35 patients (63%) in Part 2. Belantamab 
mafodotin may cause transient worsening of thrombocytopenia in some patients, but in 
most cases these events are resolved during between-dosing intervals. In the Part 2 MM 
population, 2 serious bleeding events were reported: intracranial hemorrhage in a patient 
with a history of an intracranial bleeding in the setting of disease progression, and 
hematuria in a patient with a large bladder mass in the setting of progressive disease 
(PD). 
Corneal events are the most frequently reported AEs associated with belantamab 
mafodotin in the clinic, which include keratopathy (microcyst-like superficial deposits in 
the corneal epithelium), blurred vision, dry eyes and photophobia. These findings are 
consistent with those previously reported with other antibody drug conjugates utilizing 
monomethyl auristatin F in terms of manifestation and incidence of events [Eaton, 2015]. 
In Part 2 of BMA117159 (n=35 patients treated at 3.4 mg/kg q3w), corneal events were 
reported in 24/35 (69%) patients, most commonly blurred vision (18/35; 51%), dry eye 
(13/35; 37%) and photophobia (10/35; 29%). Nineteen (19; 54%) patients experienced 
Grade 1 or 2 corneal events; 5 (14%) patients had Grade 3 events. The median duration 
of corneal events for patients with a resolution date (n=16) was 35 days (range 5–442). 
Corneal events led to dose reduction in 16 (46%) patients, and dose interruptions or 
delays in 17 (49%) patients [Trudel, 2018; Trudel, 2019].  

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In Part 2 of BMA117159 (n=35), belantamab mafodotin demonstrated an ORR of 60.0% 
(95% CI: 42.1%, 76.1%), sCR of 6%, CR of 9%, VGPR of 40%, and PR of 6%, with 
RRMM [Trudel, 2018; Trudel, 2019]. The median duration of response (DoR) was 14.3 
months (95% CI: 10.6 months, NR). The mPFS in this population was 12.0 months 
(95% CI: 3.1 months, NR). For patients refractory to both immunomodulators and PIs 
(n=32/35), the confirmed ORR was 56% (95% CI: 37.7%, 73.6%) and mPFS was 
7.9 months (95% CI: 2.3 months, Not Estimable [NE]) [Lonial, 2020]. In Study 
BMA117159, the maximum clinical benefit (by ORR) was observed at the 3.4 mg/kg 
dose level, but a significant number of patients required dose delays and dose reductions 
to manage AEs. 
In the Phase II pivotal Study 205678 (NCT03525678, DREAMM-2), belantamab 
mafodotin was further evaluated as monotherapy in RRMM patients at doses of 
2.5 mg/kg and 3.4 mg/kg q3w. It was a two-arm, randomized study in patients who have 
failed at least 3 prior lines of anti-myeloma therapy, including an anti-CD38 antibody, 
and who are refractory to an immunomodulator and a PI (97 in the 2.5 mg/kg cohort and 
99 in the 3.4 mg/kg cohort) [Lonial, 2020]. The DREAMM-2 study final analysis was 
completed and the results are presented in the final Study Report (October 2022). 
However, there are participants continuing treatment in PACT (Post-Analysis Continued 
Treatment) phase. 
 
As of the cut-off date of 31 March 2022, the ORR was 32% (97.5% CI: 21.7%,43.6%) in 
the 2.5 mg/kg cohort and 35% (97.5% CI: 24.8%, 47.0%) in the 3.4 mg/kg cohort. The 
median DoR was 12.5 months (95% CI: 4.2 months, 19.3 months) at 2.5 mg/kg and 
6.2 months (95% CI: 4.8 months, 18.7 months) at 3.4 mg/kg. The mPFS in this 
population was 2.8 months (95% CI: 1.6 months, 3.6 months) and 3.9 months (95% CI: 
2.0 months, 5.8 months), respectively and the median OS was 15.3 months (95% CI: 9.9 
months, 19.2 months) at 2.5 mg/kg and 14.0 months (95% CI: 10.0 months, 18.1 months) 
at 3.4 mg/kg. Positive clinical activity was also demonstrated at the 3.4 mg/kg lyophilized 
dose (ORR 52% [97.5% CI: 28.9%, 74.5%]).  
2.3.2. 
Safety 
Single-agent belantamab mafodotin was demonstrated to have a manageable safety 
profile in heavily pre-treated participants with RRMM. Safety data for single-agent 
belantamab mafodotin were pooled (data as of 20 September 2019) for DREAMM-2 
study and supportive FTIH study DREAMM-1 by treatment cohorts of 2.5 mg/kg and 3.4 
mg/kg. 
The most common AEs in both treatment cohorts were keratopathy (corneal epithelium 
changes observed on ophthalmic examination), thrombocytopenia and anemia. The 
incidence of AEs, including Grade 3 to 4 AEs was comparable between belantamab 
mafodotin 2.5 mg/kg and 3.4 mg/kg cohorts. AEs leading to dose delays, and reductions 
were less frequent in 2.5 mg/kg cohort, 51% and 32% compared with the 3.4 mg/kg 
cohort, 67% and 52%, respectively. AEs leading to permanent treatment discontinuation 
occurred in 10% and 11% of participants in the 2.5 and 3.4 mg/kg cohorts, respectively. 
More participants in the 3.4 mg/kg cohort experienced SAEs (50%) and fatal SAEs (6%) 
compared with the 2.5 mg/kg cohort (41% and 3%, respectively). 

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Single-agent belantamab mafodotin 2.5 mg/kg was selected as the recommended dose 
based on comparable efficacy with a more favorable safety profile (i.e., lower incidence 
of thrombocytopenia and neutropenia and less frequent dose delays or reductions) 
compared with the 3.4 mg/kg dose. 
Adverse events of special interest (AESIs) for belantamab mafodotin are corneal events, 
thrombocytopenia and infusion-related reactions, and are described below. 
Corneal Events 
Corneal events, reported in most cases as keratopathy, blurred vision and dry eye events 
are the most frequently reported AEs with belantamab mafodotin. 
In DREAMM-2 final analysis report (data as of 31 March 2022), events in the Eye 
disorders System Organ Class occurred in 98% of participants treated with belantamab 
mafodotin 2.5 mg/kg (n=95). The most common ocular AEs were keratopathy (71%, 
changes in corneal epithelium identified on eye exam, with or without symptoms), 
blurred vision (23%), and dry eye (15%). Belantamab mafodotin can cause keratopathy 
with or without vision impairment. In the safety population treated with belantamab 
mafodotin 2.5 mg/kg (n=95), median time to onset for the first occurrence of a 
keratopathy event was 28 days. 
Dose modifications, specifically dose delays, appear to be the most important mitigation 
strategy. Concomitant use of preservative-free artificial tear drops might also be 
beneficial, although they are not expected to prevent the occurrence of the epitheliopathy. 
Participants with a history of dry eye symptoms prior to starting belantamab mafodotin 
were more likely to develop keratopathy compared with participants without a history of 
dry eye symptoms. Therefore, active management of dry eye symptoms prior to and 
during treatment is recommended (i.e., administration of preservative-free artificial 
tears). Permanent treatment discontinuations due to corneal events were rare and occurred 
in <5% of participants. 
The ocular sub-study of DREAMM-2 provided no evidence that corticosteroid eye drops 
are an effective mitigation strategy for keratopathy/corneal events. 
Thrombocytopenia 
In DREAMM-2 (data as of 31 March 2022), thrombocytopenic events (thrombocytopenia 
and platelet count decreased) occurred in 38% participants treated with belantamab 
mafodotin 2.5 mg/kg; severity ranging between Grade 1 and 4. Grade 3 or higher events 
occurred in 22% of participants, and 1% overall were considered SAEs. The median time 
to onset of the first thrombocytopenic event was 25.5 days and the median time to 
resolution was 21.5 days. 
Most participants had a decrease from baseline in their platelet counts during the study. 
In general, participants who initiated treatment with lower platelet numbers tended to 
continue to have thrombocytopenia while on treatment with belantamab mafodotin. 

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Infusion-Related Reactions 
IRRs are expected for biologic agents. The majority of IRRs were non-serious and 
between grade 1 and grade 2 in severity. In DREAMM-2, IRRs occurred in 21% of 
participants receiving belantamab mafodotin 2.5 mg/kg. Symptoms of IRRs have 
included chills, asthenia, hypertension, lethargy, pyrexia, nausea, diarrhea, tachycardia, 
hypotension, and vomiting. Most IRRs occurred with the first infusion and few 
participants experienced IRRs with subsequent infusions. 
Although not protocol-mandated, pre-medications for IRR prophylaxis (including 
paracetamol, antihistamines, and steroids) were administered to 26% to 27% of 
participants. One participant (2.5 mg/kg cohort) discontinued treatment due to IRRs 
(Grade 3 IRRs at first and second infusion). 
2.3.3. 
Pharmacokinetics and Pharmacodynamics in Humans 
The pharmacokinetics (PK) and pharmacodynamics (PD) of belantamab mafodotin 
(ADC, including complex) and total monoclonal antibody (total mAb; including 
complex), and cysteine maleimidocaproyl monomethyl auristatin F (cys-mcMMAF) were 
investigated in 291 participants with RRMM following IV administration at doses from 
0.03 to 4.6 mg/kg q3w in DREAMM-1 (n=73) and at doses of 2.5 or 3.4 mg/kg q3w in 
DREAMM-2 (n=218). 
Maximum plasma concentration (Cmax) of belantamab mafodotin and total monoclonal 
antibody were observed at or shortly after the end of infusion (EOI), whereas cys-
mcMMAF Cmax values were generally observed on Day 2.  On a molar basis, plasma 
concentrations of cys-mcMMAF were 1% of belantamab mafodotin concentrations. 
There was limited accumulation (less than 2-fold) of belantamab mafodotin or cys-
mcMMAF during subsequent cycles.  
Belantamab mafodotin PK were well described by a linear, 2-compartment population 
model, with a time-varying decrease in clearance in a population PK analysis. At Cycle 1, 
belantamab mafodotin had a systemic clearance of 0.924 L/day, steady-state volume of 
distribution of 10.8 L, and an elimination half-life of 12 days in participants with RRMM 
in DREAMM-2. Over time, clearance was reduced by 28%, with an elimination half-life 
of 14 days. The time to 50% change in clearance was approximately 50 days.  
No clinically significant differences in the PK of belantamab mafodotin or cys-mcMMAF 
were observed based on age (34 to 89 years), sex, race (African American/Black and 
White), body weight (42 to 130 kg), mild or moderate renal impairment (estimated 
glomerular filtration rate [eGFR] ≥30 ml/min/1.73m2) or mild hepatic impairment 
(National Cancer Institute Organ Dysfunction Working Group classification). Higher 
serum levels of 2-microglobulin, immunoglobulin (Ig) G, and sBCMA and lower levels 
of albumin were associated with more advanced MM or a higher MM disease burden. 
Higher baseline IgG and sBCMA levels and lower baseline albumin levels were 
associated with higher belantamab mafodotin clearance leading to lower average and 
trough concentrations (Ctau) of belantamab mafodotin.  Higher baseline IgG and sBCMA 
levels were associated with higher cys-mcMMAF central volume of distribution leading 
to lower cys-mcMMAF Cmax. 

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In nonclinical studies, cys-mcMMAF had limited metabolic clearance. In vitro data 
suggested that belantamab mafodotin and cys-mcMMAF are unlikely to perpetrate a 
drug-drug interaction or to be a victim of a drug-drug interaction with inhibitors or 
inducers of cytochrome P450 enzymes (CYP). Cys-mcMMAF was an in vitro substrate 
of organic anion transporting polypeptides (OATPs) OATP1B1 and OATP1B3, 
multidrug resistance associated proteins (MRP) MRP1, MRP2, and MRP3, a borderline 
substrate of bile salt export pump, and a possible substrate of P-glycoprotein (P-gp). 
Following the administration of belantamab mafodotin to participants with RRMM, only 
intact cys-mcMMAF was detected in pooled human urine, with no evidence of other 
MMAF-related urinary metabolites.  
Free sBCMA levels were measured in DREAMM-1 and DREAMM-2. All subjects 
exhibited reductions in free sBCMA concentration at EOI compared to baseline at Cycle 
1, with a return to near-baseline level by 7 days after dosing, reflecting binding of 
belantamab mafodotin to sBCMA. Maximum decreases ranged from 2% to 97%, which 
were qualitatively dose-dependent, with larger reductions in free sBCMA at higher doses.  
Exposure-response analyses performed for DREAMM-2 and/or DREAMM-1found that 
ocular safety endpoints were most strongly associated with belantamab mafodotin 
exposure, while efficacy endpoints had a weaker association with belantamab mafodotin 
exposure. Both safety and efficacy endpoints were associated with patient characteristics. 
Belantamab mafodotin Ctau was associated with probability of corneal events and 
keratopathy and cys-mcMMAF Cmax was associated with probability of 
thrombocytopenia. Probability of occurrence of dry eye, blurred vision, neutropenia and 
IRR were not associated with an exposure measure. In addition, the results of the analysis 
of concentration against corrected QT interval (QTc) demonstrated that belantamab 
mafodotin or cys-mcMMAF did not have a significant effect on cardiac repolarization. 
In addition, the pharmacokinetics of belantamab mafodotin were further investigated in 
monotherapy from 217 participants with RRMM following IV administration of 
2.5 mg/kg q3w in DREAMM-3; in combination with lenalidomide/dexamethasone 
(n=45) or bortezomib/dexamethasone (n=107) in participants with RRMM following IV 
administration at doses ranging from 1.9 mg/kg to 3.4 mg/kg in DREAMM-6; in 
combination with nirogacestat (n=44, SubStudy 3) in participants with RRMM following 
IV administration at doses ranging from 0.95 mg/kg in DREAMM-5; and in combination 
with lenalidomide/bortezomib/dexamethasone (n=90) in transplant ineligible newly 
diagnosed MM participants following IV administration at doses ranging from 1.0 mg/kg 
to 1.9 mg/kg in DREAMM-9. Overall, the pharmacokinetics of belantamab mafodotin 
were similar in these earlier line patient populations to that observed in later line RRMM 
patients receiving belantamab mafodotin monotherapy. 
Additional information related to belantamab clinical PK, PD, and exposure-response 
relationships can be found in the IB [GSK Document Number RPS-CLIN-051778, IB 
V11, 2023]. 

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2.3.4. 
Study 209418: Belantamab mafodotin in combination with 
pomalidomide and dexamethasone  
Study 209418 (or MCRN007) is an ongoing Phase I/II, dose-escalation study conducted 
by the MCRN to evaluate the safety and efficacy of belantamab mafodotin given IV q4w 
in combination with pomalidomide and dexamethasone (B-Pd) in patients with RRMM. 
The study consists of two parts: Part 1 is dose-finding and Part 2 is the expansion phase.  
All patients receive multiple dose levels of belantamab mafodotin administered IV q4w 
in combination with pomalidomide and dexamethasone in a 28-day treatment cycle.  
Pomalidomide is administered at 4 mg QD on Days 1 to 21 of a 28-day cycle and 
dexamethasone at 40 mg QD (participants ≤75 years old) or 20 mg QD (participants >75 
years old) on Days 1, 8, 15, and 22 of each 28-day cycle.  Treatment will be administered 
until disease progression or unacceptable toxicity.   
In the original protocol, as of the data cut-off on 01 February 2020, 7 patients received 
belantamab mafodotin at 2.5 mg/kg dose when administered in combination with Pd q4w 
(2.5 mg/kg in Cycle 1 followed by 1.9 mg/kg in Cycle 2+ q4w) and 11 patients received 
1.92 mg/kg in Study 209418. Briefly, both doses of belantamab mafodotin were shown to 
be tolerable with demonstrated clinical activity when administered in combination with 
Pd in each 28-day cycle. The 1.92 mg/kg q4w belantamab mafodotin dosing regimen was 
associated with less frequent dose interruptions and reductions and a lower incidence of 
AEs (including corneal events) compared with 2.5 mg/kg q4w. Additional preliminary 
blinded data, based on the instream data (cut-off date of 15 July 2021), a total of 60 
patients were included in this report, of which the following dosing levels/schedules were 
explored: 1.92 mg/kg q4w (n=12), 2.5 mg/kg q4w (n=7), 2.5 mg/kg in cycle 1 followed 
by 1.9 mg/kg in cycle 2+ Q4W (n=5), 2.5 mg/kg q8w (n=12), 2.5 mg/kg q12w (n=11), 
2.5 mg/kg SPLIT (n=8) and 3.4 kg/mg SPLIT (n=5) (i.e. one half dose was given on D1 
and D8 of each 28-day cycle).  
The overall safety profile for belantamab mafodotin in combination with Pd remains 
consistent with known toxicities of each component, and no new safety concerns were 
identified. The most frequently reported AEs were corneal and haematological toxicities 
and most events resolved (or were resolving) following protocol defined monitoring and 
dose modifications. 
As of 15 July 2021, 54 of 60 participants in Study 209418 were evaluable for efficacy 
response, and across all cohorts the ORR was 87% (10 PR, 24 VGPR, and 13 CR). In the 
cohort of 2.5 mg/kg in cycle 1 followed by 1.92 mg/kg in cycle 2+; ORR was 100% (1 
PR, 2 VGPR and 2 CR) with a VGPR or better rate achieved by 80% of participants. The 
rationale of the selected belantamab mafodotin dosing regimen in DREAMM-8 is 
supported by a clinically significant positive predictive impact on reduction in corneal 
toxicity with minimal predictive negative impact on efficacy.  
2.4. 
Benefit:Risk Assessment 
Information regarding the known and expected benefits and adverse reactions associated 
with belantamab mafodotin are provided in the Investigator Brochure [GSK Document 

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Number RPS-CLIN-051778, IB V11, 2023]. A summary of risk assessment for potential 
overlapping toxicities with the combination of B-Pd are described below. 
Details on risks for pomalidomide, dexamethasone and bortezomib can be found in 
respective prescribing information; see Pharmacy Manual. 

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2.4.1. 
Summary of Risk Assessment for the Combination Therapy of B-Pd (Arm A) 
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Potential overlapping toxicities for belantamab mafodotin/pomalidomide/dexamethasone (Treatment Arm A) 
Thrombocytopenia 
Belantamab mafodotin:  Belantamab mafodotin may cause transient 
thrombocytopenia in some participants, which for most cases recovered 
between doses. 
In study 205678, which included participants treated with belantamab 
mafodotin 2.5 mg/kg, thrombocytopenia was noted in 38% of participants 
and ranged between Grade 1 to 4 in severity. 
Pomalidomide: May cause thrombocytopenia and anemia.  
Routine monitoring of hematologic panels as outlined in the SoA. 
Supportive therapy per local medical practice (e.g., platelet transfusion, 
growth factors). 
Dose modification guidelines are outlined in Section 6.6.1 and Section 
6.7.1. 
Pneumonitis 
Belantamab mafodotin: Non-clinical safety experiments have 
demonstrated the presence of progressive microscopic changes in the 
lungs (prominent alveolar macrophages associated with eosinophilic 
material; mixed perivascular/neutrophilic inflammation) in rats at all doses 
tested. 
Cases of pneumonitis, including fatal events, have been observed with 
belantamab mafodotin although a causal association has not been 
established.   
Pomalidomide: Interstitial lung disease and related events, including 
cases of pneumonitis, have been observed with pomalidomide. 
Monitoring for clinical signs and symptoms related to pulmonary 
toxicity. 
If a participant experiences new or worsening pulmonary symptoms, 
(e.g., cough, dyspnea) without obvious etiology, appropriate diagnostic 
evaluation should be performed (see protocol Section 6.7) and further 
treatment with belantamab mafodotin delayed. An overall benefit/risk 
assessment should be considered for the participant prior to continuing 
belantamab mafodotin treatment. 
Further diagnostic tests and management will be implemented 
immediately in cases of suspected pneumonitis as described in Table 
13 and Table 19. 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Hepatotoxicity 
Belantamab mafodotin: Nonclinical safety studies have identified the 
liver as a target organ for toxicity, with increased liver weights and/or 
raised hepatobiliary enzymes and transaminases observed in both rat and 
monkey. These changes in the liver were without clinical consequence in 
the shorter duration studies and in the rat 13-week study. In the monkey 
13-week study, progression of liver toxicity to include minimal multifocal 
hepatocellular necrosis was observed at all doses administered (≥3 
mg/kg/week).  
Elevated liver enzymes including AST, ALT, GGT and bilirubin have been 
observed in clinical trials with belantamab mafodotin. 
Pomalidomide: Hepatic failure, including fatal cases and elevated levels 
of alanine aminotransferase (ALT) and bilirubin reported. 
Only participants with well-preserved liver function per the 
inclusion/exclusion criteria will be allowed on study. 
Participants with Hepatitis B and C may be enrolled if meeting entry 
and agreeing to monitoring/treatment criteria. See Table 4 and Table 5 
and exclusion criteria in Section 5.2.   
Liver function tests will be monitored per SoA. 
Liver stopping criteria outlined in Section 7.1.1 
Increased Infections due 
to immunosuppression or 
neutropenia  
Belantamab mafodotin: In non-clinical studies, belantamab mafodotin 
has been associated with decrease in immunoglobulins in monkeys, at all 
doses. An increase in immunoglobulins was seen in rats (rats are not an 
antigen-specific species for belantamab mafodotin). 
Immunosuppression is frequently associated with an increased risk of 
infection. Serious and non-serious infections have been reported in 
belantamab mafodotin studies, including respiratory infections, 
pneumonia, and sepsis. 
Neutropenic events, including febrile neutropenia have been observed 
with belantamab mafodotin. 
Pomalidomide: Neutropenia was reported, rate of Grade 3-4 neutropenia 
was 46% and febrile neutropenia was 8%. 
Dexamethasone: Patients who are on corticosteroids are more 
susceptible to infections or exacerbation of latent infections than healthy 
individuals. Chickenpox and measles can have a more serious or even 
fatal course in pediatric and adult patients on corticosteroids. 
Patients with an active infection will be excluded. 
Monitoring for infections and immediate treatment of 
immunosuppression according to standard practice. 
Routine monitoring of hematologic panels as outlined in the SoA. 
Supportive therapy per local medical practice (e.g. growth factors). 
Prophylactic antibiotics, per local institutional guidance, in participants 
with Grade 3-4 neutropenia. 
Immediate hospitalization of participants with febrile neutropenia. 
Dose modification guidelines are outlined in Section 6.6.1 and Section 
6.7.1 
Keratopathy (changes to 
the corneal epithelium, 
Belantamab mafodotin: Changes in the corneal epithelium on ocular 
examination have been frequently observed with belantamab mafodotin 
and were most commonly associated with keratopathy (changes in the 
Active monitoring of the corneal epithelium and visual acuity as outlined 
in the SoA. 
Evaluation and management by an eye care professional. 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
potentially resulting in 
vision changes) 
corneal epithelium upon examination), blurred vision, dry eyes, 
photophobia, and changes in visual acuity. 
Participants with a history of dry eye were more prone to develop changes 
in the corneal epithelium. 
Based on available follow-up data, visual acuity returned to, or near 
baseline in most cases. 
Dexamethasone: Use of corticosteroids may produce posterior 
subcapsular cataracts, glaucoma with possible damage to the optic 
nerves, and may enhance the establishment of secondary ocular 
infections due to bacteria, fungi, or viruses. 
Dose modification guidelines are outlined in Section 6.6.1, Section 
6.7.1, and Section 7.1. 
Embryo-Fetal Toxicity 
Belantamab mafodotin: Nonclinical reproductive studies with belantamab 
mafodotin have not been conducted. Embryo-fetal toxicity is expected due 
to the cytotoxic component, cys-mcMMAF, via nonspecific uptake and/or 
BCMA-mediated toxicity (due to reports of BCMA expression in human 
placental cells [Langat, 2008]). 
Use of belantamab mafodotin in pregnant women may cause fetal harm. 
Pomalidomide: Pomalidomide is a thalidomide analogue and is 
contraindicated for use during pregnancy. Thalidomide is a known human 
teratogen that causes severe birth defects or embryo-fetal death. 
Pomalidomide is available only through a pregnancy prevention/controlled 
distribution program 
Pregnancy testing outlined in the SoA. 
Contraception requirements detailed in Section 10.3. 
Participants receiving pomalidomide must register with any pregnancy 
prevention/controlled distribution program in place locally (see SRM for 
details). 
Risks related to belantamab mafodotin not listed under potential overlapping toxicities 
Infusion-Related 
Reactions (IRRs) 
IRRs were reported in participants treated with belantamab mafodotin. 
Most IRRs were Grade 1-2 and manageable with medical treatment. 
Close monitoring for signs of IRR. 
Consider premedication for IRR. 
If an IRR occurs, follow the guidance in Section 7.1.3. 

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Potential Risk of Clinical 
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Summary of Data/Rationale for Risk 
Mitigation Strategy 
Nephrotoxicity 
Non-clinical safety experiments have demonstrated primary glomerular 
injury and tubular degeneration/regeneration (in rat and monkey). These 
morphologic changes were accompanied by large molecular weight 
proteinuria (albuminuria) and enzymuria. Single cell necrosis of the kidney 
and bladder urothelium was also noted in the 13-week monkey study. The 
renal changes were dose dependent and reversible. Severe tubular 
degeneration/regeneration and marked glomerulonephritis as a result of 
immune complex disease associated with ADA led to the early euthanasia 
of 1 monkey following 5 weekly doses of 10 mg/kg. 
Increased albumin/creatinine ratio (albuminuria) not indicative of disease 
progression has been reported in clinical trials and named patient 
programs with belantamab mafodotin, and in such cases appropriate 
monitoring and dose modification should be considered. 
Kidney function monitoring including albumin/creatinine ratio. 
Education of participants on the need to maintain adequate urinary 
output. 
Dose modification guidelines for increased serum creatinine and 
urinary albumin/creatinine ratio are outlined in Section 6.7.1. 
Risks related to Study Procedures 
BM Aspiration/Biopsy 
Pain, infection, bleeding may occur after the procedure. 
Participants will be treated according to institution’s practice. 
Incidental Findings 
During Imaging Data 
Acquisition 
During the acquisition of imaging data (e.g., MRI, CT, PET-CT), non-MM 
disease or clinically relevant abnormalities could be found by the 
radiographer performing the examinations. 
Copies of all medical images that include non-MM disease  clinically 
relevant abnormalities will be stored at the site. 
Abbreviations: ADA=Anti-Drug Antibody; AE=Adverse Event; ALT=Alanine Aminotransferase; AST=Aspartate Aminotransferase; BCMA=B Cell Maturation Antigen; BM=bone marrow; 
CK=Creatine Kinase; CT=Computed Tomography; cys-mcMMAF=Cysteine Maleimidocaproyl Monomethyl Auristatin F; DRESS=Drug Reaction With Eosinophilia And Systemic 
Symptoms; GGT=Gamma-glutamyl transferase; IRR=Infusion Related Reaction; LDH=Lactate Dehydrogenase;  MM=Multiple Myeloma; MRI=Magnetic Resonance Imaging; 
PET/CT=Positron Emission Tomography/Computed Tomography; PML=Progressive Multifocal Leukoencephalopathy; PRES=Posterior Reversible Encephalopathy Syndrome; 
PVd=Pomalidomide Plus Bortezomib And Dexamethasone; RPLS=Reversible Posterior Leukoencephalopathy Syndrome; SJS=Stevens Johnson Syndrome; SoA=Schedule Of 
Activities; SRM=Study Reference Manual; TEN=Toxic Epidermal Necrolysis; TLS=Tumor Lysis Syndrome; TTP/HUS=Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic 
Syndrome; ULN=Upper Limit Of Normal; VZIG=Varicella Zoster Immune Globulin. 
1. 
Refer to belantamab mafodotin Investigator’s Brochure and to local prescribing information for pomalidomide, bortezomib, and dexamethasone for further information. 

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2.4.2. 
Benefit Assessment 
As of 27 February 2019, results from the FTIH Study BMA117159 (DREAMM-1) 
indicated that belantamab mafodotin monotherapy administered at 3.4 mg/kg (n=35) is 
active in the RRMM population and demonstrated an ORR of 60.0% (95% CI: 42.1%, 
76.1%) and mPFS of 12.0 months (95% CI: 3.1 months, NR). In the Phase II pivotal 
Study 205678 (DREAMM-2), belantamab mafodotin was further evaluated as 
monotherapy in RRMM patients at doses of 2.5 mg/kg and 3.4 mg/kg q3w (97 in the 2.5 
mg/kg cohort and 99 in the 3.4 mg/kg cohort) [Lonial, 2020]. As per the inclusion 
criteria, all patients were refractory to immunomodulatory drugs and PIs, and had 
previously received an anti-CD38 monoclonal antibody. As of 31 January 2020, the ORR 
was 31% (97.5% CI: 21.7%,43.6%) in the 2.5 mg/kg cohort and 35% (97.5% CI: 24.8%, 
47.0%) in the 3.4 mg/kg cohort. The combination treatment of a highly active drug 
belantamab mafodotin with Pd is relatively safe with early signs of clinical activity as 
measured by objective response in an ongoing Phase I/II study conducted by the MCRN 
(Study 209418).  Responses obtained in 7 participants with 2.5 mg/kg belantamab 
mafodotin with Pd, were achieved deep responses (best overall response 6 VGPR and 1 
sCR). Based on this data, it is reasonable to hypothesize that such a combination will 
benefit MM patients, who are refractory to currently available treatments. 
This Phase III study is being performed to evaluate the efficacy and safety of belantamab 
mafodotin in combination with pomalidomide and dexamethasone (B-Pd) vs 
pomalidomide plus bortezomib and dexamethasone (PVd), an emerging SoC, for 
participants with RRMM who have been previously treated with at least 1 prior therapy, 
including lenalidomide. The study population enrolled in this study has a high unmet 
medical need. Participants failing multiple lines of prior treatments do not have many 
therapeutic options left, and if a response can be achieved with currently available drugs, 
it is usually of short duration.  
2.4.3. 
Overall Benefit:Risk Conclusion 
Considering the observed clinical activity of belantamab mafodotin as a single agent and 
when combined with Pd in patients with RRMM and based on the emerging data from B-
Pd in 209418 (MCRN 007), it is reasonable to assume that B-Pd may offer additional 
benefit over PVd to patients with RRMM by improving progression-free survival.  
Although there were overlapping toxicities, it is anticipated that belantamab mafodotin 
toxicities will be manageable. Considering the measures taken to minimize risks to 
participants in this study, the potential risks identified in association with belantamab 
mafodotin when combined with Pd are justified by the anticipated benefits that may be 
afforded to participants with MM. 

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3. 
OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 
To compare the efficacy of B-Pd with that of PVd in 
participants with RRMM 
• Progression-Free Survival (PFS), defined as the 
time from randomization until the earliest date of PD 
based on IRC-assessment per IMWG criteria, or 
death due to any cause. 
Key Secondary 
To further compare the efficacy of B-Pd with that of PVd 
in participants with RRMM 
• Overall Survival (OS), defined as the interval of time 
from randomization to the date of death due to any 
cause. 
• Duration of Response (DoR), defined as the time 
from first documented evidence of PR or better until 
progressive disease (PD) or death due to any 
cause. Response will be based on IRC-assessment 
per IMWG criteria.  
• MRD negativity rate, defined as the percentage of 
participants who achieve MRD negative status (as 
assessed by NGS at 10-5 threshold) at least once 
during the time of confirmed CR or better response 
based on IRC-assessment per IMWG. 
Secondary 
To further assess the efficacy of B-Pd in terms of other 
efficacy outcomes in participants with RRMM 
• Overall Response Rate (ORR), defined as the 
percentage of participants with a confirmed partial 
response (PR) or better (i.e., PR, VGPR, CR, and 
sCR) based on IRC-assessment per IMWG criteria. 
• Complete Response Rate (CRR), defined as the 
percentage of participants with a confirmed 
complete response (CR) or better (i.e., CR and 
stringent complete response (sCR)) based on IRC-
assessment per IMWG criteria. 
• Very Good Partial Response (VGPR) or better rate, 
defined as the percentage of participants with a 
confirmed VGPR or better (i.e., VGPR, CR, and 
sCR) based on IRC-assessment per IMWG criteria. 
• Time to Best Response (TTBR), defined as the 
interval of time between the date of randomization 
and the earliest date of achieving best response 
among participants with a confirmed PR or better 
based on IRC-assessment per IMWG. 
• Time to Response (TTR), defined as the time 
between the date of randomization and the first 
documented evidence of response (PR or better) 
among participants who achieve a response (i.e., 
confirmed PR or better) based on IRC-assessment 
per IMWG. 
• Time to Progression (TTP), defined as the time from 
randomization until the earliest date of PD based on 

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Objectives 
Endpoints 
IRC-assessment per IMWG criteria, or death due to 
PD. 
• PFS2, defined as time from randomization to 
disease progression (investigator-assessed 
response) after initiation of new anti-myeloma 
therapy or death from any cause, whichever is 
earlier. If disease progression after new anti-
myeloma therapy cannot be measured, a PFS 
event is defined as the date of discontinuation of 
new anti-myeloma therapy, or death from any 
cause, whichever is earlier. 
To evaluate the safety and tolerability of B-Pd 
• Incidence of AEs and changes in laboratory 
parameters  
• Ocular findings on ophthalmic exam 
To describe the exposure to belantamab mafodotin after 
infusion  
• Plasma concentrations of belantamab mafodotin, 
and cys-mcMMAF 
To evaluate the PK of pomalidomide in combination with 
belantamab mafodotin and dexamethasone, in a subset 
of participants 
• Derived PK parameter values, as data permit 
To assess ADAs against belantamab mafodotin 
• Incidence and titers of ADAs against belantamab 
mafodotin 
To evaluate the safety and tolerability of belantamab 
mafodotin based on self-reported symptomatic adverse 
effects when administered in combination with 
pomalidomide and dexamethasone 
• Maximum post-baseline PRO-CTCAE score for 
each item attribute 
To evaluate and compare changes in symptoms and 
HRQoL 
• Change from baseline in HRQoL as measured by 
EORTC QLQ-C30, EORTC QLQ-MY20* and 
EORTC IL52 
Exploratory 
To further evaluate the safety and tolerability of 
belantamab mafodotin when administered in 
combination with pomalidomide and dexamethasone 
• Changes in safety assessments, including vital 
signs 
To further characterize the PK profile of belantamab 
mafodotin when administered in combination with 
pomalidomide and dexamethasone 
• Derived PK parameter values for belantamab 
mafodotin and cys-mcMMAF, as data permit 
To evaluate self-reported ocular symptomatic AEs of 
belantamab mafodotin when administered in 
combination with pomalidomide and dexamethasone 
• Changes from baseline in symptoms and related 
impacts as measured by OSDI 
To further evaluate and compare changes in HRQoL 
and symptoms 
• Change from baseline in HRQoL as measured by 
EQ-5D-3L  
• Change from baseline in PGIS and change over 
time in PGIC 
To further evaluate the impact of side effects on QoL 
• Change from baseline in FACT-GP5 
To further explore the efficacy in terms of MRD-
negativity 
• Sustained MRD negativity rate: defined as the 
percentage of participants who achieve MRD 
negative status assessed by NGS at 10-5 threshold 
at least twice, a minimum of 12 months apart and 

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Objectives 
Endpoints 
with no MRD positive result in between, during the 
time of confirmed CR or better response.  
• Imaging plus MRD-negativity rate, defined as the 
percentage of participants who achieve MRD 
negative status assessed by NGS at 10-5 threshold 
and have no evidence of disease on PET-CT at 
least once during the time of confirmed CR or better 
response  
To evaluate and compare nonprotocol-specified HCRU 
• Out-patient visits by physician specialty 
• Emergency room visits 
• Home healthcare visits 
• Inpatient hospitalizations (including duration by 
wards (intensive care unit vs. general ward) 
To explore the exposure-response relationship between 
belantamab mafodotin exposure and clinical endpoints 
in participants treated with B-Pd 
• Belantamab mafodotin exposure (e.g., 
concentration, Cmax, or AUC) vs. efficacy and safety 
endpoints (e.g., PFS, ORR, CRR, corneal events) 
To explore the relationship between clinical response 
and biologic characteristics including, but not limited to, 
BCMA expression on tumor cells and sBCMA 
concentrations  
• Assess various tumor and blood-based biomarkers 
at baseline and on-treatment, by analysis of DNA, 
RNA and/or protein, including but not limited to 
evaluating baseline BCMA expression and/or 
immune status in tumor sample and in the tumor 
microenvironment and/or serum soluble BCMA 
levels, and their relationship to response to 
belantamab mafodotin 
To explore the effect of host genetic variation on the 
response to belantamab mafodotin and disease under 
study as well as related drug classes and diseases 
• Effect of host genetic variation in 1 or more 
candidate genes or across the genome on response 
to belantamab mafodotin and disease under study 
as well as related drug classes and diseases 
Abbreviations: ADA=anti-drug antibody; AE=adverse event; AUC=area under the concentration time curve; 
BCMA=B-cell maturation antigen; BM=Bone marrow; B-Pd=Belantamab mafodotin in combination with pomalidomide 
and dexamethasone; CR=Complete Response; CRR=Complete Response Rate; Cmax=maximum plasma 
concentration; cys-mcMMAF=cysteine-maleimidocaproyl monomethyl auristatin F; DoR=Duration of Response; 
EORTC IL52=European Organisation for Research and Treatment of Cancer Item Library 52; EORTC 
QLQ-C30=European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item core 
module; EORTC QLQ-MY20=European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire 20-item Multiple Myeloma Module; EoT=End of Treatment; EQ-5D-3L=European Quality of Life 5 
Dimensions 3 Level Scale; FACT-GP5=Functional Assessment of Cancer Therapy – General Population; 
HCRU=Healthcare Resource Utilization; HRQoL=Health-Related Quality of Life; MRD=Minimal Residual Disease; 
NGS=next-generation sequencing; ORR=Overall Response Rate; OS=Overall Survival; OSDI=Ocular Surface Disease 
Index; PFS=Progression-free Survival; PFS2=Progression-free Survival on subsequent line of therapy; PGIC=Patient 
Global Impression of Change, PGIS=Patient Global Impression of Severity; PK=Pharmacokinetic(s); PR=Partial 
Response; PRO-CTCAE=Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse 
Events; PVd=pomalidomide plus bortezomib and dexamethasone; QoL=quality of life; RRMM=relapsed/refractory 
multiple myeloma; sBCMA=soluble B-cell maturation antigen; sCR=stringent complete response; TTBR=time to best 
response; TTP=time to disease progression; TTR=time to response; VGPR=Very Good Partial Response. 
*EORTC IL52 applies to participants enrolled under the original protocol; EORTC QLQ-MY20 applies to participants 
enrolled under protocol amendment 1. 

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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This is a Phase III, multicenter, open-label, randomized study evaluating the efficacy and 
safety of B-Pd vs. PVd in participants with RRMM.  
The study will include a Screening Period, a Treatment Period, and a Follow-up Period.  
During the 28-day Screening Period, participants will be evaluated for study eligibility 
per protocol as defined in the Inclusion / Exclusion criteria (Section 5.1 and Section 5.2). 
Eligible participants must have a confirmed diagnosis of MM, been previously treated 
with at least 1 prior line of therapy including lenalidomide and must have documented 
disease progression during, or following, the most recent line of therapy.  
Following Screening, participants will be stratified based on the number of prior lines of 
therapy (1 vs. 2 / 3 vs. ≥4), prior bortezomib treatment (yes or no) and prior anti-CD38 
treatment (yes or no), and centrally randomized in a 1:1 ratio to either arm, as described 
in Section 6.1. Based on the emerging data and anti-CD38 such as daratumumab approval 
in the front-line setting, prior anti-CD38 exposure has been selected as a stratification 
factor, replacing ISS status. No more than 50% of participants with 2 or more prior lines 
of treatment will be enrolled. It is anticipated that no more than 15% of participants will 
be enrolled in with 4 or more prior lines of treatment. No cross-over between 2 treatment 
arms will be allowed. 
If the number of participants required by local regulatory agencies are not recruited 
within the planned recruitment target, enrollment may continue in separate cohorts until 
the country enrolment requirements are met, as requested by local regulatory authorities. 
Additional participants that are enrolled in separate cohorts will not be included in the 
analysis portion of the study planned for the marketing application. However, these 
additional participants will be included in country-specific supplemental analyses, as 
detailed in the country-specific Statistical Analysis Plan (SAP). 
During the Treatment Period, safety and disease assessments will be performed regularly 
according to the schedule of activities (SoA) (Section 1.3) for each arm. Treatment will 
continue in both arms until PD, death, unacceptable toxicity, start of a new anti-myeloma 
therapy, withdrawal of consent, or end of study, whichever occurs first. Dose 
interruptions or reductions may be required following potential drug-associated toxicities 
(see Section 6.6 and Section 6.7). 
For participants who discontinue study treatment for reasons other than PD, disease 
evaluations will continue to be performed every 4 weeks (±3 days) until confirmed PD 
(documented), death, start of a new anti-myeloma therapy, withdrawal of consent, loss to 
follow-up or end of the study, whichever occurs first. In case of PD, participants will be 
followed to ascertain subsequent anti-myeloma therapy, progression free survival on the 
subsequent line of therapy (PFS2), and survival status every 12 weeks (q12w) (±14 days) 
until withdrawal of consent, loss to follow-up, death or the end of the study as defined in 
Section 4.4. 

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Following the DCO (data cut-off) date for the final analysis (See Section 4.4), 
DREAMM-8 will move into the post analysis continued treatment (PACT) phase. This 
includes the global study population and participants in any country-specific expansion 
cohorts. At that time the collection of new data for participants who no longer receive 
study treatment will stop entirely and the clinical trial database will be closed. 
Participants in survival follow-up will be considered to have completed the study. Those 
participants still benefiting from study treatment in the opinion of their treating physician 
may continue to receive study treatment and only SAEs, AEs leading to treatment 
discontinuation, overdose, and pregnancy cases, and pre-specified ocular data (Arm A 
only) will be reported directly to GSK. 
The end of study is defined as the end of the safety follow-up following the last 
participant last dose i.e. the completion of the PACT phase.  
Note: In its most common usage, the start of a cycle is defined by when a participant 
takes the first dose of a drug for the given cycle. But because this study is assessing 3 
drugs given in combination, within the context of this protocol “cycle” refers to a planned 
cycle of doses for the 3 drugs, as per their individual planned dosing schedules. If 
administration of 1 or 2 of the drugs are delayed for any reason, the dosing of the other 
drug(s) should continue within the cycle as per the planned dosing schedule. If drug(s) 
that were delayed can be administered again during an ongoing planned cycle, dosing 
would resume according to what day it is relative to Day 1 of the planned cycle, and only 
the remaining planned doses for that cycle would be given. For example, if belantamab 
mafodotin is administered on Day 1 of a 28-day cycle, but pomalidomide and 
dexamethasone were both delayed until Day 8, pomalidomide would then be given on 
Days 8-21, and dexamethasone would be given on Days 8, 15, and 22. Dosing would 
then resume on Day 1 of the next planned cycle as per the planned dosing schedule. 
4.2. 
Scientific Rationale for Study Design 
Immunomodulatory drugs and PIs have been a cornerstone in the treatment of MM for 
many years [Kumar, 2014, Kumar, 2008, Richardson, 2007]. Combining active agents 
with lenalidomide/dexamethasone or bortezomib/dexamethasone treatment may yield 
improved patient outcomes with acceptable toxicity profiles, establishing new global SoC 
regimens. 
With the increasing use of lenalidomide in first-line either in combination with other anti-
myeloma drugs or as maintenance therapy after ASCT, pomalidomide is also emerging as 
a second-line regimen for RRMM. PVd (pomalidomide with twice-weekly bortezomib 
injected SC and low-dose dexamethasone) showed clinical activity when given in 21-day 
cycles (i.e., q3w) in a randomized Phase III trial (OPTIMISMM Study, N=559) in 
patients previously treated with lenalidomide and 1 to 3 prior lines of therapy [San 
Miguel, 2013; Paludo, 2017; Richardson, 2019]. PVd reduced the risk of progression and 
death by 39% compared with Vd (HR: 0.61; 95% CI: 0.49, 0.77, p<0.0001) with mPFS 
of 11.2 (vs. 7.1) months and an ORR of 82% (vs. 50%), including 15.7% sCR/CR, 37% 
VGPR, and 29.5% PR. The safety profile was consistent with known toxicities associated 
with other immunomodulatory agents, mostly comprising myelosuppression, infections, 
and neuropathy [Richardson, 2019]. Based on these findings, PVd has been approved by 

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EMA for treatment of patients with at least 1 prior lines of therapy including 
lenalidomide and thus has been selected as the control arm for the study. It is anticipated 
that the combination of PVd will become a SoC option for second line treatment of 
RRMM in other countries/regions as well.  
Belantamab mafodotin has demonstrated strong single-agent activity in two clinical 
studies (DREAMM-1 and DREAMM-2) conducted in heavily pre-treated participants 
with RRMM (Trudel, 2018; Trudel, 2019; Lonial, 2020). In the Phase II Study 205678 
(DREAMM-2), belantamab mafodotin was further evaluated as monotherapy in RRMM 
patients at doses of 2.5 mg/kg and 3.4 mg/kg q3w. The belantamab mafodotin dose of 
2.5 mg/kg q3w has been recommended as the monotherapy dose for RRMM due to its 
lower incidence of AEs, less frequent dose delays and reductions, and with similar 
efficacy as the 3.4 mg/kg dose as measured by ORR. Additional nonclinical studies have 
been performed to evaluate the anti-tumor activity of belantamab mafodotin in 
combination with bortezomib, pomalidomide or dexamethasone in two established MM 
xenograft mouse model. Belantamab mafodotin combinations with pomalidomide or 
bortezomib provided additional benefit compared to each single agent by significantly 
increasing survival in both mouse models [GSK Document Number RPS-CLIN-051778, 
IB V11, 2023].  
Based on the nonclinical data available for the belantamab mafodotin/pomalidomide 
combination and the clinical data for belantamab mafodotin monotherapy, it is therefore 
hypothesized that B-Pd may result in significant additive or synergistic effect, which 
could potentially translate into better clinical benefits compared to PVd in RRMM 
participants who are progressing on or after treatment with a lenalidomide-containing 
regimen. It is expected that due to its unique MOA, belantamab mafodotin will 
significantly improve mPFS and may be able to overcome the resistance to previously 
used drugs in the RRMM population. Initial safety and efficacy data of belantamab 
mafodotin at multiple dose levels in combination with Pd q4w has been evaluated in an 
ongoing Phase I/II study conducted by the MCRN (Study 209418, see Section 2.3.4). 
Preliminary data showed that B-Pd has resulted in early signal of clinical activity. The 
observed safety profile of B-Pd is consistent with the safety profile of belantamab 
mafodotin and pomalidomide. 
The two-arm design for Study 207499 will enable a comparison of the efficacy and safety 
between B-Pd q4w and PVd q3w in participants previously treated with lenalidomide and 
with at least 1 prior line of therapy. The belantamab mafodotin dose of 2.5 mg/kg will be 
administered in C1 followed by 1.9 mg/kg in C2+ in combination with Pd q4w in 
participants with RRMM.  The primary endpoint for Study 207499 is PFS, defined as the 
time from the date of randomization until the earliest date of documented disease 
progression (assessed by a blinded IRC), or death, whichever occurs first. Studies have 
shown a strong correlation between improvements in PFS and resultant OS benefits in 
MM, including RRMM [Dimopoulos, 2016; Cartier, 2015]. PFS is an acceptable 
regulatory endpoint with supporting OS data, with the advantages of requiring shorter 
duration of follow-up and not being confounded by subsequent treatments. Progression-
free survival as a primary endpoint has supported registration of several therapies for 
MM including lenalidomide-based therapy and the recent regulatory approvals of 

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carfilzomib and daratumumab combination regimens [Krypolis SmPC, 2019; Darzalex 
USPI, 2018]. 
The study will evaluate the duration of response (DoR), minimal residual disease (MRD) 
negativity rate and OS (defined as the time from the date of randomization until the date 
of death due to any cause), as well as a comprehensive panel of secondary endpoints 
(Section 3) including response rates. An Independent Data Monitoring Committee 
(IDMC) will review data from the interim analysis (IA) (see Section 9.6.1). 

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4.3. 
Justification for Dose 
4.3.1. 
Belantamab Mafodotin Dose 
Belantamab mafodotin has demonstrated strong single-agent activity in 2 clinical studies 
(DREAMM-1 and DREAMM-2) conducted in heavily pre-treated participants with 
RRMM (Trudel, 2018; Trudel, 2019; Lonial, 2020). The belantamab mafodotin 
monotherapy dose in RRMM has been selected to be 2.5 mg/kg when administered on a 
q3w schedule. This is based on the results from Study 205678 (DREAMM-2) that 
evaluated 2 doses of belantamab mafodotin (2.5 and 3.4 mg/kg) administered q3w until 
disease progression in patients who have failed at least 3 prior lines of anti-myeloma 
therapy, including an anti-CD38 antibody, and who are refractory to an 
immunomodulatory agent and a PI (n=218). Belantamab mafodotin monotherapy has 
generally been well tolerated, with manageable toxicities. The most frequent AEs (≥30% 
of participants) were corneal examination findings, cough, increased AST, 
thrombocytopenia/decreased platelet count, nausea, anemia, diarrhea, pyrexia, and chills 
(Section 2.3.1).  
Belantamab mafodotin at multiple dose levels q4w is currently being evaluated in 
combination with Pd in the Phase I/II Study 209418 conducted by the Myeloma Canada 
Research Network in RRMM participants who have failed at least one prior line of 
therapy. Based on the dose escalation criteria, both 1.92 mg/kg and 2.5 mg/kg doses of 
belantamab mafodotin have been considered to be safe with early signs of clinical 
activity when administered in combination with Pd in each 28-day cycle.  The observed 
safety profile of B-Pd is consistent with the safety profile of belantamab mafodotin and 
pomalidomide/ dexamethasone (see Section 2.3.4).  
Based on the totality of the data, the dosing regimen will be belantamab mafodotin 2.5 
mg/kg initial dose in Cycle 1 followed by 1.9 mg/kg in Cycle 2 and beyond (C2+) when 
combined with Pd q4w, for maximizing the tolerability and potential efficacy while 
limiting the dose delays/interruptions.  
Doses may be modified for Grade 2 or higher corneal events based on the KVA scale 
from 1.9 mg/kg q4w to Dose Level -1 of 1.9 mg/kg every other cycle (every 8 weeks) or 
in the event of a Grade 4 corneal event on KVA scale to Dose Level -2 of 1.4 mg/kg q8w 
(Protocol Section 6.7.1). The flexibility of an every other cycle dosing schedule as well 
as the reduced dose of 1.4 mg/kg may improve tolerability and is anticipated to still allow 
for meaningful target engagement given the reduction of belantamab mafodotin clearance 
and disease burden over time.  
In conjunction with the Dose Level –1 and Dose Level –2 a more aggressive toxicity 
management to prevent high-grade corneal events has been included.  Using a time-
course model developed with data from the DREAMM-2 study, different dose 
modification schedules were simulated to predict impact on corneal events over time.  
Results suggested dose modification at Grade 2 vs. Grade 3 corneal event has the 
potential to decrease the occurrence and duration of time at Grade 3 or higher corneal 
events. Therefore, the dose modification for corneal events (KVA scale) will occur at the 
first Grade 2 or greater event.  

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4.3.2. 
Pomalidomide Dose 
Pomalidomide is a thalidomide analogue indicated, in combination with dexamethasone, 
for patients with MM who have received at least 2 prior therapies including lenalidomide 
and a PI and have demonstrated disease progression from their last therapy [POMALYST 
USPI, 2019; Imnovid SmPC, 2019].  
In treatment Arm A, pomalidomide will be administered at the approved dosing regimen 
for use in combination with dexamethasone, i.e., PO at 4 mg daily on Days 1 to 21 of 
repeated 28-day cycles [POMALYST USPI, 2019; Imnovid SmPC, 2019]. In treatment 
Arm B, pomalidomide will be administered per the dosing schedule used in the PVd 
treatment arm of the OPTIMISMM trial, i.e., PO at 4 mg daily on Days 1 to 14 of 
repeated 21-day cycles [Richardson, 2019]. 
4.3.3. 
Bortezomib Dose 
Bortezomib is a proteasome inhibitor approved for use in patients with MM. In Arm B, 
bortezomib will be administered at the approved dose regimen at 1.3 mg/m2 SC on Days 
1, 4, 8, and 11 of every 21-day cycle for Cycles 1 through 8 and then on Days 1 and 8 for 
Cycles 9+ [VELCADE USPI, 2019; VELCADE SmPC, 2021].  
At least 72 hours should elapse between consecutive doses of bortezomib. 
4.3.4. 
Dexamethasone Dose 
Dexamethasone will be administered according to the regimen approved for use in 
combination with pomalidomide or bortezomib [POMALYST USPI, 2019; Imnovid 
SmPC, 2019; VELCADE USPI, 2019; VELCADE SmPC,, 2021]. 
In Arm A, dexamethasone will be administered PO at a dose of 40 mg per day on Days 1, 
8, 15, and 22 of each 28-day cycle. For participants who are >75 years old or have 
comorbidities or are intolerant to 40 mg, dexamethasone may be administered at the 
lower dose of 20 mg in Arm A at the discretion of the investigator. Refer to Section 6.6.1 
and Section 6.7.1 for instructions on dose delays and dose modification guidelines. 
In Arm B, dexamethasone will be administered PO at a dose of 20 mg on Days 1, 2, 4, 5, 
8, 9, 11, and 12 of every 21-day cycle for the first 8 cycles and on Days 1, 2, 8, and 9 of 
every 21-day cycle for Cycles 9+. For participants who are >75 years or have 
comorbidities or are intolerant to 20 mg, the dexamethasone dose may be lowered to 10 
mg on day of and day after bortezomib in Arm B at the discretion of the investigator. 
Refer to Section 6.6.2 and Section 6.7.2 for instructions on dose delays and dose 
modification guidelines. 

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4.4. 
End of Study Definition 
A final DCO representing the end of data collection, prior to the end of study (EOS), is defined as 
5 years from Last Participant First Visit (LPFV), or when all participants have died, 
withdrawn consent or have been lost to follow-up, whichever occurs first. Following the 
final analysis DCO date the study may move into the PACT phase and the clinical study 
database will be closed to new data. Participants who are receiving study treatment may 
continue to receive study treatment if they are gaining clinical benefit as assessed by the 
investigator until they meet any protocol-defined treatment discontinuation criteria. 
Participants in survival follow-up at the time of the final DCO date will be considered to have 
completed the study. Although the clinical study database will be closed at the time of the final 
DCO date, the study remains open until all participants discontinue study treatment and the EOS 
definition is reached. Any participants within an expansion cohort will have the option to 
move into the PACT phase following the global or country-specific planned final analysis 
DCO date, whichever is later. 
The end of study is defined as the end of the safety follow-up following the last 
participant last dose i.e. the completion of the PACT phase.  

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5. 
STUDY POPULATION 
The study will enroll adult participants with RRMM who have been previously treated 
with lenalidomide and at least 1 prior line of therapy, and who have documented disease 
progression during, or after, their most recent therapy. No more than 50% of participants 
with 2 or more prior lines of treatment will be enrolled. Prospective approval of protocol 
deviations to recruitment and enrollment criteria, also known as protocol waivers or 
exemptions, is not permitted. Full criteria are included below. 
5.1. 
Inclusion Criteria 
General Eligibility 
Participants are eligible to be included in the study only if all of the following criteria are 
met: 
1. Capable of giving signed informed consent as described in Section 10.1.3, which 
includes compliance with the requirements and restrictions listed in the Informed 
Consent Form (ICF) and in this protocol. 
2. Male or female, 18 years or older (at the time consent is obtained). 
Note: In the Republic of Korea, a participant must be over 19 years of age inclusive 
at the time of signing the informed consent. 
3. Have a confirmed diagnosis of multiple myeloma as defined by the International 
Myeloma Working Group (IMWG) criteria [Rajkumar, 2016]. 
Diagnosis and Disease Status 
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 
(Section 10.6). 
5. Have been previously treated with at least 1 prior line of MM therapy including a 
lenalidomide-containing regimen (lenalidomide must have been administered for at 
least 2 consecutive cycles) and must have documented disease progression during or 
after their most recent therapy. 
Note: Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive 
cycles are eligible. 
Participants intolerant or refractory to bortezomib at 1.3 mg/m2 dose twice weekly 
dosing schedule are not eligible. 
6. Must have at least ONE aspect of measurable disease, defined as one the following:  
a. Urine M-protein excretion ≥200 mg/24 h, or 
b. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or 
c. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) 
and an abnormal serum free light chain ratio (<0.26 or >1.65) only if patient has 
no measurable urine or serum M spike. 

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7. Have undergone autologous stem cell transplant (ASCT) or are considered transplant 
ineligible. Participants with a history of ASCT are eligible for study participation 
provided the following eligibility criteria are met: 
a. ASCT was >100 days prior to the first dose of study medication 
b. No active bacterial, viral, or fungal infection(s) present 
8. All prior treatment-related toxicities (defined by National Cancer Institute -Common 
Terminology Criteria for Adverse Events [NCI-CTCAE] v5.0) must be Grade ≤1 at 
the time of enrolment, except for alopecia.  
Organ System Function 
9. Adequate organ system functions as defined by the laboratory assessments listed in 
Table 6. 
Table 6 
Adequate Organ System Function Based on Safety Assessments 
Organ System and Laboratory Tests 
Laboratory Values 
Hematologic1 
Absolute neutrophil count (ANC) 
1.5×109/L 
Hemoglobin 
8.0 g/dL 
Platelets  
75×109/L 
Hepatic 
Total bilirubin 
≤1.5×ULN; (isolated bilirubin >1.5×ULN is acceptable if bilirubin is 
fractionated and direct bilirubin is <35%) 
ALT 
2.5×ULN 
Renal 
eGFR2 
30 mL/min/1.73 m2  
Urine dipstick  
 
OR  
Albumin/creatinine ratio (from spot urine) 
Negative/trace (if 1+ only eligible if confirmed 500 mg/g 
(56 mg/mmol) by albumin/creatinine ratio (spot urine from first void) 
 
500 mg/g (56 mg/mmol) 
Abbreviations: ALT=Alanine Aminotransferase; ANC=Absolute Neutrophil Count; eGFR=Estimated Glomerular 
Filtration Rate; ULN=Upper Limit Of Normal; MDRD=Modified Diet In Renal Disease. 
Note: Laboratory results obtained during Screening should be used to determine eligibility criteria. In situations where 
laboratory results are outside the permitted range, the investigator may re-test the participant and the subsequent 
within range Screening result may be used to confirm eligibility. 
1. 
Without growth factor support, blood transfusion or platelet stimulating agents within 14 days of assessment, 
excluding erythropoietin. 
2. 
As calculated by MDRD formula (Section 10.7). 
Contraception 
10. Female Participants: 
Contraceptive use by women should be consistent with local regulations regarding 
the methods of contraception for those participating in clinical studies. 

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A female participant is eligible to participate if she is not pregnant or breastfeeding, 
and at least 1 of the following conditions applies: 
Is not a woman of childbearing potential (WOCBP) 
or 
Due to pomalidomide being a thalidomide analogue with a risk for embryofetal 
toxicity and prescribed under a pregnancy prevention/controlled distribution 
programme, WOCBP participants will be eligible if they commit either to abstain 
continuously from heterosexual sexual intercourse or use two methods of reliable 
birth control (one method that is highly effective plus an additional barrier method) 
[Section 10.3], beginning at least 4 weeks prior to initiating treatment with 
pomalidomide, during therapy, during dose interruptions and continuing for at least 4 
weeks following discontinuation of pomalidomide treatment. Thereafter, WOCBP 
participants must use one contraceptive method that is highly effective (with a failure 
rate of <1% per year) for a further 3 months for WOCBP in Arm A, and 6 months for 
WOCBP in Arm B. 
The investigator should evaluate the effectiveness of the contraceptive method in 
relationship to the first dose of study intervention. 
Two negative pregnancy tests must be obtained prior to initiating pomalidomide 
therapy in Arm A and Arm B. The first test should be performed within 
10 to 14 days and the second test within 24 hours prior to taking pomalidomide 
therapy. 
The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy.  
Additional requirements for pregnancy testing during and after study intervention are 
provided in Section 10.3 and the SoA. 
All WOCBP must agree not to donate eggs (ova, oocytes) for the purpose of 
reproduction during this period. 
11. Male Participants: 
Contraceptive use by men should be consistent with local regulations regarding the 
methods of contraception for those participating in clinical studies.  
Male participants are eligible to participate if they agree to the following from the 
time of first dose of study treatment until 6 months (Arm A) and 4 months (Arm B) 
after the last dose of study treatment to allow for clearance of any altered sperm:  
Refrain from donating sperm 
plus either: 
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle 
(abstinent on a long term and persistent basis) and agree to remain abstinent  
or 
Must agree to use contraception/barrier as detailed below 

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Agree to use a male condom, even if they have undergone a successful vasectomy 
and female partner to use an additional highly effective contraceptive method with a 
failure rate of <1% per year as described in Section 10.3 when having sexual 
intercourse. Male participants should also use a condom with pregnant females. 
12. In France, a participant will be eligible for inclusion in this study only if either 
affiliated to or a beneficiary of a social security category. 
5.2. 
Exclusion Criteria 
A participant will not be eligible for inclusion in this study if any of the following criteria 
are met: 
Prior or Concomitant Therapies 
1. Active plasma cell leukemia at the time of Screening. Symptomatic amyloidosis, 
active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, 
monoclonal plasma proliferative disorder, and skin changes). 
2. Participants after prior allogeneic SCT. 
Note: Participants who have undergone syngeneic transplant will be allowed only if 
no history of or no currently active graft versus host disease (GvHD). 
3. Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) or 
use of an investigational drug within 14 days or five half-lives (whichever is shorter) 
preceding the first dose of study drug; Prior treatment with an anti-MM monoclonal 
antibody drug within 30 days of receiving the first dose of study drugs.  
4. Plasmapheresis within 7 days prior to the first dose of study drug.  
5. Received prior treatment with or intolerant to pomalidomide.  
6. Received prior BCMA targeted therapy. 
7. Intolerant to bortezomib or refractory to bortezomib (i.e., participant experienced 
progressive disease during treatment, or within 60 days of completing treatment, 
with a bortezomib-containing regimen of 1.3 mg/m2 twice weekly). 
Prior or Concomitant Diseases or Conditions 
8. Evidence of cardiovascular risk including any of the following: 
a. Evidence of current clinically significant untreated arrhythmias, including 
clinically significant ECG abnormalities including 2nd degree (Mobitz Type II) or 
3rd degree atrioventricular (AV) block. 
b. History of myocardial infarction, acute coronary syndromes (including unstable 
angina), coronary angioplasty, or stenting or bypass grafting within 3 months of 
Screening 
c. Class III or IV heart failure as defined by the New York Heart Association 
(NYHA) functional classification system (Section 10.8). 
d. Uncontrolled hypertension 
9. Any major surgery within the last 4 weeks. 

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10. Previous or concurrent invasive malignancy other than multiple myeloma, except: 
a. The disease must be considered medically stable for at least 2 years; or 
b. The participant must not be receiving active therapy, other than hormonal therapy 
for this disease. 
11. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to 
belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any 
of the components of the study treatment. 
12. Evidence of active mucosal or internal bleeding. 
13. Cirrhosis or current unstable liver or biliary disease per investigator assessment 
defined by the presence of ascites, encephalopathy, coagulopathy, 
hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice.  
Note: Stable non-cirrhotic chronic liver disease (including Gilbert’s syndrome or 
asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria). 
14. Active infection requiring treatment. 
15. Known human immunodeficiency virus (HIV) infection, unless the participant can 
meet all of the following criteria: 
• 
Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral 
load <400 copies/mL 
• 
CD4+ T-cell (CD4+) counts ≥350 cells/L 
• 
No history of AIDS-defining opportunistic infections within the last 
12 months  
Note: consideration must be given to ART and prophylactic antimicrobials that may 
have a drug:drug interaction and/or overlapping toxicities with belantamab 
mafodotin or other combination products as relevant (See Section 6.5.2): 
16. Patients with Hepatitis B will be excluded unless the following criteria can be met, 
Table 7: 
Table 7 
Hepatitis B criteria 
Serology* 
Screening 
During Study Treatment 
HbcAb+, HbsAg- 
• 
HBV DNA undetectable 
• 
Monitoring per protocol 
(Section 8.2.8) 
• 
Antiviral treatment instituted 
if HBV DNA becomes 
detectable 
HBsAg+ at screen 
or within 3 months 
prior to first dose  
• 
HBV DNA undetectable 
• 
Highly effective antiviral treatment 
started at least 4 weeks prior to first 
dose of study treatment 
• 
Baseline imaging per protocol 
• 
Participants with cirrhosis are excluded 
• 
Japan only: must test HBeAg and 
HBeAb Eligibility verification should be 
evaluated and agreed with a 
• 
Antiviral treatment 
maintained throughout study 
treatment 
• 
Monitoring and management 
per protocol (Section 8.2.8)  

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Serology* 
Screening 
During Study Treatment 
hepatologist (after they record the 
approval in the patient medical record). 
Abbreviations: DNA=deoxyribonucleic acid; HBcAb=hepatitis B core antibody; HBsAb= hepatitis B surface antibody; 
HBsAg=hepatitis B surface antigen; HBV=hepatitis B virus; HBeAg=hepatitis B e antigen; HBeAb=hepatitis B e 
antibody 
Note: Presence of isolated Hep B surface antibody (HBsAb), indicating previous vaccination, will not exclude a 
participant 
*Japan only: Patients with serology of HBcAb+ and/or HBsAb+ AND HbsAg- are eligible if HBV DNA is undetectable. 
see Appendix 10 for country-specific requirements. 
17. Positive hepatitis C antibody (Hep C Ab) test result or positive hepatitis C RNA 
(Hep C RNA) test result at Screening or within 3 months prior to first dose of study 
treatment unless the participant can meet the following criteria: 
• RNA test negative 
• Successful anti-viral treatment (usually 8 weeks duration) is required, followed 
by a negative HCV RNA test after a washout period of at least 4 weeks.  
18. Intolerance or contraindications to anti-viral prophylaxis. 
19. Presence of active renal conditions (e.g., infection, severe renal impairment requiring 
dialysis or any other condition that could affect participant’s safety). Participants 
with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria 
given in Table 6 
20. Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to 
randomization or ≥ Grade 3 peripheral neuropathy. 
21. Active or history of venous and arterial thromboembolism within the past 3 months. 
22. Contraindications to or unwilling to undergo protocol-required anti-thrombotic 
prophylaxis. 
23. Current corneal disease except for mild punctate keratopathy.  
24. Any serious and/or unstable pre-existing medical, psychiatric disorder or other 
conditions (including laboratory abnormalities) that could interfere with participant’s 
safety, obtaining informed consent or compliance to the study procedures. 
25. Pregnant or lactating female. 
5.3. 
Lifestyle Considerations 
Following lifestyle restrictions applies while the participants are in the study:  
• 
Contact lenses are prohibited for participants on Treatment Arm A, while they 
are receiving belantamab mafodotin treatment. Contact lens use may be restarted 
after a qualified eye care specialist (see Appendix 11) confirms there are no 
other contraindications. Use of bandage contact lenses is permitted during study 
treatment as directed by the treating eye care specialist. 
• 
Killed or inactivated vaccines may be administered; however, the response to 
such vaccines cannot be predicted. 

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• 
Participants must fast for at least 2 hours before and 1 hour after pomalidomide 
dosing in Cycle 1 Day 1 only. 
• 
Because corticosteroids may increase blood glucose concentrations, dose 
adjustments of antidiabetic agents may be required. 
• 
Participants must not donate blood when receiving pomalidomide, during dose 
interruptions, and for 28 days following discontinuation of pomalidomide, as 
transfused blood might be given to a pregnant female whose fetus must not be 
exposed to the drugs. 
No other lifestyle restrictions are required for participants in this study. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study 
but are not subsequently randomized. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants to meet the 
Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to 
respond to queries from regulatory authorities. Minimal information includes 
demography, screen failure details, eligibility criteria, and any serious adverse events 
(SAEs). 
Individuals who do not meet the criteria for participation in this study (screen failures) 
may be rescreened. Rescreening of a participant more than once requires discussion with 
the Medical Director. Rescreened participants must be assigned a new unique participant 
number that is different from the initial number.  

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6. 
STUDY INTERVENTION 
6.1. 
Study Intervention(s) Administered 
Refer to the Pharmacy Manual for further details on preparation, handling, and 
administration instructions for study interventions. A summary of the identity and 
characteristics of the individual components of the Study Treatment is shown in Table 8.  
Table 8 
Study Treatment(s) Administered 
Treatment Arm 
Arm A (Experimental arm): B-Pd 
Arm B (Active Comparator arm): PVd 
Intervention Name 
Belantamab Mafodotin 
Pomalidomide 
Dexamethasone 
Pomalidomide 
Bortezomib 
Dexamethasone 
Treatment Cycle 
28-day cycle (q4w) 
21-day cycle (q3w) 
Dose Formulation 
Belantamab Mafodotin: lyophilized powder  
Pomalidomide: capsule 
Dexamethasone: tablet 
Pomalidomide: capsule 
Bortezomib: solution 
Dexamethasone: tablet 
Route of 
Administration 
Belantamab Mafodotin: IV  
Pomalidomide: PO 
Dexamethasone: PO 
Pomalidomide: PO 
Bortezomib: SC  
Dexamethasone: PO 
IV Dosing 
Instructions 
Belantamab mafodotin: Reconstitute 
belantamab mafodotin lyophilized powder 
100 mg/vial with 2.0 mL of sterile WFI, dilute 
with saline before use.  
Dilute belantamab mafodotin in normal 0.9% 
saline to the appropriate concentration for 
the dose. Doses of belantamab mafodotin 
are to be administrated as an IV infusion via 
an infusion pump. See the Belantamab 
Mafodotin IB for compatible administration 
materials. 
N/A 
Abbreviations: B-Pd=Belantamab Mafodotin In Combination With Pomalidomide And Dexamethasone; 
IB=Investigator’s Brochure; PVd=Pomalidomide Plus Bortezomib And Dexamethasone; q3w=Every 3 Weeks; 
q4w=Every 4 Weeks; WFI=Water For Injection. 
For both treatment arms, when participants self-administer pomalidomide and 
dexamethasone at home, compliance will be recorded in the Participant’s Study Diary. 
The entries in the Diary will be assessed through querying the participant during the site 
visits and documented in the source documents and Case Report Form (CRF). A record 
of the number of pomalidomide capsules and dexamethasone tablets dispensed to and 
taken by each participant must be maintained and reconciled with study intervention and 
compliance records. Intervention start and stop dates, including dates for intervention 
delays and/or dose reductions will also be recorded in the CRF. 

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6.1.1. 
Treatment Arm A Dosing Schedule 
The dosing schedule for Treatment Arm A (B-Pd) is depicted in Figure 3. 
Figure 3 
Summary of Dosing Schedule for Treatment Arm A (B-Pd) 
 
Abbreviations: B-Pd=Belantamab Mafodotin In Combination with Pomalidomide and Dexamethasone; 
Belamaf=Belantamab mafodotin; q4w=every 4 weeks. 
Belantamab mafodotin will be administered intravenously (IV) over at least 30 minutes at 
a single dose of 2.5 mg/kg dose on Day 1 (D1) of Cycle 1 and 1.9 mg/kg on Day 1 of 
Cycle 2+ in each 28-day cycle until confirmed PD or unacceptable toxicity. The dose to 
be administered is based on actual body weight calculated at Baseline. However, if the 
change of body weight is greater than 10%, the dose should be re-calculated based on the 
actual body weight at the time of dosing.  
Pomalidomide will be taken orally 4 mg per day on Days 1 to 21 of each 28-day cycle 
until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation 
of another anti-myeloma therapy or end of study, whichever occurs first. On Cycle 1 Day 
1, pomalidomide should be administered as close as possible to the end of the 1-hour rest 
period after administration of belantamab mafodotin and no later than 4 hours after the 
end of the rest period after administration of belantamab mafodotin. On subsequent 
pomalidomide and belantamab mafodotin co-administration days such as Cycle 2 Day 1, 
Cycle 3 Day 1, and thereafter, pomalidomide should be administered after the end of the 
1-hour rest period after administration of belantamab mafodotin. 
Dexamethasone will be administered orally at a dose of 40 mg per day on Days 1, 8, 15, 
and 22 of each 28-day cycle. For participants who are >75 years old or have 
comorbidities or are intolerant to 40 mg, dexamethasone may be administered at the 
lower dose of 20 mg in Arm A at the discretion of the investigator. 
Efficacy assessments will be performed every 4 weeks (±3 days), irrespective of dosing. 
Detailed guidelines for dose interruption and reduction are provided in Section 6.6. 
6.1.2. 
Treatment Arm B Dosing Schedule 
The dosing schedule for Treatment Arm B (PVd) is depicted in Figure 4. 

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Figure 4 
Summary of Dosing Schedule for Treatment Arm B (PVd) 
 
Abbreviations: PVd=Pomalidomide Plus Bortezomib and Dexamethasone; q3w=Every 3 Weeks. 
Pomalidomide will be administered PO at 4 mg daily on Days 1 to 14 of each 21-day 
cycle, with bortezomib injected SC at 1.3 mg/m2 on Days 1, 4, 8, 11, of each 21-day 
cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+ until 
disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of 
another anti-myeloma therapy or end of study, whichever occurs first. 
Dexamethasone will be administered PO at a dose of 20 mg on the day of and day after 
bortezomib, of each 21-day cycle or on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle 
for Cycles 1 through 8 and then on Days 1, 2, 8, 9, q3w for Cycles 9+ (Section 1.3). For 
participants who are >75 years old or have comorbidities or are intolerant to 20 mg, 
dexamethasone may be administered at the lower dose of 10 mg on the day of and day 
after bortezomib in Arm B at the discretion of the investigator.  
Efficacy assessments will be performed every 4 weeks (±3 days), irrespective of dosing. 
If either pomalidomide or bortezomib is permanently discontinued due to an AE, the 
participant will be allowed to continue on the study with the remaining doublet in PVd 
treatment regimen. Detailed guidelines for dose interruption and reduction are provided 
in Section 6.6. 
6.1.3. 
Belantamab Mafodotin 
6.1.3.1. 
Belantamab Mafodotin Pre/Post-Medication 
Premedication is not required prior to infusion unless deemed medically appropriate by 
the investigator. Premedication should be considered in any participant who experienced 
an infusion-related reactions (IRRs) at first or any subsequent infusion with belantamab 
mafodotin. 
IRRs should be managed by guidelines provided in Section 7.1.3. A participant that 
experiences a Grade 4 IRR associated with belantamab mafodotin should be permanently 
withdrawn from the study. 

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6.1.3.2. 
Corneal Supportive Care Guidelines 
Corneal events, which commonly manifest as superficial microcystic keratopathy, have 
been observed with ADCs, including those conjugated to MMAF.  
Further information regarding corneal events associated with belantamab mafodotin, 
including prophylactic measures are in Section 6.1.3.3. See the SoA (Section 1.3) for 
guidance on required monitoring for corneal toxicity. 
Sites are required to establish a close collaboration with an eye care specialist who will 
be responsible for assessing participants on Treatment Arm A and managing those who 
develop corneal events in close communication with Medical Director and possibly a 
GSK ophthalmologist.  
Participants on Treatment Arm A will be assessed by a qualified eye care specialist at 
Screening/Baseline and then q4w prior to dosing of any study medications, at the start of 
new treatment cycle, up to the sixth dose of belantamab mafodotin (assessment window 
of up to 5 days prior to dosing, but all effort should be made to schedule as close to 
belantamab mafodotin dosing as possible). If there are no significant ocular examinations 
findings, patient’s symptoms or vision changes up to and including the sixth dose exam, 
participants may have their ophthalmologic examinations decreased to once every 3 
months. If a participant subsequently develops a change in visual acuity or other ocular 
symptoms, the participant should be promptly evaluated by a qualified eye care specialist. 
In case of persistent ophthalmic examination findings, newly developed ocular symptoms 
or vision changes, the participants will have further ophthalmologic examinations, at least 
every cycle until resolution (to Grade 1 or baseline) or more frequently as clinically 
indicated by the qualified eye care specialist. 
If steroid eye drops are deemed medically necessary and prescribed, intraocular pressure 
must be monitored if used for >7 days.  
Participants on Treatment Arm B will be assessed by a qualified eye care specialist every 
6 months (± 4 weeks) and as clinically indicated and at the End of Treatment (EoT) (see 
ocular reference manual for further details). 
Participants who have corneal signs per Keratopathy Visual Acuity (KVA) scale present 
at end of treatment will continue to be followed every 3 months for up to 12 months, until 
they return to their baseline, or are deemed clinically stable by a qualified eye care 
specialist , whichever comes first. The definition of “clinically stable” may include any 
Grade 1 finding for mild keratopathy or a one-line change in vision due to intervisit 
variability, which is well defined/understood. Once clinically stable, an event will not be 
followed up further and no repeat examination is necessary. 
Treatment-related corneal events are to be graded according to the KVA scale. Dose 
modification guidelines and stopping criteria for belantamab mafodotin treatment-related 
corneal events based on the KVA scale and KVA scale are provided in Table 15.  

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6.1.3.3. 
Ocular Prophylaxis for Treatment Arm A 
Ocular prophylaxis should be instituted for all participants on Treatment Arm A as 
detailed in the SoA. Ocular prophylaxis is provided in Table 9: 
Table 9 
Prophylactic Measures for Corneal Toxicity Associated with 
Belantamab Mafodotin 
Prophylactic Measure1 
Dose and Administration 
Timing 
Preservative-free artificial tears 
Must administer in each eye at least 
4 to 8 times daily  
Administer daily beginning on 
Cycle 1 Day 1 until End of 
Treatment.  
Cooling eye mask 
May apply cooling eye mask to both 
eyes for approximately 1 hour or as 
much as tolerated by the participant  
At the start of each belantamab 
mafodotin infusion administration in 
the first hour for up to 4 hours, as 
tolerated 
1. 
Dose modifications and treatment for ocular toxicities are discussed in Section 6.6. 
While not yet clinically demonstrated, it is theoretically possible that the application of a 
cooling eye mask during belantamab mafodotin administration, and in the first few hours 
after infusion may subsequently decrease ocular side effects. 
Corticosteroid eye drops are not required but can be used if clinically indicated per 
discretion of an eye-care specialist. Allow at least 5-10 minutes between administration 
of artificial tears and steroid eye drops (if administered together). If steroid eye drops are 
deemed medically necessary and prescribed, intraocular pressure must be monitored if 
used for >7 days. 
In the event of ocular symptoms (i.e., dry eyes), the use of artificial tears may be 
increased up to every 2 hours, as needed. 
On Treatment Arm A, contact lenses are prohibited while the participant is on study 
treatment. Contact lens use may be restarted after a qualified eye care specialist confirms 
there are no other contraindications. 
Use of bandage contact lenses is permitted during study treatment as directed by the 
treating qualified eye care specialist.  
6.1.4. 
Pomalidomide 
Pomalidomide will be taken PO 4 mg per day in both arms on Days 1 to 21 of each 
28-day cycle (Arm A) or Days 1 to 14 of each 21-day cycle (Arm B). Pomalidomide 
capsules should be swallowed whole with water; the capsules should not be opened, 
broken, or chewed. Pomalidomide 4 mg PO or any reduced dose should be taken in the 
morning approximately at the same time each day and may be taken at home. 
Pomalidomide will be administered according to institutional instructions. 
If considered appropriate based on an assessment of a participant’s underlying risk 
factors, prophylactic anti-thrombotic agents may be prescribed by the investigator. 

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Refer to the Pharmacy Manual for further details on preparation, handling, and 
administration. 
6.1.4.1. 
Dosing for Participants with Hepatic Impairment 
Pomalidomide is metabolized primarily by the liver. Following single dose 
administration, the area under the concentration time curve (AUC) of pomalidomide 
increased 51%, 58%, and 72% in participants with mild (Child-Pugh class A), moderate 
(Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment compared to 
participants with normal liver function. 
Therefore, participants with normal hepatic function will receive 4 mg daily dose but 
participants with mild or moderate hepatic impairment require a 25% reduction in 
pomalidomide dose while participants with severe hepatic impairment should be 
receiving pomalidomide at a 50% reduced dose. See the pomalidomide label for further 
details. 
6.1.4.2. 
Dosing for Participants with Renal Impairment 
Participants with mild to severe renal impairment not requiring dialysis do not require a 
dose adjustment and should be treated per the recommended pomalidomide dose.  
In patients with severe renal impairment requiring dialysis, the AUC of pomalidomide 
increased by 38% and the rate of SAE increased by 64% relative to patients with normal 
renal function; therefore, dose adjustment by at least 25% is recommended. For these 
participants, pomalidomide should be administered after the completion of hemodialysis 
on dialysis days because exposure of pomalidomide could be significantly decreased 
during dialysis. See the pomalidomide label for further details. 
6.1.5. 
Bortezomib 
In Arm B, bortezomib 1.3 mg/m2 SC will be administered on Days 1, 4, 8, and 11 of 
every 21-day cycle for Cycles 1 through 8 and then on Days 1 and 8 of every 21-day 
cycle for Cycles 9+. In participants who experience a local injection site reaction, 
bortezomib will be delayed until the injection site reaction has resolved and the 
participant is considered clinically stable.  
Bortezomib dosing is based on the participant’s body surface area (BSA), which is 
calculated using a nomogram [West, 2000]. The reconstituted concentration of 
bortezomib for subcutaneous administration (2.5 mg/mL) is greater than the reconstituted 
concentration of bortezomib for intravenous administration (1 mg/mL). Because each 
route of administration has a different reconstituted concentration, caution should be used 
when calculating the volume to be administered.  
Dose modifications may be required for safety. Refer to Section 6.7 for more 
information. 
At least 72 hours should elapse between consecutive doses of bortezomib.  

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Sites for each SC injection (thigh, abdomen, or per institutional guidance) should be 
rotated. New injections should be given at least one inch from an old site and never into 
areas where the site is tender, bruised, erythematous, or indurated. 
If local injection site reactions occur following administration of bortezomib SC, a less 
concentrated solution (1 mg/mL instead of 2.5 mg/mL) may be administered SC.  
Refer to the Pharmacy Manual for further details on preparation, handling, and 
administration. 
6.1.5.1. 
Dose Calculation 
After determining the participant’s BSA in m2, use the following equations to calculate 
the total volume (mL) of reconstituted bortezomib to be administered: 
For subcutaneous administration (2.5 mg/mL concentration): 
[bortezomib dose (mg/m2) × participant BSA (m2)] ÷ [2.5 mg/mL] = Total bortezomib 
volume (mL) to be administered 
6.1.5.2. 
Dosing for Participants with Hepatic Impairment 
Participants with mild hepatic impairment do not require a starting dose adjustment and 
should be treated per the recommended bortezomib dose. During study treatment, 
participants with moderate or severe hepatic impairment should be receiving bortezomib 
at a reduced dose (see Section 6.7.2 for dose reductions). See the bortezomib label for 
further details. 
6.1.5.3. 
Dosing for Participants with Renal Impairment 
No clinically significant differences in the pharmacokinetics of bortezomib were 
observed based on renal impairment (including patients administered bortezomib after 
dialysis). Dosing adjustments of bortezomib in participants with renal impairment are 
therefore not necessary. However, since dialysis may reduce bortezomib concentrations, 
bortezomib should be administered after the dialysis procedure. See the bortezomib label 
for further details. 
6.1.6. 
Dexamethasone 
In Arm A, dexamethasone will be administered orally at a dose of 40 mg per day on Days 
1, 8, 15, and 22 of each 28-day cycle. For participants who are >75 years old or have 
comorbidities or are intolerant to 40 mg, dexamethasone may be administered at the 
lower dose of 20 mg in Arm A at the discretion of the investigator. 
In Arm B, dexamethasone 20 mg PO will be given on Days 1, 2, 4, 5, 8, 9, 11, and 12 of 
each 21-day cycle for the first 8 cycles and then on Day 1, 2, 8, and 9 for Cycles 9+. 
Dexamethasone should be taken at the same time of the day and may be taken at home. 

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For participants who are >75 years old or have comorbidities or are intolerant to 20 mg, 
dexamethasone may be administered at the lower dose of 10 mg on the day of and day 
after bortezomib in Arm B at the discretion of the investigator. 
Refer to the Pharmacy Manual for further details on preparation, handling, and 
administration contained in package inserts. 
6.2. 
Preparation/Handling/Storage/Accountability 
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are 
reported and resolved before use of the study intervention. 
Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention. All study interventions 
must be stored in a secure, environmentally controlled, and monitored (manual or 
automated) area in accordance with the labeled storage conditions with access limited to 
the investigator and authorized site staff. 
The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(i.e., receipt, reconciliation, and final disposition records). 
Further guidance and information for the final disposition of unused study intervention 
are provided in the Pharmacy Manual. 
Precaution will be taken to avoid direct contact with the study interventions. A Material 
Safety Data Sheet (MSDS) describing occupational hazards and recommended handling 
precautions will be provided to the investigator. In the case of unintentional occupational 
exposure notify the Medical Director and/or GSK study contact. 
6.3. 
Measures to Minimize Bias: Randomization and Blinding 
6.3.1. 
Interactive Response Technology System 
This is an open-label study. All participants will be centrally randomized using a central 
Interactive Response Technology (IRT) system. Before the study is initiated, log-in 
directions for the IRT system will be provided to each site to be used to for study drug 
supply. 
Each participant will be assigned a unique number that will not be reassigned to another 
participant if a participant assigned a number is found to be a Screen Failure. The unique 
participant number will remain for the duration of the study. 
Randomization list will be done centrally using a randomization schedule generated by 
the GSK Clinical Statistics Department in RandALL NG or by the Contract Research 
Organization, which will assign participants in a 1:1 ratio to Treatment Arm A and 
Treatment Arm B. As this is an open-label study, no blinding of treatment identity is 
needed for either Treatment Arm A or Treatment Arm B. 

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Upon completion of all the required Screening assessments, eligible participants will be 
registered into the Cenduit Interactive Response Technology (CIRT) system by the 
investigator or authorized site staff. Cenduit allows study sites to register and randomize 
participants, and also records stratification information. 
Cenduit Study-specific User Guide and Clinical Support Helpdesk contact information 
will be provided to sites. 
Study intervention will be dispensed at the study visits summarized in SoA. Returned 
study intervention should not be re-dispensed to the participants. 
6.3.2. 
Stratification 
Factors used for randomization include number of prior lines of therapy (1 vs. 2 /3 vs. 
≥4), prior bortezomib treatment (yes or no), and prior anti-CD38 treatment (yes or no).  
ISS status (I vs II/III) was a randomization factor but was replaced by prior anti-CD38 
treatment (yes or no) in Protocol Amendment 1.  
Refer to Section 9.5 for further details on how these randomization factors will be 
considered within the statistical analyses. 
No more than 50% of participants with 2 or more prior lines of treatment will be enrolled. 
It is anticipated that no more than 15% of participants will be enrolled with 4 or more 
prior lines of treatment. No cross-over will be allowed. 
6.4. 
Study Intervention Compliance 
When participants are dosed at the site, they will receive study intervention directly from 
the investigator or designee, under medical supervision. The date and time of each dose 
administered in the clinic will be recorded in the source documents. The dose of study 
intervention and study participant identification will be confirmed at the time of dosing 
by a member of the study site staff other than the person administering the study 
intervention. For orally administered doses, study site personnel will examine each 
participant’s mouth to ensure that the study intervention was ingested. 
Belantamab mafodotin will be intravenously administered to participants at the site. 
Bortezomib will be subcutaneously administered to participants at the site. 
Administration will be documented in the source documents and reported in the CRF. 
When participants self-administer oral study treatment(s) at home, dosing will be 
recorded in the Participant’s Study Medication Diary. The entries in the Diary will be 
assessed through querying the participant during the site visits and documented in the 
source documents and CRF. A record of the number of doses dispensed to and taken by 
each participant must be maintained and reconciled with study treatment and compliance 
records. Treatment start and stop dates, including dates for treatment delays and/or dose 
reductions will also be recorded in the CRF. 

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6.5. 
Concomitant Therapy 
Participants will be instructed to inform the investigator prior to starting any new 
medications from the time of first dose of study treatment until the EoT Visit. Any 
concomitant medication (including over-the-counter or prescription medicines, vitamins, 
and/or herbal supplements) that the participant is receiving at the time of enrolment or 
receives during the study must be recorded along with: 
• 
reason for use 
• 
dates of administration including start and end dates 
• 
dosage information including dose and frequency 
The Medical Director should be contacted if there are any questions regarding 
concomitant therapy. 
6.5.1. 
Permitted Concomitant Therapies 
Participants should receive full supportive care during the study, including transfusions of 
blood products, growth factors, and treatment with antibiotics, anti-emetics, anti-
diarrheals, and analgesics, as appropriate. 
• 
While the participants are receiving treatment with pomalidomide in either arm of 
the study, thromboprophylaxis is recommended and the choice of regimen should be 
based on an assessment of the participant’s underlying risks, in accordance with local 
prescribing information. 
• 
Antiviral prophylaxis is recommended in accordance with local prescribing 
information in participants being treated with bortezomib. 
• 
Concomitant therapy with bisphosphonates is allowed and recommended.  
• 
Concomitant prophylactic treatment for tumor lysis syndrome (according to local 
standards) in participants with high tumor load should be considered  
• 
Concomitant treatment or prophylaxis using monoclonal antibodies for serious 
conditions unrelated to MM, such as COVID, may be permitted after discussion with 
the GSK Medical Director. The preference is that doses are not given on the same 
day while on belantamab mafodotin treatment (applicable for all treatment cycles). 
Participants may receive local irradiation for pain or stability control. Appropriate 
imaging should be performed to establish presence of new lesions, which would 
constitute disease progression. 
While on study, a participant who is diagnosed with an unrelated malignancy that can be 
addressed by local therapy can can remain on study, study treatment may be resumed 
after discussion with the GSK Medical Director.  The participant should continue to be 
followed for disease progression of multiple myeloma as per the SoA. 

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6.5.2. 
Prohibited Concomitant Therapies 
Chronic treatment with oral steroids other than treatment specified in the SoA is 
prohibited while the participant is on study, with the exception of low-dose prednisolone 
(≤10 mg/day) as substitution in participants with adrenal insufficiency. A short course 
(7 days) of steroids is allowed to manage an AE. Steroids may be used to treat IRRs. 
Inhaled, intranasal, topical and topical ophthalmic steroids are not prohibited. 
Other prohibited therapies include: 
• 
Plasmapheresis: prohibited from 7 days prior to first dose through the end of study.  
• 
Any other approved or investigational anti-myeloma therapy not specified in this 
protocol (including but not limited to immunomodulatory and antineoplastic drugs or 
protease inhibitors). This is inclusive of all medications with activity against multiple 
myeloma and medications used for other indications that have anti-myeloma 
properties. 
• 
Investigational agents other than belantamab mafodotin. 
• 
Administration of live or live-attenuated vaccines are contraindicated 30 days prior 
to the first dose of study treatment and while on study. Use of live or live-attenuated 
vaccines is further contraindicated for at least 70 days following the last dose of 
belantamab mafodotin. 
For participants receiving belantamab mafodotin: 
• 
Elimination pathways for belantamab mafodotin and cys-mcMMAF have not been 
characterized in humans. Cys-mcMMAF was not an inhibitor, an inducer, or a good 
substrate of cytochrome P450 enzymes in vitro. Cys-mcMMAF was shown to be a 
substrate of P-glycoprotein (P-gp), OATP1B1, and OATP1B3 transporters in vitro.  
• 
Caution should be exercised when belantamab mafodotin is combined with strong 
inhibitors of P-gp, and strong inhibitors of OATP1B1 and OATP1B3 should be 
avoided unless considered medically necessary. See the SRM for more information. 
• 
For participants receiving anti-HIV and anti-microbials: 
Anti-HIV and anti-microbials that are OATP inhibitors (list provided in SRM;) and 
thus prohibited unless considered medically necessary. Preferably alternative 
antimicrobials and anti-HIV drugs would need to be prescribed to these patients. 
Pomalidomide is predominantly metabolized by CYP1A2 and CYP3A4 and is a P-
gp substrate.  In vitro pomalidomide was neither an inducer nor inhibitor of CYP, nor an 
inhibitor of transporter proteins P-gp.  Co-administration of pomalidomide with a strong 
CYP1A2 inhibitor, fluvoxamine, approximately doubled pomalidomide exposure.  
Thus, concomitant use of strong CYP1A2 inhibitors with pomalidomide should be 
avoided.   If a strong CYP1A2 inhibitor must be used, reduce pomalidomide dose by 
50%.  For further information see the prescribing information. 
Bortezomib is a substrate of CYP3A4, CYP2C19 and CYP1A2. Caution should be 
exercised when bortezomib is combined with CYP3A4 or CYP2C19 
substrates.  Participants should be closely monitored when bortezomib is administered in 

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combination with potent CYP3A4 inhibitors for signs of bortezomib toxicity and 
consider reducing bortezomib dose.  Strong CYP3A4 inducers may decrease exposure 
which may reduce bortezomib toxicity.  For further information see the prescribing 
information. 
6.6. 
Dose Modification and Delay 
Dose delays and reductions are permitted throughout the study as described below. 
After Cycle 1 Day 1, dose modifications may be made for individual participants based 
on safety findings. 
Dosing delays are also permitted for medical/surgical events or logistical reasons not 
related to study therapy (e.g., elective surgery, unrelated medical events, participant 
vacation, and/or holidays) but not for participant’s decision to delay treatment. For dose 
delays or interruptions lasting >1 cycle, the Medical Director should be contacted to 
discuss restarting treatment. 
For potential overlapping toxicities, such as hematologic toxicity, the investigator should 
use their clinical judgement on which agent should be dose-reduced first, or for severe 
toxicities, more than one agent can be held/ dose modified. Whenever possible, step-wise 
dose modification is recommended first in order to minimize the potential to compromise 
treatment efficacy. 
The reason for any dose delay must be documented in the participant's electronic Case 
Report Form (eCRF) and clinic record. Where safety findings cannot be ascribed solely 
to one study treatment, follow the guidance provided in Table 14. 
Efficacy and safety assessments must remain the same as scheduled for the study 
regardless of dose delay/interruption or modification. In any dosing delay scenario, 
response assessments should be carried out q4w (±3 days) in Arm A and at q3w±3 days 
(for safety) or q4w±3 days (for efficacy) in Arm B as described in the SoA (see Section 
1.3). For treatment delays within the treatment window, subsequent treatment dates will 
not be adjusted. 
6.6.1. 
Guidance on Dose Delays for Treatment Arm A (B-Pd) 
Table 10 summarizes the guidance on dose interruptions/delays for Treatment Arm A. 

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Table 10 
Dose Delays for B-Pd in Treatment Arm A 
Scenario 
Actions for belantamab mafodotin 
Actions for Pd 
1. Delay of only 
belantamab mafodotin 
After Cycle 1, a window of ± 3 days is 
acceptable for belantamab mafodotin 
dosing, but subsequent dosing dates will 
not be adjusted. Outside this window, 
treatment should be given on D1 of the 
next planned cycle, q4w. 
Continue Pd according to the regimen 
outlined in the SoA. 
2. Delay of only 
pomalidomide 
Continue belantamab mafodotin 
according to the schedule, q4w as 
outlined in the SoA. 
If pomalidomide treatment cannot be 
administered as planned, when a participant 
is ready to resume treatment, pomalidomide 
may be restarted at the appropriate time in 
the planned dosing regimen. If the 
participant is unable to receive 
pomalidomide on D1-21 of a given cycle, 
treatment could resume on D1 of next cycle, 
and missed pomalidomide doses will not be 
made up. Dexamethasone should be 
administered on the planned treatment day. 
3. Delay of only 
dexamethasone 
Continue belantamab mafodotin 
according to the schedule, q4w as 
outlined in the SoA. 
If participant is ready to resume treatment, 
dexamethasone may be restarted at the 
appropriate time in the planned dosing 
regimen (e.g., on Days 1, 8, 15, 22 q4w). If 
the participant is unable to receive 
dexamethasone on D22 of a given cycle, 
treatment could resume on D1 of next cycle, 
and missed dexamethasone doses will not 
be made up. Pomalidomide should be 
administered on the planned treatment day. 
4. Delay of Pd 
components in Arm A 
Continue belantamab mafodotin 
according to the schedule, q4w as 
outlined in the SoA if Pd are delayed. 
Follow Pd delay guidelines as outlined 
above for pomalidomide only delay 
(Scenario 2) or dexamethasone only delay 
(Scenario 3). 
5. Delay of both 
belantamab mafodotin 
and Pd 
Follow belantamab mafodotin only delay 
guidelines as outlined above (Scenario 
1). 
Follow Pd delay guidelines as outlined 
above for pomalidomide only delay 
(Scenario 2) or dexamethasone only delay 
(Scenario 3). 
6, Permanent 
discontinuation of 
belantamab mafodotin 
N/A 
Pd will be allowed to continue according to 
the schedule, q4w as outlined in the SoA. 
7. Permanent 
discontinuation of 
either pomalidomide or 
dexamethasone or 
both 
Continue belantamab mafodotin 
according to the schedule, q4w as 
outlined in the SoA. 
If either pomalidomide or dexamethasone is 
permanently discontinued, the remaining 
drug in Pd combination will be allowed to 
continue in Arm A. 
Abbreviations: B-Pd=Belantamab Mafodotin In Combination with Pomalidomide And Dexamethasone; N/A=Not 
Applicable; Pd=Pomalidomide In Combination with Dexamethasone; q4w=Every 4 Weeks; SoA=Schedule of Activities. 
6.6.2. 
Guidance on Dose Delays for Treatment Arm B (PVd) 
Table 11 summarizes the guidance on dose interruptions/delays for Treatment Arm B. 

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Table 11 
Dose Delays for PVd in Treatment Arm B 
Scenario 
Actions for 
Pomalidomide 
Actions for Bortezomib 
Actions for 
Dexamethasone 
1. Delay of only 
pomalidomide 
If pomalidomide treatment 
cannot be administered as 
planned, when a 
participant is ready to 
resume treatment, 
pomalidomide may be 
restarted at the 
appropriate time from D1 
to D14 of any 21-day 
cycle in the planned 
dosing regimen. If the 
participant is unable to 
receive pomalidomide on 
D1-14 of a given cycle, 
treatment could resume 
on D1 of next cycle, and 
missed pomalidomide 
doses will not be made 
up. 
Continue bortezomib 
according to the regimen 
outlined in the SoA. 
Continue dexamethasone 
according to the regimen 
outlined in the SoA. 
2. Delay of only 
bortezomib 
Continue pomalidomide 
according to the regimen 
outlined in the SoA. 
 
If bortezomib treatment 
cannot be administered as 
planned, when a 
participant is ready to 
resume treatment, 
bortezomib may be 
restarted at the 
appropriate time (e.g., on 
Days 1, 4, 8, or 11, q3w) 
in the planned dosing 
regimen. If the participant 
is unable to receive 
bortezomib on D11 of a 
given cycle, treatment 
could resume on D1 of 
next cycle, and missed 
bortezomib doses will not 
be made up.  
Continue dexamethasone 
according to the regimen 
outlined in the SoA. 
 
3. Delay of only 
dexamethasone 
Continue pomalidomide 
according to the schedule, 
q3w as outlined in the 
SoA. 
Continue bortezomib 
according to the regimen 
outlined in the SoA. 
If participant is ready to 
resume treatment, 
dexamethasone may be 
restarted at the 
appropriate time in the 
planned dosing regimen 
(e.g., on Days 1, 2, 4, 5, 8, 
9, 11, 12, of each 21-day 
cycle (q3w) for C1-8 and 
then then on Days 1, 2, 8, 
9, q3w for C9+). If the 
participant is unable to 
receive dexamethasone 
on D15 of a given cycle, 

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Scenario 
Actions for 
Pomalidomide 
Actions for Bortezomib 
Actions for 
Dexamethasone 
treatment could resume 
on D1 of next cycle, and 
missed dexamethasone 
doses will not be made 
up. 
4. Delay of Pd 
components in Arm B 
Follow the guidelines as 
outlined above for 
pomalidomide only delay 
(Scenario 1). 
Continue bortezomib 
according to the regimen 
outlined in the SoA. 
Follow the guidelines as 
outlined above for 
dexamethasone only 
delay (Scenario 3). 
5. Delay of Vd 
components in Arm B 
Continue pomalidomide 
according to the schedule, 
q3w as outlined in the 
SoA. 
Follow the guidelines as 
outlined above for 
bortezomib only delay 
(Scenario 2). 
Follow the guidelines as 
outlined above for 
dexamethasone only 
delay (Scenario 3). 
6. Delay of both 
pomalidomide and 
bortezomib 
Follow the guidelines as 
outlined above for 
pomalidomide only delay 
(Scenario 1). 
Follow the guidelines as 
outlined above for 
bortezomib only delay 
(Scenario 2). 
Continue dexamethasone 
according to the regimen 
outlined in the SoA. 
7, Permanent 
discontinuation of 
pomalidomide 
N/A 
Continue bortezomib 
according to the schedule, 
q3w as outlined in the 
SoA. 
Continue dexamethasone 
according to the regimen 
outlined in the SoA. 
8. Permanent 
discontinuation of 
bortezomib 
Continue pomalidomide 
according to the schedule, 
q3w as outlined in the 
SoA. 
N/A 
Continue dexamethasone 
according to the regimen 
outlined in the SoA. 
9. Permanent 
discontinuation of either 
pomalidomide and 
bortezomib or 
dexamethasone alone 
Continue the remaining 
drug(s) according to the 
schedule, q3w as outlined 
in the SoA 
Continue the remaining 
drug(s) according to the 
schedule, q3w as outlined 
in the SoA 
Continue the remaining 
drug(s) according to the 
schedule, q3w as outlined 
in the SoA 
Abbreviations: D=Day; N/A=Not Applicable; PVd=Pomalidomide Plus Bortezomib And Dexamethasone; q3w=Every 3 
Weeks; SoA=Schedule of Activities; Vd=Bortezomib Plus Dexamethasone. 
6.7. 
Dose Reductions Due to Toxicity 
6.7.1. 
Guidance on Dose Reductions in Treatment Arm A (B-Pd) 
After Cycle 1, participants may have their dose delayed or reduced for toxicities 
according to the recommendations. See Section 4.3 for the justification of dose. See 
Table 13 for dose modification guidelines for belantamab mafodotin-related AEs, Table 
14 for guidelines for drug-related otherwise specified AEs, and Table 15 for dose 
modification guidelines for corneal-related AEs associated with belantamab mafodotin 
based on the KVA scale. 
• 
Belantamab mafodotin will be administered at 2.5 mg/kg on D1 of Cycle 1 and then 
followed at 1.9 mg/kg on Day 1 of Cycle 2+ q4w. 
• 
Belantamab mafodotin dose may be reduced only for corneal toxicities, based on  
KVA scale, from 1.9 mg/kg q4w to Dose Level -1 of 1.9 mg/kg every other cycle (or 

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every 8 weeks). For Grade 4 corneal AEs, reduce to Dose Level -2 of 1.4 mg/kg 
q8w. Belantamab mafodotin dose modification for other treatment-related toxicity is 
described in Table 13 and Table 14. 
• 
If the participant cannot tolerate belantamab mafodotin at the lowest dose level, 
subsequent doses may be delayed/interrupted or discontinued. If belantamab 
mafodotin treatment is delayed/interrupted, the participant may continue Pd therapy. 
Table 12 
Belantamab Mafodotin Dose Levels for Corneal Toxicities 
Management: Treatment Arm A 
Dose Level 
Belantamab Mafodotin Dose 
Dose Level -1* 
1.9 mg/kg IV q8w (Only for Grade 2 and Grade 3; Corneal toxicities based on KVA 
Scale) 
Dose Level -2* 
1.4 mg/kg IV q8w (Only for Grade 4 Corneal toxicities based on KVA Scale) 
    *: Dose modifications are permitted for Corneal toxicities based on KVA Scale, see Table 15 

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Table 13 
Dose Modifications Guidelines for Belantamab Mafodotin Treatment-Related Adverse Events 
Toxicity 
Grade/Symptoms 
Recommendations for Belantamab Mafodotin 
Serum creatinine 
Graded according to NCI-CTCAE criteria 
Grade 2 
>1.5 - 3.0 x baseline;  
>1.5 - 3.0 x ULN 
• 
Repeat within 48 hours if elevation cannot be explained by concomitant sepsis, TLS, 
other severe condition with fever or dehydration. 
• 
If confirmed: withhold belantamab mafodotin, initiate treatment and monitoring as 
clinically indicated, and follow for resolution. 
• 
Discuss any further dosing with Medical Director 
Grade 3  
>3.0 x baseline;  
>3.0 - 6.0 x ULN 
Or 
Grade 4 
>6.0 x ULN 
• 
Provide appropriate medical treatment 
• 
If drug related, permanently discontinue treatment with belantamab mafodotin  
• 
If due to another cause (e.g. sepsis, dehydration), withhold treatment with Belantamab 
Mafodotin. Upon recovery to Grade 1, restart treatment at the same dose level. 
Spot urine (albumin/creatinine ratios) 
>2000 mg/g 
(or 224 mg/mmol) 
Re-test (at least 7 days apart). 
• 
If not confirmed, continue belantamab mafodotin at pre-held dose 
• 
If confirmed on re-test and no clear evidence of disease progression 
o 
Interrupt treatment with belantamab mafodotin 
o 
Repeat testing within 4 weeks 
o 
If spot urine <2000 mg/g (224 mg/mmol), may restart belantamab mafodotin at 
same dose level  
o 
If spot urine remains >2000 mg/g (224 mg/mmol) after 4 weeks, consider 
permanently discontinuing belantamab mafodotin; provide treatment as clinically 
indicated, and follow for resolutionb 

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Toxicity 
Grade/Symptoms 
Recommendations for Belantamab Mafodotin 
Urine Dipstick 
2+ 
• 
May continue belantamab mafodotin dosing 
• 
Confirm by quantitative assessment using albumin/creatinine (spot urine from first void)  
• 
If albumin/creatinine 2000 mg/g, at the next cycle follow guidance above for Spot 
Urine. 
3 
• 
Interrupt treatment and follow up for recovery. Implement quantification of 
albumin/creatinine ratio 
Thrombocytopenia 
(on days of dosing) 
 
Graded according to NCI-CTCAE criteria 
Grade 3 
• 
No bleeding: continue treatment with at the same dose level 
• 
With bleeding: withhold the dose, continue treatment after recovery at the same dose 
level 
• 
Consider additional supportive treatment (e.g., transfusion), as clinically indicated and 
per local practice. 
Grade 4 
• 
Withhold the dose. Consider restarting at the same dose level if recovered, or 
transfused to  Grade 3 only if there is no active bleeding at time of treatment restart 
• 
If thrombocytopenia is considered disease related, is not accompanied by bleeding, 
and recovers with transfusion to >25x109/L continuing treatment at the same dose 
level may be considered after discussion with the Medical Director 
Afebrile Neutropenia 
 
Graded according to NCI-CTCAE criteria 
Grade 3 
(Defined as ANC <1.0x109/L) 
• 
If noted on Day 1 of any cycle, withhold belantamab mafodotin dose 
• 
Resume belantamab mafodotin at pre-held dose once neutropenia recovers to Grade 
≤ 2 (ANC ≥ 1.0x109/L) on Day 1 of the subsequent cycle. 
• 
Prophylactic antibiotics, per physician discretion and local institutional guidance. 
Consider growth factors. 
• 
Local guidance must be followed for hematological monitoring, if more conservative 
than the protocol SoA specifications. 
• 
In cases of frequent recurrent neutropenia (ANC <1.0x109/L), consider at the same 
dose level of belantamab mafodotin 

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Toxicity 
Grade/Symptoms 
Recommendations for Belantamab Mafodotin 
Febrile neutropenia 
 
Graded according to NCI-CTCAE criteria 
Grade 3-4 
(Defined as: single temp of 38.3C, or 
sustained 38C for >1 hr AND ANC 
<1.0×109/L   
• 
Withhold the dose and immediately hospitalize participant with appropriate 
management, per local institutional guidance. 
• 
Consider additional supportive treatment per local practice (e.g. growth factors). 
• 
Upon recovery, consider at the same dose level of belantamab mafodotin, if 
neutropenia was drug-related. 
Infusion reaction2 
 
Graded according to NCI-CTCAE criteria 
Grade 2 
• 
Stop the infusion, provide medical treatment and continue at a reduced rate after 
resolution to Grade 0-1 
Grade 3 
• 
Further treatment with belantamab mafodotin needs to be discussed with Medical 
Director. Continuation only allowed after recovery to Grade 1 and with pre-
medication, and extension of infusion time to 2-4 hours. Any future infusion needs to be 
premedicated. 
Grade 4 
• 
Permanently discontinue 
Pneumonitis 
Graded according to NCI-CTCAE criteria 
Grade 2 
• 
Withhold treatment with belantamab mafodotin  
• 
Upon recovery to Grade 1, restart treatment at the same dose level. 
• 
Rechallenge with the same dose must be discussed with the GSK Medical Director 
Grade 3-4 
• 
Permanently discontinue treatment with belantamab mafodotin 
Abbreviations: ANC=absolute neutrophil count; NCI-CTCAE=National Cancer Institute-Common Terminology Criteria for Adverse Events v05; SoA=schedule of activities; TLS=tumor 
lysis syndrome; ULN=upper limit of normal. 
1. 
GSK Medical Director may consult GSK’s renal safety panel about plans to continue therapy. 
2. 
If symptoms resolve within 1 h of stopping drug infusion, the infusion may be restarted at 50% of the original infusion rate (e.g., from 100 mL/h to 50 mL/h). Otherwise dosing will 
be held until symptoms resolve and the participant should be premedicated at the next scheduled dose. 

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Table 14 
General Dose Modification and Management Guidelines for Drug-Related Adverse Events Not Otherwise 
Specified 
Severity 
Management 
Follow-up 
Grade 1 
• 
Administer symptomatic treatment as appropriate 
• 
Continue study drug(s)2 
• 
Provide close follow-up to evaluate for increased severity, no dose modification necessary 
Grade 2 
• 
Administer symptomatic treatment 
• 
Investigate etiology 
• 
Consider consulting subspecialist, and/or 
diagnostic procedure 
Symptoms resolved in ≤7 days: 
• 
Continue after resolution at the current dose 
Symptoms ongoing >7 days or worsening: 
• 
Delay study drug3, or consider at the same dose level  
• 
If recovery takes >3 weeks, consult GSK Medical Director 
• 
If symptoms continue or worsen to Grade 3-4, see below 
Grade 3 
• 
Provide appropriate medical treatment 
• 
Consider consulting subspecialist 
• 
Delay treatment till recovery to Grade 1 or less.  
• 
Consider restarting at the same dose level  
• 
Consider consultation with GSK Medical Director. 
• 
Exceptions: Participants who develop Grade 3 toxicities which respond to standard treatment 
and resolve to ≤ Grade 1 within 48 hours may continue treatment at scheduled dose  
Grade 4 
• 
Provide appropriate medical treatment 
• 
Consider consulting subspecialist 
• 
Discuss with Sponsor/Medical Director 
• 
Interrupt treatment.  
• 
Further treatment with belantamab mafodotin only allowed on individual basis if in the 
discussion with MM it is agreed that benefits outweigh the risks for a given participant 
1. 
Graded according to NCI-CTCAE v5.0 criteria. 
2. 
Treatment-related decisions can be made based on local laboratory results if central results are not available or delayed. 
3. 
In case a dose is delayed, the participant should wait for the next scheduled dose to resume treatment. 

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Table 15 
KVA Scale and Dose Modification Guidelines for Belantamab Mafodotin Treatment-Related Corneal Events Based 
on KVA Scale 
KVA Scale 
Grade 1 
Grade 2  
Grade 3 
Grade 4 
Corneal Events 
Corneal examination finding(s) 
Mild superficial keratopathy1 
Moderate superficial keratopathy2 
Severe superficial 
keratopathy3 
Corneal epithelial defect4 
Change in Snellen-equivalent 
BCVA5,6,7 
Decline from baseline of 1 line on 
Snellen-equivalent BCVA 
Decline from baseline of 2 or 3 lines 
(and Snellen-equivalent BCVA not 
worse than 20/200) 
Decline from baseline by more 
than 3 lines (and Snellen-
equivalent BCVA not worse 
than 20/200) 
Snellen-equivalent BCVA worse 
than 20/200 
Recommended Dosage Modifications per KVA scale 
Recommended Dosage 
Modifications8 
Continue treatment at current 
dose. 
Withhold treatment and allow to 
recover to Grade ≤1. The 
participant should restart at a lower 
dose, as follows: 
∙ If toxicity was identified prior to 
dosing Cycle 2, then the participant 
should be dosed at 1.9 mg/kg every 
4 weeks thereafter, as planned. 
∙ If toxicity was identified Cycle 2+, 
the participant should be dosed at 
1.9 mg/kg every 8 weeks thereafter. 
Follow the instructions 
provided for Grade 2. 
Hold treatment and allow to 
recover to Grade ≤1.  
Participant may be restarted 
following benefit/risk assessment 
and discussion between 
the eye care specialist, the 
investigator, and 
the Sponsor. 
If restart is approved, participant 
should be restarted at 1.4 mg/kg 
every 8 weeks. 
Abbreviations: BCVA=Best-Corrected Visual Acuity; KVA=Keratopathy Visual Acuity. 
1. 
Mild superficial keratopathy=mild superficial punctate keratopathy (documented worsening from baseline), with or without symptoms. 
2. 
Moderate superficial keratopathy=any/or a combination of: moderate superficial punctate keratopathy, patchy microcyst like deposits, subepithelial haze (peripheral), or a new 
peripheral stromal opacity. 
3. 
Severe superficial keratopathy=any/or a combination of: severe superficial punctate keratopathy, diffuse microcyst like deposits involving the central cornea, subepithelial haze 
(central), or a new central stromal opacity. 

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4. 
Corneal epithelial defect such as corneal ulcers. Corneal ulcer by definition means an epithelial defect with underlying stromal infiltration. 
5. 
Changes in visual acuity due to treatment-related corneal findings.  
• 
For participants who have BCVA worse than 20/20 in either eye at baseline, dose modification for that eye will be determined by the worsening of vision from baseline only 
(not by absolute BCVA at the visits).  
• 
If a participant has a baseline BCVA of 20/200 or worse in an eye, then belantamab mafodotin related changes in vision in the other eye will drive the dose modification. If a 
participant has baseline BCVA of 20/200 or worse in both the eyes, then the decision to delay or reduce belantamab mafodotin dose will be based on Principal Investigator’s 
assessment of benefit vs. risk based on corneal examination findings following a discussion with the qualified eye care specialist such as ophthalmologist/optometrist.  
• 
Dose modification should be based on the most severe grade. If eyes differ in severity, dose modification guideline should be applied based on the more severe eye.  
6. 
Snellen equivalent BCVA is recommended to be tested on a visual acuity chart which has an approximately equal number of letters per line and equal spacing between lines.    
7. 
If a participant has cataract surgery during the study the BCVA should be re-baselined (after the BCVA stabilizes if there are no corneal findings but prior to any further 
belantamab mafodotin administration) and subsequent visual acuity must then be assessed from this new “best” baseline value (see details in Ocular Study Reference Manual). 
8. 
Dose modification should be based on the most severe finding. If eyes differ in severity, dose modification guideline should be applied based on the more severe eye. Dose 
reductions of belantamab mafodotin will be triggered by Grade 2 or worse events of ocular exam findings or decrease in BCVA on day of dosing.  

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In Arm A, pomalidomide and dexamethasone dose reductions will be permitted in each 
28-day treatment cycle (i.e., q4w). Permitted dose level -1, level -2, and level -3 
reductions for pomalidomide and dexamethasone in Arm A are shown in Table 16 and 
Table 17. 
Table 16 
Permitted Dose Reductions for Pomalidomide  
Starting Dose Level 
Dose Level -1 
Dose Level -2 
Dose Level -3 
4 mg 
3 mg 
2 mg 
1 mg 
Table 17 
Permitted Dose Reductions for Dexamethasone in Arm A 
Starting Dose Level 
Dose Level -1 
Dose Level -2 
40 mg (≤75 years of age) 
20 mg 
12 mg 
20 mg (>75 years of age) 
12 mg 
8 mg 
See Table 19 for dose modifications guidelines for pomalidomide-related AEs and Table 
21 for dexamethasone-related AEs. If recovery from toxicities is prolonged beyond 
21 days in 28-day cycles, then the dose of dexamethasone will be decreased by 1 dose 
level. 
6.7.2. 
Guidance on Dose Reductions in Treatment Arm B (PVd) 
Pomalidomide dose reduction will be permitted in each 21-day treatment cycle (i.e., 
q3w). Permitted dose level -1, level -2 and level -3 reductions for pomalidomide are 
shown in Table 18. Detailed dose modification guidelines for pomalidomide-related AEs 
are described in Table 19. 
Table 18 
Permitted Dose Reductions for Pomalidomide 
Starting Dose Level 
Dose Level -1 
Dose Level -2 
Dose Level -3 
4 mg 
3 mg 
2 mg 
1 mg 

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Table 19 
Dose Modifications Guidelines for Hematologic and Other Toxicities 
associated with Pomalidomide Plus Dexamethasone 
Toxicity 
Dose Modification 
Neutropenia 
ANC <500 per L (<0.5×109/L) or febrile neutropenia 
(fever ≥38.5˚C and ANC <1000 per L [<1×109/L]) 
ANC return to ≥500 per L  
Interrupt pomalidomide treatment, follow CBC weekly 
Resume pomalidomide treatment at 3 mg daily 
For each subsequent drop <500 per L (<0.5×109/L) 
Return to ≥500 per L 
Interrupt pomalidomide treatment 
Resume pomalidomide treatment at 1 mg less than the 
previous dose 
Thrombocytopenia 
Platelet count <25,000 per L (<25×109/L) 
Platelet count returns to ≥50,000 perL (≥50×109/L) 
Interrupt pomalidomide treatment, follow CBC weekly 
Resume pomalidomide treatment at 3 mg daily 
For each subsequent drop <25,000 perL (<25×109/L) 
Return to ≥50,000 perL (≥50×109/L) 
Interrupt pomalidomide treatment 
Resume pomalidomide treatment at 1 mg less than the 
previous dose 
Cutaneous reactions 
Grade 2–3 
Consider dose interruption or discontinue pomalidomide 
Grade 4 
Permanently discontinue pomalidomide 
Hypersensitivity 
Angioedema and anaphylaxis reactions 
Permanently discontinue pomalidomide 
For other non-hematologic toxicities judged to be related to pomalidomide 
Grade 3-4 
Hold pomalidomide treatment and restart at the 
physician's discretion at next lower dose level when 
toxicity has resolved to Grade ≤2 
Abbreviations: ANC=Absolute Neutrophil Count; CBC=Complete Blood Count. 
• 
To initiate a new cycle of pomalidomide, the neutrophil count must be ≥500 per L, 
the platelet count must be ≥50,000 per L (≥50×109/L). 
• 
In case of neutropenia, the physician should consider the use of growth factors. 
• 
If adverse reactions occur after dose reductions to 1 mg, then the medicinal product 
should be discontinued. 
• 
Concomitant use of strong CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin and 
fluvoxamine) should be avoided. If strong inhibitors of CYP1A2 must be used, 
reduce pomalidomide dose by 2 dose levels. 
Dexamethasone dose reduction in Arm B will be permitted in each 21-day treatment 
cycles (i.e., q3w). If recovery from toxicities is prolonged beyond 14 days in 21-day 
cycles, then the dose of dexamethasone will be decreased by 1 dose level. Dose 
modification guidelines are described in Table 21 for dexamethasone-related AEs. 

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Permitted dose level -1 and level -2 reductions for dexamethasone in Arm B are shown in 
Table 20. 
Table 20 
Permitted Dose Reductions for Dexamethasone in Arm B 
Starting Dose Level 
Dose Level -1 
Dose Level -2 
20 mg (≤75 years of age) 
12 mg 
8 mg 
10 mg (>75 years of age) 
⎯ 
8 mg 
Table 21 
Dose Modifications Guidelines for Dexamethasone-Related AEs 
Toxicity 
Dose Modification 
Dyspepsia Grade 1-2 
Dyspepsia Grade ≥3 
Maintain dose and treat with H2 receptor blockers or 
equivalent. Decrease by 1 dose level if symptoms persist.  
Interrupt dose until symptoms are controlled. Add H2 blocker 
or equivalent and decrease 1 dose level when dose restarted.  
Edema Grade ≥3  
Use diuretics as needed and decrease by 1 dose level.  
Confusion or mood alteration Grade ≥2 
Interrupt dose until symptoms resolve. When dose restarted 
decrease by 1 dose level. 
Muscle weakness Grade ≥2  
Interrupt dose until muscle weakness Grade ≤1. Restart with 
decrease by 1 dose level. 
Hyperglycemia Grade ≥3 
 
Decrease dose by 1 dose level. Treat with insulin or oral 
hypoglycemic agents as needed  
Acute pancreatitis  
Discontinue dexamethasone treatment. 
Other Grade ≥3 dexamethasone-related AEs 
Stop dexamethasone dosing until AE resolves to Grade ≤2. 
Resume with 1 dose level decrease. 
Abbreviations: AE = adverse event; H2 = histamine H2 receptor. 
Bortezomib dose reduction will be permitted in each 21-day treatment cycle (q3w). 
Detailed dose modification guidelines are described in Table 23 for bortezomib-related 
AEs. 
Permitted dose level -1 and level -2 reductions for bortezomib in Arm B are shown in 
Table 22. 
Table 22 
Permitted Dose Reductions for Bortezomib in Arm B 
Starting Dose Level 
Dose Level -1 
Dose Level -2 
1.3 mg/m2 
1.0 mg/m2 
0.7 mg/m2 

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Table 23 
Dose Modification Guidelines for Hematologic and Other Toxicities 
Associated with Bortezomib Plus Dexamethasone in Arm B 
Toxicity 
Grade1 
Recommendations 
Hematological Toxicity2 
Grade 4 
• Withhold bortezomib therapy until symptoms of toxicity have 
resolved. 
• Bortezomib may then be reinitiated with 1 dose level reduction 
(from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2). 
Non-hematological 
toxicities (excluding 
peripheral neuropathy)2 
Grade 3 
• Withhold bortezomib therapy until symptoms of toxicity have 
resolved to Grade 1 or baseline. Then, bortezomib may be 
reinitiated with 1 dose level reduction (from 1.3 mg/m2 to 1 mg/m2, 
or from 1 mg/m2 to 0.7 mg/m2).  
• For bortezomib-related neuropathic pain and/or peripheral 
neuropathy, hold or modify bortezomib as outlined below. 
Peripheral neuropathy3 
Grade 1 
• Asymptomatic, without pain or loss of function: no action needed 
• With pain: reduce bortezomib dose to 1 mg/m2 
Grade 2 
• Moderate symptoms; limiting instrumental ADL4 
• With no pain: reduce bortezomib dose to 1 mg/m2 
• With pain: withhold bortezomib therapy until toxicity resolves. 
When toxicity resolves reinitiate with a reduced dose of 
bortezomib at 0.7 mg/m2 once per week. 
Grade 3 
• Severe symptoms; limiting self-care ADL5 
• Withhold bortezomib therapy until toxicity resolves. When toxicity 
resolves reinitiate with a reduced dose of bortezomib at 0.7 mg/m2 
once per week. 
Grade 4 
• Life-threatening consequences; urgent intervention indicated. 
• Discontinue bortezomib 
Abbreviations: ADL=activities of daily living; NCI-CTCAE=National Cancer Institute-Common Terminology Criteria for 
Adverse Events. 
1. 
Grading based on NCI-CTCAE v5.0, 27 November 2017. 
2. 
Criteria and Recommendations taken from Table 2 of Bortezomib Approved Labelling. 
3. 
Criteria and recommendations for peripheral neuropathy are taken from Section 2.7 and Table 5 of Bortezomib 
Approved Labelling. 
4. 
Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using phone, managing money, 
etc.  
5. 
Self-care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and 
not bedridden. 
6.8. 
Continued Access to Study Intervention after the Final 
Analysis and the End of the Study 
Study participants that continue to benefit from study intervention beyond the final 
analysis DCO date will continue to have access to study intervention until the end of the 
study as defined in Section 4.4. There is no planned intervention following the end of the 
study. 
The investigator is responsible for ensuring that consideration has been given to the post-
study care of the participant’s medical condition. 

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6.8.1. 
Continued Access to Study Intervention After Final Analysis Data 
Cut-off prior to EOS 
Participants who have not died, withdrawn consent or have been lost to follow-up and 
who continue to receive treatment at the time of the final analysis may continue to 
receive the same study drug(s) as received up until final analysis DCO date if in the 
opinion of their treatment physician, they are continuing to derive clinical benefit from 
continued treatment, and they do not meet any protocol-defined treatment discontinuation 
criteria (See Section 7.1). This includes the global study population and participants in 
any country-specific expansion cohorts. Any participants within an expansion cohort will 
have the option to move into the PACT phase following the global or country-specific 
planned final analysis DCO date, whichever is later. Study treatment will continue until a 
protocol defined treatment discontinuation criterion, as assessed by the investigator, has 
been met (see Section 7.1) 
Participants who continue study treatment in the PACT phase will be cared for in 
accordance with local standard clinical practice. Participants will continue to be 
monitored for all SAEs, AEs leading to treatment discontinuation, prespecified ocular 
data (Arm A only), overdoses and pregnancy while receiving study drugs. Information 
relating to participant care will be recorded on participant medical records but, with the 
exception of SAEs, AEs leading to treatment discontinuation, prespecified ocular data, 
overdoses and pregnancy outcomes that must continue to be reported to GSK, but will 
not otherwise be reported for the purposes of this study. 
Investigators must report all SAEs, AEs leading to treatment discontinuation, overdose 
and pregnancy cases until 70 days after receipt of their last dose of study treatmen in 
accordance with Section 8.3.1. Pre-specified ocular data (Arm A only) will be reported as 
outlined in Section 8.3.1. 
During the PACT phase, recording and follow up of SAEs, AEs leading to treatment 
discontinuation, overdose, pregnancy and pre-specified ocular data (Arm A only) will be 
done via paper forms 

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7. 
DISCONTINUATION OF STUDY INTERVENTION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Intervention 
Participants will receive study treatment according to the SoA (Section 1.3). Study drug 
must be permanently discontinued in the case of: 
• 
Confirmed disease progression, as defined by IMWG criteria [Kumar, 2016] 
• 
Unacceptable toxicity to the combination 
• 
Note: see below for advice on unacceptable toxicity for individual agents. 
• 
Participant has met any of the protocol defined safety stopping criteria. 
• 
Pregnancy  
Discontinuation of Individual Components of Combination Regimens 
At the discretion of the investigator, participant who must permanently discontinue any 
of the individual agents may continue with the rest of the study treatment until protocol-
defined treatment discontinuation criteria are met. Before discontinuing study treatment 
strictly due to disease progression, sites must contact the GSK Medical monitor to 
confirm progression meets IMWG criteria [Kumar, 2016]. The GSK Medical monitor 
will review the central laboratory results as well as imaging results (if applicable) to 
confirm progressive disease as per IMWG criteria.  If progressive disease criteria are not 
met, the investigator retains the decision to determine if treatment should be 
discontinued. However, the reason for treatment discontinuation should only be 
documented as disease progression if IMWG criteria for confirmed disease progression 
are met.  
In addition, study treatment may be permanently discontinued for any of the following 
reasons: 
• 
Deviation(s) from the protocol 
• 
Request of the participant or proxy (withdrawal of consent by participant or proxy) 
• 
Investigator’s discretion 
• 
Participant is lost to follow-up  
• 
The study is closed or terminated 
If the participant voluntarily discontinues from treatment due to toxicity, the AE will be 
recorded as the primary reason for permanent discontinuation on the eCRF.  
Once a participant has permanently discontinued from a study treatment, the participant 
will not be allowed to restart study treatment. 
All participants who permanently discontinue study treatment will have safety 
assessments at the time of discontinuation and during EoT follow-up as specified in the 
SoA.  

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Participants who permanently discontinue study treatment for reasons other than disease 
progression will remain in the study and will be followed for PFS according to the 
protocol schedule described in Section 1.3 until (whichever occurs first): 
• 
New anti-myeloma therapy is initiated 
• 
Disease progression 
• 
Death  
• 
Withdrawal of consent 
• 
Loss to follow-up 
• 
End of study 
Participants with documented disease progression whilst on treatment, or during PFS 
follow-up, will be followed for PFS2 and OS until death, withdrawal of consent, loss to 
follow-up or DCO at final analysis (as described in Section 4.4), whichever occurs first. 
Participants who have treatment-related ocular AEs at the EoT should be followed to 
resolution, as described in the SoA and Section 8.2.6 before discontinuing from the study. 
The primary reason for discontinuation of any of the individual components of the 
combination regimen study treatment must be documented independently in the medical 
record and within the clinical study database. 
All participants must be followed for survival, up to DCO at final analysis as defined in 
the protocol. Discontinuation of study treatment does not impact a participant’s 
participation in the study. The participant should comply to the protocol schedule of 
assessments and data collection should continue.  
If the participant does not agree to continue in-person visits, a modified follow-up must 
be arranged to ensure the collection of endpoints and safety information. This could be a 
telephone contact with the participant, a contact with a relative or treating physician, or 
collecting information from medical records. The approach taken should be recorded in 
the medical records. A participant who agrees to modified follow-up is not considered to 
have withdrawn consent or to have withdrawn from the study. 
 
7.1.1. 
Liver Chemistry Stopping Criteria 
Liver chemistry stopping and increased monitoring criteria have been designed to assure 
participant safety and evaluate liver event etiology. Discontinuation of study treatment 
for abnormal liver tests is required when the participant satisfies any of the stopping rules 
as shown in Figure 5. 

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Figure 5 
Liver Stopping and Monitoring Event Algorithm 
 
Abbreviations: ALT=Alanine Aminotransferase; INR=International Normalized Ratio; SAE=Serious Adverse Event; 
ULN=Upper Limit of Normal 
Refer to Section 10.4 for required Liver Safety Actions and Follow-Up Assessments and 
for required process for study intervention restart/rechallenge, if considered for the 
participant. 

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Figure 6 
Liver Monitoring Event Algorithm with Continued Therapy for 
ALT≥3×ULN but <8×ULN 
 
Abbreviations: ALT=Alanine Aminotransferase; INR=International Normalized Ratio; SAE=Serious Adverse Event; 
Tbili=Total Bilirubin; ULN=Upper Limit of Normal. 
Refer to Section 10.4 for required Liver Safety Required Actions and Follow-up 
Assessments and for required process for study intervention restart/rechallenge, if 
considered for the participant. 
7.1.1.1. 
Study Intervention Restart or Rechallenge after Liver Stopping Criteria 
Are Met 
A participant who met liver chemistry stopping criteria cannot resume study intervention 
unless all of the following conditions are met: 
• 
GSK approval is granted (as described below), 
• 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval, if 
required, is obtained and 
• 
Separate ICF for study intervention restart/rechallenge is signed by the participant 
and participant is informed of any associated risks 

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If GSK approval to restart/rechallenge participant with study intervention is not granted, 
then participant must permanently discontinue study intervention and may continue in the 
study for protocol-specified follow-up assessments. 
Refer to Section 10.4 and the SRM for full guidance. 
7.1.2. 
Corneal Event Stopping Criteria 
Belantamab mafodotin dose delay/interruption and stopping criteria are to be based on 
the Keratopathy Visual Acuity (KVA) Scale (Table 15). 
Participants who develop Grade 4 corneal events according to the  KVA scale must be 
discussed in detail between the treating qualified eye care specialist (Section 10.11), the 
GSK Medical Director and possibly a third party ophthalmologist, in order to determine 
whether the participant can be allowed to continue treatment with belantamab mafodotin, 
or permanently discontinue treatment (Section 6.7.1). The decision will be documented in 
study files, together with individual assessment of risk-benefit. 
7.1.3. 
Infusion-Related Reactions Stopping Criteria 
7.1.3.1. 
Belantamab Mafodotin 
Premedication is not required prior to first infusion unless deemed medically appropriate 
by the investigator following evaluation of IRRs. Premedication should be considered in 
any participant who experienced an IRR at first or any subsequent infusion with 
belantamab mafodotin. For infusion reactions of any grade/severity, immediately 
interrupt the belantamab mafodotin infusion and manage symptoms. Once reaction 
symptoms resolve, resume the infusion at a reduced rate. Premedication may be required 
with subsequent infusions (Section 6.1.3.1). 
A participant that experiences a Grade 4 IRR associated with belantamab mafodotin 
should be permanently withdrawn from the study. 
7.1.4. 
Allergic Reactions and Anaphylactic Reactions Stopping Criteria 
All participants will be monitored carefully for evidence of allergic response to treatment. 
A participant that exhibits signs or symptoms of severe hypersensitivity or anaphylaxis 
will receive appropriate medical treatment and will permanently discontinue study 
treatment. 
7.2. 
Participant Withdrawal from the Study 
• 
A participant may withdraw from the study at any time at his/her own request or may 
be withdrawn at any time at the discretion of the investigator for safety, behavioral, 
compliance or administrative reasons. This is expected to be uncommon. The 
primary reason for participant withdrawal from the study will be documented in the 
clinical study database. 

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• 
At the time of withdrawal from the study treatment, if possible, an (end of treatment) 
EoT Visit should be conducted and data collected, as shown in the SoA (Section 
1.3). See SoA for data to be collected at the End of Treatment Visit.  
• 
If a participant wishes to withdraw from study at the time of treatment 
discontinuation they should be asked as to whether they are willing to continue with 
survival follow up (which can be conducted by telephone). If a full study withdrawal 
including survival follow up is requested then this should be documented in the 
patients notes and within the clinical study database. 
• 
If the participant withdraws consent for disclosure of future information, the Sponsor 
may retain and continue to use any data collected before such a withdrawal of 
consent. 
• 
If a participant withdraws from the study, he/she may request destruction of any 
samples taken and not tested, and the investigator must document this in the site 
study records. 
• 
Participants who are withdrawn from the study treatment because of AEs/SAEs must 
be clearly distinguished from participants who are withdrawn for other reasons. 
Investigator will follow participants who are withdrawn from the study treatment due 
to an AE/SAE until the event is resolved or considered clinically stable (see Section 
10.2.4). 
• 
Withdrawn participants will not be replaced. 
Survival Follow Up (for OS Analyses) 
• 
Assessments for survival should be made every 12 weeks (±14 days) following 
disease progression until the final analysis DCO.  Survival information may be 
obtained via telephone contact with the participant, participant’s family or by 
contact with the participant’s current physician.  
• 
Survival data will be collected up to the time of the final analysis (i.e. when the 
final OS analysis will be performed, see Section 9.6.2). Participants should be 
contacted in the weeks prior to the data cut off for each analysis of survival to 
provide complete survival data. An additional contact would not be required if a 
scheduled survival follow up visit/call was conducted within this timeline.  
• 
Prior to the DCO for each planned analysis, a full OS sweep will be conducted. 
During the OS sweep, each surviving participant, or a close relative, will be 
contacted for a full collection of survival data, to provide the most accurate data 
for use in OS analyses. During this time, dates of deaths may also be obtained 
from public records such as death registries. This data will be collected in the 
clinical database.  
• 
If, for any reason, a participant is unable to have disease progression 
documented per IMWG criteria (this is expected to be rare), then OS follow up 
information will still continue to be collected as per SoA.  

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7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a 
required study visit: 
• 
The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts should be documented 
in the participant’s medical record. 
• 
Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study.  
• 
Site personnel, or an independent third party, will attempt to collect the vital status of 
the participant within legal and ethical boundaries for all participants randomized, 
including those who did not get study intervention. Public sources may be searched 
for vital status information. If vital status of the participant is determined as 
deceased, this will be documented and the participant will not be considered lost to 
follow-up. Sponsor personnel will not be directly involved in any attempts to collect 
vital status information. 
Discontinuation of specific sites or of the study as a whole are detailed in Section 
10.1.11. 
8. 
STUDY ASSESSMENTS AND PROCEDURES 
A signed, written ICF must be obtained from the participant prior to any study-specific 
procedures or assessments being performed. The timing of each assessment is listed in 
the SoA (Section 1.3).  
Whenever vital signs, 12-lead ECGs, and blood draws are scheduled for the same 
nominal time, it is recommended that the assessments occur in the following order: 
12-lead ECG, vital signs, blood draws. The timing of the assessments should allow the 
blood draw to occur at the exact nominal time. Detailed procedures for obtaining each 
assessment are provided in the SRM. 
• 
Study procedures and their timing are summarized in the SoA (Section 1.3). 
• 
Protocol waivers or exemptions are not allowed.  
• 
Demographic and baseline assessments will include year of birth, sex, race, and 
ethnicity. 
• 
Medical/medication/family history will be assessed as related to the 
inclusion/exclusion criteria listed in Section 5.1 and Section 5.2. 

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• 
Immediate safety concerns must be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or 
discontinue study treatment. 
• 
Inclusion/exclusion criteria will be assessed during screening until enrollment. A 
participant is considered enrolled when the investigator or designee has confirmed, 
through the eligibility form, that all eligibility criteria have been met. Any interval 
change in the participant's clinical course (e.g., laboratory values, concomitant 
medications, clinical condition) between enrollment and the first dose of 
investigational product that could impact the ability of the participant to safely 
receive their first dose should be jointly discussed between the investigator and 
medical monitor prior to dosing. 
• 
Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct. 
• 
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening 
log to record details of all participants screened and to confirm eligibility or record 
reasons for Screening failure, as applicable.  
• 
Procedures conducted as part of the participant’s routine clinical management (e.g., 
blood count) and obtained before signing of ICF may be utilized for Screening or 
Baseline purposes provided the procedure met the protocol-specified criteria and was 
performed within the time frame defined in the SoA (Section 1.3). 
• 
Survival follow-up can be conducted by chart review, phone call, or any other form 
of communication as laid out in the SoA.  
• 
Visit windows: 
– 
Baseline disease assessments must be completed with 28 days prior to dosing 
start unless otherwise specified. Refer to the SoA in Section 1.3.  
– 
Screening assessments performed within the permitted time need not be repeated 
on Cycle 1 Day 1 unless otherwise specified. 
– 
Safety laboratory assessments completed within 72 hours of first dose do not 
need to be repeated on Cycle 1 Day 1. 
– 
Pregnancy testing must be completed within 24 hours prior to first dose. 
– 
Imaging must be completed within 30 days prior to first dose. 
– 
 During study treatment, ±7-day window is acceptable for imaging. 
– 
On study q3w or q4w visits have a ±3-day window. 
– 
Ocular examinations to performed within 5 days prior to dosing after Cycle 1 
Day 1 
– 
PFS follow-up visits have a ±3-day window. 
– 
OS follow-up visits have a ±14-day window. 
– 
For other assessments, please refer to SoA (Section 1.3) 
A list of clinical laboratory assessments required during the study is included in Table 24. 

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Table 24 
List of Clinical Laboratory Assessments 
Hematology1 
Platelet count  
RBC count 
WBC count (absolute) 
Hemoglobin 
Hematocrit 
RBC Indices: 
MCV 
MCH 
MCHC  
Automated WBC Differential: 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
Clinical Chemistry1 
Potassium 
Creatinine 
Chloride 
Glucose 
Total bicarbonate (or Total CO2 or CO2CP) 
Sodium 
Calcium 
Magnesium 
Phosphorous 
eGFR 
Aspartate aminotransferase (AST) 
Total and direct bilirubin 
Alanine aminotransferase (ALT) 
Uric acid 
Gamma glutamyl transferase (GGT) 
Albumin 
Alkaline phosphatase 
Total protein 
Creatine kinase (CK) 
Lactate dehydrogenase (LDH) 
Urinalysis1 
Optional urine dipstick2 
Spot urine (from first void) for albumin/creatinine ratio3 
Other Laboratory Tests 
Blood glucose; HbA1c1; Pregnancy test (urine or blood)1; FSH1 and estradiol1 (as needed in women of 
non-childbearing potential only); Hepatitis B surface antigen (HBsAg)1, Hepatitis B core antibody (HBcAb)1, 
Hepatitis C antibody, Hep C RNA test1,3 (optional), LDH and CK isoenzymes4, 1. 
Note: Hep C RNA testing is optional but may be done to determine participant eligibility if Hep C Ab positive. Please 
refer to Table 5 regarding Hep C RNA testing. 
HBV-DNA testing will be done to determine participant’s eligibility if HBcAb positive or HBsAg positive. • Please 
refer to Table 4 regarding HBV-DNA testing during the study. 
HBeAg and HBeAb – Japan ONLY (please refer to Table 4, Table 7 and Appendix 10) 
PK and ADA
4 
Belantamab mafodotin pharmacokinetics (PK) and pomalidomide PK (Arm A only) 
Anti-drug antibodies (ADA) to belantamab mafodotin 
Disease Evaluation Laboratory Tests4 
UPEP 
Serum immunofixation 
Ca2+ corrected for albumin (serum) 
SPEP 
Urine immunofixation 
IgG, IgM, IgA, IgD/IgE5 

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Serum kappa/lambda FLC ratio 
24-hr urine collection for M 
protein 
Beta-2 microglobulin 
Biomarker Measurements4 
sBCMA (serum) 
Optional Testing4 
Optional genetic sample for pharmacogenomics (PGx)6; Optional bone marrow sample6 (BM or tissue) for BCMA 
expression and biomarker research may collected at PD. 
Abbreviations: ADA=Anti-Drug Antibody; ALT=Alanine aminotransferase; AST=Aspartate aminotransferase; BCMA-
B-cell maturation antigen; BM=bone marrow;; CK=creatine kinase; CO2=carbon dioxide; CO2CP=carbon dioxide 
combining power; eGFR=Estimated Glomerular Filtration Rate; FISH=Fluorescence-in-situ Hybridization; FLC=free 
light chain; FSH=Follicle-Stimulating Hormone; GGT=gamma-glutamyl transferase; HbsAg=Hepatitis B surface 
antigen; HbA1c=hemoglobin A1c; HbcAb=Hepatitis B core antibody; HBV-DNA=Hepatitis B virus-deoxyribonucleic 
acid; Hep C Ab=hepatitis C antibody; Hep C RNA=Hepatitis C RNA; Ig=immunoglobulin; IHC=immunohistochemistry; 
LDH=lactate dehydrogenase; MCH=Mean Corpuscular Hemoglobin; MCHC=mean corpuscular hemoglobin 
concentration; MCV=Mean Corpuscular Volume; MRD=Minimal Residual Disease; PD=Progressive disease; 
PK=Pharmacokinetic(s); RBC=Red blood cell; sBCMA=soluble B-cell maturation antigen; sCR=Stringent complete 
response; SPEP=serum protein electrophoresis; UPEP=urine protein electrophoresis; WBC=White blood cell. 
1. 
To be performed at local laboratory.  
2. 
Urine dipstick for protein may be used to assess for presence of urine protein. Albumin/creatinine ratio needs to 
be conducted in any participant with urine dipstick result of ≥1+ (at screening visit), or ≥2+ (during study 
treatment), or with positive protein if urine dipstick protein quantification is not available. 
3. 
If not available locally it can be performed centrally. 
4. 
To be performed at a central laboratory. 
5. 
Only for participants with IgD/E myeloma.  
6. 
Informed consent for optional sub-studies (e.g., genetic research) must be obtained before collecting a sample. 
8.1. 
Efficacy Assessments 
The primary endpoint of this study is PFS. Efficacy assessments will be performed every 
4 weeks (±3 days), irrespective of dosing. Standard disease assessments for RRMM will 
include the following assessments:  
• 
Urine protein electrophoresis (UPEP), urine immunofixation, 24-hour collection for 
urine M-protein  
• 
Serum protein electrophoresis (SPEP), serum M-protein, serum immunofixation 
• 
Calcium corrected for albumin 
• 
IgG, IgM, IgA 
• 
IgD, IgE (only in participants with IgD or IgE myeloma)  
• 
Serum kappa, lambda free light chain (FLC) ratio  
• 
Bone marrow (aspirate and/or biopsy) at Screening and to confirm CR. Additional 
BM testing if CR is achieved: biopsy for immunohistochemistry (IHC) to confirm 
sCR and aspirate for MRD assessment (Section 8.1.2). 
• 
PET/CT required once when participants achieve MRD-negative status (Section 
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• 
Imaging of extramedullary disease (in participants with extramedullary disease) 
• 
Physical examination (as indicated for palpable/superficial lesions) 
• 
Skeletal surveys at Screening and as clinically indicated  
Response evaluation will be performed according to the IMWG criteria [Kumar, 2016]. 
Baseline serum/urine disease assessment will be completed during Screening Period 
(within 28 days prior to the first dose of study treatment) and baseline imaging within 30 
days prior to the first dose of study treatment. On study serum and urine-based 
assessments (M-protein, FLC, ± immunofixation) will be performed every 4 weeks. 
Details for the preparation and shipment of samples for central laboratory assessments 
will be provided in the laboratory manual. 
In participants with extramedullary myeloma, the disease assessments must include 
imaging (e.g., CT, MRI, or PET/CT scans: the same method should be used throughout 
the study) and physical examination (as indicated for palpable/superficial lesions).  
For participants who are followed by imaging for extramedullary disease the imaging 
should be performed as described in the SoA (Section 1.3).  
All efficacy assessments on study must be performed on a calendar schedule and must 
not be affected by dose interruptions/delays. For post-Baseline assessments, a window of 
±3 days is permitted to allow for flexible scheduling. 
For participants who are discontinuing study intervention due to PD, the confirmation 
based on laboratory parameters must be performed from a different sample collection 
performed either on the same day, or preferably within 14 days of the original date of 
suspected disease progression, preferably before institution of any new anti-myeloma 
therapy. The assessments to be performed during EoT Visit are described in the SoA. If 
the last imaging assessment was greater than or equal to 8 weeks prior to the participant’s 
discontinuation from study treatment and PD has not been documented, a new disease 
assessment must be obtained at the time of discontinuation from study treatment. For 
participants with PD due to extramedullary disease, confirmatory scans are not required. 
The laboratory parameters do not need to be repeated if the extramedullary disease is the 
only site of progression. 
8.1.1. 
Response Evaluation 
Response will be assessed according to the IMWG criteria [Kumar, 2016] by the 
investigator and response will also be assessed by an independent review committee 
(IRC, 
 
8.1.2. 
Minimal Residual Disease Assessment and PET/CT Imaging 
Targeted next-generation sequencing (NGS)-based clonoSEQ assay will be used to assess 
MRD status at the sensitivity threshold of 10-5, utilizing a central testing laboratory. 
MRD testing should take place when a participant first achieves a confirmed response of 
VGPR or better, and repeated every 6 months until disease progression. In case of 
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deepening response from VGPR to CR, an MRD sample should be collected at the time 
of CR assessment and repeated every 6 months until PD. Response evaluation will be 
performed according to the IMWG Uniform Response Criteria for Multiple Myeloma 
[Kumar, 2016]. To assess no evidence of underlying disease by imaging, PET/CT will be 
performed once and within 42 days of the investigaor receiving confirmation of MRD 
negativity in participants who achieved CR or better response. 
8.2. 
Safety Assessments 
Planned time points for all safety assessments are provided in the SoA. Safety 
assessments include the following: 
• 
Complete physical examinations, including height (cm) and weight (kg) 
• 
Vital signs (blood pressure, body temperature, pulse rate) 
• 
Ocular examinations 
• 
ECOG performance status 
• 
Clinical chemistry, hematology, and other laboratory tests (Table 24) 
• 
Serum beta-human chorionic gonadotropin (-HCG) pregnancy test for female 
participants of childbearing potential only  
• 
12-lead ECG at Screening 
• 
Anti-drug-antibodies, pharmacokinetic testing for belantamab mafodotin 
• 
Patient-Reported Outcome version of Common Terminology Criteria for Adverse 
Events (PRO-CTCAE, [Babb, 1998; Basch, 2014]): The PRO-CTCAE includes an 
item library of 124 items representing 78 symptomatic toxicities drawn from the 
CTCAE. PRO-CTCAE provides a systematic yet flexible tool for descriptive 
reporting of symptomatic treatment side effects in cancer clinical trials. In the 
present study, a subset of items selected from the PRO-CTCAE Version 1.0 item 
library will be administered. 
• 
Visual Functioning Questionnaire: The visual function questionnaire will include 
select items from the Ocular Surface Disease Index (OSDI) [Schiffman, 2000]. 
8.2.1. 
Physical Examinations 
At Screening, on dosing days, and at end of treatment visit a full physical examination 
will include assessments of the head, eyes, ears, nose, throat, skin, thyroid, lungs, 
cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. Height (once 
at Screening only) and weight must also be measured and recorded. 
8.2.2. 
ECOG Performance Status 
Participant performance status will be assessed at Screening and then as specified in the 
SoA, using the ECOG scale (Section 10.6). 

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8.2.3. 
Vital Signs 
Vital sign measurements must include systolic and diastolic blood pressure, temperature, 
and pulse rate. Vital signs must be measured after resting for at least 5 minutes. Vital 
signs must be measured more frequently if warranted by the clinical condition of the 
participant. On days when vital sign time points align with blood sampling time points, it 
is recommended that vital signs should be assessed prior to blood samples being drawn. 
On days where vital signs are measured multiple times, temperature does not need to be 
repeated unless clinically indicated. 
8.2.3.1. 
Vital Sign Measurement  
For Treatment Arm A, vital signs are to be measured at the following time points at the 
time of first belantamab mafodotin infusions:  
• 
Within 30 minutes prior to start of infusion (SOI) 
• 
15 minutes after SOI (± 10 minutes)  
• 
Within 15 minutes after EOI  
• 
At 1 hour (± 10 minutes) after EOI 
On subsequent dosing days, vital signs must be assessed pre-dose (within 30 minutes 
prior to SOI) and within 15 minutes after EOI, and as clinically indicated. 
For Treatment Arm B, vital signs must be assessed within 30 minutes before and within 
15 minutes after each dose of bortezomib. 
8.2.4. 
Electrocardiogram 
12-lead ECGs must be obtained at Screening as specified in the SoA. The ECG machine 
should automatically calculate the heart rate and measure pulse rate, QRS, QT, and QTc 
(as QTcF) intervals. At each assessment, a 12-lead ECG must be performed by qualified 
personnel at the site after the participant has at least a 10 -minute rest. 
8.2.5. 
Clinical Safety Laboratory Assessments 
Clinical laboratory assessments including hematology, clinical chemistry, urinalysis, and 
additional parameters to be performed are listed in Table 24; refer to the SoA for the 
timing and frequency (Section 1.3). Details for the preparation and shipment of samples 
for central laboratory assessments will be provided in the laboratory manual. 
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF. The 
laboratory reports must be filed with the source documents. Clinically significant 
abnormal laboratory findings are those which are not associated with the underlying 
disease, unless judged by the investigator to be more severe than expected for the 
participant's condition. 

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All laboratory assessments with values that are significantly abnormal during 
participation in the study or within 70 days after the last dose of study treatment must be 
repeated until the values return to normal or baseline. If such values do not return to 
normal within a period judged reasonable by the investigator, the etiology must be 
identified, and the Sponsor notified. 
Asymptomatic elevations of lactate dehydrogenase (LDH) and creatine kinase (CK) and 
AST have been observed in study BMA117159 (DREAMM-1). Participants with 
elevations of LDH, CK and/or AST should, where possible, have a sample sent for 
central testing of CK and LDH isoenzyme levels. 
8.2.6. 
Ophthalmic Assessments 
Study sites must establish a close collaboration with a qualified eye care specialist (see 
Section 10.11) who will be responsible for assessing participants while they are on study 
and managing participants who develop corneal changes associated with belantamab 
mafodotin. Management of participants with corneal findings must be performed in close 
communication with the Medical Director and the coordinating qualified eye care 
specialist. 
Participants will be assessed by a qualified eye care specialist at Screening/Baseline in 
both arms.  
A full Screening/Baseline ophthalmic examination for all participants must include:  
1. Best corrected visual acuity 
2. Documentation of manifest refraction and the method used to obtain best corrected 
visual acuity  
3. Current glasses prescription (if applicable)  
4. Selected anterior segment (slit lamp) examination with focus on the cornea and lens, 
including fluorescein staining of the cornea.  
5. Intraocular pressure measurement and time checked  
6. Dilated funduscopic examination.  
The on-treatment and follow-up ophthalmic examinations should be performed as 
described below and in the SoA. 
This should include: 
1. Best corrected visual acuity  
2. Documentation of manifest refraction and the method used to obtain best corrected 
visual acuity  
3. Anterior segment (slit lamp) examination with focus on the cornea and lens, 
including fluorescein staining of the cornea.  
4. Intraocular pressure measurement (if clinically indicated) 

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5. Dilated funduscopic examination (if clinically indicated)  
The EoT and last follow-up ophthalmic examination should match the 
Screening/Baseline examination. 
Additional examinations should be performed at the discretion of the treating eye 
specialist. 
8.2.6.1. 
Treatment Arm A: B-Pd 
On-study ocular examinations are to be performed by a qualified eye care specialist at 
Screening/Baseline and then prior to each dose of belantamab mafodotin for the first 
6 doses (the schedule of assessment window should be within 5 days prior to dosing, all 
efforts should be made to schedule as close to belantamab mafodotin dosing as possible). 
If there  has been no change in vision and no ocular exam findings,  or ocular symptoms 
consistent with toxicity up to and including the sixth dose exam, participants may have 
their ophthalmologic examinations decreased to once every 3 months. If a participant 
subsequently develops vision changes or other ocular symptoms, the participant should 
be promptly evaluated by a qualified eye care specialist. 
In case of persistent or newly developed ocular symptoms or vision changes, the 
participants will have further ophthalmologic examinations, at least every cycle until 
resolution (to Grade 1 or baseline) or more frequently as clinically indicated by the eye 
care specialist.  
If steroid eye drops are deemed medically necessary and prescribed, intraocular pressure 
must be monitored, if used for >7 days. 
Participants who have treatment-related ocular AEs present at End of Treatment will 
continue to be followed 3-monthly for up to 12 months, until they return to their baseline, 
or are deemed clinically stable by a qualified eye care specialist, whichever comes first. 
Clinically stable is defined as changes less than or equal to Grade 1 for both Ophthalmic 
Examination Findings and Visual Acuity. These examinations are referred to as “follow-
up visits.” 
8.2.6.2. 
Treatment Arm B: PVd 
Examinations should be performed as described above at Screening/Baseline, every 6 
months (± 4 weeks window), and as clinically indicated, while on study (referred to as 
On-treatment) and EoT, as shown in the SoA (Section 1.3).  
8.2.7. 
Pregnancy Testing (WOCBP Only) 
The need for a Screening pregnancy test depends on whether a female participant is of 
childbearing potential or non-childbearing potential. See Appendix 3 for definitions. 
Two negative serum pregnancy tests must be obtained prior to initiating treatment; the 
first test should be performed within 10 to 14 days prior to Cycle 1 Day 1, but the second 
must be performed within 24 hours of Cycle 1 Day 1. Participants with positive 
pregnancy test result must be excluded from the study. The study participant will not 

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receive any study treatment until the study doctor has verified the results of both pre-
treatment pregnancy tests are negative.  
Participants with negative pregnancy test result must agree to use two methods of reliable 
birth control (one method that is highly effective) [Section 10.3], beginning at least 4 
weeks prior to initiating treatment with pomalidomide, during therapy, during dose 
interruptions and continuing for at least 4 weeks following discontinuation of 
pomalidomide treatment. Thereafter, WOCBP participants must use one contraceptive 
method that is highly effective (with a failure rate of <1% per year) for a further 3 months 
for WOCBP in Arm A, and 6 months for WOCBP in Arm B. 
After the first dose, pregnancy tests will be done weekly during the first 28 days, then 
every cycle thereafter or every 2 weeks in females with irregular menses. Additionally, 
pregnancy testing will be done at treatment discontinuation and at 2 weeks (in females 
with irregular menses) and 4 weeks following treatment discontinuation. Subsequent 
pregnancy testing on dosing days may be either by serum or urine testing. Each 
pregnancy test must be performed within 24 hours prior to dosing.  
Pregnancy testing should be performed at the EoT Visit and a follow-up pregnancy 
assessment by phone should be performed 4 and 7 months after the last dose of 
belantamab mafodotin (Arm A) and bortezomib (Arm B), respectively. 
Participants receiving pomalidomide must register with any pregnancy 
prevention/controlled distribution program in place locally (see SRM for details). Ensure 
counselling is completed and documented as required by applicable pregnancy prevention 
program. 
8.2.8. 
Management of Hepatitis B+ Participants 
• 
Management by local hepatology or infectious disease services is required. If no 
subspecialist support is available, consultation with GSK Medical Director is 
required prior to enrolment into the study for participants with positive titres to 
Hepatitis B. 
• 
Participants should be monitored according to the schedule in SoA Table 4. 
• 
Participants who experience clinically significant elevations in liver chemistry 
should follow liver event monitoring and stopping criteria (Section 7.1.1), and 
careful evaluation should be immediately initiated for evaluation of etiology 
including HBV DNA testing.  
• 
Participants who develop detectable HBV DNA levels during study treatment 
should be reviewed by local specialist(s) immediately (within 1 week) and 
appropriate therapy and monitoring instituted. 
• 
Study treatment should be withheld, and GSK Medical Director should be 
contacted for any participant who develops detectable HBV DNA levels. 

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Table 25 
Dose Modification Table for HBV+ Participants  
Toxicity 
Grade/description of 
toxicity 
Actions Required 
Hepatitis B 
reactivation 
Detectable HBV DNA 
• 
Immediate consult with local specialist to 
institute/modify treatment 
• 
Hold study treatment 
• 
Contact GSK Medical Monitor promptly - 
agreement with MM must be obtained prior to 
further dosing of study treatment 
• 
Follow liver monitoring/stopping guidelines per 
protocol for elevation in liver function tests. 
8.3. 
Adverse Events and Serious Adverse Events 
The definitions of an AE or SAE can be found in Section 10.2. 
The investigator and any qualified designees are responsible for detecting, documenting, 
and reporting events that meet the definition of an AE or SAE and remain responsible for 
following up AEs that are serious, considered related to the study intervention or the 
study, or that caused the participant to discontinue the study intervention (Section 7).  
8.3.1. 
Time Period and Frequency for Collecting AE and SAE 
Information 
All SAEs will be collected from the start of study treatment until at least 70 days after 
discontinuing all study interventions regardless of initiation of a new cancer therapy or 
transfer to hospice, at the time points specified in the SoA (Section 1.3). However, any 
SAEs assessed as related to study participation (e.g., study intervention, protocol-
mandated procedures, invasive tests, or change in existing therapy) or related to a GSK 
product will be recorded from the time a participant consents to participate in the study 
up to and including any follow-up. 
Note: In China only, all SAEs should be collected from the signing of the ICF. 
All AEs will be collected from the start of treatment until at least 70 days following 
discontinuation of study treatment regardless of initiation of a new cancer therapy or 
transfer to hospice at the time points specified in the SoA. 
Medical occurrences that begin before the start of study intervention but after obtaining 
informed consent will be recorded on the Medical History/Current Medical Conditions 
section of the CRF not the AE section. 
All SAEs will be recorded and reported to the Sponsor or designee immediately and 
under no circumstance should this exceed 24 hours, as indicated in Section 10.2. The 
investigator will submit any updated SAE data to the Sponsor within 24 hours of it being 
available. 

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Investigators are not obligated to actively seek AEs or SAEs after the conclusion of the 
study participation. However, if the investigator learns of any SAE, including a death, at 
any time after a participant has been discharged from the study, and he/she considers the 
event to be reasonably related to the study intervention or study participation, the 
investigator must promptly notify the Sponsor. 
For participants in the PACT phase of the study, GSK will continue to collect safety 
information including SAEs, AEs leading to treatment discontinuation, overdose and 
pregnancy cases and pre-specified ocular data (Arm A only) via paper forms, emails 
(preferably), and fax which will be reported directly to GSK. SAEs, overdose and 
pregnancy cases will be reported during the PACT treatment period and for up to 70 days 
after last dose. Additionally, any SAEs that are ongoing at the time of the final DCO must 
be followed up to resolution unless the event is considered by the investigator to be 
unlikely to resolve, or the patient is lost to follow up. Updates to these events will also 
occur via paper forms directly to GSK. GSK retains the right to request additional 
information for any patient with ongoing AE(s)/SAE(s) at EOS, if judged necessary. 
Follow up of ocular data after the start of PACT: 
For participants continuing on belantamab mafodotin-containing study treatment as part 
of PACT: 
• 
Ocular exam schedule during PACT treatment: Participants without ocular 
(including corneal) examinations findings, symptoms or vision changes when 
entering the PACT phase, will be required to have an ocular assessment at least 
every 3 months, or as clinically indicated, until the end of treatment. For participants 
who at the time of entering PACT have ocular (including corneal) examinations 
findings, symptoms or vision changes (or develop these during PACT treatment), the 
ocular assessment will occur (increase to) every cycle (and prior to the next 
belantamab mafodotin infusion if dosing), until resolution (KVA Grade 1 or 
baseline). After resolution, the ocular exam assessment frequency reduces to at least 
every 3 months, or as clinically indicated, until the end of treatment. 
• 
Ocular exam schedule after end of PACT treatment: Participants with treatment-
related ocular (including corneal) examination findings, symptoms, or vision changes 
at the end of PACT treatment have ocular assessments at least every 3 months, or as 
clinically indicated, for up to 12 months from the end of treatment or until resolution 
(to KVA Grade 1 or baseline), or withdrawal of consent, whichever comes first. For 
participants without ocular (including corneal) examination findings, symptoms, or 
vision changes at the end of PACT treatment no further ocular exams are required. 
For participants who stopped belantamab mafodotin prior to PACT but have ongoing 
ocular events at the time of final study data-cut-off/start of PACT: 
Participants with treatment-related ocular (including corneal) examination findings, 
symptoms, or vision changes at the start of PACT have ocular assessments at least every 
3 cycles for up to 12 months from the end of treatment or until resolution (KVA Grade 1 
or baseline), or withdrawal of consent, whichever comes first. 

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GSK retains the right to request additional information for any patient with ongoing 
AE(s)/SAE(s) at the end of the study, if judged necessary.  
8.3.2. 
Method of Detecting AEs and SAEs 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 10.2. 
Care will be taken not to introduce bias when detecting AE and/or SAE. Open-ended and 
non-leading verbal questioning of the participant is the preferred method to inquire about 
AE occurrence.  
8.3.3. 
Follow-Up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. All SAEs, and non-serious AEs of special 
interest (as defined in Section 8.3.7), will be followed until the event is resolved, 
stabilized, otherwise explained, or the participant is lost to follow-up (as defined in 
Section 7.3). Further information on follow-up procedures is given in Section 10.2. 
8.3.4. 
Regulatory Reporting Requirements for SAEs 
Prompt notification by the investigator to the Sponsor or designee of an SAE is essential 
so that legal obligations and ethical responsibilities towards the safety of participants and 
the safety of a study intervention under clinical investigation are met.  
The Sponsor or designee has a legal responsibility to notify both the local regulatory 
authority and other regulatory agencies about the safety of a study intervention under 
clinical investigation. The Sponsor or designee will comply with country-specific 
regulatory requirements relating to safety reporting to the regulatory authority, 
Institutional Review Boards (IRB)/Independent Ethics Committees (IEC), and 
investigators. 
Investigator safety reports must be prepared for suspected unexpected serious adverse 
reactions (SUSAR) according to local regulatory requirements and Sponsor policy and 
forwarded to investigators as necessary. 
An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (e.g., summary or listing of SAEs) from the Sponsor or 
designee will review and then file it along with the Investigator’s Brochure and will 
notify the IRB/IEC, if appropriate according to local requirements. 
8.3.5. 
Pregnancy 
Details of all pregnancies will be collected after the start of study treatment and for 
4 months following the last dose of belantamab mafodotin (Arm A) and 7 months 
following the last dose of bortezomib (Arm B). 

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Details of pregnancies from female partners of male participants will be collected after 
the start of study treatment and for 6 months following the last dose of belantamab 
mafodotin (Arm A) and 4 months following the last dose of bortezomib (Arm B). 
If a pregnancy is reported, the investigator must inform GSK or designee within 24 hours 
of learning of the pregnancy and must follow the procedures outlined in Section 10.3. 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, and ectopic pregnancy) are considered SAE. 
8.3.6. 
Cardiovascular and Death Events 
The Death CRF is provided immediately after the occurrence or outcome of death is 
reported. Initial and follow-up reports regarding death must be completed within 1 week 
of when the death is reported. 
For any CV events detailed in Section 10.2.3, whether or not they are considered SAEs, 
and all deaths, specific CV and Death sections of the CRF will be required to be 
completed. These sections include questions regarding CV (including sudden cardiac 
death) and non-CV death.  
The CV CRFs are presented as queries in response to reporting of certain CV Medical 
Dictionary for Regulatory Activities (MedDRA) terms. The CV information should be 
recorded in the specific CV section of the CRF within 1 week of receipt of a CV Event 
data query prompting its completion.  
8.3.7. 
Adverse Events of Special Interest 
AESIs for study treatments are corneal events, thrombocytopenia and IRRs. Severity of 
AESIs will be graded using NCI-CTCAE v5.0 except for corneal events that are assessed 
and graded by KVA scale (see Table 15). Guidelines for dose modifications and 
interruptions for management of common toxicities associated with the study treatment(s) 
are provided in Section 6.6. Dose modifications for belantamab mafodotin corneal events 
will be based on the KVA scale, provided  in Table 15. 
8.4. 
Treatment of Overdose 
GSK does not recommend a specific treatment for an overdose of belantamab mafodotin. 
An overdose of belantamab mafodotin is considered if more than 10% above the 
calculated dose is administered. 
In the event of an overdose of belantamab mafodotin, the investigator must: 
• 
Contact the Medical Director immediately. 
• 
Monitor the participant closely for AEs/SAEs and laboratory abnormalities until they 
have resolved and belantamab mafodotin concentrations are predicted to be within 
the anticipated range in the absence of an overdose. 

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• 
Document the quantity of the excess dose as well as the duration of the overdosing in 
the CRF. 
• 
Obtain an additional plasma sample for PK analysis and a blood sBCMA sample if 
requested by the Medical Director (determined on a case-by-case basis). 
• 
Decisions regarding dose interruptions or modifications will be made by the 
investigator in consultation with the Medical Director based on the clinical 
evaluation of the participant. 
There is no known specific antidote for pomalidomide, bortezomib or dexamethasone 
overdose.  
Pomalidomide 
No specific information is available on the treatment of overdose with pomalidomide. 
Hemodialysis can remove pomalidomide from circulation [POMALYST USPI, 2019].  
Bortezomib 
In the event of an overdose of bortezomib, the participant’s vital signs should be 
monitored, and appropriate supportive care given to maintain blood pressure (such as 
fluids, pressors, and/or inotropic agents) and body temperature [VELCADE SmPC, 
2021].  
Dexamethasone 
It is difficult to define an excessive dose of a corticosteroid as the therapeutic dose will 
vary according to indication and patient requirements. Exaggeration of corticosteroid 
related adverse effects may occur. Treatment should be symptomatic and supportive as 
necessary [Dexamethasone SmPC, 2018]. 
8.5. 
Pharmacokinetics 
8.5.1. 
Belantamab Mafodotin Pharmacokinetic Sample Collection  
In Treatment Arm A, Enhanced and Standard PK sample collections will be obtained. 
Blood samples for PK analysis of belantamab mafodotin (ADC and cys-mcMMAF will 
be collected at the time points indicated in the SoA and Table 26 and Table 27 below. 
Each PK sample must be collected as close as possible to the planned time relative to the 
dose administered to the participant on PK sampling days. The actual date and time of 
each blood sample collection will be recorded on the eCRF. 
Approximately 20% of participants in Treatment Arm A will undergo additional 
belantamab mafodotin PK sampling (Enhanced PK Cohort) according to the schedule in 
Table 26. For all remaining participants on Treatment Arm A, the samples will be 
collected as detailed in Table 27 (Standard PK Cohort). In addition, participants from 
Korea and Japan will have PK sampling following the Enhanced PK schedule. PK-
associated sBCMA samples should be collected at all PK time points (according to either 
the standard or enhanced schedules, see also Section 8.9.1 Table 29 and Table 30). 
Soluble BCMA samples must be collected at all PK time points (according to either the 
standard or enhanced schedule).  All PK, sBCMA, and antidrug antibody (ADA) samples 

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once collected (regardless of dosing) may be analyzed if the sample date and time have 
been recorded. 
Pharmacokinetic and accompanying sBCMA sample collection may be terminated when 
sufficient data have been collected. 
Table 26 
Enhanced PK Collection Schedule 
Dose/Day1 
Timing 
Comments 
Dose1 D1 
Pre-dose 
Within 30 min prior to SOI 
EOI 
0-30 min after EOI 
2 h after SOI 
2 h (15 min) after C1D1 SOI 
Dose1 D2 
24 h after SOI on C1D1 
24 h (2 h) after Dose1 SOI 
Dose1 D4 
Any time 
72 h (±24 h) after Dose 1 SOI  
Dose1 D8-15 
1 sample between C1D8 and 
C1D15 
Any time between D8 and D15 
Dose2 D12 
Pre-dose 
Within 30 min prior to SOI 
If Dose 2  belantamab mafodotin is delayed, 1 PK 
sample must also be taken at Dose1 D29 
EOI 
0-30 min after EOI 
4th and 6th 
belantamab 
mafodotin dose 
Pre-dose 
Within 30 min prior to SOI 
EOI 
0-30 min after EOI 
9th and 12th 
belantamab 
mafodotin dose 
Pre-dose 
Within 30 min prior to SOI 
Every 6 subsequent 
doses  
Pre-dose 
 
Within 30 min prior to SOI; starting at the 18th dose of 
belantamab mafodotin (e.g., Dose18 D1, Dose24 D1, 
Dose30 D1 and so on, until the last sample at EoT) 
Abbreviations: C=Cycle; D=Day; EOI=End of infusion; EoT=End of Treatment; Pd=Pomalidomide in combination with 
dexamethasone; PK=pharmacokinetic(s); SOI=Start of infusion. 
1. 
This PK sample is tied to the dose of belantamab mafodotin. This may not correspond to the cycle of treatment 
e.g., in the event that belantamab mafodotin is held whilst Pd continues. 
2. 
If Dose 2 belantamab mafodotin is delayed, a PK and sBCMA sample must also be taken on Dose1 D29. Then at 
time of actual Dose 2 collect a PK and sBCMA sample at pre-dose and EOI. 
Table 27 
Standard PK Collection Schedule 
Dose/Day1 
Timing 
Notes 
Dose1 D1 
Pre-dose 
Within 30 min prior to SOI 
EOI 
0-30 min after EOI 
Dose1 D2 
24 h after SOI  
24 h (±2 h) after Dose1 SOI 
Dose2 D13 
Pre-dose 
Within 30 min prior to SOI 
If Dose 2 belantamab mafodotin is delayed, 1 PK sample 
must also be taken at Dose1 D29. 

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Dose/Day1 
Timing 
Notes 
EOI 
0-30 min after EOI 
4th and 6th belantamab 
mafodotin dose 
Pre-dose 
Within 30 min prior to SOI 
EOI 
0-30 min after EOI 
9th and 12th 
belantamab mafodotin 
dose 
Pre-dose 
Within 30 min prior to SOI 
Every 6 subsequent 
doses 
Pre-dose 
 
Within 30 min prior to SOI; starting at the 18th dose of 
belantamab mafodotin (e.g., Dose18 D1, Dose24 D1, 
Dose30 D1 and so on, until the last PK sample at EoT). 
Abbreviations: C=Cycle; D=Day; EOI=end of infusion; EoT=End of Treatment; Pd=pomalidomide in combination with 
dexamethasone; PK=pharmacokinetic(s); SOI=start of infusion. 
2. 
This PK sample is tied to the dose of belantamab mafodotin. This may not correspond to the cycle of treatment 
e.g., in the event that belantamab mafodotin is held whilst Pd continues. 
3. 
If Dose 2 belantamab mafodotin is delayed, a PK and sBCMA sample must also be taken on Dose1 D29. Then at 
time of actual Dose 2 collect a PK and sBCMA sample at pre-dose and EOI. 
Details on PK blood sample collection including blood volumes, processing, storage, and 
shipping procedures are provided in the Clinical Laboratory Manual. 
8.5.2. 
Belantamab Mafodotin Pharmacokinetic Sample Analysis 
Plasma PK analysis will be performed under the control of GSK. Concentrations of 
belantamab mafodotin (ADC) and cys-mcMMAF will be determined in plasma samples 
using the currently approved bioanalytical methodology. Raw data will be archived at the 
bioanalytical site . 
Once the plasma has been analyzed for belantamab mafodotin (ADC) and cys-mcMMAF, 
any remaining plasma may be analyzed for other compound-related entities and the 
results may be reported under a separate GSK protocol. 
The actual date and time of each blood sample collection will be recorded on the eCRF. 
8.5.3. 
Pomalidomide Pharmacokinetic Sample Collection and Analysis 
PK samples for pomalidomide will be collected in approximately 20 participants in Arm 
A at the selected time points indicated in Table 27 and in the SoA (Section 1.3) to 
confirm the anticipated lack of impact of belantamab mafodotin on pomalidomide PK 
[Li, 2015]. Participants getting pomalidomide PK samples collected must fast for at least 
2 hours before to 1 hour after pomalidomide dosing in Cycle 1 Day 1 only.  
Plasma analysis will be performed under the control of GSK. Concentrations of 
pomalidomide will be determined in plasma samples using the currently approved 
bioanalytical methodology. Raw data will be archived at the bioanalytical site. 

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Table 28 
PK Sampling Schedule for Pomalidomide in Arm A 
Cycle/Day 
Timing 
Notes 
C1D1 
Pre-dose 
Within 30 min prior to start of pomalidomide PO 
1 h after pomalidomide PO 
(±15 min) 
2 h after pomalidomide PO 
(±15 min) 
3 h after pomalidomide PO 
(±15 min) 
4 h after pomalidomide PO 
(±15 min) 
6 h after pomalidomide PO 
(±15 min) 
24 h after pomalidomide PO 
(± 1 h) and before pomalidomide administration on C1D2 
C1D4 
Pre-dose 
Within 30 min prior to dosing of pomalidomide PO 
C2D1 
Pre-dose 
Within 30 min prior to dosing of pomalidomide PO  
Abbreviations: C=Cycle; D=Day; PK=pharmacokinetic(s). 
8.5.4. 
Bortezomib and Dexamethasone 
No PK sampling or analysis is required for bortezomib or dexamethasone in either 
Treatment Arm A or B. 
8.6. 
Belantamab Mafodotin Immunogenicity 
Serum samples for the analysis of anti-belantamab mafodotin antibodies will be collected 
prior to each belantamab mafodotin infusion (at Doses 1, 2, 4, 6, 9 and 12 at the same 
time as the pre-infusion belantamab mafodotin PK samples are taken); for treatment 
beyond 12 doses, collect samples for ADA analysis prior to each infusion every 6th dose 
of belantamab mafodotin (Dose 18, Dose 24, Dose 30, and so on, until PD). A final ADA 
sample will be drawn at the EoT Visit. ADA sample collection may be terminated when 
sufficient data have been collected. These samples will be tested by the Sponsor or 
Sponsor’s designee.  
Anti-belantamab mafodotin antibody samples will be tested for anti-belantamab 
mafodotin antibodies using a tiered-testing scheme consisting of validated screening, 
confirmation, and titration assays. Briefly, all samples will be tested in the screening 
assay. Samples that screen positive are considered potentially positive and will be tested 
for specificity in a confirmation assay. Finally, titer values will be obtained for confirmed 
positive samples using a titration assay. The sample results (e.g., positive or negative) 
and titer values (positive samples only) will be reported. Samples that test positive for 
anti-belantamab mafodotin antibodies may be further characterized in a validated 
neutralizing antibody assay to determine the neutralizing activity of the antibodies. 
The detection and characterization of antibodies to belantamab mafodotin will be 
performed using validated assays. The anti-belantamab mafodotin antibody assay was 
designed to detect antibodies to belantamab mafodotin, the unconjugated monoclonal 
antibody and the linker-payload portion of belantamab mafodotin. Anti-belantamab 
mafodotin antibody samples will be disposed three months after final approved results are 

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provided to the Clinical Study Team or its designee or upon documented study 
termination. 
ADA sample collection may be reduced or terminated when sufficient data have been 
collected. 
8.7. 
Pharmacodynamics 
See Section 8.9 for details of biomarkers to be collected. 
8.8. 
Genetics 
A 6 mL blood sample for DNA isolation will be collected from participants who have 
consented to participate in the optional genetics analysis component of the study. 
Participation in this part of the study is optional and all enrolled participants will be given 
the opportunity to contribute samples. Participation may be declined without effect on 
medical care during the clinical study. A separate consent signature is required for 
participation in genetic research. 
In the event of DNA extraction failure, a replacement genetic blood sample may be 
requested from the participant. Signed informed consent will be required to obtain a 
replacement sample unless it was included in the original consent. 
Information regarding genetic research is included in Section 10.5. In approving the 
clinical protocol, the IRB/IEC and, where required, the applicable regulatory agency, are 
also approving the genetic research described in Section 10.5 unless otherwise indicated. 
Where required by regulatory authorities, approval of the genetic assessments can occur 
after approval is obtained for the rest of the study. In that case, written approval will 
indicate that approval of the genetic assessments is being deferred and the study, except 
for genetic assessments, can be initiated. If genetic assessments are not approved, they 
will not be conducted. 
8.9. 
Biomarkers 
Biomarker research is part of this study and will involve peripheral blood (serum and 
plasma), bone marrow samples, or tumor biopsies. Samples will be collected at the time 
points indicated in the SoA. Biomarker samples, including bone marrow and samples for 
sBCMA, once collected (regardless of dosing) could be analyzed as long as date and time 
information has been recorded. 
The sample collection strategy may be adjusted on the basis of emerging data from this 
study or other studies involving belantamab mafodotin in order to ensure optimal 
evaluation of any potential biomarkers. The relationship of protein, DNA and/or RNA 
biomarkers in blood, bone marrow, or tumor tissue samples to response to belantamab 
mafodotin and AEs may be evaluated. Unless stated otherwise, these investigations may 
be performed irrespective of whether a response to belantamab mafodotin is observed.  
Additionally, any blood, serum, plasma, and/or bone marrow samples collected during 
this study may be used to measure novel biomarkers to identify factors associated with 

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the biological and clinical responses to belantamab mafodotin. Novel biomarkers may be 
identified and measured by DNA, RNA, and/or protein analysis, and may involve use of 
sequencing of DNA and/or RNA. 
If relevant, this approach may be extended to include the identification of biomarkers 
associated with AEs. If biomarkers potentially predictive of response or associated with 
AEs are identified, samples may be used for the development of validated assays and/or 
diagnostic tests.  
Biomarkers assessed in this study may include but not be limited to those mentioned in 
sub-Sections 8.9.1 to Sections 8.9.3. 
8.9.1. 
Soluble B-Cell Maturation Antigen  
The BCMA receptor undergoes gamma-secretase mediated cleavage, leading to release 
of the BCMA extracellular domain as sBCMA into circulation [Laurent, 2015]. 
sBCMA will be measured in both Arm A and Arm B. 
For Arm A, sBCMA samples should be collected at all PK time points for all 
participants, according to either the enhanced (Table 29) or standard (Table 30) PK 
schedules. Additionally, sBCMA samples will be collected independent from PK samples 
and dosing, from approximately 100 participants from treatment arm B (Table 31). The 
actual date and time of each blood sample collection will be recorded on the eCRF. The 
sBCMA samples once collected (regardless of dosing) may be analyzed if the sample 
date and time have been recorded. 
Serum analysis for sBCMA will be performed under the control of GSK (further details 
are included in the SRM). Raw data will be archived at the bioanalytical site. 
PK and accompanying sBCMA sample collection may be terminated when sufficient data 
have been collected. 
Details on sBCMA blood sample collection including blood volumes, processing, 
storage, and shipping procedures are provided in the laboratory manual. 
Table 29 
Treatment Arm A sBCMA Blood Collections, Associated with the 
Enhanced PK Collection Schedule 
Dose/Day 
Timing 
Comments 
Screening 
Screening  
Any time during Screening  
Dose1 D1 
Pre-dose 
Within 30 min prior to SOI 
EOI 
0-30 minutes after EOI 
2 h after SOI 
2 h (15 min) after C1D1 SOI 
Dose1 D2 
24 h after SOI on C1D1 
24 h (2 h) after Dose1 SOI 
Dose1 D4 
Any time 
72 h (±24 h) after Dose 1 SOI  

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Dose/Day 
Timing 
Comments 
Dose1 D8-15 
1 sample between C1D8 and 
C1D15 
Any time between D8 and D15 
Dose2 D11 
Pre-dose 
Within 30 min prior to SOI 
If Dose 2 belantamab mafodotin is delayed, 1 sample 
must also be taken at Dose1 D29 
EOI 
0-30 min after EOI 
4th and 6th belantamab 
mafodotin dose 
Pre-dose 
Within 30 min prior to SOI 
EOI 
0-30 min after EOI 
9th and 12th 
belantamab mafodotin 
dose 
Pre-dose 
Within 30 min prior to SOI 
Every 6 subsequent 
doses  
Pre-dose 
 
Within 30 min prior to SOI; starting at the 18th dose of 
belantamab mafodotin (e.g., Dose18 D1, Dose24 D1, 
Dose30 D1 and so on, until the last sample at EoT) 
EoT 
Any time 
EoT Visit 
Abbreviations: C=Cycle; D=Day; EOI=End of infusion; EoT=End of Treatment; Pd=Pomalidomide in combination with 
dexamethasone; PK=Pharmacokinetic(s); sBCMA=Soluble B-cell maturation antigen; SOI=Start of infusion; 
VGPR=Very Good Partial Response. 
Note: PK-associated sBCMA samples are tied to the dose of belantamab mafodotin. This may not correspond to the 
cycle of treatment e.g., in the event that belantamab mafodotin is held whilst Pd continues. 
1. 
If Dose 2 belantamab mafodotin is delayed, a PK and sBCMA sample must also be taken on Dose1 D29. Then at 
time of actual Dose 2 collect a PK and sBCMA sample at pre-dose and EOI. 

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Table 30 
Treatment Arm A sBCMA Blood Collections, Associated with the 
Standard PK Collection Schedule 
Dose/Day 
Timing 
Notes 
Screening 
Screening  
Any time during Screening  
Dose1 D1 
Pre-dose 
Within 30 min prior to SOI 
EOI 
0-30 min after EOI 
Dose1 D2 
24 h after SOI  
24 h (2 h) after Dose1 SOI 
Dose2 D11 
Pre-dose 
Within 30 min prior to SOI 
If Dose 2 belantamab mafodotin is delayed, 1 sample 
must also be taken at Dose1 D29. 
EOI 
0-30 min after EOI 
4th and 6th Belantamab 
Mafodotin dose 
Pre-dose 
Within 30 min prior to SOI 
EOI 
0-30 min after EOI 
9th and 12th Belantamab 
Mafodotin dose 
Pre-dose 
Within 30 min prior to SOI 
Every 6 subsequent 
doses 
Pre-dose 
 
Within 30 min prior to SOI; starting at the 18th dose of 
belantamab mafodotin (e.g., Dose18 D1, Dose24 D1, 
Dose30 D1 and so on, until the last PK sample at EoT). 
EoT 
Any time  
EoT Visit 
Abbreviations: C=Cycle; D=Day; EOI=End of infusion; EoT=End of Treatment; Pd=pomalidomide in combination with 
dexamethasone; PK=Pharmacokinetic(s); sBCMA=soluble B-cell maturation antigen; SOI=Start of infusion. 
Note: PK-associated sBCMA samples are tied to the dose of belantamab mafodotin. This may not correspond to the 
cycle of treatment e.g., in the event that belantamab mafodotin is held whilst Pd continues. 
1. 
If Dose 2 belantamab mafodotin is delayed, a PK and sBCMA sample must also be taken on Dose1 D29. Then at 
time of actual Dose 2 collect a PK and sBCMA sample at pre-dose and EOI. 
Table 31 
Treatment Arm B sBCMA Blood Collection (Approximately 100 
Participants) 
Dose/Day1 
Timing 
Comments 
Screening 
Screening  
Any time during Screening  
Dose1 D1 
Pre-dose 
Within 30 min prior to start of dosing 
End of Dose 
Within 30 min after end of dosing  
EoT 
Any time 
EoT visit 
Abbreviations: C=Cycle; D=Day; EoT=End of Treatment; . 
 
8.9.2. 
Tumor-Related Biomarkers 
Bone marrow samples will be collected during this study at the time points indicated in 
the SoA to evaluate the relationship of protein, DNA and/or RNA biomarkers in the bone 
marrow to response to belantamab mafodotin. Biomarkers assessed in bone marrow or 
other samples may include, but not be limited to BCMA expression on multiple myeloma 
cells, immune cell characterization and/or profiling and/or DNA/RNA analyses. 

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Bone marrow or other samples collected during this study may be used to evaluate the 
relationship of BCMA expression, measured by protein and/or RNA, on multiple 
myeloma cells in the bone marrow to response to belantamab mafodotin.   
Bone marrow or other samples collected during this study may be used to interrogate the 
relationship of genetic alterations, transcriptional profile, and/or protein expression in 
bone marrow cells, including multiple myeloma cells and cells in the bone marrow 
microenvironment, with response to belantamab mafodotin. These studies may include 
genomic and/or RNA transcriptomic analysis, and may involve use of sequencing of 
DNA, RNA, and/or alternative equivalent technologies. 
8.9.3. 
RNA Transcriptome Research 
Transcriptome studies for bone marrow or other samples may be conducted using 
microarray, RNA sequencing (RNAseq), and/or alternative equivalent technologies, to 
evaluate the correlation of changes in transcriptome profiles with responses to 
belantamab mafodotin. 
The same samples may also be used to confirm findings by application of alternative 
technologies. 
8.10. 
Patient-Reported Outcomes 
Patient-reported outcomes (PROs) should be done at the start of the visit before any 
assessments and before any results are discussed. All participants will complete the self-
administered version of each questionnaire, unless their vision or other factors prevents 
them from being able to complete the questionnaire on their own. Participants who are 
not able to complete the questionnaire on their own and require assistance should have 
the PROs administered to them in an interview format. The questionnaires should be read 
to the participants verbatim, and participant responses should be recorded directly 
without any interpretation. For any additional assessments conducted via phone (either 
during participation in the Treatment Period or during follow-up), an interview format 
should be used where a site staff member administers the questionnaires over the phone.  
The questionnaires will be administered to participants in different regions based on the 
availability of translated versions. 
PRO questionnaires should be completed by participants at the start of study visits before 
receiving any results and before discussing their health status with the study staff. 
Participants enrolled under the original protocol and who completed the EORTC IL52 
questionnaire will continue to do so. Participants enrolled under protocol amendment 1 
will complete the EORTC QLQ-MY20 questionnaire. All participants will complete the 
PRO-CTCAE, EORTC QLQ-C30, OSDI, EQ-5D-3L, FACT-GP5, PGIS and PGIC at the 
required study visits. 

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8.10.1. 
Patient-Reported Outcomes Version of the Common Term 
Criteria for Adverse Events (PRO-CTCAE) 
The Patient-Reported Outcomes Version of the Common Terminology Criteria for 
Adverse Events (PRO-CTCAE) is a patient-reported outcome measure developed to 
evaluate symptomatic toxicity in patients on cancer clinical trials [Basch, 2014]. The 
PRO-CTCAE was designed to be used as a companion to the CTCAE, the standard 
lexicon for AE reporting in cancer trials. The PRO-CTCAE includes an item library of 
124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE 
provides a systematic yet flexible tool for descriptive reporting of symptomatic treatment 
side effects in cancer clinical trials. In the present study, a selection of items from the 
PRO-CTCAE v1. 0 item library will be administered to participants. 
8.10.2. 
Health-Related Quality of Life 
Five health-related quality of life (HRQoL) assessments will be performed in this study. 
8.10.2.1. 
European Organization for Research and Treatment of Cancer Quality 
of Life Questionnaire 30-Item Core Module (EORTC QLQ-C30) 
The EORTC QLQ-C30 is a 30-item questionnaire containing both single- and multi-item 
measures [Aaronson, 1993]. These include 5 functional scales (Physical, Role, Cognitive, 
Emotional, and Social Functioning), 3 symptom scales (Fatigue, Pain, and 
Nausea/Vomiting), a Global Health Status/quality of life (QoL) scale, and 6 single items 
(Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). 
Scores for each scale and single-item measure are averaged and transformed linearly to a 
score ranging from 0–100. A high score for functional scales and for Global Health 
Status/QoL represent better functioning ability or HRQoL, whereas a high score for 
symptom scales and single items represents significant symptomatology [Proskorovsky, 
2014]. 
8.10.2.2. 
European Organization for Research and Treatment of Cancer 20-item 
Multiple Myeloma Module (EORTC QLQ-MY20) and the Item Library 52 
(EORTC IL52; the Disease Symptoms Domain of the EORTC QLQ-
MY20) 
The European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire myeloma module (EORTC QLQ-MY20) is a supplement to the EORTC 
QLQ-C30 instrument used in patients with MM [Aaronson, 1993; Cocks, 2007]. It 
includes four scales (Disease Symptoms, Body Image, Future Perspective, and Side 
Effects). Participants enrolled under amendment 1 will complete the full EORTC QLQ-
MY20. Participants enrolled under the original protocol will complete the Disease 
Symptoms domain of the EORTC QLQ-MY20, which includes bone aches or pain, back 
pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The 
Disease Symptom domain of the EORTC QLQ-MY20 will be referred to as the European 
Organization for Research and Treatment of Cancer Item Library 52 (EORTC IL52). As 
with the EORTC QLQ-C30, EORTC QLQ-MY20 domain scores are averaged and 
transformed linearly to a score ranging from 0 to 100. A high score for Disease 
Symptoms represents a high level of symptomatology or problems [Proskorovsky, 2014]. 

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8.10.2.3. 
EuroQol Questionnaire (EQ-5D-3L) 
The EQ-5D-3L is a standardized instrument for use as a measure of health utility. It is 
designed for self-completion or interview administration and is cognitively simple, taking 
only a few minutes to complete.  
The EQ-5D-3L self-assessment questionnaire has 2 parts. The first part consists of 
5 items covering 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression). Each dimension is measured by a 3-point Likert scale (no problems, 
some or moderate problems, and unable or extreme problems). Respondents are asked to 
choose one level that reflects their "own health state today" for each of the 5 dimensions. 
Respondents can be then classified into one of 243 distinct health states. The second part 
is a 20-cm visual analogue scale (EQ-VAS) that has endpoints labelled "best imaginable 
health state" and "worst imaginable health state" anchored at 100 and 0, respectively. 
Respondents are asked to indicate how they rate their own health by drawing a line from 
an anchor box to that point on the EQ-VAS which best represents their own health on that 
day. EQ-5D-3L health states are converted to a single summary index by applying a 
formula that essentially attaches weights to each of the levels in each dimension. The 
formula is based on the valuation of EQ-5D health states from general population 
samples. 
8.10.2.4. 
Functional Assessment of Cancer Therapy – General Population 
(FACT-GP5)  
The FACT-G (now in Version 4) is a 27-item compilation of general questions divided 
into 4 primary QoL domains: Physical Well-Being, Social/Family Well-Being, Emotional 
Well-Being, and Functional Well-Being [Cella, 1993]. It is considered appropriate for use 
with participants with any form of cancer and has also been used and validated in other 
chronic illness condition (for example, HIV/AIDS and multiple sclerosis) and in the 
general population (using a slightly modified version). 
The FACT-GP5 item is a single item from the FACT-G, which assesses how bothersome 
the side effects of treatment are for cancer patients. The recall period is the past 7 days, 
and the item has a 5-category response scale ranging from “0=Not at all” to “4=Very 
much”. This item is being included to assess the overall tolerability of treatment from the 
participant’s perspective. 
8.10.2.5. 
Patient Global Impression Items 
The Patient Global Impression of Severity (PGIS) assesses global impression of 
symptoms severity at baseline and subsequent timepoints. The second question, the 
Patient Global Impression of Change (PGIC) serves to rate the global change in 
symptoms at subsequent time points. In addition to evaluating symptom severity and 
change, these questions serve as anchors to establish thresholds of clinically meaningful 
change for the questionnaires in the study [Guy, 1976]. 
8.10.3. 
Ocular Surface Disease Index 
The impact of potential ocular toxicity on function and health-related quality of life will 
be assessed with the use of the Ocular Surface Disease Index (OSDI). The OSDI is a 12-

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item questionnaire designed to assess both the frequency of dry eye symptoms and their 
impact on vision-related functioning [Dougherty, 2011; Schiffman, 2000]. The OSDI has 
demonstrated good reliability, validity, sensitivity, and specificity, and can be used as a 
complement to other clinical and subjective measures of dry eye disease by providing a 
quantifiable assessment of dry eye symptom frequency and the impact of these symptoms 
on vision-related functioning. The OSDI will be completed by the participants at the 
times shown in the SoA. 
8.11. 
Non-protocol Specified Healthcare Resource Utilization 
Non-protocol specified healthcare resource utilization will collect the frequency, reason, 
and dates of healthcare contact reported by participants at each visit. These data will be 
collected in the participant record and in the eCRF.  
Parameters to be measured include: 
• 
Number of emergency room/urgent care facility visits. 
• 
Number and duration of in-patient hospitalizations (total nights, including duration 
by wards [intensive care unit vs. general ward]). 
The data collected may be used to conduct exploratory economic analyses. 

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9. 
STATISTICAL CONSIDERATIONS 
9.1. 
Statistical Hypotheses 
9.1.1. 
Primary Endpoint 
The following primary hypothesis will be tested, comparing the distribution of PFS 
between the two treatment groups: 
 
where, θ is the PFS HR (B-Pd vs. PVd).  
9.1.2. 
Key Secondary Overall Survival Endpoint 
The key secondary OS analysis will be the comparison of the distribution of OS between 
the two treatment groups.  The following hypothesis will be tested: 
 
where, θ is the OS HR (B-Pd vs. PVd).  
9.1.3. 
Key Secondary Duration of Response Endpoint 
The following hypothesis will be tested: 
𝐻0: 𝜇1 −𝜇0 ≤0              𝑉𝑆.         𝐻1: 𝜇1 −𝜇0 > 0 
where μ1 is the restricted mean duration of response (RMDOR) for participants in Arm A 
(B-Pd). and μ0 is the RMDOR for participants in Arm B (PVd). 
9.1.4. 
Key Secondary Minimal Residual Disease Negativity Endpoint 
A key secondary objective of the study is to compare the proportion of participants with 
MRD negativity between the two treatment groups. The following hypothesis will be 
tested: 
H0: P1≤P0     VS.      H1: P1>P0 
where, P0=proportion of participants with MRD negativity Arm B (PVd) 
P1=proportion of participants with MRD negativity Arm A (B-Pd). 
9.2. 
Multiple Comparisons and Multiplicity 
The objective of the study is to compare the efficacy of Treatment A (B-Pd) versus 
Treatment B (PVd) and will consist of evaluating one primary and three key secondary 
endpoints (OS, DoR, and MRD Negativity). The analyses will be performed as defined in 
Section 9.6.2. The study will provide multiplicity control for multiple hypotheses as well 

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as interim analyses (planned interim analyses are defined in Section 9.6). The global 
family-wise error rate (FWER) is strongly controlled at 2.5% (one-sided).  
Evaluation of primary and key secondary endpoints will be structured in terms of two 
families of hypotheses. The first family will be based on the primary endpoint PFS, and 
the second family will be based on the three key secondary endpoints OS, DoR, and 
MRD Negativity. Testing of the second family of hypotheses is conditional on the 
successful rejection of the null hypothesis for the first family. If successful, the full alpha 
will be propagated to the second family of hypotheses. For the second family, a weighted 
Bonferroni procedure will be applied across OS and DoR. Alpha will be split between the 
endpoints, with a larger proportion assigned to OS initially. Testing of MRD will be 
conditional on the successful rejection of the null hypothesis for OS, aligned with a step-
down (or hierarchical) testing procedure [Bretz, 2009; Li, 2017]. Details regarding alpha 
allocation and propagation will be defined in the SAP. 
PFS will be tested across 3 planned analyses; an analysis for harm (IA1), an analysis for 
efficacy (IA2), and the Primary PFS analysis/IA3. A gamma beta-spending function with 
parameter of -3 is used to define a non-binding boundary for IA1. The Lan DeMet 
approach that approximates the O’Brien and Fleming spending function [Lan, 1983] will 
be used to maintain an overall one-sided 2.5% type I error when testing PFS across IA2 
and the Primary PFS analysis/IA3, since these analyses provide the opportunity to make a 
claim of efficacy. The efficacy boundaries (see Section 9.6) will be adjusted based on the 
actual number of PFS events observed at the time of analysis. 
OS will be tested across 4 planned analyses: IA2, Primary PFS analysis/IA3, IA4, and the 
final analysis. The Lan DeMet approach that approximates the O’Brien and Fleming 
spending function [Lan, 1983] will be used. The efficacy boundaries will be adjusted 
based on the actual number of OS events observed at the time of analysis. Additional 
analyses of OS may be performed upon requests or to provide updated data to the health 
authorities. The details of these analyses including the associated alpha-adjustment, if 
any, will be described in the SAP. 
Further details regarding the multiplicity strategy will be provided in the SAP. 
9.3. 
Sample Size Determination  
9.3.1. 
Primary Endpoint 
Based on data from the OPTIMISMM study [Richardson, 2019], the median PFS in the 
PVd arm is expected to be around 12 months. It is expected that treatment with B-Pd will 
lead to a 40% reduction in the risk of progression or death, i.e., an expected PFS HR of 
0.6, which corresponds to an increase in median PFS from 12 months to 20 months under 
the exponential assumption. 
The primary PFS analysis will be conducted after observing approximately 173 PFS 
events, in the randomized participants contributing to the analysis. To ensure >90% 
power to test the null hypothesis: PFS HR=1, vs. the specific alternative hypothesis: PFS 
HR=0.6, a total of approximately 173 PFS events are needed. The calculation assumes a 
comparison of PFS by log-rank test at 1-sided alpha level of 2.5%, an interim analysis for 

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harm and an interim analysis for efficacy (see Section 9.2 and 9.6). Assuming a total of 
approximately 302 participants will be randomized in a 1:1 ratio to receive B-Pd or PVd 
and a uniform enrolment rate of 11.2 participants per month, enrolment will continue for 
approximately 27 months. It is estimated that the targeted 173 PFS events will be 
observed approximately 35 months from the first participant randomized under H1 
assuming an annual dropout rate of 5%. These calculations were conducted using EAST 
v6.5. 
If the number of participants required by local regulatory agencies are not recruited 
within the planned recruitment target, enrollment may continue in separate cohorts until 
the country enrollment requirements, as required by local regulatory bodies, have been 
reached. Additional participants that are enrolled in separate cohorts will not be included 
in the analysis portion of the study planned for the marketing application. However, these 
additional participants will be included in country-specific supplemental analyses, 
requested by the applicable regulatory authorities, as detailed in the country-specific 
SAP. 
9.3.2. 
Sample Size Re-Estimation 
A sample size re-estimation may be considered at the time of the interim analysis for 
harm to ensure adequate power to demonstrate the treatment effect. The key idea is to 
evaluate conditional power (CP) at the interim look at approximately 25% information 
fraction. If the CP is either too low or too high, we do not alter the number of events for 
the final analysis. However, if conditional power falls in a range that we deem promising, 
then the number of events may be increased, subject to a pre-determined upper limit 
[Mehta, 2011]. Further details will be described in the SAP and IDMC charter. Adequate 
firewalls will be maintained to ensure the integrity of the study. 
9.4. 
Populations for Analyses 
For the purpose of this analysis, the following populations are defined: 
Population 
Description 
All Screened  
The All Screened Population will consist of all participants who sign the 
ICF to participate in the clinical trial. Participants in this population will be 
used for screen failure summary. 
Intent-to-Treat (ITT) 
ITT Population will consist of all randomized participants whether or not 
randomized treatment was administered. This population will be based on the 
treatment to which the participant was randomized and stratified and will be the 
primary population for the analysis of efficacy data. Any participant who 
receives a treatment randomization number will be considered to have been 
randomized. 
Modified ITT 
Participants who met all three criteria below will be included: 
• Have received at least 1 line of prior therapy including a lenalidomide-based 
therapy 
• Randomized and received at least one dose of planned study treatment 
– Participant randomized to the belantamab mafodotin arm but 
received bortezomib will be excluded or vice versa  

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Population 
Description 
– Participant randomized but never treated will be excluded 
• With measurable disease at baseline  
Safety  
All randomized participants who receive at least 1 dose of study intervention 
(any component). Participants will be analyzed according to the intervention 
they actually received. 
 
For Arm A: B-Pd, if participants are incorrectly dosed with bortezomib at 
>50% of dosing visits then they will be assigned to Arm B: PVd as their 
actual treatment. Similarly, for Arm B: PVd, if participants are incorrectly 
dosed with belantamab mafodotin at >50% of dosing visits then they will be 
assigned to Arm A: B-Pd as their actual treatment. 
Data should be reported according to the actual treatment. 
Belantamab mafodotin 
Pharmacokinetic (PK) 
The belantamab mafodotin Pharmacokinetic Population will consist of those 
participants in the Safety Population from whom at least 1 belantamab 
mafodotin PK sample was obtained, analyzed and was measurable (Non-
quantifiable [NQ] values will be considered as non-missing values). This 
population will be the primary population for PK analyses related to belantamab 
mafodotin. 
Pomalidomide Pharmacokinetic 
(Pom PK) 
The Pomalidomide Pharmacokinetic Population will consist of those participants 
in the Safety Population from whom at least 1 pomalidomide PK sample was 
obtained, analyzed, and was measurable (Non-quantifiable [NQ] values will be 
considered as non-missing values). This population will be the primary 
population for pomalidomide PK analyses. 
Abbreviations: ICF=Informed Consent Form; ITT=Intent-to-Treat; PK=pharmacokinetic(s). 
9.5. 
Statistical Analyses 
9.5.1. 
Efficacy Analyses 
An independent-review committee (IRC, 
 will be utilized to 
assess response and disease progression per IMWG criteria (See Section 10.1.6). 
Analysis of efficacy endpoints will be based on IRC-assessed confirmed response and 
dates according to IMWG criteria [Kumar, 2016] (with the exception of PFS2 which will 
be based on investigator-reported disease progression) with the Intent-to-Treat (ITT) 
Population, unless otherwise specified.  
The analytical methods planned for each endpoint are described in Table 32. 
Based on Amendment 01 as depicted in the table below, the study would have two 
stratification cohorts per randomization, with the first having stratification according to 
A*B*C for 12 strata and the second having stratification according to A*B*D for 12 
strata; and so in all, it has 24 strata since Cohort 1 vs. Cohort 2 is also a stratification 
factor as a consequence of Cohort 2 having a revised structure for stratification that 
differs from the initial structure for stratification for Cohort 1. 
CCI

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Prior to Amendment 01 
[Stratification Cohort 1] 
After Amendment 01  
[Stratification Cohort 2] 
A: number of prior lines of therapy  
(1 vs. 2/3 vs. ≥4) 
A: number of prior lines of therapy  
(1 vs. 2/3 vs. ≥4) 
B: prior bortezomib treatment (yes or no) 
B: prior bortezomib treatment (yes or no) 
C: ISS status (I vs II/III) 
D: Prior anti-CD38 treatment (yes or no)  
Since stratification produces balance of the randomized treatment groups for the 
corresponding factors for stratification, there is no bias to analysis from its ignoring of a 
factor for stratification. Also, adjustment for all strata can lead to some strata being 
entirely non-informative by having 0 events for an endpoint like PFS or only including 
participants from one of the two treatment groups.  The strata are at least minimally 
informative by when each stratum include at least one participant for each of the two 
treatment groups and at least one participant with an event and at least one participant 
with no event and follow-up at least as long as at least one participant with the event. 
Usually the strata should be somewhat more informative than minimally informative, 
with this implying that each stratum should have approximately 10 participants and 
approximately 5 participants with a PFS event (or event appropriate per the endpoint).  
Based on the above, primary analyses for all stratified analyses will be stratified by two 
randomization factors; number of prior lines of therapy and prior bortezomib treatment. 
As appropriate (refer to Table 32) and detailed in the SAP, sensitivity analyses will be 
performed at the time of Primary PFS analysis considering all 4 randomization factors as 
possible stratification factors, using a prespecified pooling of strata so that each stratum 
has approximately 10 participants and approximately 5 participants with a PFS event (or 
event appropriate per the endpoint). For the primary endpoint of PFS, an additional 
supportive analysis will be performed as defined in Table 32. 
Appropriate subgroup analyses may be performed if data permits, e.g., the primary 
endpoint PFS may be analyzed by age (e.g., <65 years, ≥65 years), gender (Female, 
Male), ethnicity (Hispanic, non-Hispanic) and race groups (e.g., American Indian or 
Alaskan Native, Asian, Black, Native Hawaiian or Other Pacific Islander, White, Mixed 
Race – groups may be combined to provide sufficiently large groups for comparison), 
region (e.g., North America, Europe, North East Asia [consisting of Japan, China and 
Republic of Korea], Rest of World), prior anti-myeloma therapy, randomization factors 
and other baseline characteristics. Further details will be provided in the SAP. 

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Table 32 
Statistical Analytical Methods: Efficacy 
Endpoint 
Statistical Analysis Methods 
Primary 
PFS is the primary endpoint of this study; it is defined as the time from randomization until the 
earliest date of PD based on IRC-assessment per IMWG criteria [Kumar, 2016], or death due to 
any cause. Determination of dates for PFS event and dates for censoring is described in Section 
10.9. 
 
The distribution of PFS for each treatment arm will be estimated using the Kaplan-Meier 
method. The median, 25th and 75th percentiles of PFS will be estimated and corresponding 95% 
confidence intervals will be estimated using the Brookmeyer-Crowley method [Brookmeyer 
1982). The proportional hazard assumption will be checked through the Kaplan-Meier plot, log(-
log(survival) against log (survival time) plot, Schoenfeld residuals, and evaluation of time 
dependency of HR by adding an interaction term of time by treatment in the Cox proportional 
hazard model. The distribution of PFS will be compared between the two treatment arms using 
log-rank test stratified by two randomization factors, number prior lines of therapy and prior 
bortezomib use. A one-sided p-value will be produced. HR and corresponding two-sided 95% CI 
will be estimated from Cox proportional hazard model stratified by these two randomization 
factors with treatment arm as the sole explanatory variable. If the proportional hazard 
assumption does not hold, restricted mean survival time may be conducted in addition as 
appropriate.  
Sensitivity analyses will be performed using a stratified log-rank test, considering stratification by 
all 4 randomization factors (including all factors used prior to and following protocol amendment 
1). However, a prespecified pooling of strata strategy will be applied so that each stratum has 
informative information (e.g.  approximately 10 participants and approximately 5 participants 
with a PFS event).  
As a supportive analysis, HR and corresponding two-sided 95% CI will be estimated from Cox 
proportional hazard model stratified by number prior lines of therapy and prior bortezomib use 
with treatment, ISS status and prior anti-CD38 treatment as explanatory variables. The same 
pre-specified pooling strategy as used for the log-rank test will be applied. Details will be 
provided in the SAP. 
Additional sensitivity analyses will be conducted using alternative PFS censoring rules as 
described in Section 10.9 and using investigator-assessed responses and dates. These will be 
defined in the SAP.  
Appropriate subgroup PFS analyses may be performed if data permits. 
Key Secondary 
OS, defined as the interval of time from randomization to the date of death due to any cause. 
Participants who are alive will be censored at the date last known alive.  
OS will be compared using a similar approach for PFS. Estimates of milestone OS rates and 
associated two-sided 95% confidence intervals will be provided. 
The distribution of OS for each treatment arm will be estimated using the Kaplan-Meier method. 
The median, 25th and 75th percentiles of PFS will be estimated and corresponding two-sided 
95% confidence intervals will be estimated using the Brookmeyer-Crowley method [Brookmeyer, 
1982]. The distribution of OS will be compared between the two treatment arms using log-rank 
test stratified by two randomization factors, number prior lines of therapy, and prior bortezomib 
use. A one-sided p-value will be produced. HR and corresponding two-sided 95% CI will be 
estimated from Cox proportional hazard model stratified by these two randomization factors with 
treatment arm as the sole explanatory variable. If the proportional hazard assumption does not 
hold, restricted mean survival time may be conducted in addition as appropriate. 
DoR is defined as the time from first documented evidence of PR or better until progressive 
disease (PD) or death due to any cause. For the primary analysis of DoR, all participants will be 
included in the analysis regardless of response status, to enable a valid statistical comparison 
between the two arms. Response will be based on IRC-assessment per IMWG criteria [Kumar, 
2016]. DoR will be analyzed based on the restricted mean DoR (RMDOR) using a non-

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parametric approach [Huang , 2022]. Using this approach, non-responders will have an 
observed DoR of zero.  Comparison of RMDOR between the two treatment arms will be based 
on a one-sided Z test at the overall 2.5% level of significance. The RMDOR and the 
corresponding two-sided 95% confidence interval will be calculated for each arm. The difference 
in the RMDOR and the associated one-sided p-value will be provided.  
Sensitivity analysis will be conducted using investigator-assessed responses. 
A supplementary analysis will be conducted based on a conventional DoR analysis, where DoR 
will be defined as the time from first documented evidence of PR or better until the earliest date 
of disease progression (PD), or death due to any cause, among participants who achieve a 
response (i.e., confirmed PR or better) based on IRC-assessment per IMWG criteria [Kumar, 
2016]. Responders without disease progression will be censored at the censoring time point for 
TTP. Distribution of DoR will be summarized using the Kaplan-Meier method by treatment arm. 
The median, 25th and 75th percentiles of DoR will be estimated and corresponding 95% 
confidence intervals will be estimated using the Brookmeyer-Crowley method [Brookmeyer 
1982]. 
MRD negativity rate, defined as the percentage of participants who achieve MRD negative 
status (as assessed by NGS at 10-5 threshold) at least once during the time of confirmed CR or 
better response based on IRC-assessment per IMWG [Kumar, 2016]. For analysis purposes, 
participants with a confirmed CR or better response who do not achieve MRD negative status 
(including missing/inconclusive assessment(s)) and participants without a confirmed CR or 
better response will be considered as having non-negative MRD. MRD negativity rate will be 
summarized by treatment arm. Corresponding 95% exact CIs will also be provided. MRD 
negativity rate will also be compared between treatment arms using the Cochran Mantel 
Haenszel test stratified by the two randomization factors: number of prior lines of therapy and 
prior bortezomib use.  
A sensitivity analysis will be performed, with MRD negativity rate defined similarly, but instead 
using investigator confirmed response according to IMWG. 
Supplementary analyses may be performed based on participants with VGPR or better, using 
investigator-assessed and IRC-assessed confirmed response, separately.  
An additional sensitivity analysis will be performed using the stratified Cochran Mantel Haenszel 
test, considering stratification by all 4 randomization factors. However, a prespecified pooling of 
strata strategy will be applied so that each stratum has informative information. Further details are 
provided in the SAP. 
Secondary 
The following secondary analyses will be conducted:ORR, defined as the percentage of 
participants with a confirmed PR or better (i.e., PR, VGPR, CR, and sCR) based on IRC-
assessment per IMWG criteria [Kumar, 2016].  
The number and percentage of participants with the best confirmed response in the following 
response categories at will be summarized by treatment arm: sCR, CR, VGPR, PR, overall 
response (sCR+CR+VGPR+PR), minimal response (MR), stable disease (SD), progressive 
disease (PD), and not evaluable (NE). The corresponding exact two-sided 95% CI for ORR will 
also be provided. Participants with unknown or missing responses will be treated as non-
responders, i.e., these participants will be included in the denominator when calculating 
percentages of response. The exact two-sided 95% CI for the difference will be calculated. 
Sensitivity analysis will be conducted using investigator-assessed responses. 
CRR, defined as the percentage of participants with a confirmed CR or better (i.e., CR, and 
sCR) based on IRC-assessment per IMWG criteria [Kumar, 2016]. 
The number and percentage of participants with CR or better as the Best Overall Response 
(BOR) will be summarized by treatment arm. The corresponding exact 95% CI for CRR will also 
be provided. Participants with unknown or missing responses will be treated as non-responders, 
i.e., these participants will be included in the denominator when calculating percentages of 
complete response.  The exact 95% CI for the difference will be calculated. 

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VGPR or better rate, defined as the percentage of participants with a confirmed Very Good 
Partial Response (VGPR) or better (i.e. VGPR, CR, and sCR) based on IRC-assessment per 
IMWG criteria [Kumar, 2016]. 
TTBR is defined as the interval of time between the date of randomization and the earliest date 
of achieving best response among participants with a confirmed PR or better based on IRC-
assessment per IMWG [Kumar, 2016]. 
TTBR will be summarized descriptively by treatment arm using medians and quartiles in the 
subset of participants with a confirmed response of PR or better as the BOR.  
TTR is defined as the time between the date of randomization and the first documented 
evidence of response (PR or better), among participants who achieve a response (i.e., 
confirmed PR or better) based on IRC-assessment per IMWG [Kumar, 2016].  
TTR will be summarized descriptively by treatment arm using medians and quartiles in the 
subset of participants with a confirmed response of PR or better as the BOR.  
Sensitivity analysis will be conducted using investigator-assessed responses. 
TTP is defined as the time from randomization until the earliest date of PD based on IRC-
assessment per IMWG criteria [Kumar, 2016], or death due to PD. Determination of dates of 
TTP event and dates for censoring will be described in the SAP.  
TTP analysis will be conducted using similar approach as for the PFS analysis.  
PFS2, defined as time from randomization to disease progression (investigator-assessed 
response) after initiation of new anti-myeloma therapy or death from any cause, whichever is 
earlier. If disease progression after new anti-myeloma therapy cannot be measured, a PFS 
event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any 
cause, whichever is earlier. Distribution of PFS2 for each treatment arm will be estimated using 
the Kaplan-Meier method. PFS2 will be compared using similar approach for PFS. 
Exploratory 
Exploratory analyses will be described in the SAP. For example,  
To further evaluate the safety and tolerability of belantamab mafodotin when administered in 
combination with pomalidomide and dexamethasone (i.e., changes in safety assessments, 
including vital signs) 
To further characterize the pharmacokinetic profile of belantamab mafodotin when administered 
in combination with pomalidomide and dexamethasone (i.e., derived PK parameter values for 
belantamab mafodotin  and cys-mcMMAF, as data permit) 
To evaluate self-reported ocular symptomatic AEs of belantamab mafodotin when administered 
in combination with pomalidomide and dexamethasone (i.e., changes from baseline in 
symptoms and related impacts as measured by OSDI) 
To further evaluate and compare changes in health-related quality of life (HRQoL) and 
symptoms (i.e., change from baseline in HRQoL as measured by EQ-5D-3L; and change from 
baseline in PGIS and change over time in PGIC) 
To further evaluate the impact of side effects on QoL (i.e., change from baseline in FACT-GP5) 
To evaluate and compare nonprotocol-specified healthcare resource utilization (HCRU) (i.e., 
out-patient visits by physician specialty; emergency room visits; home healthcare visits; and 
inpatient hospitalizations (including duration by wards (intensive care unit vs. general ward)) 
To explore the exposure-response relationship between belantamab mafodotin exposure and 
clinical endpoints in participants treated with B-Pd (i.e., belantamab mafodotin exposure (e.g., 
concentration, Cmax, or AUC) vs. efficacy and safety endpoints (e.g., PFS, ORR, CRR, corneal 
events)) 
To explore the relationship between biologic characteristics and clinical response (i.e., Baseline 
BCMA expression levels in bone marrow and/or tumor tissue, baseline serum soluble BCMA 
levels and/or immune characteristics relative to clinical response; changes from baseline in 
sBCMA levels;  at MRD assessments and at end of treatment). Pharmacodynamic and/or 
biomarker exploratory analyses will be described in the SAP or biomarker reporting and analysis 
plan   

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To further explore the efficacy in terms of sustained MRD negativity rate, defined as the 
percentage of participants who achieve MRD negative status assessed by NGS at 10-5 
threshold at least twice, a minimum of 12 months apart and with no MRD positive result in 
between, during the time of confirmed CR or better response based on IRC-assessed response 
according to IMWG. Participants who do not achieve sustained MRD negative status and 
participants without a confirmed CR or better response will be considered as not achieving 
sustained MRD negativity.  
To further explore the efficacy in terms of imaging plus MRD-negativity rate, defined as the 
percentage of participants who achieve MRD negative status assessed by NGS at 10-5 
threshold and have no evidence of disease on PET-CT at least once during the time of 
confirmed CR or better response, based on IRC-assessed response according to IMWG. 
Participants who do not meet the criteria will be considered as non-imaging plus MRD-negative, 
i.e. participants meeting any of the following: 
1) do not achieve MRD negative status (including missing/inconclusive assessment) at 
least once during the time of confirmed CR or better response, or 
2) do not have no evidence of disease on PET-CT at least once during the time of 
confirmed CR or better response, or 
3) participants without a confirmed CR or better response. 
To explore the effect of host genetic variation on the response to belantamab mafodotin and 
disease under study as well as related drug classes and diseases 
 Abbreviations: AE=Adverse Event; AUC=Area Under The Concentration Time Curve; BCMA=B-Cell Maturation 
Antigen; BM=Bone Marrow; BOR=Best Overall Response; B-Pd=Belantamab Mafodotin In Combination With 
Pomalidomide And Dexamethasone; Cmax=Maximum Plasma Concentration; CR=Complete Response; 
CRR=Complete Response Rate; Cys-Mcmmaf=Cysteine-Maleimidocaproyl Monomethyl Auristatin F; DoR=Duration Of 
Response; EoT=End Of Treatment; FACT-GP5=Functional Assessment Of Cancer Therapy – General Population; 
HCRU=Healthcare Resource Utilization; HR=Hazard Ratio; HRQoL=Health-Related Quality Of Life; 
IMWG=International Myeloma Working Group; ITT=Intent-To-Treat; MR=Minimal Response; MRD=Minimal Residual 
Disease; NE=Not Evaluable; NGS=Next-Generation Sequencing; ORR=Overall Response Rate; OS=Overall Survival; 
OSDI=Ocular Surface Disease Index; PD=Progressive Disease; PFS2=Progression-Free Survival On Subsequent Line 
Of Therapy; PGIC=Patient Global Impression Of Change; PGIS=Patient Global Impression Of Severity; 
PK=Pharmacokinetic(S); PR=Partial Response; QoL=Quality Of Life; SAP=Statistical Analysis Plan; sBCMA=Soluble 
B-Cell Maturation Antigen; sCR=Stringent Complete Response; SD=Stable Disease; TTBR=Time To Best Response; 
TTP=Time To Disease Progression; TTR=Time To Response; VGPR=Very Good Partial Response. 
9.5.2. 
Safety Analyses 
All safety analyses will be performed on the Safety Population.  

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Table 33 
Statistical Analytical Methods: Safety 
Endpoint 
Statistical Analysis Methods 
Secondary 
All adverse events whether serious or non-serious, will be reported from the start of treatment 
until at least 70 days after the last dose of study treatment, until the participant withdraws 
consent for study participation, or until the participant starts subsequent anti-myeloma therapy, 
whichever occurs first. AEs will be recorded using standard medical terminology and graded 
according to the NCI-CTCAE (v5.0) with exception of corneal events, which will be graded 
using the scale detailed in Table 15. For AE reporting, the verbatim term used in the CRF by 
investigators to identify AEs will be coded using the latest version of MedDRA coding dictionary 
[NCI, 2017]. 
AEs will be summarized by frequency and proportion of total participants, by system organ 
class and preferred term. Separate summaries will be given for all AEs, common (>5%) AEs, 
treatment-related AEs, SAEs, and AEs leading to dose delays and discontinuation of study 
treatment and AE of special interest. AEs, if listed in the NCI-CTCAE (v5.0) or detailed in 
Section 10.9 will be summarized by the maximum grade. 
Characteristics (e.g., number of occurrences, action taken, grade, etc.) of the following safety 
profile of clinical interest will be summarized separately:  
• The incidence of deaths and the primary cause of death will be summarized. 
• Clinical Laboratory Evaluation: The evaluation of clinical laboratory tests will focus on 
selected laboratory analytes from the hematology and blood chemistry panel. 
• Descriptive statistics (mean, standard deviation, median, range) will be used to summarize 
change from baseline in observed value at each scheduled visit. 
• The worst-case- toxicity grade in hematology and chemistry result during the treatment will 
be summarized. 
For each selected item from the PRO-CTCAE library: Maximum PRO-CTCAE score at post-
baseline for each item attribute will be summarized by counts and proportions. Supportive 
analyses will be provided: proportion of PRO-CTCAE scores for attributes (frequency, severity 
and/or interference) will be presented with stacked bar charts by visit. Proportion of patients 
with a maximum score of 3 or 4 for each item attribute (severe or very severe, frequently or 
almost constantly, quite a bit or very much) will also be reported. Proportions will be based on 
the number of  patients with available data and subject with missing response will be excluded 
from analysis. 
Exploratory 
Other Safety Measures: Data for vital signs, ECGs, and ophthalmic examination findings will be 
summarized. For continuous variables, these summaries will include sample size, mean, 
median, standard deviation, minimum, and maximum. For categorical variables, the summaries 
will include frequencies and corresponding percentages. Details will be provided in SAP. 
Abbreviations: AE=Adverse Event; CRF=Case Report Form; ECG=Electrocardiogram; MedDRA=Medical Dictionary 
for Regulatory Activities; NCI-CTCAE=National Cancer Institute-Common Terminology Criteria for Adverse Events; 
SAP=Statistical Analysis Plan; SAE=Serious Adverse Event. 
9.5.3. 
Pharmacokinetic Analyses 
Belantamab Mafodotin: 
Concentration-time data: Linear and semi-logarithmic individual concentration-time 
profiles and mean and/or median profiles (when appropriate) may be plotted for 
belantamab mafodotin and cys-mcMMAF. Concentrations of belantamab mafodotin and 
cys-mcMMAF will be listed for each participant and summarized (when appropriate) by 
planned time point. 

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Derived pharmacokinetic parameters: Plasma belantamab mafodotin and/or cys-
mcMMAF concentration-time data may be combined with data from other studies and 
analyzed using a population pharmacokinetic approach. The initial analysis will use the 
population pharmacokinetic model at the time of the analysis to generate post hoc 
belantamab mafodotin pharmacokinetic parameter estimates for the individual 
participants in Treatment Arm A. Summary exposure measures (e.g., Cmax, AUC) will 
also be computed. Results of this analysis may be provided in a separate report. 
Concentration-time data from the participants with enhanced PK schedule may also be 
analyzed using standard noncompartmental approach. 
Pharmacokinetic parameters will be listed and summarized descriptively (mean, standard 
deviation, median, minimum, maximum, geometric mean, and the standard deviation, 
CV%, and 95% CI of log-transformed parameters) by cycle. 
Pomalidomide: 
Concentration-Time Data: Linear and semi-logarithmic individual concentration-time 
profiles and mean and/or median profiles (when appropriate) will be plotted for 
pomalidomide. Concentrations of pomalidomide will be listed for each participant and 
summarized (when appropriate) by planned time point. 
Derived PK Parameters: Pomalidomide PK in the presence of belantamab mafodotin may 
be analyzed using standard noncompartmental methods, data permitting, or analyzed 
using a published population PK model [Li, 2015]. Results of the population PK analysis 
may be provided in a separate report.  
PK parameters will be listed and summarized descriptively (mean, standard deviation, 
median, minimum, maximum, geometric mean, and the standard deviation, CV%, and 
95% CI of log-transformed parameters). 
9.5.4. 
Pharmacokinetic/Pharmacodynamic Analyses 
If deemed appropriate and if data permit, exposure-response relationships between 
belantamab mafodotin exposure (e.g., dose, dose intensity, concentration, Cmax, or AUC) 
and clinical activity and/or toxicity (e.g., response, corneal event) may be explored using 
population methods. If data permit, the effects of covariates may be explored. Results 
may be reported separately. 
9.5.5. 
Other Analyses 
PK, pharmacodynamic, and biomarker exploratory analyses will be described in the SAP 
or biomarker reporting and analysis plan.  The population PK, pharmacodynamic, and 
biomarker exploratory analyses may be presented separately from the main Clinical 
Study Report (CSR). PRO analyses will be described in the reporting and analysis plan or 
PRO reporting and analysis plan and may be presented separately from the main CSR. 

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9.6. 
Interim Analyses 
Four interim analyses (IAs) are planned for the study, including an interim analysis at the 
time of Primary PFS analysis (Table 34). Additional analyses of OS may be performed 
upon request or to provide updated data to the health authorities. The details of these 
analyses, including the associated alpha-adjustment, if any, will be described in the SAP. 
Table 34 
Summary of Planned Interim Analyses 
 
Purpose 
Timing 
Interim analysis for harm 
(IA1) 
Harm (inferior efficacy) ~35 PFS events (25% PFS information fraction) 
(~8 months under H1) 
IA2 
Efficacy 
~145 PFS events (~84% PFS information fraction) 
Primary PFS analysis/ IA3  Efficacy. This will also 
be the planned primary 
analysis of PFS. 
~173 PFS events (~100% PFS information fraction) if 
PFS does not demonstrate statistical significance at 
IA2 
 
OR 
 
~130 OS events (~60% OS information fraction) if 
PFS demonstrates statistical significance at IA2 
IA4 
Efficacy. 
~163 OS events (~75% OS information fraction) 
Abbreviations: IA=interim analysis; PFS=progression-free survival. 
The IA for harm (IA1) is planned at the time of approximately 35 of the 139 targeted PFS 
events (25% information) have been observed (expected around 8 months from the date 
of first participant randomized in the study under H1). The interim analysis will allow for 
stopping early for harm (inferior efficacy). It is expected that 212 participants have been 
enrolled at the time of IA. A non-binding gamma spending function with parameter -3 
will be used to calculate the boundary based on actual observed number of PFS events.  
Table 35 shows the stopping boundary for the IA assuming 35 PFS events are observe. 
The stopping boundaries will be revised based on the observed PFS events included in 
the IA data. Further details of the interim analysis will be provided in the IDMC charter.  
Table 36 provides a summary of boundary crossing probabilities for harm under a range 
of underlying true hazard ratios. 
Boundary crossing probabilities for each of the planned PFS analyses for efficacy based 
on the revised targeted 173 PFS events are provided in Table 37. The boundaries will be 
revised based on the observed number of PFS events at the time of analysis. 
If PFS demonstrates statistical significance at IA2 (see Section 9.2), the rationale for 
Primary PFS analysis will be driven by the requirements for OS (PFS will not be 
retested). The timing of subsequent analyses will be determined based on the OS 
information fraction. Details of the boundaries and boundary crossing probabilities for 

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each of the planned OS analyses will be provided in the SAP. OS boundaries will be 
based on the observed number of OS events at the time of analysis. 
In addition, safety data will be reviewed periodically starting from when ~60 participants 
have been followed for 8 weeks, and then every 6 months or as requested by the IDMC 
thereafter. 
GSK CPMS analysts or delegate(s) not involved in the study conduct will have access to 
a blinded population PK dataset (including, but not limited to, concentration, actual 
dosing information, demographics, and some vital sign and laboratory information, but 
excluding adverse event and efficacy information) at several time points (e.g., prior to 
interim and primary PFS analyses) throughout the trial for population PK model 
development/refinement. Additionally, designated representatives not involved with 
study conduct may be unblinded for performing population PK and PKPD datasets 
preparation in support of planned analyses and PK display review. All other personnel 
will remain blinded to aggregate data by treatment group until database lock. 

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Table 35 
Stopping Boundaries for Interim Analysis for Harm (based on 139 targeted PFS events) 
Information 
Fraction 
N of Events 
Cum. α 
Spent 
Cum. β Spent 
Boundary 
(p-value) 
Boundary (HR) 
Boundaries Crossing Probabilities for (Harm) 
(Incremental) 
Under H0 
Under H1 
0.25 
35 
0 
0.009 
0.805 
1.337 
0.195 
0.009 
1 
139 
0.025 
0.148 
0.025 
0.717 
0.78 
0.141 
Abbreviations: HR=hazard ratio; N/A=not applicable. Per protocol, null hypothesis H0: θ≥1 vs alternative hypothesis H1: θ<1 where θ is the PFS HR (B-Pd vs PVd). To calculate the 
boundary crossing probabilities, it has been assumed that under H0: HR=1 and under H1: HR=0.6. 
Table 36 
Boundary Crossing Probabilities for Harm at the Interim Analysis Under a Range of Underlying True Hazard 
Ratios 
Information Fraction 
N of Events 
Boundary 
(p-value) 
Boundary (HR) 
Underlying True HR 
Boundaries Crossing 
Probabilities (Harm) 
0.25 
 
35 
 
0.805 
 
1.337 
 
0.6 
0.9% 
0.7 
2.8% 
0.8 
6.3% 
0.9 
11.7% 
1 
19.1% 
1.1 
27.4% 
1.2 
36.4% 
1.3 
46.0% 
1.4 
54.6% 
Abbreviations: HR=hazard ratio; N/A=not applicable.  

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Table 37 
Stopping Boundaries for Interim Analyses for PFS Efficacy (based on 173 targeted PFS events) 
Information 
Fraction 
N of 
Events 
Cum. 
α 
Spent 
Boundary (p-value) 
Boundary (HR) 
Boundaries Crossing Probabilities 
(Incremental) 
Under H0 
Under H1 
0.838 
145 
0.014 
0.014 
0.695 
0.014 
0.812 
1 
173 
0.025 
0.021 
0.734 
0.01 
0.1 
Abbreviations: HR=hazard ratio; N/A=not applicable. Per protocol, null hypothesis H0: θ≥1 vs alternative hypothesis H1: θ<1 where θ is the PFS HR (B-Pd vs PVd). To calculate the 
boundary crossing probabilities, it has been assumed that under H0: HR=1 and under H1: HR=0.6. 

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9.6.1. 
Independent Data Monitoring Committee 
An Independent Data Monitoring Committee (IDMC) consisting of at least 2 physicians 
and 1 statistician as defined in the IDMC Charter will review data from the interim 
analyses (as appropriate) and periodic safety review. Safety data will be reviewed 
periodically starting from when ~60 participants have been followed for 8 weeks, and 
then every 6 months or as requested by the IDMC thereafter. Descriptive summaries of 
efficacy (response rates, number of PFS/OS events) may be included in the safety 
reviews to support the benefit:risk assessment. Further details are provided in the IDMC 
charter. 
Ad hoc meetings may be convened at the discretion of the IDMC or if requested by the 
Sponsor. Additional details will be provided in the IDMC Charter. 
9.6.2. 
Sequence of Interim and Other Planned Analyses 
All planned analyses are listed in Table 38, below.  
Table 38 
Details of Planned Analyses 
Analysis 
Reason/impact 
Timing 
Endpoints included  
Data to be used 
Safety review by 
IDMC 
Safety review 
Reviewed 
periodically starting 
from when ~60 
participants have 
been followed for 8 
weeks, and then 
every 6 months or 
as requested by the 
IDMC thereafter. 
Key safety (AEs, SAEs, 
AESIs, deaths, ocular, 
exposure, dose 
modifications, laboratory 
parameters), descriptive 
efficacy summaries (e.g. 
response rates, counts of 
PFS/OS events) and 
study population 
summaries. 
All data available 
at the time of the 
data cut 
Interim analysis 
for harm (IA1) 
Harm (inferior 
efficacy) based on 
PFS and potential 
sample-size re-
estimation 
~35 PFS events 
(25% PFS 
information fraction) 
(~8 months under 
H1) 
Key safety, study 
population and PFS. 
Additional analyses may 
be performed to support 
decision making if 
requested by IDMC. 
All data available 
at the time of the 
data cut 
IA2 
Efficacy 
~145 PFS events 
(84% information 
fraction) (~31 
months under H1 to 
observe ~145 PFS 
events) 
Minimally, key safety, 
study population and 
PFS.  
Additional analyses may 
be performed to support 
decision making if 
requested by IDMC.  
All endpoints may be 
included if PFS is 
statistically significant.  
All data available 
at the time of the 
data cut 
Final analysis 
To ensure OS data 
is more mature and 
provide updated 
efficacy and safety 
~217 OS events 
(~100% OS 
information fraction) 
Minimally, updated key 
safety, study population 
summaries and OS. 
All data  
All endpoints will be analyzed as per Section 9.5. 

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10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations 
10.1.1. 
Regulatory and Ethical Considerations 
• 
This study will be conducted in accordance with the protocol and with: 
– 
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
– 
Applicable International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) 
Guidelines 
– 
Applicable laws and regulations 
• 
The protocol, protocol amendments, Informed Consent Form (ICF), Investigator’s 
Brochure, and other relevant documents (e.g., advertisements) must be submitted to 
an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) by the 
investigator and reviewed and approved by the IRB/IEC before the study is initiated.  
• 
Any amendments to the protocol will require IRB/IEC and regulatory authority 
approval before implementation of changes made to the study design, as per national 
requirements, except for changes necessary to eliminate an immediate hazard to 
study participants.  
• 
The investigator will be responsible for the following: 
– 
Providing written summaries of the status of the study to the IRB/IEC annually 
or more frequently in accordance with the requirements, policies, and 
procedures established by the IRB/IEC 
– 
Notifying the IRB/IEC of SAE or other significant safety findings as required by 
IRB/IEC procedures 
– 
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European Clinical Trials 
Directive 2001/20/EC, and all other applicable local regulations 
10.1.2. 
Financial Disclosure 
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate 
financial information as requested to allow the Sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate regulatory authorities. 
Investigators are responsible for providing information on financial interests during the 
course of the study and for 1 year after completion of the study. 

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10.1.3. 
Informed Consent Process 
• 
The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study.  
• 
Participants must be informed that their participation is voluntary. Participants or 
their legally authorized representative will be required to sign a statement of 
informed consent that meets the requirements of 21 CFR 50, local regulations, ICH 
guidelines, Health Insurance Portability and Accountability Act (HIPAA) 
requirements, where applicable, and the IRB/IEC or study center.  
• 
The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained. The authorized person obtaining the informed consent must 
also sign the ICF. 
• 
Participants must be re-consented to the most current version of the ICF(s) during 
their participation in the study.  
• 
A copy of the ICF(s) must be provided to the participant or the participant’s legally 
authorized representative.  
• 
In case of unexpected pregnancy, participant must be informed that investigator such 
as [date of birth, sex] of the baby will be collected as part of safety follow-up. 
Consent for the baby may be obtained from the participant and/or their partner as per 
local regulations. 
• 
If partners of male participants become pregnant during the study, consent will need 
to be obtained or notification given as per local regulation to the partner before 
collecting their PI such as [e.g. LMP, year of birth] or the investigator such as [date 
of birth, sex] of their baby as part of safety follow-up. 
10.1.4. 
Recruitment Strategy 
• 
Recruitment will be performed by the investigators at the participating sites. The 
Sponsor will NOT participate in recruitment of participants to the study. The 
Sponsor will prepare informational material such as infographics, pamphlets, poster 
and a patient letter to be distributed to the sites to support the investigators in the 
recruitment process. In addition, the study will be published in public databases such 
as ClinicalTrials.gov. 
10.1.5. 
Data Protection 
• 
Participants will be assigned a unique identifier by the Sponsor. Any participant 
records or datasets that are transferred to the Sponsor will contain the identifier only; 
participant names or any information which would make the participant identifiable 
will not be transferred.  
• 
The participant must be informed that his/her personal study-related data will be 
used by the Sponsor in accordance with local data protection law. The level of 
disclosure must also be explained to the participant.  

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• 
The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
Sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
• 
GSK will ensure protection of the personal data of the investigator and site staff 
which is collected within the framework of and for the purpose of the study. 
• 
The contract between sponsor and study sites specifies responsibilities of the parties 
related data protection, including handling of data security breaches and respective 
communication and cooperation of the parties. 
• 
Information technology systems used to collect, process, and store study-related data 
are secured by technical and organizational security measures designed to protect 
such data against accidental or unlawful loss, alteration, or unauthorized disclosure 
or access. GSK and/or trusted third parties working on behalf of GSK and/or 
institutions working with GSK for the purposes of this study are contractually bound 
to protect participant coded data. GSK will protect participant coded data and will 
only share it as described in the ICF. 
10.1.6. 
Committee Structure 
• 
Periodic safety and interim analyses will be reviewed by an Independent Data 
Monitoring Committee (IDMC). Details of interim analyses are included in Section 
9.6. Additional information will be included in the IDMC charter. 
• 
An independent-review committee (IRC, 
) will be utilized 
to assess response and disease progression per IMWG criteria. The IRC will remain 
blinded to all treatment arm assignments, as no treatment information will be 
provided to the IRC members. Data required for IRC-assessment (e.g. laboratory, 
imaging and bone marrow data) will be reviewed and adjudicated in-stream. Further 
details on the IRC process will be defined in the IRC charter. Results from the IRC 
will not be provided to the investigative sites. 
10.1.7. 
Publication Policy 
• 
The results of this study may be published or presented at scientific meetings. If this 
is foreseen, the investigator agrees to submit all manuscripts or abstracts to the 
Sponsor before submission. This allows the Sponsor to protect proprietary 
information and to provide comments.  
• 
The Sponsor will comply with the requirements for publication of study results. In 
accordance with standard editorial and ethical practice, the Sponsor will generally 
support publication of multicenter studies only in their entirety and not as individual 
site data. In this case, a coordinating investigator will be designated by mutual 
agreement. 
• 
Authorship will be determined by mutual agreement and in line with International 
Committee of Medical Journal Editors authorship requirements. 
CCI

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10.1.8. 
Dissemination of Clinical Study Data 
• 
Disclosure of Clinical Study Reports (CSRs), periodic safety reports, and clinical 
study summary reports after review by regulatory authorities. This includes access to 
CSRs from studies with negative outcomes and from terminated development 
programs. 
• 
The posting of company-sponsored study information and tabular study results on 
the United States National Institutes of Health’s website www.ClinTrials.gov and 
other publicly-accessible sites.  
• 
Publication planning and other activities related to non-promotional, peer-reviewed 
publications, to ensure the scientific integrity and credibility of publication activities 
performed by or on behalf of the company. The granting of access to analyzable 
datasets from clinical studies through a secure system, following an independent 
assessment of the scientific merit of a rigorously defined research question from a 
third party.  
• 
Where required by applicable regulatory requirements, an investigator signatory will 
be identified for the approval of the CSR. The investigator will be provided 
reasonable access to statistical tables, figures, and relevant reports and will have the 
opportunity to review the complete study results at a GSK site or other mutually-
agreeable location. 
• 
GSK will also provide the investigator with the full summary of the study results. 
The investigator is encouraged to share the summary results with the study 
participants, as appropriate. 
• 
The procedures and timing for public disclosure of the results summary and for 
development of a manuscript for publication will be in accordance with GSK Policy. 
• 
A manuscript will be progressed for publication in the scientific literature if the 
results provide important scientific or medical knowledge. 
10.1.9. 
Data Quality Assurance 
• 
All participant data relating to the study will be recorded on printed Case Report 
Form (CRF) or electronic Case Report Form (eCRF) unless transmitted to the 
Sponsor or designee electronically (e.g., laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.  
• 
Guidance on completion of eCRFs will be provided in eCRF completion guidelines. 
• 
The investigator must maintain accurate documentation (source data) that supports 
the information entered in the CRF.  
• 
The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents.  
• 
Quality Tolerance Limits (QTLs) will be predefined in the QTL plan to identify 
systematic issues that can impact participant right, safety and/or reliability of study 
results. These predefined parameters will be monitored during the study, and 

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important deviations from the QTLs and remedial actions taken will be summarized 
in the CSR. 
• 
Monitoring details describing strategy, including definition of study critical data 
items and processes (e.g., risk-based initiatives in operations and quality such as risk 
management and mitigation strategies and analytical risk-based monitoring, 
involvement of central reading mechanism) methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring 
techniques (central, remote, or on-site monitoring) are provided in the monitoring 
plan. 
• 
The Sponsor or designee is responsible for the data management of this study 
including quality checking of the data. Detailed information about study data 
collection and management process including systems used can be found in a group 
of documents which govern various processes used by the CRO. 
• 
The sponsor assumes accountability for actions delegated to other individuals (e.g., 
contract research organizations). 
• 
Study monitors will perform ongoing source data verification to confirm that data 
entered into the CRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements.  
• 
Records and documents, including signed ICF, pertaining to the conduct of this study 
must be retained by the investigator for 25 years from the issue of the final 
CSR/equivalent summary unless local regulations or institutional policies require a 
longer retention period. No records may be destroyed during the retention period 
without the written approval of the Sponsor. No records may be transferred to 
another location or party without written notification to the Sponsor.  
• 
When copies of source documents are shared externally for review by a central 
reader mechanism (e.g., endpoint adjudication committee; expert reader), documents 
are stored by the external body for agreed timeframe according to the charter or 
contract. 
10.1.10. 
Source Documents 
• 
Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected. Source documents are filed at the 
investigator’s site. 
• 
Data entered in the eCRF that are transcribed from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, 
depending on the study. Also, current medical records must be available. 
• 
The investigator must maintain accurate documentation (source data) that supports 
the information entered in the eCRF. 

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• 
The sponsor or designee will perform monitoring to confirm that data entered into 
the eCRF by authorized site personnel are accurate, complete, and verifiable from 
source documents; that the safety and rights of participants are being protected; and 
that the study is being conducted in accordance with the currently approved protocol 
and any other study agreements, ICH GCP, and all applicable regulatory 
requirements. 
• 
Copies of documents are shared with external third parties contracted by GSK for 
review by a central reader mechanism (e.g. endpoint adjudication committee; expert 
reader). The non-exhaustive list of documents shared to inform the central reader 
may include, imaging reports, pathology reports, etc. Participant names or any 
information which would make the participant identifiable or is not essential for the 
central reader mechanism will be redacted by the investigator sites prior to transfer. 
Details of the list of documents and the redaction procedure are provided in the site 
manual or equivalent. These documents will be used by the third party solely for the 
purpose indicated within this protocol. 
10.1.11. 
Study and Site Start and Closure 
First Act of Recruitment 
The start of study is defined as first subject first visit (FSFV) at a country-level. 
Study/Site Termination 
GSK or its designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of GSK. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable 
cause and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or investigator may include 
but are not limited to: 
For study termination 
• 
Discontinuation of further study intervention development. 
For site termination 
• 
Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the Sponsor's procedures, or GCP guidelines. 
• 
Inadequate or no recruitment (evaluated after a reasonable amount of time) of 
participants by the investigator. 
• 
Total number of participants included earlier than expected 
If the study is prematurely terminated or temporarily suspended, the sponsor shall 
promptly inform the investigators, the IECs/IRBs, the regulatory authorities, and any 
contract research organization(s) used in the study of the reason for termination or 
temporary suspension, as specified by the applicable regulatory requirements. The 
investigator shall promptly inform the participant and should assure appropriate 
participant therapy and/or follow-up. 

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10.2. 
Appendix 2: Adverse Events: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting 
10.2.1. 
Definition of Adverse Event 
AE Definition 
• 
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of 
a study treatment, whether or not considered related to the study treatment. 
Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 
Events Meeting the AE Definition  
• 
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments 
(e.g., electrocardiogram, radiological scans, vital signs measurements), including those that worsen from 
baseline, considered clinically significant in the medical and scientific judgment of the investigator (i.e., not 
related to progression of underlying disease). 
• 
Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or 
intensity of the condition. 
• 
New conditions detected or diagnosed after study treatment administration even though it may have been 
present before the start of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment or a concomitant 
medication. Overdose per se will not be reported as an AE/serious adverse event (SAE) unless it is an 
intentional overdose taken with possible suicidal/self-harming intent. Such overdoses must be reported 
regardless of sequelae. 
• 
"Lack of efficacy" or "failure of expected pharmacological action" per se will not be reported as an AE or SAE. 
Such instances will be captured in the efficacy assessments. However, the signs, symptoms, and/or clinical 
sequelae resulting from lack of efficacy will be reported as AE or SAE if they fulfil the definition of an AE or 
SAE.  
Events NOT Meeting the AE Definition  
• 
Any clinically significant abnormal laboratory findings or other abnormal safety assessments which are 
associated with the underlying disease, unless judged by the investigator to be more severe than expected for 
the participant’s condition. 
• 
 The disease/disorder being studied or expected progression, signs, or symptoms of the disease/disorder 
being studied, unless more severe than expected for the participant’s condition.Medical or surgical procedure 
(e.g., endoscopy, appendectomy): the condition that leads to the procedure is the AE. 
• 
Situations in which an untoward medical occurrence did not occur (social and/or convenience admission to a 
hospital). 
• 
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of 
the study that do not worsen. 
10.2.2. 
Definition of Serious Adverse Event 
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, 
death due to progression of disease). 

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An SAE is defined as any untoward medical occurrence that, at any dose: 
a. 
Results in death 
b. Is life-threatening 
The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant was at risk of death 
at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more 
severe. 
c. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• 
In general, hospitalization signifies that the participant has been detained (usually involving at least an 
overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been 
appropriate in the physician’s office or outpatient setting. Complications that occur during hospitalization are 
AE. If a complication prolongs hospitalization or fulfils any other serious criteria, the event is serious. When in 
doubt as to whether “hospitalization” occurred or was necessary, the AE must be considered serious. 
• 
Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is not 
considered an AE. 
d. Results in persistent disability/incapacity 
• 
The term disability means a substantial disruption of a person’s ability to conduct normal life functions. 
• 
This definition is not intended to include experiences of relatively minor medical significance such as 
uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (e.g., sprained ankle) 
which may interfere with or prevent everyday life functions but do not constitute a substantial disruption. 
e. 
Is a congenital anomaly/birth defect 
f. 
Other situations: 
• 
Medical or scientific judgment must be exercised in deciding whether SAE reporting is appropriate in other 
situations such as important medical events that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent 
one of the other outcomes listed in the above definition. These events must usually be considered serious. 
– 
Examples of such events include invasive or malignant cancers, intensive treatment in an emergency 
room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in 
hospitalization, or development of drug dependency or drug abuse. 
g. Is associated with liver injury and impaired liver function defined as: 
• 
Alanine aminotransferase (ALT) 3×upper limit of normal (ULN) and total bilirubin* 2×ULN (>35% direct), or 
• 
ALT3×ULN and international normalized ratio (INR)** >1.5 
* Serum bilirubin fractionation should be performed if testing is available; if unavailable, measure urinary 
bilirubin via dipstick. If fractionation is unavailable and ALT3×ULN and total bilirubin 2×ULN, then the event 
is still to be reported as an SAE. 
** INR testing not required per protocol and the threshold value does not apply to participants receiving 
anticoagulants. If INR measurement is obtained, the value is to be recorded on the SAE form. 
Refer to Section 10.4 for liver chemistry follow-up procedures. 

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10.2.3. 
Definition of Cardiovascular Events 
Cardiovascular Events Definition 
Investigators will be required to fill out the specific cardiovascular (CV) event page of the Case Report Form (CRF) 
for the following AEs and SAEs: 
• 
Myocardial infarction/unstable angina 
• 
Congestive heart failure 
• 
Arrhythmias 
• 
Valvulopathy 
• 
Pulmonary hypertension 
• 
Cerebrovascular events/stroke and transient ischemic attack 
• 
Peripheral arterial thromboembolism 
• 
Deep venous thrombosis/pulmonary embolism 
• 
Revascularization 
10.2.4. 
Recording and Follow-Up of Adverse Events and Serious 
Adverse Events 
AE and SAE Recording 
• 
When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation (e.g., hospital 
progress notes, laboratory, and diagnostics reports) related to the event. 
• 
The investigator will then record all relevant AE/SAE information in the CRF. 
• 
It is not acceptable for the investigator to send photocopies of the participant’s medical records to GSK in lieu 
of completion of the GSK AE/SAE CRF page. 
• 
There may be instances when copies of medical records for certain cases are requested by GSK. In this case, 
all participant identifiers, with the exception of the participant number, will be redacted on the copies of the 
medical records before submission to GSK. 
• 
The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or other 
clinical information. Whenever possible, the diagnosis (not the individual signs/symptoms) will be documented 
as the AE/SAE. 
 
Assessment of Intensity 
The investigator will assess intensity for each AE and SAE reported during the study and assign it to 1 of the 
following categories:  
• 
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not 
indicated. 
• 
Grade 2: Moderate; minimal, local or non-invasive intervention indicated; limiting age appropriate instrumental 
activities of daily living (ADL)*. 
• 
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of 
hospitalization indicated; disabling; limiting self-care ADL**. 
• 
Grade 4: Life-threatening consequences; urgent intervention indicated. 
• 
Grade 5: Death related to AE. 
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the phone, managing 
money, etc. 
**Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, 
and not bedridden. 

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In addition to reporting eye disorders using CTCAE criteria, corneal events associated with belantamab mafodotin 
must also be graded according to the guidelines provided in Table 15. 
Assessment of Causality 
The investigator is obligated to assess the relationship between study treatment and each occurrence of each 
AE/SAE. 
• 
A "reasonable possibility" of a relationship conveys that there are facts, evidence, and/or arguments to suggest 
a causal relationship, rather than a relationship cannot be ruled out. 
• 
The investigator will use clinical judgment to determine the relationship. 
• 
Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well as the 
temporal relationship of the event to study treatment administration will be considered and investigated. 
• 
The investigator will also consult the Investigator’s Brochure (IB) and/or Product Information, for marketed 
products, in his/her assessment. 
• 
For each AE/SAE, the investigator must document in the medical notes that he/she has reviewed the AE/SAE 
and has provided an assessment of causality. 
• 
There may be situations in which an SAE has occurred, and the investigator has minimal information to include 
in the initial report to GSK. However, it is very important that the investigator always make an assessment 
of causality for every event before the initial transmission of the SAE data to GSK. 
• 
The investigator may change his/her opinion of causality in light of follow-up information and send an SAE 
follow-up report with the updated causality assessment. 
• 
The causality assessment is one of the criteria used when determining regulatory reporting requirements. 
Follow-up of AE and SAE 
• 
The investigator is obligated to perform or arrange for the conduct of supplemental measurements and/or 
evaluations as medically indicated or as requested by GSK to elucidate the nature and/or causality of the AE or 
SAE as fully as possible. This may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other health care professionals. 
• 
New or updated information will be recorded in the originally completed CRF. 
• 
The investigator will submit any updated SAE data to GSK within 24 hours of receipt of the information. 
10.2.5. 
Reporting of Serious Adverse Events to GSK or Designee 
SAE Reporting to GSK or Designee via Electronic Data Collection Tool 
• 
The primary mechanism for reporting SAE to GSK will be the electronic data collection tool. 
• 
If the electronic system is unavailable, then the site will use the paper SAE data collection tool (see next 
section) in order to report the event within 24 hours. 
• 
The site will enter the SAE data into the electronic system as soon as it becomes available. 
• 
The investigator or medically-qualified sub-investigator must review and verify the relationship of each SAE to 
Investigational Product/study participation (causality) and documented in source. 
• 
After the study is completed at a given site, the electronic data collection tool will be taken off-line to prevent 
the entry of new data or changes to existing data. 
• 
If a site receives a report of a new SAE from a study participant or receives updated data on a previously 
reported SAE after the electronic data collection tool has been taken off-line, then the site can report this 
information on a paper SAE form (see next section). 
• 
Contacts for SAE reporting can be found in the Study Reference Manual (SRM). 

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SAE Reporting to GSK via Paper CRF 
• 
Facsimile transmission of the SAE paper CRF is the preferred method to transmit this information. Details 
provided in the SRM. 
• 
In rare circumstances and in the absence of facsimile equipment, notification by phone is acceptable with a 
copy of the SAE data collection tool sent by overnight mail or courier service. 
• 
Initial notification via phone does not replace the need for the investigator to complete and sign the SAE CRF 
pages within the designated reporting time frames. 
• 
Contacts for SAE reporting can be found in the SRM. 

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10.3. 
Appendix 3: Contraceptive Guidance and Collection of 
Pregnancy Information 
10.3.1. 
Definitions 
Woman of childbearing potential (WOCBP): 
A woman is considered fertile following menarche and until becoming post-menopausal 
unless permanently sterile (see below). 
If fertility is unclear (e.g., amenorrhea in adolescents or athletes) and a menstrual cycle 
cannot be confirmed before first dose of study intervention, additional evaluation should 
be considered. 
Women in the following categories are not considered WOCBP: 
1. Premenarchal 
2. Premenopausal female with 1 of the following: 
• 
Documented hysterectomy 
• 
Documented bilateral salpingectomy 
• 
Documented bilateral oophorectomy 
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (e.g., Mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry. 
Note: Documentation can come from the site personnel’s: review of participant’s medical 
records, medical examination, or medical history interview. 
1. Postmenopausal female 
• 
A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause. A high follicle-stimulating hormone (FSH) level in 
the postmenopausal range may be used to confirm a postmenopausal state in 
women not using hormonal contraception or hormone replacement therapy 
(HRT). However, in the absence of 12 months of amenorrhea confirmation with 
more than 1 FSH measurement is required [in questionable cases a blood sample 
with simultaneous FSH >40 MIU/mL and estradiol <40 pg/mL (<147 pmol/L) is 
confirmatory].  
• 
Females on HRT and whose menopausal status is in doubt will be required to 
use 1 of the non-estrogen hormonal highly effective contraception methods if 
they wish to continue their HRT during the study. Otherwise, they must 
discontinue HRT to allow confirmation of postmenopausal status before study 
enrolment. 

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10.3.2. 
Contraception Guidance 
CONTRACEPTIVES1 ALLOWED DURING THE STUDY 
Highly Effective Methods2 That Have Low User Dependency: 
• Implantable progestogen-only hormone contraception associated with inhibition of ovulation3 
• Intrauterine device (IUD) 
• Intrauterine hormone-releasing system (IUS) 
• Bilateral tubal occlusion 
• Vasectomized partner 
– Note: Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole 
sexual partner of the woman of childbearing potential and the absence of sperm has been confirmed. If not, 
an additional highly effective method of contraception should be used. Spermatogenesis cycle is 
approximately 90 days. 
Highly Effective Methods2 That Are User Dependent: 
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of 
ovulation3 
– intravaginal 
– transdermal 
– injectable 
• Progestogen-only hormone contraception associated with inhibition of ovulation3 
– oral 
– injectable 
• Sexual abstinence 
– Note: Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability 
of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and 
usual lifestyle of the participant. 
Abbreviations: CTFG=Clinical Trial Facilitation Group; IUD=intrauterine device; IUS=intrauterine hormone-releasing 
system; LAM=lactational amenorrhea method 
1. 
Note: Periodic abstinence (calendar, sympto-thermal, post-ovulation methods), withdrawal (coitus interruptus), 
spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception for 
this study. Male condom and female condom should not be used together (due to risk of failure with 
friction).Contraceptive use by men or women should be consistent with local regulations regarding the use of 
contraceptive methods for those participating in clinical studies. 
2. 
Failure rate of <1% per year when used consistently and correctly. Typical use failure rates differ from those 
when used consistently and correctly. 
3. 
Male condoms must be used in addition to hormonal contraception. If locally required, in accordance with 
Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive methods are limited to those 
which inhibit ovulation as the primary mode of action. 
10.3.3. 
Collection of Pregnancy Information 
Male participants with partners who become pregnant: 
• 
Investigator will attempt to collect pregnancy information on any male participant’s 
female partner who becomes pregnant while participating in this study and for 6 
months following the last dose of belantamab mafodotin (Arm A) and 4 months 

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following the last dose of bortezomib (Arm B), by phone for WOCBP partners only. 
This applies only to male participants who receive study treatment. 
• 
After obtaining the necessary signed informed consent from the pregnant female 
partner directly, the investigator will record pregnancy information on the 
appropriate form and submit it to GSK within 24 hours of learning of the partner’s 
pregnancy.  
• 
The female partner will also be followed to determine the outcome of the pregnancy. 
Information on the status of the mother and child will be forwarded to GSK. 
• 
Generally, follow-up will be no longer than 6 to 8 weeks following the estimated 
delivery date. Any termination of the pregnancy will be reported regardless of fetal 
status (presence or absence of anomalies) or indication for procedure. 
Female participants who become pregnant: 
• 
Investigator will collect pregnancy information on any female participant, who 
becomes pregnant while participating in this study and for 4 months following the 
last dose of belantamab mafodotin (Arm A) or 7 months from the last dose of 
bortezomib (Arm B).  
• 
Information will be recorded on the appropriate form and submitted to GSK within 
24 hours of learning of a participant's pregnancy.  
• 
Participant will be followed to determine the outcome of the pregnancy. The 
investigator will collect follow-up information on participant and neonate, which will 
be forwarded to GSK. Generally, follow-up will not be required for longer than 6 to 
8 weeks beyond the estimated delivery date.  
• 
Any termination of pregnancy will be reported, regardless of fetal status (presence or 
absence of anomalies) or indication for procedure.  
• 
While pregnancy itself is not considered to be an adverse event (AE) or serious 
adverse event (SAE), any pregnancy complication or elective termination of a 
pregnancy for medical reasons will be reported as an AE or SAE.  
• 
A spontaneous abortion is always considered to be an SAE and will be reported as 
such.  
• 
Any SAE occurring as a result of a post-study pregnancy which is considered 
reasonably related to the study treatment by the investigator, will be reported to GSK 
as described in Section 10.2. While the investigator is not obligated to actively seek 
this information in former study participants, he or she may learn of an SAE through 
spontaneous reporting.  
• 
Any female participant who becomes pregnant while participating will discontinue 
study treatment. 

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10.4. 
Appendix 4: Liver Safety: Required Actions, Follow-up 
Assessments, and Study Treatment Rechallenge Guidelines 
Liver chemistry stopping and increased monitoring criteria have been designed to assure 
participant safety and evaluate liver event etiology. 
Liver Chemistry Stopping Criteria – Liver Stopping Event 
ALT-absolute 
ALT 8×ULN 
ALT Increase 
ALT 5×ULN but <8×ULN persists for 2 weeks 
ALT 3×ULN but <5×ULN persists for 4 weeks 
Bilirubin1, 2 
ALT 3×ULN and total bilirubin 2×ULN (>35% direct bilirubin)  
INR2  
ALT 3×ULN and INR>1.5 
Cannot Monitor 
ALT 5×ULN but <8×ULN and cannot be monitored weekly for 2 weeks 
ALT 3×ULN but <5×ULN and cannot be monitored weekly for 4 weeks 
Symptomatic3 
ALT 3×ULN associated with symptoms (new or worsening) believed to be related to 
liver injury or hypersensitivity 
Required Actions, Monitoring, and Follow-Up Assessments 
Actions 
Follow-Up Assessments 
• Immediately discontinue study intervention 
• Report the event to GSK within 24 hours 
• Complete the liver event form and complete SAE data 
collection tool if the event also meets the criteria for an 
SAE2 
• Perform liver event follow-up assessments as 
described in the Follow-Up Assessment column 
• Monitor the participant until liver chemistries resolve, 
stabilize, or return to within baseline (see 
MONITORING) 
MONITORING: 
If ALT 3×ULN AND total bilirubin 2×ULN or INR >1.5:  
• Repeat liver chemistries (include ALT, AST, alkaline 
phosphatase, total bilirubin and INR) and perform liver 
event follow-up assessments within 24 hours 
• Monitor participants twice weekly until liver chemistries 
resolve, stabilize or return to within baseline 
• A specialist or hepatology consultation is 
recommended 
For all other criteria (bilirubin <2×ULN and INR 1.5):  
• 
Repeat liver chemistries (include ALT, AST, alkaline 
phosphatase, total bilirubin and INR) and perform 
liver event follow-up assessments within 24-72 hours 
• 
Monitor participants weekly until liver chemistries 
resolve, stabilize or return to within baseline 
RESTART/RECHALLENGE: 
• Viral hepatitis serology4 
• Obtain INR and recheck with each liver chemistry 
assessment until the aminotransferases values 
show downward trend 
• Blood sample for belantamab mafodotin 
pharmacokinetic (PK) analysis (Arm A only) and 
a blood sample for sBCMA (Arm A and Arm B), 
obtained within 70 days after last dose of 
belantamab mafodotin; blood sample for 
pomalidomide PK to be obtained within 48 hours 
of last pomalidomide dose5 
• CPK and LDH, GGT, glutamate dehydrogenase 
[GLDH], and serum albumin 
• Fractionate bilirubin, if total bilirubin2×ULN 
• Obtain complete blood count with differential to 
assess eosinophilia 
• Record the appearance or worsening of clinical 
symptoms of liver injury, or hypersensitivity, on the 
liver event form 
• Record use of concomitant medications on the 
concomitant medications report form including 
acetaminophen, herbal remedies, recreational 
drugs and other over the counter medications 
• Record alcohol use on the liver event alcohol 
intake form 
If ALT 3×ULN AND total bilirubin 2×ULN or INR 
>1.5 obtain the following in addition to the 
assessments listed above: 

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Liver Chemistry Stopping Criteria – Liver Stopping Event 
• 
Restart/rechallenge is allowed per protocol but do 
not resume study intervention unless GSK 
approval is granted; If restart/rechallenge is not 
granted, permanently discontinue study intervention 
and continue participant in the study for any protocol 
specified follow-up assessments. Refer to 
Restart/Rechallenge guidelines in Appendix 4. 
• Anti-nuclear antibody, anti-smooth muscle 
antibody, Type 1 anti-liver kidney microsomal 
antibodies, and quantitative total immunoglobulin 
G (IgG or gamma globulins) 
• Serum acetaminophen adduct assay should be 
conducted (where available) to assess potential 
acetaminophen contribution to liver injury unless 
acetaminophen use is very unlikely in the 
preceding week. (e.g., where the participant has 
been resident in the clinical unit throughout) Note: 
not required in China 
• Liver imaging (ultrasound, magnetic resonance 
imaging, or computed tomography) to evaluate 
liver disease; complete Liver Imaging form 
• Liver biopsy may be considered and discussed 
with local specialist if available, for instance: 
– In participants when serology raises the 
possibility of autoimmune hepatitis (AIH) 
– In participants when suspected DILI 
progresses or fails to resolve on withdrawal of 
study intervention 
– In participants with acute or chronic atypical 
presentation:  
• If liver biopsy conducted complete liver biopsy 
form. 
Liver Chemistry Increased Monitoring Criteria and Actions with Continued Study Intervention Liver 
Monitoring Event 
Criteria 
Actions 
ALT 5×ULN and <8×ULN and total bilirubin <2×ULN or 
INR ≤1.5 without symptoms believed to be related to liver 
injury or hypersensitivity, and who can be monitored 
weekly for 2 weeks. 
OR 
ALT 3×ULN and <5×ULN and total bilirubin <2×ULN or 
INR ≤1.5 without symptoms believed to be related to liver 
injury or hypersensitivity, and who can be monitored 
weekly for 4 weeks. 
• Notify the GSK Medical Director within 24 hours 
of learning of the abnormality to discuss 
participant safety.  
• Participant can continue study intervention 
• For HBV patients, obtain HBV-DNA testing  
• For HCV patients, obtain HCV-RNA testing 
• Participant must return weekly for repeat liver 
chemistries (ALT, AST, alkaline phosphatase, 
total bilirubin and INR) until they resolve, stabilize 
or return to within baseline 
• If at any time participant meets the liver chemistry 
stopping criteria, proceed as described above 
• If ALT decreases from ALT 5×ULN and <8×ULN 
to ≥3×ULN but <5×ULN (total bilirubin <2×ULN 
and INR ≤1.5), continue to monitor liver 
chemistries weekly. 
• If, after 4 weeks of monitoring, ALT <3×ULN and 
bilirubin <2×ULN and INR ≤1.5, monitor 
participants twice monthly until liver chemistries 
resolve or return to within baseline. 

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Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; CPK=serum creatine phosphokinase; 
DILI=drug-induced liver injury; GGT=gamma-glutamyl transferase; Ig=immunoglobulin; INR=international normalized 
ratio; LDH=lactate dehydrogenase; PK=pharmacokinetic(s); SAE=serious adverse event; sBCMA=soluble B-cell 
maturation antigen; SRM=Study Reference Manual; ULN=upper limit of normal. 
1. 
Serum bilirubin fractionation should be performed if testing is available. If serum bilirubin fractionation is not 
immediately available, discontinue study intervention for that participant if ALT 3×ULN and total bilirubin 
2×ULN. Additionally, if serum bilirubin fractionation testing is unavailable, record presence of detectable 
urinary bilirubin on dipstick, indicating direct bilirubin elevations and suggesting liver injury.  
2. 
All events of ALT 3×ULN and total bilirubin 2×ULN (>35% direct bilirubin) or ALT 3×ULN and INR>1.5, which 
may indicate severe liver injury (possible ‘Hy’s Law’), must be reported as an SAE (excluding studies of 
hepatic impairment or cirrhosis); the INR threshold value stated will not apply to participants receiving 
anticoagulants 
3. 
New or worsening symptoms believed to be related to liver injury (such as fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, or jaundice) or believed to be related to hypersensitivity (such as fever, rash or 
eosinophilia) 
4. 
Includes: hepatitis A IgM antibody; hepatitis B surface antigen and hepatitis B core antibody (IgM); hepatitis C 
RNA; cytomegalovirus IgM antibody; Epstein-Barr viral capsid antigen IgM antibody (or if unavailable, obtain 
heterophile antibody or monospot testing); hepatitis E IgM antibody. In those with underlying chronic hepatitis B at 
study entry (identified by positive hepatitis B surface antigen) quantitative hepatitis B DNA and hepatitis delta 
antibody. If hepatitis delta antibody assay cannot be performed, it can be replaced with a PCR or hepatitis D RNA 
virus (where needed) [Le Gal, 2005]. 
5. 
Record the date/time of the PK/sBCMA blood sample draw and the date/time of the last dose of study intervention 
(belantamab mafodotin and pomalidomide) prior to blood sample draw on the CRF. If the date or time of the last 
dose is unclear, provide the participant’s best approximation. If the date/time of the last dose cannot be 
approximated or a PK/sBCMA sample cannot be collected in the time period indicated above, do not obtain a 
PK/sBCMA sample. Instructions for sample handling and shipping are in the SRM. A sample for sBCMA should 
be collected at the time of PK sample collection. 
References 
James LP, Letzig L, Simpson PM, Capparelli E, Roberts DW, Hinson JA, Davern TJ, Lee 
WM. Pharmacokinetics of Acetaminophen-Adduct in Adults with Acetaminophen 
Overdose and Acute Liver Failure. Drug Metab Dispos 2009; 37:1779-1784. 
Le Gal F, Gordien E, Affolabi D, Hanslik T, Alloui C, Dény P, Gault E.  Quantification 
of Hepatitis Delta Virus RNA in Serum by Consensus Real-Time PCR Indicates 
Different Patterns of Virological Response to Interferon Therapy in Chronically Infected 
Patients.  J Clin Microbiol. 2005;43(5):2363–2369. 
10.4.1. 
Liver Safety Drug Restart or Rechallenge Guidelines 
A participant who met liver chemistry stopping criteria cannot resume study intervention 
unless all of the following conditions are met: 
• 
GSK approval is granted (as described below), 
• 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval, if 
required, is obtained and 
• 
Separate Informed Consent Form for study intervention restart/rechallenge is signed 
by the participant and participant is informed of any associated risks 

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If GSK approval to restart/rechallenge participant with study intervention is not granted, 
then participant must permanently discontinue study intervention and may continue in the 
study for protocol-specified follow-up assessments. 
10.4.1.1. 
Rechallenge Following Liver Stopping Events that are Possibly Related 
to Study Treatment 
Following drug-induced liver injury (DILI), drug rechallenge is associated with a 13% 
mortality across all drugs in prospective studies [Andrade, 2009]. Clinical outcomes 
vary by drug, with nearly 50% fatality with halothane re-administered within 1 month of 
initial injury. However, some drugs seldom result in recurrent liver injury or fatality.  
Risk factors for a fatal drug rechallenge outcome include: 
• 
Hypersensitivity with initial liver injury (e.g., fever, rash, eosinophilia) [Andrade, 
2009]  
• 
Jaundice or bilirubin >2x ULN with initial liver injury (direct bilirubin >35% of 
total) 
• 
Ongoing severe liver injury defined by: ALT ≥3×ULN, bilirubin ≥2×ULN (direct 
bilirubin >35% of total), or INR >1.5. 
• 
SAEs or fatality has earlier been observed with drug rechallenges [Hunt, 2010; 
Papay, 2009]. 
• 
Evidence of drug-related pre-clinical liability (e.g., reactive metabolites; 
mitochondrial impairment)  
Rechallenge refers to resuming study treatment following study treatment induced liver 
injury (DILI). Because of the risks associated with rechallenge after DILI this should 
only be considered for a participant for whom there is compelling evidence of benefit 
from a critical or life-saving medicine, there is no alternative approved medicine 
available, and a benefit:risk assessment of rechallenge is considered to be favorable. 
Approval by GSK for rechallenge with study treatment can be considered where: 
• 
The Principal Investigator requests consideration of rechallenge with study treatment 
for a participant who is receiving compelling benefit with study treatment that 
exceeds risk, and no effective alternative therapy is available. 
• 
IRB/IEC approval for rechallenge with study treatment has been obtained, if 
required. 
If the rechallenge is approved by GSK in writing: 
• 
The participant must be provided with a clear description of the possible benefits and 
risks of study treatment administration, including the possibility of recurrent, more 
severe liver injury or death. 
• 
The participant must also provide signed informed consent specifically for the 
rechallenge with study treatment. Documentation of informed consent must be 
recorded in the study file. 

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• 
Study treatment must be administered at the dose specified by GSK. 
• 
Participants approved by GSK for rechallenge with study treatment must return to 
the clinic twice a week for liver chemistry tests until stable liver chemistries have 
been demonstrated and then standard laboratory monitoring may resume as per 
protocol. 
• 
If after study treatment rechallenge, participant meets protocol-defined liver 
chemistry stopping criteria, study treatment should be permanently discontinued.  
• 
GSK Medical Director and the IRB/IEC as required, must be informed of the 
participant’s outcome following study treatment rechallenge.  
• 
GSK to be notified of any adverse events (AEs), as per Section 10.2. 
10.4.1.2. 
Restart Following Transient Resolving Liver Stopping Events NOT 
Related to Study Treatment 
Restart refers to resuming study treatment following liver stopping events in which there 
is a clear underlying cause (other than DILI) of the liver event (e.g., biliary obstruction, 
pancreatic events, hypotension, acute viral hepatitis). Furthermore, restart is not permitted 
following liver stopping event when the underlying cause was alcohol-related hepatitis.  
Approval by GSK for study treatment restart can be considered where: 
• 
Principal Investigator requests consideration for study treatment restart if liver 
chemistries have a clear underlying cause (e.g., biliary obstruction, hypotension and 
liver chemistries have improved to normal or are within 1.5×baseline and ALT 
<3×ULN). 
• 
Possible study treatment-induced liver injury has been excluded by the principal 
investigator and the study team. This includes the absence of markers of 
hypersensitivity (otherwise unexplained fever, rash, eosinophilia). Where a study 
treatment has an identified genetic marker associated with liver injury (e.g., 
lapatinib, abacavir, amoxicillin/clavulanate), the presence of the marker should be 
excluded. If study treatment-related liver injury cannot be excluded, the guidance on 
rechallenge as stated in previous section, Section 10.4.1, will apply. 
• 
There is no evidence of alcohol-related hepatitis. 
• 
IRB/IEC approval of study treatment restart must be obtained, as required. 
If restart of study treatment is approved by GSK in writing: 
• 
The participant must be provided with a clear description of the possible benefits and 
risks of study treatment administration, including the possibility of recurrent, more 
severe liver injury or death. 
• 
The participant must also provide signed informed consent specifically for the study 
treatment restart. Documentation of informed consent must be recorded in the study 
file. 
• 
Study treatment must be administered at the dose specified by GSK. 

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• 
Participants approved by GSK for restarting study treatment must return to the clinic 
once a week for liver chemistry tests until stable liver chemistries have been 
demonstrated and then laboratory monitoring may resume as per protocol.  
• 
If participant meets protocol-defined liver chemistry stopping criteria after study 
treatment restart, study treatment should be permanently discontinued. 
• 
GSK Medical Director and the IRB/IEC must be informed of the participant’s 
outcome following study treatment restart. 
• 
GSK to be notified of any AEs, as per Section 10.2. 
References 
Andrade RJ, Robles M, Lucena MI. Rechallenge in drug-induced liver injury: the 
attractive hazard. Expert Opin Drug Saf. 2009;8:709-714. 
Hunt CM. Mitochondrial and immunoallergic injury increase risk of positive drug 
rechallenge after drug-induced liver injury: A systematic review. Hepatol. 2010; 52:2216-
2222. 
Papay JI, Clines D, Rafi R, et al. Drug-induced liver injury following positive drug 
rechallenge. Regul Tox Pharm. 2009;54:84-90. 

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10.5. 
Appendix 5: Genetics 
USE/ANALYSIS OF DNA 
• 
Genetic variation may impact a participant’s response to study intervention, 
susceptibility, severity and progression of disease. Variable response to study 
intervention may be due to genetic determinants that impact drug absorption, 
distribution, metabolism, and excretion; mechanism of action of the drug; disease 
etiology; and/or molecular subtype of the disease being treated. Therefore, where 
local regulations and Institutional Review Board/Independent Ethics Committee 
allow, a blood sample will be collected for DNA analysis. 
• 
DNA samples will be used for research related to belantamab mafodotin or multiple 
myeloma (MM) and related diseases. They may also be used to develop tests/assays 
(including diagnostic tests) related to belantamab mafodotin or study interventions of 
this drug class, and MM. Genetic research may consist of the analysis of 1 or more 
candidate genes or the analysis of genetic markers throughout the genome or analysis 
of the entire genome (as appropriate). 
• 
DNA samples will be analyzed for relationships between genetic variants in the host 
and response to belantamab mafodotin. A detailed description of any planned 
analyses will be documented in a Statistical Analysis Plan (SAP) prior to initiation of 
analyses. Planned analyses and results of genetic investigations will be reported 
either as part of the clinical SAP and Clinical Study Report (CSR), or in a separate 
genetics SAP and report, as appropriate.  
• 
The samples may be analyzed as part of a multi-study assessment of genetic factors 
involved in the response to belantamab mafodotin or study interventions of this class. 
The results of genetic analyses may be reported in the CSR or in a separate study 
summary. 
• 
The Sponsor will store the DNA samples in a secure storage space with adequate 
measures to protect confidentiality.  
• 
The samples will be retained while research on belantamab mafodotin (or study 
interventions of this class) or MM continues but no longer than 15 years after the 
Last Participant Last Visit (LSLV) or other period as per local requirements. 

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10.6. 
Appendix 6: Eastern Cooperative Oncology Group (ECOG) 
Functional Status 
Performance Grade 
Description 
0 
Normal activity. Fully active, able to carry on all pre-disease performance without 
restriction. 
1 
Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory 
and able to carry out work of a light or sedentary nature (e.g., light housework. 
2 
In bed <50% of the time. Ambulatory and capable of all self-care, but unable to carry 
out any work activities. Up and about more than 50% of waking hours. 
3 
In bed >50% of the time. Capable of only limited self-care, confined to bed or chair 
more than 50% of waking hours. 
4 
100% bedridden. Completely disabled. Cannot carry on any self-care. Totally confined 
to bed or chair. 
5 
Dead. 
[Oken, 1982] 

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10.7. 
Appendix 7: Modified Diet in Renal Disease Formula 
The Modified Diet in Renal Disease (MDRD) formula for calculating the estimated 
glomerular filtration rate (eGFR) is as follows: 
eGFR = 175 × (serum creatinine)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if 
African American) 
eGFR is expressed in mL/min/1.73 m2, serum creatinine is expressed in mg/dL, and age 
is expressed in years.  
The following link will auto-calculate the creatinine clearance:  
http://nephron.org/cgi-bin/MDRD_GFR/cgi 

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10.8. 
Appendix 8: New York Heart Association Classification 
The New York Heart Association (NYHA) Functional Classification: Class I, II, III, or 
IV Heart Failure [New York Heart Association, 1994] provides a simple way of 
classifying the extent of heart failure. It places participants in 1 of 4 categories based on 
the level of limitation experienced during physical activity: 
Class 
Symptoms 
Class I 
(Mild) 
No limitation of physical activity. Ordinary physical activity does not cause undue 
fatigue, palpitation or dyspnea (shortness of breath). 
Class II 
(Mild) 
Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity 
results in fatigue, palpitation or dyspnea. 
Class III 
(Moderate) 
Marked limitation of physical activity. Comfortable at rest, but less than ordinary 
physical activity results in fatigue, palpitation or dyspnea. 
Class IV 
(Severe) 
Unable to carry out any physical activity without discomfort. Symptoms of cardiac 
insufficiency at rest. If any physical activity is undertaken, discomfort is increased. 
 

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10.9. 
Appendix 9: Progression-Free Survival Event and Censoring 
Rules 
Situation 
Date of Event  
(Progression/Death) or Censored 
Event  
(Progression/Death) or Censored 
No (or inadequate) Baseline 
assessments¹ and the participant 
has not died (if the participant has 
died follow the rules for death 
indicted at the bottom of the table) 
Randomization  
 
Censored 
No adequate post-Baseline 
assessments and the participant 
has not died (if the participant has 
died follow the rules for death 
indicted at the bottom of the table) 
Randomization 
Censored 
Progression documented at 
scheduled visits and Progression 
documented without extended loss-
to-follow-up time4 
Date of assessment of progression 
Event 
Progression documented between 
scheduled visits and Progression 
documented without extended loss-
to-follow-up time4 
Date of assessment of progression 
(S1) min (Date of next scheduled 
visit, date of death) 
Event 
(S1) Event 
With post-Baseline assessment but 
no progression (or death)  
Date of last ‘adequate’ assessment 
of response2 
Censored 
No adequate post-Baseline 
assessment before start of new 
anti-myeloma therapy (prior to 
documented disease progression or 
death) 
Randomization  
(S2) Date of starting new anti-
myeloma therapy 
Censored 
(S2) Event 
With adequate post-Baseline 
assessment and new anti-myeloma 
treatment started (prior to 
documented disease progression or 
death)3 
Date of last ‘adequate’ assessment 
of response2 (on or prior to starting 
anti-myeloma therapy)  
(S2) Date of starting new anti-
myeloma therapy 
Censored 
(S2) Event 
Death before first scheduled 
assessment (or death at Baseline or 
without any adequate assessments) 
Date of death 
Event 
Death between adequate 
assessment visits  
Date of death 
Event 
Death without extended loss-to-
follow-up time4 
Date of death 
Event 

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Situation 
Date of Event  
(Progression/Death) or Censored 
Event  
(Progression/Death) or Censored 
Death or progression after missing 
two or more scheduled 
assessments4 
Date of randomization if no post-
baseline assessments, or date of 
last ‘adequate’ assessment of 
response2 (prior to missed 
assessments): since disease 
assessment is every 4 weeks, a 
window of 63 days (8 weeks + 7-
day window) will be used to 
determine whether there is 
extended time without adequate 
assessment. If the time difference 
between PD/death and max(last 
adequate disease assessment, 
randomization) is more than 63 
days, PFS will be censored at the 
last adequate disease assessment 
prior to PD/death. 
(S3) Date of death or progression 
Censored 
(S3) Event 
(S4) Treatment discontinuation due 
to clinical PD5 before PD or death 
(S4) Date of treatment 
discontinuation 
(S4) Event 
Abbreviations: CR=Complete Response; FLC=Free Light Chain; MR=Minimal Response; PD=Progressive Disease; 
PR=Partial Response; sCR=Stringent Complete Response; SD=Stable Disease; VGPR=Very Good Partial Response. 
Note: (S1) (S2) (S3) (S4) Rules To Be Applied For PFS Sensitivity Analysis. 
Event or censored are based on confirmed responses. 
1. 
Adequate baseline assessment is defined as at baseline, a patient has at least one of the following 
measurements: Serum M-protein ≥0.5 g/dL (≥5 g/L) or b. Urine M-protein ≥200 mg/24h or c. Serum FLC assay: 
Involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (<0.26 or >1.65) 
2. 
An adequate assessment is defined as an assessment where the response is sCR, CR, PR, VGPR, MR or SD. If 
the adequate assessment occurred on the same date as new anti-myeloma therapy, it is assumed that the 
assessment occurred first. 
3. 
If PD or death and new anti-myeloma therapy occur on the same day, assume the progression or death was 
documented first; e.g., the outcome is progression or death and the date is the date of the assessment of 
progression or death. If anti-myeloma therapy is started prior to any adequate assessments, censoring date 
should be the date of randomization. 
4. 
Extended loss-to-follow-up time = 8 weeks + 7 day window = 63 day window; Without extended loss-to-follow-up 
time is defined as: <= 63 days; after an extended loss-to-follow-up time is defined as: >63 days. 
5. 
Treatment discontinuation of any component due to physician decision = clinical relapse or where physician 
decision indicates clinical progression. 

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10.10. 
Appendix 10: Country Specific Requirements 
Inclusion Criteria: 
• 
In the Republic of Korea, a participant must be over 19 years of age inclusive, at the 
time of signing the informed consent. 
• 
In France a participant will be eligible for inclusion in this study only if either 
affiliated to or a beneficiary of a social security category.  
• 
In Israel, participants must have prior treatment with daratumumab, if available, 
cannot get access to daratumumab for any reason, or cannot tolerate daratumumab. 
• 
In Japan, Hepatitis B participants who are HbsAg- (e.g. HBsAb+/HbsAg-, 
HBcAb+/HbsAg-, HBcAb+/HBsAb+/HbsAg-) are eligible for inclusion in this study 
if HBV DNA is undetectable. A patient with HBsAg+ are eligible if HBV DNA is 
undetectable after assessing HBeAg, HBeAb and HBV DNA, and if a hepatologist 
agrees with the participation into this study.  
Adverse Events: 
• 
For all studies conducted in China, SAEs will be collected from signing of the ICF 
and NOT from the start of treatment. 
Other Assessments: 
• 
In China, the following assessment will not be performed as a follow-up to bilirubin 
or INR meeting Liver Chemistry stopping criteria: Serum acetaminophen adduct 
assay. 
• 
In China, the following samples will not be collected: bone marrow biopsy sample 
for BCMA IHC, BM aspirate for exploratory endpoints, and pharmacogenetic 
samples 
• 
In China, MRD sample collection and assessment will not be performed until 
approval from Human Genetic Resource Administration of China (HGRAC) is 
obtained 
Contraception Guidance: 
Of the contraceptive methods defined in Section 10.3.2 Contraceptives Allowed During 
the Study, the following are NOT approved in Japan as contraceptive method: 
Highly Effective Methods That Have Low User Dependency  
• 
Implantable progestogen-only hormone contraception associated with inhibition of ovulation 
Highly Effective Methods That Are User Dependent 
• 
Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulation 
• 
intravaginal 
• 
transdermal 
• 
injectable 
• 
Progestogen-only hormone contraception associated with inhibition of ovulation 
• 
oral 
• 
injectable 

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10.11. 
Appendix 11: Eye Care Specialist’s Qualifications and 
Requirements 
For examiners with a degree in ophthalmology or optometry, those involved in eye 
evaluations in the protocol will, at a minimum, be able to provide comprehensive eye 
care to participants, which includes everything from routine check-ups to treatment and 
ongoing management of visual disease.  
Specifically, qualified eye care specialists must be able to: 
• 
Perform comprehensive eye examinations  
• 
Perform visual Acuity with manual refraction tests and analyze results 
• 
Perform slit lamp tests and analyze results 
• 
Perform intraocular pressure examination 
• 
Dilated fundoscopic examination 
• 
Diagnose and treat ocular issues and diseases such as keratopathy or glaucoma 

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10.12. 
Appendix 12: Home Healthcare and Telemedicine 
Approaches 
Home Healthcare (General Visit) 
Where applicable country and local regulations and infrastructure allow, home healthcare 
may be permitted. Home healthcare is defined as a remote visit(s) that is/are performed at 
the participant’s home by qualified personnel (e.g., nurse).  
Activities that may be done as part of a home healthcare visit must follow the schedule 
provided in the schedule of activities (SoA) (Section 1.3) and include:  
• 
Collection of blood and urine samples including:  
– 
Safety assessments which may include routine blood and urine sampling 
– 
Pharmacokinetic and anti-drug antibody specimen collection 
– 
Efficacy assessments to be sent to central lab 
– 
Biomarker, immunogenicity and genetic assessments 
– 
Pregnancy tests 
– 
Note: Biological samples should not be collected if they cannot be processed in 
a timely manner or appropriately stored until their intended use. Refer to the 
Study Reference Manual/Laboratory Manual for sample collection and storage 
requirements. 
• 
Measurement of vital signs (BP, heart rate, body temperature) and weight 
• 
Physical examination 
• 
Administration of pre/post-medication 
• 
Identification and reporting of concomitant medications. 
• 
Dosing diary review for medication compliance. 
• 
Identification and reporting of adverse events (AEs)/serious adverse events (SAEs). 
Note: The investigator or other qualified medical professional must ensure reporting 
of AEs and SAEs is completed in accordance with the protocol and applicable 
regulations and that the appropriate medical intervention, therapeutic intervention, 
and/or support measures are instituted, as necessary.  
The participant should be informed of any potential risks associated with Home 
Healthcare and sign a revised Informed Consent Form (ICF) if required. Institutional 
Review Board (IRB)/Independent Ethics Committee (IEC) should be informed and/or 
approve of this change in approach and the process documented in study files. 

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Home Healthcare (Ophthalmologic Examination) 
Where applicable country and local regulations and infrastructure allow, protocol-
required eye examinations may be done in the participant’s home or specified alternative 
eye care specialist clinic. Activities that may be done as part of in-home eye 
examinations, must follow the schedule provided in the SoA (Section 1.3) and include:  
• 
Visual Acuity (VA) by near-chart VA or pinhole. 
• 
Slit lamp examination  
• 
Tonometry 
• 
Ophthalmoscopy 
The participant should be informed of any potential risks associated with Home 
Healthcare Ophthalmologic examinations and sign a revised ICF, if required. IRB/IEC 
should be informed and/or approve of this change in approach and the process 
documented in study files. 
Telemedicine 
Where applicable country and local regulations and infrastructure allow, telemedicine 
visits may be permitted. Telemedicine visits are defined as online (virtual) visits which 
will use secure video conference, phone calls, a web portal and/or mobile application as a 
way of communicating with and monitoring the participant’s progress. Telemedicine 
visits are conducted by an investigator or other qualified medical professional and may be 
done in combination with visits from Home Healthcare personnel (see above). 
Activities that may be done as part of a telemedicine visit include: 
• 
Medical evaluation of the participant  
• 
Identification and reporting of concomitant medications. 
• 
Dosing diary review for medication compliance. 
• 
Identification, management, and reporting of AEs and SAEs.  
Note: The investigator or other qualified medical professional must ensure reporting 
of AEs and SAEs is completed in accordance with the protocol and applicable 
regulations and that the appropriate medical intervention, therapeutic intervention, 
and/or support measures are instituted, as necessary. Participants utilizing 
telemedicine can report AEs at any time via an app, phone call or videoconference 
with site staff. 
The participant should be informed of any potential risks associated with the virtual 
medium and sign a revised ICF if required. IRB/IEC should be informed and/or approve 
of this change in approach and the process documented in study files. 

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Remote Patient -Reported Outcomes Administration 
Where applicable country and local regulations and infrastructure allow, remote patient 
reported outcome (PRO) administration may be permitted. Remote PRO administration is 
defined administration of protocol PROs by a qualified third party over the phone. The 
remote PRO Administrator will use the versions of the PROs designed for verbal 
administration. The remote PRO Administrator will have access to the electronic PRO 
portal for the study and input participant responses as the interview is being conducted.  
The participant should be informed of any potential risks associated with the remote PRO 
administration and sign a revised ICF if required. IRB/IEC should be informed and/or 
approve of this change in approach and the process documented in study files. 

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10.13. 
Appendix 13: Data Management/Monitoring: 
Source Data Verification/Source Document Review (SDV/SDR) 
During periods in which on-site monitoring is not permitted, GSK will consider remote 
Source Data Verification/Source Document Review (SDV/SDR) where permitted by the 
clinical site/institution and in accordance with local law and regulatory guidance 
documents. 
Remote SDV/SDR will be proposed to study sites to meet a patient and/or critical data 
quality need, e.g., to assess patient safety or to ensure data integrity. The study specific 
monitoring plan will be updated in accordance with remote monitoring practices adopted 
for the country/study. The subject informed consent will be updated in line with local 
regulations to permit remote monitoring practices. In case of remote SDV/SDR, GSK 
will work with the site to ensure subject privacy 
eCRF/CRF Final or Interim Sign off Process:  
The Principal Investigator (PI) is responsible for ensuring that the data within the eCRF 
casebook and any other data sources utilized during the study for each study patient is 
complete and consistent with source documents throughout the study (ICH GCP 4.9.1 
4.9.2). The PI may sign/re-sign the eCRF from any computer/location by accessing the 
eDC platform) using his/her unique eCRF login credentials. 
Essential Document Sign Off Process:  
If an investigator is unable to print and sign essential documents such as Protocol 
/Amendment signature page then Email approval can be accepted by replying to the 
relevant email that is sent by GSK. Please note that unblinding procedures remain the 
same as those documented in the protocol and other study-related documents. 

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10.14. 
Appendix 14: List of Abbreviations, Trademarks, and 
Definitions of Terms 
Abbreviations 
2L 
Second-line 
ADA 
Anti-Drug Antibody 
ADC 
Antibody-Drug Conjugate 
ADCC 
Antibody-Dependent Cellular Cytotoxicity 
ADL 
Activities of Daily Living 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
ALT 
Alanine Aminotransferase 
ANC 
Absolute Neutrophil Count 
APRIL 
A Proliferation-Inducing Ligand 
APT 
All-Patients Treated 
AST 
Aspartate Aminotransferase 
ASCT 
Autologous Stem Cell Transplant 
AUC 
Area Under The Concentration Time Curve 
B-Pd 
Belantamab Mafodotin In Combination With Pomalidomide And Dexamethasone 
BAFF 
B-Cell Activating Factor 
BCMA 
B-Cell Maturation Antigen 
BCVA 
Best-Corrected Visual Acuity 
BM 
Bone Marrow 
BOR 
Best Overall Response 
BSA 
Body Surface Area 
BUN 
Blood Urea Nitrogen 
CBC 
Complete Blood Count 
CI 
Confidence Interval 
CIOMS 
Council For International Organizations Of Medical Sciences 
CIRT 
Cenduit Interactive Response Technology 
CK 
Creatine Kinase 
Cmax 
Maximum Plasma Concentration 
CO2 
Carbon dioxide 
CO2CP 
Carbon dioxide combining power 
CONSORT 
Consolidated Standards Of Reporting Trials 
CPK 
Serum Creatine Phosphokinase 
CR 
Complete Response 
CRBN 
Cereblon 
CRF 
Case Report Form 
CRR 
Complete Response Rate 
CSR 
Clinical Study Report 
CT 
Computed Tomography 
Ctau 
Trough Concentration 
CTCAE 
Common Terminology Criteria For Adverse Events 
CV 
Cardiovascular 
CV% 
Percent Coefficient Of Variation 
CYP 
Cytochrome P450 Enzymes 
Cys-mcMMAF 
Cysteine-Maleimidocaproyl Monomethyl Auristatin F 
DILI 
Drug-Induced Liver Injury 

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DLT 
Dose-Limiting Toxicity 
DNA 
Deoxyribonucleic acid 
DoR 
Duration Of Response 
DREAMM 
Driving Excellence In Approaches To Multiple Myeloma 
DRESS 
Drug Reaction With Eosinophilia And Systemic Symptoms 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic Case Report Form 
eGFR 
estimated glomerular filtration rate 
EMA 
European Medicines Agency 
EMD 
Extramedullary diseases 
EOI 
End of infusion 
EORTC IL52 
European Organisation for Research and Treatment of Cancer Item Library 52 
EORTC 
QLQ-C30 
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire 30-item core module 
EORTC 
QLQ-MY20 
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire  20-item Multiple Myeloma Module 
EoS 
End of Study 
EoT 
End of Treatment 
EU 
European Union 
FACT-GP5 
Functional Assessment of Cancer Therapy – General Population 
FDA 
Food and Drug Administration 
FISH 
Fluorescence-In-Situ Hybridization 
FLC 
Free Light Chain 
FSH 
Follicle-Stimulating Hormone 
FTIH 
First-Time-In-Human 
FWER 
Family-Wise Error Rate 
GCP 
Good Clinical Practice 
GGT 
Gamma-Glutamyl Transferase 
HbsAg 
Hepatitis B Surface Antigen 
HbA1c 
Hemoglobin A1c 
HBV-DNA 
Hepatitis B Virus-Deoxyribonucleic Acid 
HbcAb 
Hepatitis B Core Antibody 
Hep C Ab 
Hepatitis C Antibody 
Hep C RNA 
Hepatitis C RNA 
HBeAb 
Hepatitis B e antibody 
HBeAg 
Hepatitis B e antigen 
HCRU 
Healthcare Resource Utilization 
HD 
High-Dose Dexamethasone 
HGRAC 
Human Genetic Resource Administration of China 
HIPAA 
Health Insurance Portability And Accountability Act 
HIV 
Human Immunodeficiency Virus 
HR 
Hazard Ratio 
HRQoL 
Health-Related Quality Of Life 
HRT 
Hormone Replacement Therapy 
IA 
Interim Analysis 
IB 
Investigator’s Brochure 
ICD 
Immunogenic Cell Death 
ICF 
Informed Consent Form 

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ICH 
International Council For Harmonisation Of Technical Requirements For 
Pharmaceuticals For Human Use  
IDMC 
Independent Data Monitoring Committee 
IEC 
Independent Ethics Committee 
Ig 
Immunoglobulin 
IgG1 
Immunoglobulin G1 
IHC 
Immunohistochemistry 
IMWG 
International Myeloma Working Group 
IP 
Investigational Product 
IRB 
Institutional Review Board 
IRC 
Independent Review CommitteE 
IRR 
Infusion-Related Reaction 
IRT 
Interactive Response Technology 
ISS 
International Staging System 
ITT 
Intent-to-Treat 
IV 
Intravenous/Intravenously 
kg 
Kilogram 
KVA 
Keratopathy Visual Acuity 
LDH 
Lactate Dehydrogenase 
LPFV 
Last Participant First Visit 
LSLV 
Last Participant Last Visit 
LVEF 
Left Ventricular Ejection Fraction 
MCH 
Mean Corpuscular Hemoglobin 
MCHC 
Mean Corpuscular Hemoglobin Concentration 
MCRN 
Myeloma Canada Research Network 
MCV 
Mean Corpuscular Volume 
MDRD 
Modified Diet In Renal Disease 
MedDRA 
Medical Dictionary For Regulatory Activities 
mg 
Milligram 
MM 
Multiple Myeloma 
MMAF 
Monomethyl Auristatin-F 
MOA 
Mechanism Of Action 
mPFS 
Median Progression-Free Survival 
MR 
Minimal Response 
MRD 
Minimal Residual Disease 
MRP 
Multidrug Resistance Associated Protein 
MRI 
Magnetic Resonance Imaging 
NCI-CTCAE 
National Cancer Institute-Common Terminology Criteria For Adverse Events 
NEA 
North East Asian 
NGS 
Next-Generation Sequencing 
NYHA 
New York Heart Association 
OATP 
Organic Anion Transporting Polypeptide 
ORR 
Overall Response Rate 
OS 
Overall Survival 
OSDI 
Ocular Surface Disease Index 
PACT 
Post Analysis Continued Treatment 
Pd 
Pomalidomide In Combination With Dexamethasone 
PD 
Progressive Disease 
PDy 
Pharmacodynamic(S) 
PET/CT 
Positron Emission Tomography/Computed Tomography 

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PFS 
Progression-Free Survival 
PFS2 
Progression-Free Survival On Subsequent Line Of Therapy 
PGIC 
Patient Global Impression Of Change 
PGIS 
Patient Global Impression Of Severity 
P-gp 
P-Glycoprotein 
PI 
Proteasome Inhibitor 
PK 
Pharmacokinetic(S) 
PML 
Progressive Multifocal Leukoencephalopathy 
PO 
Oral/Orally 
POEMS 
Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Plasma Proliferative 
Disorder, And Skin Changes 
PR 
Partial Response 
PRES 
Posterior Reversible Encephalopathy Syndrome 
PRO 
Patient-Reported Outcome 
PRO-CTCAE 
Patient-Reported Outcomes version of the Common Terminology Criteria for 
Adverse Events 
PVd 
Pomalidomide Plus Bortezomib And Dexamethasone 
q12w 
Every 12 Weeks 
q3w 
Every 3 Weeks 
q4w 
Every 4 Weeks 
q8w 
Every 8 Weeks 
QoL 
Quality Of Life 
QRS 
Electrocardiogram Q, R, And S Waves 
QT 
Electrocardiogram Q And T Waves 
QTc 
Corrected QT Interval 
QTcF 
QT Interval Corrected Using Fridericia’s Formula 
QTL 
Quality Tolerance Limit 
RBC 
Red Blood Cell 
RNAseq 
RNA Sequencing 
RPLS 
Reversible Posterior Leukoencephalopathy Syndrome 
RRMM 
Relapsed/Refractory Multiple Myeloma 
RMDOR 
Restricted Mean Duration of Response 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
sBCMA 
Soluble B-Cell Maturation Antigen 
SC 
Subcutaneous/Subcutaneously 
sCR 
Stringent Complete Response 
SD 
Stable Disease 
SJS 
Stevens-Johnson Syndrome 
SoA 
Schedule Of Activities 
SoC 
Standard Of Care 
SOI 
Start Of Infusion 
SPEP 
Serum Protein Electrophoresis 
SRM 
Study Reference Manual 
SUSAR 
Suspected Unexpected Serious Adverse Reactions 
TEN 
Toxic Epidermal Necrolysis 
TLS 
Tumor Lysis Syndrome 
TNFRSF17 
Tumor Necrosis Factor Receptor Super Family Member 17 
TNFSF 
Tumor Necrosis Factor Super Family 
TTBR 
Time To Best Response 

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TTP 
Time To Disease Progression 
TTP/HUS 
Thrombotic Thrombocytopenic 
TTR 
Time To Response 
ULN 
Upper Limit Of Normal 
UPEP 
Urine Protein Electrophoresis 
US 
United States 
USPI 
United States Prescribing Information 
Vd 
Bortezomib Plus Dexamethasone 
VGPR 
Very Good Partial Response 
VZIG 
Varicella Zoster Immune Globulin 
WBC 
White Blood Cell 
WOCBP 
Woman Of Childbearing Potential 
Trademark Information 
Trademarks of the GSK group of companies 
 
Trademarks not owned by the GSK group of 
companies 
NONE 
 
EAST 
 
 
MedDRA 
 
 
POMALYST 
 
 
VELCADE 
 
Term 
Definition 
Adverse Drug Reaction 
An adverse event where a causal relationship between a medicinal 
product and the adverse event is at least a reasonable possibility, 
i.e., the relationship cannot be ruled out. 
a. In the context of a clinical trial, an ADR can be serious or non-
serious. Serious ADRs may be subject to expedited reporting if they 
are considered unexpected (see SUSAR definition). 
b. For marketed products, ADRs are subject to expedited reporting 
within the country where they are authorized 
Auxiliary Medicinal Product 
(AxMP) 
a) Authorised AxMP 
 
 
 
b) Unauthorized AxMP 
Medicinal products used in the context of a clinical trial but not as 
investigational medicinal products, such as medicinal products used 
for background treatment, challenge agents, rescue medication, or 
used to assess end-points in a clinical trial. Auxiliary medicinal 
products should not include concomitant medications, that is 
medications unrelated to the clinical trial and not relevant for the 
design of the clinical trial. 
a. Medicinal product authorized in accordance with Regulation 
(EC) No 726/2004, or in any Member State concerned in 
accordance with Directive 2001/83/EC, irrespective of changes 
to the labelling of the medicinal product.  
1. Safety reporting with regard to auxiliary medicinal products 
shall be made in accordance with Chapter 3 of Title IX of 
Directive 2001/83/EC. 

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Term 
Definition 
b. Medicinal product not authorized in accordance with Regulation 
(EC) No 726/2004 
1. Safety reporting for unauthorised auxiliary medicinal 
products will follow the same processes and procedures as 
SUSAR safety reporting 
Blinding: 
A procedure in which 1 or more parties to the study are kept 
unaware of the intervention assignment in order to reduce the risk 
of biased study outcomes. The level of blinding is maintained 
throughout the conduct of the study, and only when the data are 
cleaned to an acceptable level of quality will appropriate personnel 
be unblinded or when required in case of a SAE. 
In an open-label study, no blind is used. Both the investigator and 
the participant know the identity of the intervention assigned. 
Caregiver 
A ‘caregiver’ is someone who  
– lives in the close surroundings of a participant and has a 
continuous caring role or 
– has substantial periods of contact with a participant and is 
engaged in their daily health care (e.g., a relative of the 
participant, a nurse who helps with daily activities in case 
of residence in a nursing home).  
In the context of a clinical study, a caregiver could include an 
individual appointed to oversee and support the participant's 
compliance with protocol-specified procedures. 
Certified copy 
A copy (irrespective of the type of media used) of the original record 
that has been verified (i.e. by a dated signature or by generation 
through a validated process) to have the same information, 
including data that describe the context, content, and structure, as 
the original. 
Co-administered (concomitant) 
products 
A product given to clinical trial participants as required in the 
protocol as part of their standard care for a condition which is not 
the indication for which the IMP is being tested and is therefore not 
part of the objective of the study. 
Combination product 
Combination product comprises any combination of  
– drug  
– device  
– biological product  
Each drug, device and biological product included in a combination 
product is a constituent part.  
Comparator 
Any product used as a reference (including placebo, marketed 
product, GSK or non-GSK) for an investigational product being 
tested in a clinical trial. This is any product that is being used to 
assess the safety, efficacy, or other measurable value against the 
test product (IMP). 

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Term 
Definition 
Decentralized Trial Platform 
A digital engagement technology allowing for the remote delivery 
and access to trials for participants, sites, and sponsors.  
Direct-from-Participant Shipments 
Home pickup of collected biological specimens, or pickup and return 
of unused/partially used/expired trial materials for return to 
investigator site. 
Direct-to-Participant Shipments 
Shipping of Investigational Product, lab kits, devices, etc., to the 
participant’s residence under secure and controlled conditions. 
eDiary 
Electronically registered patient data and automated data entries 
on, for example, a handheld mobile device, tablet or computer. 
Eligible 
Qualified for enrollment into the study based upon strict adherence 
to inclusion/exclusion criteria. 
Essential documents 
Documents which individually and collectively permit evaluation of 
the conduct of a study and the quality of the data produced 
Home Healthcare Services  
Deployment of mobile health care professional(s) (nurses or 
phlebotomists) to perform study activities remotely. 
Intervention number 
A number identifying an intervention to a participant, according to 
intervention allocation. 
Investigational product 
A pharmaceutical form of an active substance or placebo being 
tested or used as a reference in a clinical study, including products 
already with a marketing authorization but used or assembled 
(formulated or packaged) in a way different from the authorized 
form, or when used for an unauthorized indication, or when used to 
gain further information about the authorized form.  
Investigator 
A person responsible for the conduct of the clinical study at a study 
site. If a study is conducted by a team of individuals at a study site, 
the investigator is the responsible leader of the team and may be 
called the principal investigator.  
The investigator can delegate study-related duties and functions 
conducted at the study site to qualified individual or party to perform 
those study-related duties and functions 
Legally acceptable representative 
An individual, judicial or other body authorized under applicable law 
to consent on behalf of a prospective participant to the participant's 
participation in the clinical study. 
The terms legal representative or legally authorized representative 
are used in some settings. 
Medicinal products used to 
assess end-points 
A product given to the participant in a Clinical Trial as a tool to 
assess a relevant clinical trial endpoint; it is not being tested or used 
as a reference in the clinical trial. 
Participant number 
A unique identification number assigned to each participant who 
consents to participate in the study. 
Participant 
Term used throughout the protocol to denote an individual who has 
been contacted to participate or who participates in the clinical 

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Term 
Definition 
study as a recipient of the study intervention 
(vaccine(s)/product(s)/control). 
Synonym: subject 
Pharmacogenomics 
The ICH E15 Guidance for Industry defines pharmacogenomics as 
the “Study of variation of DNA and RNA characteristics as related to 
drug or treatment response.”  
Pharmacogenetics, a subset of pharmacogenomics, is “the study of 
variations in DNA sequence as related to drug response.” 
Pharmacogenomic biomarkers include germline (host) DNA and 
RNA as well as somatic changes (e.g., mutations) that occur in cells 
or tissues.  
Pharmacogenomic biomarkers are not limited to human samples 
but include samples from viruses and infectious agents as well as 
animal samples. The term pharmacogenomic experiment includes 
both the generation of new genetic or genomic (DNA and/or RNA) 
data with subsequent analysis as well as the analysis of existing 
genetic or genomic data to understand drug or treatment response 
(PK, safety, efficacy or effectiveness, mode of action).  
Proteomic and metabolomic biomarker research is not 
pharmacogenomics. 
Placebo 
An inactive substance or treatment that looks the same as, and is 
given in the same way as, an active drug or intervention/treatment 
being studied. 
Primary Completion Date 
The date on which the last participant in a clinical study was 
examined or received an intervention to collect final data for 
the primary outcome measure. 
Whether the clinical study ended according to the protocol or was 
terminated does not affect this date. For clinical studies with more 
than one primary outcome measure with different completion dates, 
this term refers to the date on which data collection is completed for 
all the primary outcome measures.  
Randomization 
Process of random attribution of intervention to participants to 
reduce selection bias. 
Remote visit 
This term refers to the visit conducted in the place other than the 
study site. 
Self-contained study 
Study with objectives not linked to the data of another study. 
Source data 
All information in original records and certified copies of original 
records of clinical findings, observations, or other activities in a 
clinical study necessary for the reconstruction and evaluation of the 
study. Source data are contained in source documents (original 
records or certified copies). 
Standard of Care 
Medicine(s) for a specific indication, or a component of the standard 
care for a particular medical indication, based on national and/or 

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Term 
Definition 
international consensus; there is no regulatory significance to this 
term. 
1. Products/regimens considered standard of care may differ 
country to country, depending on consensus in individual countries 
Study intervention 
Term used throughout the clinical study to denote a set of 
investigational product(s) or marketed product(s) or placebo 
intended to be administered to a participant. 
Note: “Study intervention” and “study treatment” are used 
interchangeably unless otherwise specified. 
Study completion date 
The date on which the last participant in a clinical study was 
examined or received an intervention/treatment to collect final data 
for the primary outcome measures, secondary outcome measures, 
and AEs (that is, the last participant's last visit or LSLV). 
Study monitor 
An individual assigned by the sponsor and responsible for assuring 
proper conduct of clinical studies at 1 or more investigational sites. 
Subcohort 
A group of participants for whom specific study procedures are 
planned as compared to other participants or a group of participants 
who share a common characteristic (e.g., ages, vaccination 
schedule, etc.) at the time of enrollment. 
SUSAR 
Suspected Unexpected Serious Adverse Reaction; in a clinical trial, 
a serious adverse reaction that is considered unexpected, i.e., the 
nature or severity of which is not consistent with the reference 
safety information (e.g., Investigator's Brochure for an unapproved 
investigational medicinal product). All adverse drug reactions 
(ADRs) that are both serious and unexpected are subject to 
expedited reporting. 
Telemedicine 
The use of electronic information and telecommunications 
technologies (both video-based and audio-only) to facilitate remote 
health care delivery, participant and professional health-related 
education, public health and health administration. 
Virtual visit 
This term refers to study visits conducted using multimedia or 
technological platforms. 
 

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10.15. 
Appendix 15: Protocol Amendment History 
The Protocol Amendment Summary of Changes Table for the current amendment is 
located directly before the Table of Contents (TOC). 
Summary of Previous Amendments 
Amendment 03 23 Feb 2023 
Overall Rationale for the Amendment 3: 
• 
This protocol amendment changes the primary analysis of response-based efficacy 
endpoints (with the exception of Progression-Free Survival On Subsequent Line Of 
Therapy [PFS2]) from being based on a proprietary algorithm-derived confirmed 
response and dates per IMWG [Kumar, 2016] criteria to being based on Independent 
Review Committee (IRC) assessed response and dates per IMWG criteria. PFS2 will 
continue to be analysed based on investigator assessment. 
• 
Timing of primary Progression-Free Survival (PFS) analysis revised: the primary 
PFS analysis will be conducted after observing approximately 139 PFS events and a 
minimum of 6 months follow-up, in the randomized participants contributing to the 
analysis. 
• 
Duration of Response (DoR) moved from secondary to key secondary endpoint and 
will be tested following PFS and prior to MRD negativity; included in hierarchical 
testing strategy at time of Primary PFS analysis; endpoint definition revised to 
include all participants regardless of response status and primary analysis method 
revised to compare restricted mean DoR (RMDOR) and align with endpoint 
definition.  
• 
Revised Overall Survival (OS) as another key secondary endpoint (moved from 
secondary) per regulatory request; included in hierarchical testing strategy at time of 
Primary PFS analysis. 
• 
Additional details of the sample size re-estimation and IA for harm boundary 
crossing probabilities have been provided 
• 
Addition of Post Analysis Continued Treatment (PACT) to allow eligible 
participants to receive study treatment after final analysis DCO.  
• 
Revised EoS definition as “the end of the safety follow-up following the last 
participant last dose i.e. the completion of the PACT phase”. 
• 
Revised PRO-CTCAE endpoint definition: maximum post-baseline PRO-CTCAE 
score for each item attribute. Added details of analysis. To align with the planned 
analyses performed across the program.  
• 
Additional actions to reduce lost to follow-up to help limit the amount and impact of 
missing data. 
• 
Removed total monoclonal antibody (total mAb) from secondary and exploratory 
endpoints. 

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• 
Removed collection and analysis of circulating plasma cell-free DNA (cfDNA). 
• 
Defined the countries included in the North East Asia region subgroup.  
• 
Additional changes were incorporated which align with program revisions and/or 
updates.  
• 
Administrative updates to add clarification and/or remove discrepancies 
All changes are listed in table below 
Section # and Name 
Description of Change 
Brief Rationale 
Headers, cover page, and 
Protocol Amendment 
Summary of Changes 
Table 
Headers and cover page were updated with new 
document number; Protocol Amendment Summary 
of Changes Table section was created and 
populated to include details and rationale for this 
amendment 
Editorial changes to align 
with the GSK’s standard 
protocol template 
Throughout 
Administrative updates to add clarification and/or 
remove discrepancies 
Editorial changes were made 
for accuracy, clarity, 
conformity, flow, and 
typographical error 
corrections 
Throughout 
Removal of proprietary algorithm-derived confirmed 
response and instead, primary efficacy analyses for 
response-based endpoints will be based on IRC 
assessment (with the exception of PFS2 which 
continues to be based on investigator assessment in 
line with the data collection for second progression) 
To address FDA comments 
at protocol amendment 2 
Section 1.1 Synopsis 
Section 4.1 Overall Design 
Section 9.3.1 Primary 
Endpoint  
Section 9.5.1 Efficacy 
Analyses 
Section 9.6.2 Sequence of 
Interim and Other Planned 
Analyses 
The primary PFS analysis will be conducted after 
observing approximately 139 PFS events and a 
minimum of 6 months follow-up, in the randomized 
participants contributing to the analysis. Revised 
from requiring approximately 139 PFS events only. 
 
To ensure adequate follow-
up for the study population 
and specifically, for 
participants with one prior 
line of therapy 
Section 1.1 Synopsis 
Section 3 Objectives and 
Endpoints 
Section 9 Statistical 
Considerations (Section 
9.1, 9.2, 9.3 and 9.5.1). 
Revised DoR as another key secondary endpoint 
(moved from secondary); updated testing hierarchy; 
changed DoR definition to include all participants 
regardless of response status (not just based on 
responder) and updated primary analysis method for 
DoR to be based on a comparison of the restricted 
mean DoR (RMDOR) between the treatment arms. 
Analyses of DoR among responders retained as 
supplementary analyses. 
Inclusion of DoR as key secondary above MRD 
Negativity changes section numbering: 9.1.2 and 
9.1.3 become 9.1.3 and 9.1.4, respectively. 9.3.2,  
9.3.3 and 9.3.4 become 9.3.3, 9.3.4 and 9.3.5, 
respectively. 
To enable an ITT analysis 
using all participants 
(responders and non-
responders) with increased 
sensitivity and to account for 
the expected difference in 
the proportion of responders 
between the treatment arms 
so that valid statistical 
comparisons can be made. 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 1.1 Synopsis 
Section 3 Objectives and 
Endpoints 
Section 9 Statistical 
Considerations 
Revised overall survival (OS) as another key 
secondary endpoint (moved from secondary 
endpoint); updated testing hierarchy 
Addition of sections 9.1.4 Key Secondary Overall 
Survival Endpoint (to define the hypothesis test) and 
9.3.4 Key Secondary Endpoint Overall Survival. 
Revised Section 9.2 to include OS in the hierarchical 
testing and clarify sequence/timing of testing. 
Section 9.5.1 moved details of the OS analyses to 
key secondary and clarified timing of primary OS 
analyses to align with the planned hypothesis testing 
To address FDA comments 
at protocol amendment 2 
Section 1.1 Synopsis 
Section 1.3 Schedule of 
Activities 
Section 4.1 Overall Design 
Section 4.4 EOS Definition 
Section 6.8 Continued 
Access to Study 
Intervention after the End 
of the Study 
Section 8.3.1 Time Period 
and Frequency for 
Collecting AE and SAE 
Addition of an option for post analysis continued 
treatment (PACT) to allow eligible participants to 
continue study treatment 
Revised End of Study definition 
Addition subSection 6.8.1 Continued Access to 
Study Intervention After Final Analysis Data Cut-off 
prior to EOS 
Added instructions of the scope and the time period 
of data collection and reporting during the PACT 
phase 
To allow continued access to 
belantamab mafodotin and 
other study drugs in eligible 
participants and guidance on 
data collection and reporting 
Section 1.1 Synopsis 
Section 3 Objectives and 
Endpoints 
Section 8.5 
Pharmacokinetics 
Section 9.5.1 Efficacy 
Analyses 
Section 9.5.3 PK Analyses 
Removed total mAb from secondary and exploratory 
endpoints, and relevent sections in 
pharmacokinetics 
Total mAb concentrations 
are highly correlated with 
ADC concentrations which 
are already being collected  
Section 8.6 Belantamab 
Mafodotin Immunogenicity 
 
Deleted analysis of belantamab mafodotin plasma 
concentration for ADA samples 
 
 
 
Added statement on ADA sample collection 
Drug concentration is not 
needed for interpretation of 
ADA data due to the high 
drug tolerance of the 
immunogenicity assays. 
 
To allow reducing and 
termination of ADA sample 
collection when clinical data 
of immunogenicity within and 
cross studies are deemed 
sufficient. 
Section 1.1 Synopsis 
Section 3 Objectives and 
Endpoints 
Section 9.5.2 Safety 
Analyses 
Revised PRO-CTCAE endpoint definition: maximum 
post-baseline PRO-CTCAE score for each item 
attribute 
Added details of secondary endpoint analysis of 
PRO-CTCAE data 
To align with the planned 
analyses performed across 
the program. Intended 
analysis has not changed 
but endpoint wording revised 
to align with the intent.  

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Section # and Name 
Description of Change 
Brief Rationale 
Section 1.2 Schema 
Follow-up for OS from every 3 months to every 12 
weeks (Figure 1) 
To align with the description 
in SoA 
Section 1.3 Schedule of 
Activities 
Section 8 Study 
assessments and 
procedure 
Section 8.9.3 Circulating 
Plasma Cell-Free DNA 
Analysis 
Section 9.5.1 Efficacy 
Analyses 
Removed sample collection of circulating plasma 
cell-free DNA (cfDNA) (Table 1 and Table 2) 
Removed analysis of cfDNA (Section 8 Table 24, 
Section 8.9.3 and in Table 33 in Section 9.5.1) 
In line with program level 
changes 
Section 1.3 Schedule of 
Activities 
Section 8.2.6. Ophthalmic 
Assessments 
Clarify the instruction and frequency of ocular 
examinations after the 6th dose of belantamab 
mafodotin (Table 1, footnote 3, and Section 8.2.6.1) 
Clarification  
Section 1.3 Schedule of 
Activities Table 1 and Table 
2 
Added Footnote 26 for GSK for collecting survival 
data outside the protocol window 
Clarification 
Section 1.3 Schedule of 
Activities Table 3 
Reorganized header in Table 3,  
Clarification  
Added optional EMD tissue sample collection at PD 
in footnote 14 (Table 1 and Table 2) 
Clarification 
Added ±1 month window for follow-up MRD testing 
in Table 3 footnote f 
Clarification 
Section 5.1 Inclusion 
Criteria 
Clarification of lenalidomide exposure requirement in 
inclusion criteria #5 
Clarification 
Clarification of footnote 1 in Table 6 
Clarification 
Section 5.2 Exclusion 
Criteria 
Clarification of exclusion criteria #3 
Clarification 
Section 5.2 Exclusion 
Criteria Table 7 
Section 10.10 Country 
Specific Requirements 
Additional requirements for Japan Hepatitis B 
participants 
Clarification 
Section 6.1.3.2 Corneal 
Supportive Care Guidelines 
Section 8.2.6.2 Treatment 
Arm B 
Added ±4 weeks window for on study ocular 
assessment in Arm B 
Clarification 
Section 6.1.5 Bortezomib 
Updated the reconstituted concentration of 
bortezomib for intravenous administration (1 mg/mL) 
instead of subcutaneous administration;  
Addition of SC injection site per institutional 
guidance and alternative route of administration 
Clarification 
Section 6.5.1 Permitted 
Concomitant Therapies 
Allowing concomitant treatment or prophylaxis using 
monoclonal antibodies for serious conditions 
unrelated to MM, such as COVID 
To align with program 
language 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 6.7.1 Guidance on 
Dose Reductions in 
Treatment Arm A 
Dose modification for creatinine and ACR updated 
(Table 13) 
To align with CTCAE 
Clarify Belantamab mafodotin dose modification for 
other treatment-related toxicity is described in Table 
13 and Table 14 
Clarification 
Section 7.1 
Discountinuation of Study 
Intervention 
Additional instructions of discontinuation of study 
intervention and PD confirmation 
Clarification 
Section 7.2 Participant 
Withdrawal from the study 
Additional instructions on withdrawal from study 
treatment and from the study 
To help limit the amount and 
impact of missing data 
Section 7.3 Lost to Follow-
up 
Added follow-up data collection by third party or from 
public sources 
To help limit the amount and 
impact of missing data 
Section 8.3.7 Disease-
Related Events and/or 
Disease-related Outcomes 
Not Qualifying as SAE 
Removed 
In line with program level 
changes 
Section 8.9 Biomarkers 
Removed Table 31  
Removed Dose 1 D4 and later time points in Table 
32 (only collect at screening, C1D1 and EoT) 
In line with program level 
changes 
Section 9.1.3 Key 
secondary MRD negativity 
endpoint 
Changed definition of the null hypothesis from H0: 
P1=P0 to H0: P1≤P0. 
For consistency with the 
primary when reflecting a 
one-sided test. No change to 
planned analysis.   
Section 9.3.5 Sample Size 
Re-Estimation 
Added further details of sample size re-estimation 
Clarification 
Section 9.4 Populations for 
Analyses 
Clarified how to identify the actual treatment arm 
assignment in the safety population definition (no 
changes to intended analyses).  
Separate PK populations are considered for the PK 
analysis of belantamab mafodotin and 
pomalidomide, due to differences in data collection. 
Also added requirement for measurable samples.  
Clarification. Separate PK 
populations are considered 
due to differences in data 
collection and for 
consistency across the 
program, ensuring sufficient 
evaluable data is available 
for analysis.  
Section 9.5.1 Efficacy 
Analyses 
Defined the countries included in the North East Asia 
region consisting of Japan, China, and Republic of 
Korea 
 
Clarified that the same pre-specified pooling strategy 
as used for the log-rank test will be applied for the 
cox proportional hazards model used in the 
supportive PFS analysis – these analyses are 
expected to align.  
 
95% confidence intervals for the difference (and the 
implied derivation of the difference between 
treatment arms) will not be produced for MRD 
negativity.  
Health authority request to 
clarify definition of NEA 
pooled analysis based on 
ICH E17 guidelines 
 
Clarification 
 
For alignment with the use of 
the stratified Cochran Mantel 
Haenszel test and 
consistency across the 
program. 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 9.6 Interim 
Analyses 
Table 35 revised to add clarification (footnotes 
included and obsolete text related to efficacy 
boundaries and efficacy boundary crossing 
probabilities which are not relevant for the IA for 
harm have been removed) and corresponding text in 
Section 9.6 updated to clarify that boundaries will be 
revised based on the observed events at the time of 
interim analysis for harm.  
Addition of Table 36 provides a summary of 
boundary crossing probabilities for harm under a 
range of underlying true hazard ratios. 
Clarification 
 
 
 
 
 
To address FDA comments 
at protocol amendment 2 
Section 9.6.1 Independent 
Data Monitoring Committee 
Section 9.6.2 Sequence of 
Interim and Other Planned 
Analyses 
Addition of descriptive efficacy summaries which 
may be included alongside safety data for IDMC 
safety reviews.  
Updated to allow safety 
findings to be put into 
context with respect to 
benefit:risk. 
Section 9.6.2 Sequence of 
Interim and Other Planned 
Analyses 
Table of Details of Planned Aalyses revised. More 
details provided in places where clarification 
required. Corrected inconsistencies (Primary PFS 
analysis at approximately 29 months under H1, 
descriptive OS analyses at 2L analysis will be for all 
participants not not based on safety population). 
Reference to Final analysis instead of EOS/Final 
analysis to avoid confusion due to updated End of 
Study definition in Section 4.4. 
Corrected inconsistencies 
and added clairfications  
Section 10.1.11 Third 
Parties and Sub-
contractors 
Section 3 Objectives and 
Endpoints 
Addition of Section 10.1.11 listing all vendors used in 
primary and secondary endpoints. Added a footnote 
at the end of Section 3 
For transparency 
Section 10.1.5 Committee 
Structure 
Added purpose and scope of the independent-
review committee (IRC)  
To align with the 
implementation of IRC 
Section 10.2.1 Definition of 
AE 
Clarify event NOT meeting the AE definition: The 
disease/disorder being studied or expected 
progression, , signs, or symptoms of the 
disease/disorder being studied, unless more severe 
than expected for the participant’s condition. 
Clarification 
Section 10.4 Liver Safety 
In a liver event, blood sample for pharmacokinetic 
(PK) and sBCMA in the follow-up assessment only 
apply to participants on Arm A, Blood sample for 
pomalidomide PK to be obtained within 48 hours of 
last pomalidomide dose within 48 hours 
Clarification 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 10.9 Appendix 9 
Intent of analysis remains unchanged. Separated the 
planned sensitivity analysis scenarios and censoring 
rules as 4 separate sensitivity analyses; associated 
minor changes for clarity. Footnotes updated to align 
with the appropriate superscripts in the table. 
Adequate baseline footnote included.  
 
Footnote associated with proprietary-algorithm 
removed. 
Clarification 
 
 
 
To align with planned 
analyses across the 
program.  
 
Analysis update to be based 
on IRC-assessment. 
Proprietary-algorithm no 
longer used. 
Section 10.10 Country 
Specific Requirements 
Added contraceptives methods which are NOT 
approved in Japan to update country specific 
requirement. 
Clarification 
Amendment 02 12 Jul 2022 
Overall Rationale for the Amendment: Amendment 02 is a global amendment to 
include:  
• 
Reduced the total number of participants to be randomized in the study while 
required number of events, study power, hazard ratio and type 1 error remains the 
same; 
• 
Updated and clarified key secondary endpoint definition of minimal residual disease 
(MRD) negativity rate to address Food and Drug Administration (FDA) comments at 
amendment 01;  
• 
Updated efficacy analyses and addition of a section of sequence of interim and other 
planned analyses for clarification; 
• 
Updated sections of pharmacokinetics and pharmacodynamics in humans; benefit 
and risk assessment to align with the changes made in current belantamab mafodotin 
Investigator Brochure (IB);  
• 
Updated sample collection requirements to reduce testing burden for sites and 
patients;  
• 
Addition of country-specific requirements of enrolment and sample testing; 
• 
Refined permitted concomitant local therapy for unrelated malignancies and the 
scope of anti-myeloma therapy in prohibited medications 
• 
Additional changes were incorporated which align with program revisions and/or 
updates as listed in table below. 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Headers, cover 
page, and Protocol 
Amendment 
Summary of 
Changes Table 
Headers and cover page were updated 
with new document number; Protocol 
Amendment Summary of Changes Table 
section was created and populated to 
include details and rationale for this 
amendment 
Editorial changes to align with the 
GlaxoSmithKline’s (GSK’s) standard 
protocol template 
Throughout 
Administrative updates to add 
clarification and/or remove discrepancies 
Editorial changes were made for 
accuracy, clarity, conformity, flow, 
and typographical error corrections 
Replaced ‘anti-cancer therapy’ with ‘anti-
myeloma therapy’ 
To align with program-wide updates 
Section 1.1 
Synopsis 
Revised the number of participants and 
removed global enrollment cap on North 
East Asian (NEA) region, allows 
continuation of enrollment in regional 
cohorts after global enrollment completed 
Revised based on reduced sample 
size and to support regional 
recruitment expectations 
Section 1.2 Study 
Schema 
Updated Figure 1 
To reflect on reduced number of 
participants 
Section 1.3 
Schedule of 
Activities 
Addition of instruction to participants with 
a history of Hepatitis B or C (footnote 11 
in Table 1 and Table 2) 
To reflect the procedures indicated in 
Table 4 and Table 5 
 
Replace ‘imaging for extramedullary 
disease will be collected and stored by a 
central vendor’ to ‘Digital copies of all 
scans must be maintained at Investigator 
sites as source document’ (footnote 14 in 
Table 1 and Table 2) 
Central vendor for imaging is not 
applicable in this study, in line with 
program level requirements 
Update of ocular surface disease index 
(OSDI) collection frequency (footnote 23 
in Table 1 and Table 2) 
To clarify OSDI collection frequency 
matched in both arms 
Changed language in Bone Marrow 
Assessments for Biomarkers from “BM 
Biopsy and/or Aspirate for BCMA 
Expression and Biomarker Research” to 
“BM Biopsy or Aspirate for BCMA 
Expression and Biomarker Research” 
Biomarkers does not need both a BM 
biopsy and BM aspirate 
 
Removed circulating plasma cell-free 
DNA (cfDNA) collections at MRD 
assessment time points (Table 1 and 
Table 2) 
Removed cfDNA collections at MRD 
assessment time points to reduce 
testing burden for sites and patients 

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Section # and 
Name 
Description of Change 
Brief Rationale 
 
Removed additional bone marrow 
collection for biomarker research at MRD 
assessments, at very good partial 
response (VGPR) or better confirmation 
of complete response (CR), stringent 
complete response (sCR), at suspected 
progressive diseases (PD). Clarified the 
language in footnote that biopsy is the 
preferred sample type for biomarker 
research when medically feasible and 
consistent with institutional practice, but 
bone marrow aspirate is acceptable if 
biopsy is not obtainable (Table 3, 
footnote g and h) 
Biomarkers only requesting bone 
marrow sample at screening and 
optional sample at PD. Reflects 
change in biomarker collections 
throughout program 
Section 2.3.3 
Pharmacokinetics 
and 
Pharmacodynamics 
in Humans 
Updated with results from ongoing 
DREAMM studies 
Updated and added newly available 
information in the current IB 
Section 2.3.4 Study 
209418 Belantamab 
mafodotin in 
combination with 
pomalidomide and 
dexamethasone 
Updated with study results 
Added available information in this 
study 
Section 2.4 
Benefit:Risk 
Assessment 
Update of Risk Assessment table to 
reflect current information from the 
belantamab mafodotin program 
Updated based on emerging data 
from belantamab mafodotin program 
in the current IB  
Section 3. 
Objectives and 
Endpoints 
MRD negativity rate will be as assessed 
in participants with CR or better using 
derived confirmed response according to 
International Myeloma Working Group 
(IMWG) criteria 
To address FDA comments at 
protocol amendment 1, updated and 
clarified key secondary endpoint 
definition of MRD negativity rate 
Updated language in Exploratory 
Biomarker Endpoint: Clarified tumor and 
blood-based biomarkers 
• Changed “DNA, RNA and protein” to 
“DNA, RNA and/or protein” 
• Changed “clinical response” to 
“Response to belantamab mafodotin” 
Provided Flexibility as not all 
deoxyribonucleic acid (DNA), 
ribonucleic acid (RNA), protein 
assays may be performed 
“Tissue” not required 
Language change to use samples for 
broader analysis 
Section 4.1 Overall 
Design 
Addition of requirement by local 
regulatory agencies on country-specific 
enrollment 
To support recruitment expectations 
in these regions 
Section 6.5 
Concomitant 
Therapy 
Addition of permitted concomitant 
therapies while on study (section 6.5.1 
permitted concomitant therapies) 
Clarify prohibited anti-myeloma therapies 
while on study (section 6.5.2 prohibited 
concomitant therapies) 
Define the allowance of local therapy 
for unrelated malignancies 
 
Define scope of myeloma therapy 
 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Section 6.7 Dose 
Reductions due to 
Toxicity 
Table 15: consolidated footnote to reduce 
redundancy. Addition of criteria to re-
baseline best-corrected visual acuity 
(BCVA) if participant has cataract surgery 
during the study  
To support accurate assessment of 
belantamab mafodotin-associated 
change in BCVA 
Section 8.Study 
Assessments and 
Procedures  
Table 24 List of Clinical Laboratory 
Assessments  
Added an option regarding testing for 
Total carbon dioxide (CO2) or carbon 
dioxide combining power (CO2CP) 
Updated note for hepatitis B virus-
deoxyribonucleic acid (HBV-DNA) testing 
Updated BM biopsy/aspirate collection 
requirements. 
 
To allow flexibility based on local 
country practices regarding testing 
for Total CO2 or CO2CP 
 
To align with program language 
Section 8.1.2 
Minimal Residual 
Disease 
Assessment and 
PET/CT Imaging 
Addition of clonoSEQ and the sensitivity 
threshold for MRD assay 
To address FDA comments at 
protocol amendment 1 
Section 8.5 
Pharmacokinetics 
Section 8.9 
Biomarkers 
 
Clarify pharmacokinetic (PK) and 
accompanying soluble B cell maturation 
antigen (sBCMA) sample collection may 
be terminated when sufficient data have 
been collected 
To reduce testing burden for sites 
and patients 
Section 8.6 
Belantamab 
Mafodotin 
Immunogenicity 
 
Clarify anti-drug antibody (ADA) sample 
collection may be terminated when 
sufficient data have been collected 
To reduce testing burden for sites 
and patients 
Section 8.9 
Biomarkers 
Consolidated Biomarker section 
 
Removed extraneous text and 
redundant description of biomarkers 
assessed 
Section 8.9.1 
Soluble B-Cell 
Maturation Antigen 
Removed sBCMA collection at MRD 
assessment for biomarkers (Table 29, 
Table 30, Table 31, Table 32) 
Reflects change in biomarker 
collections throughout program 
Section 8.9.2 
Tumor-Related 
Biomarkers 
Section 8.9.4 RNA 
Transcriptome 
Research 
Removed specific paragraphs for RNA 
expression research of a subset of RNA 
species (was in Section 8.9.5) and added 
language inclusive of potential RNA 
research in sub-section 8.9.2 and Section 
8.9.4 
To consolidate and simplify 
description 
Section 8.9.3 
Circulating Plasma 
Cell-Free DNA 
Analysis 
Removed extraneous text and clarified 
exploratory analysis 
To clarify the description 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Section 9.3 Sample 
Size Determination 
Reduced total number of participants to 
be randomized in the study, from 450 to 
approximately 300 
Based on observed recruitment rates 
and total progression-free survival 
(PFS) events projection, additional 
participants would not be needed to 
reach the required number of total 
events for the primary PFS analysis.  
Study assumptions including power, 
hazard ratio (HR) and type 1 error 
are maintained with reduced sample 
size.  
Section 9.3.2 Key 
Secondary Endpoint 
Minimal Residual 
Disease Negativity 
Rate 
Revision of power for MRD negativity 
rate from 99% to at least 88% 
 
Revised based on reduced sample 
size 
Section 9.5.1 
Efficacy Analyses 
Updated key secondary endpoint 
definition of MRD negativity rate.  
Added sensitivity analysis using 
investigator response. Additional 
supplementary analyses will be 
conducted using both derived and 
investigator response, separately, based 
on participants with VGPR or better 
(Table 33). 
Updated definition of duration of 
response (DoR): replaced “death due to 
PD” with “death due to any cause”. 
To address FDA comments at 
protocol amendment 1 
Section 9.5.1 
Efficacy Analyses 
Second line (2L) participants PFS 
subgroup analysis added 
A large proportion of 2L participants 
were enrolled towards the end of the 
recruitment period. This ensures that 
the PFS subgroup analysis will have 
sufficient follow-up of the 2L 
participants. 
Section 9.6 Interim 
Analyses 
Added Section 9.6.2 Sequence of Interim 
and Other Planned Analyses (Table 37) 
To clarify the planned analyses, the 
order in which they occur, what data 
will be included and what 
objectives/endpoints addressed.  
Appendix 2 – 10.2.5 
Reporting of Serious 
Adverse Events to 
GlaxoSmithKline or 
Designee 
Removal of the requirement for 
investigators to enter serious adverse 
event (SAE) causality in electronic case 
report form (eCRF) within 72 hours 
In line with program level 
requirements 
Appendix 9 - 10.9 
Progression-Free 
Survival Event and 
Censoring Rules 
Corrected errors in the definition of 
extended time without adequate 
assessment 
To align with the schedule of 
assessments and align with program 
updates to consider a 7 day window 
for delayed assessments within the 
programming logic only.  

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Section # and 
Name 
Description of Change 
Brief Rationale 
Appendix 10 - 10.10 
Country Specific 
Requirements 
In China, SAEs will be collected from 
signing of the informed consent form 
(ICF) and NOT from the start of 
treatment; 
the following samples will not be 
collected: bone marrow biopsy sample 
for B-cell maturation antigen (BCMA) 
immunohistochemistry (IHC), BM 
aspirate for exploratory endpoints, cfDNA 
and pharmacogenetic samples 
MRD sample collection and assessment 
are subject to regulatory approval 
Updated according to local country 
regulatory requirement 
Appendix 12-10.12 
Home Healthcare 
and Telemedicine 
Approaches 
Cardiac monitoring test 
(electrocardiogram) removed from home 
healthcare (General) visit 
In line with cardiac monitoring 
requirements across belantamab 
mafodotin program, based on 
emerging safety data 
 
Amendment 01: 20-APR-2021 
Overall Rationale for the Amendment: Amendment 01 is a global amendment to 
include Keratopathy Visual Acuity (KVA) scale and modified dose modifications based 
on KVA scale; update stratification strategy and Hep B+, and Hep C+ participants in 
order to align with the latest regulatory (US FDA) guidance. Additional changes were 
incorporated which align with program revisions and/or updates as listed in table below.   
Section # and Name 
Description of Change 
Brief Rationale 
Headers, cover page, and Protocol 
Amendment Summary of Changes 
Table 
Headers and cover page were 
updated with new document number; 
Protocol Amendment Summary of 
Changes Table section was created 
and populated to include details and 
rationale for this amendment 
Editorial changes to align with the 
GSK’s standard protocol template 
Throughout 
Administrative updates to add 
clarification and/or remove 
discrepancies 
Editorial changes were made for 
accuracy, clarity, conformity, flow, 
and typographical error corrections 
Section 1.2 Study Schema 
 
Corrected schema for Cycle 1 Arm A 
from 2.5 mg/kg IV q4w to state 2.5 
mg/kg IV 
Stratification strategy was updated to 
include prior anti-CD38 treatment 
(yes or no) 
To clarify as the 2.5 mg/kg IV dose 
is only once in Cycle 1 and not 
every 4 weeks. 
 
Based on emerging data from 
investigator sponsored study 
(MCRN 007/Study 209418) with B-
Pd.  

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Section # and Name 
Description of Change 
Brief Rationale 
Section 1.3. Schedule of Activities/ 
Table 1 Treatment Arm A – 
Belantamab Mafodotin in 
Combination with Pomalidomide 
and Dexamethasone (B-Pd), Table 
2 Treatment Arm B – Pomalidomide 
Plus Bortezomib and 
Dexamethasone (PVd) 
Section 8.1.2. Minimal Residual 
Disease Assessment and PET/CT 
Imaging 
Extended timepoint for MRD 
negativity confirmation by PET/CT 
from 28 to 42 days 
 
Simplified MRD collection language 
to align with the program wide 
guidance  
 
To align with GSK program wide 
guidance allowing flexibility in the 
timelines.  
Section 1.3. Schedule of Activities/ 
Table 1 Treatment Arm A – 
Belantamab Mafodotin in 
Combination with Pomalidomide 
and Dexamethasone (B-Pd), Table 
2 Treatment Arm B – Pomalidomide 
Plus Bortezomib and 
Dexamethasone (PVd) 
Section 8.2.7. Pregnancy Testing 
(WOCBP Only) 
Pregnancy testing following 
belantamab mafodotin 
discontinuation must be repeated at 
least 70 days after last dose 
 
Use of contraceptive for Arm A 
WOCBP was updated from further 8 
months to further 3 months 
Clarification 
Section 1.3. Schedule of Activities/ 
Table 2 Treatment Arm B – 
Pomalidomide Plus Bortezomib and 
Dexamethasone (PVd) 
Clarified that select disease 
evaluations occurring at 
Cycles 1-8/Day 1 are for Cycle 1 
Day 1, only if disease evaluation at 
Screening visit was not done 
Clarified that pregnancy prevention 
counseling should occur at Screening 
Clarified that sBCMA biomarker 
sampling should occur at Screening 
Error corrections 
Section 1.3. Schedule of Activities/ 
Table 2 Treatment Arm B – 
Pomalidomide Plus Bortezomib and 
Dexamethasone (PVd) 
Section 6.1.3.2. Corneal Supportive 
Care Guidelines 
Section 8.2.6.2. Treatment Arm B: 
PVd 
Removed ocular examination 
requirement at PFS and OS 
Follow-Up Visits 
Clarified that On Treatment ocular 
examinations should occur every 6, 
not every 3 months, and as clinically 
indicated 
Per GSK program-wide guidance, 
the frequency of ocular 
assessments should occur every 6 
months and at the end of treatment, 
and not required at PFS and OS 
visits for Arm B.  

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Section # and Name 
Description of Change 
Brief Rationale 
Section 1.3. Schedule of Activities 
Added Table 3 for BM Aspirate and 
Biopsy collection 
Added Table 4 for additional 
procedures for participants with a 
history of Hepatitis B 
Added Table 5  for additional 
procedures for participants with a 
history of Hepatitis C 
To clarify BM sample collection  
 
To align with the latest regulatory 
guidance 
Section 2 Introduction;  
Section 2.2.1 Clinical Management 
of Multiple Myeloma;  
Section 4.3.2 Pomalidomide use 
Section 4.3.3 Bortezomib dose 
Figure 2 was updated to align with 
the mechanism of action in the 
investigator brochure 
 
Removed the year from the 
references to USPI/SmPC of 
Pomalyst/ pomalidomide and Velcade 
/bortezomib  
Alignment with the recent 
investigator brochure 
 
To avoid discrepancies as the most 
recent information is widely 
available 
Section 2.3.1 Studies with 
Belantamab Mafodotin 
Section 2.3.2 Safety 
Section 2.3.3 Pharmacokinetics and 
Pharmacodynamics in Humans 
Aligned with new data from the recent 
belantamab mafodotin Investigator’s 
brochure  
Updated based on the recent 
investigator brochure  
Section 2.4.1 Summary of Risk 
Assessment for the Combination 
Therapy of B-Pd (Arm A) and PVd 
(Arm B)  
Removal of the risk of potential for 
cardiotoxicity related to inflammatory 
response.  
 
 
Revisions to wording of risks for 
thrombocytopenia, Keratopathy, IRR, 
pulmonary pneumonitis, 
nephrotoxicity, other laboratory 
abnormalities, immunosuppression, 
fertility and data acquisition  
 
Risks related to approved multiple 
myeloma treatments viz. 
pomalidomide and bortezomib are 
removed 
Based on a comprehensive review 
of the data from studies BMA117159 
and 205678, the risks are 
considered discharged. 
 
To align with current program level 
wording based on additional data 
from DREAMM-2/205678 study and 
in alignment with Investigator 
brochure update. 
 
 
For the simplification as updated 
data are available outside of the 
protocol  
 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 3 Objectives and Endpoints 
(corresponding change in Section 
1.1 Synopsis) 
 
Revision of the HRQoL endpoint to 
include change from baseline in 
HRQoL as measured by EORTC 
QLQ-MY20, in addition to EORTC 
IL52 and to clarify the EORTC QLQ-
MY20 applies to participants enrolled 
under Protocol Amendment 1 
 
Revision of Endpoint to exploratory 
Objective of Exploring the relationship 
between biologic characteristics and 
response 
To maintain program-wide 
consistency 
 
 
 
To clarify and encompass all 
exploratory biomarkers and to 
maintain program-wide consistency 
Section 4.3.1 Belantamab Mafodotin 
Dose  
Dosing rationale for dose reduction 
for management of corneal toxicities 
was added 
Clarification 
Section 5.1 Inclusion Criterion 
(contraception criterion 10) 
Typographical correction, that the 
length of contraceptive use 
post -pomalidomide treatment for 
women of childbearing potential in 
Arm B is 6 months and not 5 months 
Error correction/to align with Section 
8.2.7 where this information is 
correctly provided  
Section 5.2 Exclusion Criteria 16 
and 17 
Updated exclusion criteria for HIV+, 
Hep B+, and Hep C+ participants 
To align with the latest regulatory 
guidance 
Section 5.2 Exclusion Criteria 
(ongoing Grade 2 peripheral 
neuropathy criterion 20) 
Ongoing Grade 2 peripheral 
neuropathy with pain within 14 days 
prior to randomization or ≥ Grade 3 
peripheral neuropathy 
To align with clinical practice to 
allow Grade 2 (without pain) or less. 
Section 5.2 Exclusion Criteria 
(criterion 21) 
Added ‘arterial’ to include the history 
of venous thromboembolism  
Clarification 
Section 6.1.1 Treatment Arm A 
Dosing Schedule 
Figure 3 was updated to show dosing 
of belantamab mafodotin Cycle 1 and 
Cycle 2+ 
Clarification 
Section 6.1.3.2 Corneal Supportive 
Care Guidelines 
Section 6.7.1. Guidance on Dose 
Reductions in Treatment Arm A 
(B-Pd)/Table 15 Dose Modification 
Guidelines for Belantamab 
Mafodotin Treatment-Related 
Corneal Events Based on KVA 
Scale 
Section 7.1.3. Corneal Event 
Stopping Criteria 
Corneal events associated with 
belantamab mafodotin, will be graded 
using the modified KVA scale, 
replacing  NCI-CTCAE v5.0 for 
corneal toxicities  
KVA scale has been developed 
following feedback from Regulatory 
Authorities for grading treatment 
related corneal events, taking into 
consideration findings from both 
corneal examinations and visual 
acuity changes 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 6.5.2 Prohibited 
Concomitant Therapies 
Addition of the language for 
participants receiving anti-HIV and 
anti-microbials 
Clarification 
Section 6.6.2 Guidance on Dose 
Delays for Treatment Arm B (PVd) 
Table 11, item #3 Delay in only 
dexamethasone, actions for 
dexamethasone were inadvertently 
incorrect. These were corrected to 
align with the planned dosing regimen 
Correction 
Section 6.7.1 Guidance on Dose 
Reductions in Treatment Arm A (B-
Pd) 
 
Inclusion of a step-down dose levels 
for belantamab mafodotin following 
onset of corneal AEs:  
Dose level  -1 of belantamab 
mafodotin 1.9 mg/kg q8w  
Dose level -2 as 1.4 mg/kg q8w 
Dose reduction of belantamab 
mafodotin to manage treatment 
related corneal toxicities. 
Section 7.1.2 QTc Stopping Criteria 
The section was removed. 
Discharged risk 
Section 8 Study Assessments and 
Procedures/Table 24 List of Clinical 
Laboratory Assessments 
Removed blood type assessment, 
INR, BUN, bone marrow biopsy.  
 
The footnotes were revised to be in 
the order, as it appears in the table  
The tests should be performed as 
clinically indicated, but not required 
for the study.  
 
 
Correction 
Section 8.2.8 Management of 
Hepatitis participants 
Added section to clarify management 
of Hepatitis B+ participants 
To align with the latest regulatory 
guidance 
Section 8.4 Treatment of Overdose 
The overdose for belantamab 
mafodotin was defined as more than 
10% above the calculated dose 
Clarification 
Section 8.5.1 Belantamab Mafodotin 
Pharmacokinetic Sample Collection 
Added a statement, “All PK, sBCMA, 
and anti-drug antibody (ADA) 
samples once collected (regardless of 
dosing) will be analyzed if the sample 
date and time have been recorded.” 
To accurately reflect study conduct 
Section 8.9.1 Soluble B-Cell 
Maturation Antigen/Table 
31Treatment Arm A sBCMA Blood 
Collection Schedule (Enhanced 
sBCMA Cohort) (Approximately 100 
Participants) 
Added the qualifier “approximately” 
regarding the number of sBCMA 
samples to be collected 
To accurately reflect study conduct 
Section 8.10 Patient-Reported 
Outcomes 
Edits were made to align with  
EORTC QLQ-MY20 changes 
Clarification 
Section 8.11 Non-protocol Specified 
Healthcare Resource Utilization 
Updated the language  
To align with the GSK protocol 
template 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 9.2 Multiple Comparisons 
and Multiplicity 
Added details for the final primary 
analysis 
Clarification 
Section 9.5.1 Efficacy Analyses  
 
Added strategy for pre-specified 
pooling of strata  
To align with the change with 
stratification strategy.  
Section 10.3.2 Contraception 
Guidance 
Removed oral contraception as a 
combined hormonal contraception in 
Section 10.3.2 
Aligned with pomalidomide labelling 
(EU SmPC), where oral 
contraceptive pills are not permitted 
due to increased risk of venous 
thromboembolism in patients with 
multiple myeloma receiving Pd; per 
protocol addendum DEU01 
Section 10.4 Appendix 4: Liver 
Safety: Required Actions, Follow-up 
Assessments, and Study Treatment 
Rechallenge Guidelines 
Added requirement for a blood 
sample collection for sBCMA analysis 
as a follow-up assessment after a 
liver stopping event, along with the 
PK sample collection 
sBCMA sample should be collected 
alongside the PK sample in the case 
of a liver stopping event 
Section 10.9 Appendix 9: 
Prophylactic Interventions for 
Corneal Toxicity Corneal Event 
Grading for Belantamab Mafodotin 
Treatment-Related Corneal Events 
(Treatment Arm A) 
The contents moved to Section 6.1.3. 
3 and Appendix 9 was removed.  
Clarification  
Section 10.10 Appendix 10: Country 
Specific Requirements 
An additional inclusion criterion for 
participants in Israel regarding prior 
multiple myeloma treatment: 
Participants must have prior 
treatment with daratumumab, if 
available, cannot get access to 
daratumumab for any reason, or 
cannot tolerate daratumumab 
Due to local guidelines in Israel for 
multiple myeloma treatment, 
additional consideration is to be 
given for prior exposure to 
daratumumab for participants there 
(per protocol addendum ISR01) 
Section 10.12 Appendix 12: Home 
Healthcare and Telemedicine 
Approaches (new) 
Added a new appendix to allow for 
home healthcare and telemedicine 
approaches 
To allow flexibility in study conduct 
Section 10.13 Appendix 13: Data 
Management/Monitoring (new) 
Added a new appendix  
To allow flexibility in study conduct 
Abbreviations: ADA=Antidrug Antibody; B-Pd=Belantamab Mafodotin In Combination With Pomalidomide And 
Dexamethasone; INR=International Normalized Ratio; KVA=Keratopathy Visual Acuity; MRD=Minimal Residual 
Disease; NCI-CTCAE=National Cancer Institute Common Terminology Criteria For Adverse Events; OS=Overall 
Survival; Pd=Pomalidomide In Combination With Dexamethasone; PET/CT=Positron Emission Tomography/Computed 
Tomography; PFS=Progression-Free Survival; PK=Pharmacokinetic; PVd=Pomalidomide In Combination With 
Bortezomib And Dexamethasone; sBCMA-Soluble B Cell Maturation Antigen; WOCBP=Women of Childbearing 
Potential. 

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11. 
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Signature Page for  207499 TMF-16737343 v2.0
Signature Page for TMF-16737343 v2.0
Reason for signing: Approved
Name: 
Role: Approver
Date of signature: 28-Sep-2023 13:14:23 GMT+0000
PPD