A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)
Phase: PHASE3
Conditions: Multiple Myeloma
Sponsor: GlaxoSmithKline

Protocol Amendment 5
Study ID:  207495
Official Title of Study: A Phase III, Open-Label, Randomized Study to Evaluate the 
Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide 
Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory 
Multiple Myeloma (RRMM) (DREAMM 3)
NCTID: NCT04162210
Date of Document: 7 September 2022

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GSK group of companies 
 
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TITLE PAGE 
Protocol Title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and 
Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Low-
dose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple 
Myeloma (RRMM) (DREAMM 3) 
Protocol Number: 207495/Amendment 5 
 
Compound Number: GSK2857916 
 
 
Study Phase: Phase 3  
Short Title: Phase III Study of Single Agent Belantamab Mafodotin versus 
Pomalidomide plus Low-dose Dexamethasone in Participants with Relapsed/Refractory 
Multiple Myeloma  
Sponsor Name and Legal Registered Address:  
GSK Research & Development Limited 
980 Great West Road 
Brentford 
Middlesex, TW8 9GS 
UK 
Regulatory Agency Identifying Number(s): IND 119333; EudraCT No: 2018-
004252-38 
Medical Director Name and Contact Information will be provided in the Study 
Reference Manual (SRM) 
Sponsor Signatory: 
Sumita Roy-Ghanta 
Group Sr. Medical Director, Clinical 
Development Lead 
 
 
Approval Date: 07 Sep 2022 
 
Copyright 2022 the GSK group of companies.  All rights reserved.  Unauthorised 
copying or use of this information is prohibited.

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PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE 
DOCUMENT HISTORY 
Document 
Date of Issue 
DNG/TMF Number 
Amendment 5 
07 Sep 2022 
TMF-14920746 
Amendment 4 
07 Sep 202220-Apr-2022 
TMF-14577505 
Amendment 3 
21-Oct-2021 
TMF-14062052 
Amendment 2 
20-Sept-2021 
TMF-13954921 
Amendment 1 
23-Oct-2020 
2017N336101_01 
Original Protocol 
30-Sep-2019 
2017N336101_00 
 
Amendment 5: 07 Sep 2022 
This amendment is considered to be non-substantial based on the criteria defined in EU 
Clinical Trial Regulation No 536/2014 of the European Parliament and the Council of the 
European Union because it neither significantly impacts the safety of participants nor the 
scientific value of the study. 
Overall Rationale for the Amendment:  
This protocol amendment changes the method for the primary analysis of efficacy 
endpoints from being based on algorithm-derived confirmed response and dates per 
IMWG [Kumar, 2016] criteria, to being based on investigator-assessed responses and 
dates per IMWG. The primary efficacy analysis will be supported by a pre-specified 
Independent Review Committee (IRC) audit for the analysis of the efficacy endpoints. 
In addition, the definition for duration of response was updated, the countries included in 
the North East Asia subgroup defined, the required number of events for the primary PFS 
analysis aligned, the language for anti-myeloma therapy updated, and the PACT language 
including ocular follow up update.  
Section # and Name  
Description of Change  
Brief Rationale  
Throughout the protocol 
Change from anti-cancer therapy 
wording to anti-myeloma therapy 
To define the allowance of local therapy for 
unrelated malignancies, to define the scope of 
permitted myeloma therapy, to clarify 
confirmation of disease progression as per 
IMWG criteria prior to initiating a new anti-
myeloma therapy, to define prior lines of 
therapy appropriately 
Section 1.1 Synopsis 
Section 5.1 Overall Design 
Section 5.4 EOS Definition 
Section 10.5: Planned 
analysis 
Clarification to when final analysis will 
occur  
Clarification 
Section 1.1 Synopsis 
Section 5.1 Overall Design 
Section 5.4 EOS Definition 
Section 9.3.1 Time period 
and Frequency for 
Update to PACT language to clarify End 
of Study vs Final analysis langauge; to 
clarify ocular assessment during the 
PACT phase 
Clarification 

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Section # and Name  
Description of Change  
Brief Rationale  
Collecting AE and SAEs 
Section 1.1 Synopsis 
Section 4: Objectives and 
endpoints 
Section 10.4.1 Efficacy 
Analyses 
Change to duration of response (DoR) 
definition to include death due to any 
cause. 
Health authority request to update DoR 
definition 
Section 4: Objectives and 
endpoints 
Section 9.1 Efficacy 
Assessments  
Section 10.4.1 Efficacy 
Analyses. 
Section 11.1.5 Committee 
Structures 
Removal of algorithm-derived 
assessment of response and instead, 
efficacy analysis will be based on 
Investigator-assessed response, 
supported by the results of an IRC audit 
Health authority request for  PFS to be 
determined by Investigator-assessed response, 
supported by the results of an IRC audit 
Section 7.5.1 Permitted 
Medications 
Clarify treatment for an unrelated 
malignancy 
To allow optimal patient treatment 
Section 7.5.2 Prohibited 
Mediications 
Clarify prohibited treatments 
To ensure appropriate treatment in the study 
Section 7.6.2.1 Belantamab 
mafodotin – Arm 1 (Table 
11) 
Dose modification for creatinine and 
ACR updated 
To align with CTCAE 
Section 7.7: Continued 
Access to Study 
Intervention after the End 
of the Study   
Title updated to distinguish between 
Continued access after EOS and after 
Final analysis 
To align with PACT process 
Section 7.7.1: Continued 
Access to Study 
Intervention after Final 
DCO prior to EOS   
New section to distinguish between 
Continued access after EOS and after 
Final analysis 
To align with PACT process 
Section 9.1.1 Independent 
review Committee 
New section to explain the purpose and 
scope of the IRC 
To align with the implementation of an IRC audit 
Section 10.4.1 Efficacy 
Analyses 
NE Asia region definition clarified to be a 
region consisting of Japan, China, and 
Republic of Korea  
Health authority request to clarify definition of 
NEA pooled analysis based on ICH E17 
guidelines 
Section 10.2: Sample Size 
Determination 
Change in PFS events required from ‘at 
least’ 151 to ‘approximately’ 151 
To align language throughout the statistical 
consideration section  
Section 10.5: Planned 
analysis 
Correction of footnote for OS IA 
Correction 
 
 

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TABLE OF CONTENTS 
PAGE 
1.1. 
Synopsis ..................................................................................................... 11 
1.2. 
Schema ...................................................................................................... 17 
2. 
SCHEDULE OF ACTIVITIES (SOA) ....................................................................... 18 
3. 
INTRODUCTION .................................................................................................... 37 
3.1. 
Study Rationale .......................................................................................... 37 
3.2. 
Background on BCMA and Multiple Myeloma ............................................. 38 
3.3. 
Antibody-Drug Conjugate Belantamab Mafodotin ....................................... 39 
3.4. 
Human Experience with Belantamab Mafodotin .......................................... 39 
3.4.1. 
Clinical studies ............................................................................. 39 
3.4.2. 
Safety .......................................................................................... 41 
3.4.3. 
Pharmacokinetics and Pharmacodynamics in Humans ................ 42 
3.5. 
Benefit/Risk Assessment ............................................................................ 44 
3.5.1. 
Risk Assessment ......................................................................... 45 
3.5.2. 
Benefit Assessment ..................................................................... 49 
3.5.3. 
Overall Benefit: Risk Conclusion .................................................. 49 
4. 
OBJECTIVES AND ENDPOINTS ........................................................................... 50 
5. 
STUDY DESIGN .................................................................................................... 52 
5.1. 
Overall Design ............................................................................................ 52 
5.2. 
Scientific Rationale for Study Design .......................................................... 53 
5.3. 
Justification for Dose .................................................................................. 54 
5.3.1. 
Belantamab mafodotin – Arm 1 .................................................... 54 
5.3.2. 
Starting dose of SOC (Pom/Dex) – Arm 2 .................................... 55 
5.4. 
End of Study Definition ............................................................................... 55 
6. 
STUDY POPULATION ........................................................................................... 56 
6.1. 
Inclusion Criteria ......................................................................................... 56 
6.2. 
Exclusion Criteria ........................................................................................ 59 
6.3. 
Lifestyle Considerations .............................................................................. 61 
6.3.1. 
Contact Lenses ............................................................................ 61 
6.3.2. 
Tobacco ....................................................................................... 61 
6.3.3. 
Other Lifestyle Considerations ..................................................... 61 
6.4. 
Screen Failures........................................................................................... 62 
7. 
STUDY INTERVENTION ........................................................................................ 62 
7.1. 
Study Intervention(s) Administered ............................................................. 63 
7.1.1. 
Supportive Care Guidelines for Belantamab Mafodotin – 
Arm 1 ........................................................................................... 63 
7.1.2. 
Supportive Care Guidelines for Pom/Dex – Arm 2 ....................... 64 
7.2. 
Preparation/Handling/Storage/Accountability .............................................. 64 
7.3. 
Measures to Minimize Bias: Randomization and Blinding ........................... 65 
7.4. 
Study Intervention Compliance ................................................................... 66 
7.5. 
Concomitant Therapy.................................................................................. 66 
7.5.1. 
Permitted Medication(s) ............................................................... 67 
7.5.2. 
Prohibited Medication(s) .............................................................. 67 
7.5.3. 
Drug Interactions ......................................................................... 68 
7.6. 
Dose Modification and Delay ...................................................................... 68 

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7.6.1. 
Dose Adjustments Due to Body Weight ....................................... 69 
7.6.2. 
Dose Modifications ...................................................................... 69 
7.7. 
Continued Access to Study Intervention after the End of the study ............. 78 
7.7.1. 
Continued Access to Study Intervention After Final Data 
Cut-off prior to EOS ..................................................................... 79 
8. 
DISCONTINUATION CRITERIA ............................................................................. 80 
8.1. 
Discontinuation of Study Intervention .......................................................... 80 
8.2. 
Safety Stopping Criteria .............................................................................. 81 
8.2.1. 
Liver Chemistry Stopping Criteria ................................................ 81 
8.2.2. 
Allergic and Anaphylactic Reaction Stopping Criteria ................... 84 
8.2.3. 
Corneal Event Stopping Criteria ................................................... 84 
8.2.4. 
Infusion-Related Reactions Stopping Criteria ............................... 84 
8.3. 
Participant Discontinuation/Withdrawal from the Study ............................... 84 
8.4. 
Lost to Follow Up ........................................................................................ 85 
9. 
STUDY ASSESSMENTS AND PROCEDURES ..................................................... 85 
9.1. 
Efficacy Assessments ................................................................................. 87 
9.1.1. 
Independent Review Committee .................................................. 89 
9.2. 
Safety Assessments ................................................................................... 89 
9.2.1. 
Physical Examinations ................................................................. 89 
9.2.2. 
Vital Signs .................................................................................... 89 
9.2.3. 
Electrocardiograms ...................................................................... 90 
9.2.4. 
ECOG Performance Status .......................................................... 90 
9.2.5. 
Clinical Safety Laboratory Assessments ...................................... 90 
9.2.6. 
Ocular Examinations and Procedures .......................................... 90 
9.2.7. 
Pregnancy Tests (WOCBP only) .................................................. 92 
9.2.8. 
Pomalidomide Risk Evaluation and Mitigation Strategy 
(REMS) /Pregnancy Prevention/Controlled Distribution 
Program ....................................................................................... 93 
9.3. 
Adverse Events and Serious Adverse Events ............................................. 93 
9.3.1. 
Time Period and Frequency for Collecting AE and SAE 
Information ................................................................................... 93 
9.3.2. 
Method of Detecting AEs and SAEs ............................................. 95 
9.3.3. 
Follow-up of AEs and SAEs ......................................................... 95 
9.3.4. 
Regulatory Reporting Requirements for SAEs ............................. 95 
9.3.5. 
Adverse Events of Special Interest .............................................. 96 
9.3.6. 
Pregnancy ................................................................................... 96 
9.3.7. 
Cardiovascular and Death Events ................................................ 96 
9.3.8. 
Management of Hepatitis B+ Participants .................................... 96 
9.4. 
Treatment of Overdose ............................................................................... 97 
9.5. 
Pharmacokinetics ....................................................................................... 98 
9.5.1. 
Blood Sample Collection for Pharmacokinetics ............................ 98 
9.5.2. 
Pharmacokinetic Sample Analysis ............................................. 100 
9.6. 
Pharmacodynamics .................................................................................. 101 
9.7. 
Genetics ................................................................................................... 101 
9.8. 
Biomarkers ............................................................................................... 101 
9.8.1. 
sBCMA Sample Analysis ........................................................... 102 
9.8.2. 
BCMA Myeloma Expression ...................................................... 102 
9.8.3. 
RNA Transcriptome Research ................................................... 102 
9.8.4. 
RNA Expression Research of a Subset of RNA Species ............ 102 
9.9. 
Immunogenicity Assessments ................................................................... 103 

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9.10. 
Health Economics ..................................................................................... 103 
9.11. 
Patient-Related Outcomes ........................................................................ 104 
9.11.1. 
Patient Reported Outcome Version of the Common Term 
Criteria for Adverse Events (PRO-CTCAE) ................................ 104 
9.11.2. 
Visual Function Questionnaire ................................................... 104 
9.11.3. 
European Organization for Research and Treatment of 
Cancer Quality of Life Questionnaire 30-item Core module 
(EORTC QLQ-C30) ................................................................... 105 
9.11.4. 
European Organization for Research and Treatment of 
Cancer Multiple Myeloma Module 20 (EORTC QLQ 
MY20) and EORTC IL52 ............................................................ 105 
.... 106 
.... 106 
.... 106 
9.12. 
... 107 
... 107 
... 107 
... 108 
... 109 
... 109 
... 109 
10. STATISTICAL CONSIDERATIONS ...................................................................... 109 
10.1. 
Statistical Hypotheses............................................................................... 109 
10.2. 
Sample Size Determination ...................................................................... 110 
10.3. 
Populations for Analyses .......................................................................... 111 
10.4. 
Statistical Analyses ................................................................................... 112 
10.4.1. 
Efficacy Analyses ....................................................................... 112 
10.4.2. 
Safety Analyses ......................................................................... 115 
10.4.3. 
Ocular Sub Study Analysis ........................................................ 115 
10.4.4. 
Other Analyses .......................................................................... 116 
10.5. 
Planned Analyses ..................................................................................... 117 
10.5.1. 
Independent Data Monitoring Committee ................................... 119 
11. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ............................................................................................. 120 
11.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations .......................................................................................... 120 
11.1.1. 
Regulatory and Ethical Considerations ...................................... 120 
11.1.2. 
Financial Disclosure ................................................................... 120 
11.1.3. 
Informed Consent Process ........................................................ 120 
11.1.4. 
Data Protection .......................................................................... 121 
11.1.5. 
Committees Structure ................................................................ 121 
11.1.6. 
Dissemination of Clinical Study Data ......................................... 122 
11.1.7. 
Data Quality Assurance ............................................................. 123 
11.1.8. 
Source Documents .................................................................... 124 
11.1.9. 
Study and Site Closure .............................................................. 124 
11.1.10. Publication Policy ....................................................................... 124 
11.2. 
Appendix 2: Clinical Laboratory Tests ....................................................... 125 
11.3. 
Appendix 3: Adverse Events: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting ..................................... 128 
CCI
CCI

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11.3.1. 
Definition of AE .......................................................................... 128 
11.3.2. 
Definition of SAE ........................................................................ 129 
11.3.3. 
Definition of Cardiovascular Events ........................................... 130 
11.3.4. 
Recording and Follow-Up of AE and SAE .................................. 131 
11.3.5. 
Reporting of SAE to GSK ........................................................... 133 
11.4. 
Appendix 4: Contraceptive Guidance and Collection of Pregnancy 
Information ................................................................................................ 134 
11.4.1. 
Woman of Childbearing Potential (WOCBP) .............................. 134 
11.4.2. 
Contraception Guidance ............................................................ 135 
11.4.3. 
Collection of Pregnancy Information .......................................... 137 
11.5. 
Appendix 5: Genetics ................................................................................ 139 
11.6. 
Appendix 6: Liver Safety: Required Actions and Follow-up 
Assessments and Study Intervention Rechallenge Guidelines .................. 140 
11.7. 
Appendix 7: Liver Safety Drug Restart or Rechallenge Guidelines ............ 144 
11.7.1. 
Rechallenge Following Liver Stopping Events that are 
Possibly Related to Study Intervention ....................................... 144 
11.7.2. 
Restart Following Transient Resolving Liver Stopping 
Events Not Related to Study Intervention................................... 145 
11.8. 
Appendix 8: Abbreviations and Trademarks .............................................. 147 
11.9. 
Appendix 9: ECOG Performance Status ................................................... 153 
11.10. Appendix 10: Modified Diet in Renal Disease (MDRD).............................. 154 
11.11. Appendix 11: NYHA Functional Classification System .............................. 155 
11.12. Appendix 12: Eye Care Specialist’s Qualifications and 
Requirements ........................................................................................... 156 
11.13. Appendix 13: Home Healthcare and Telemedicine Approaches ................ 157 
11.14. Appendix 14: Data Management/Monitoring ............................................. 160 
11.15. Appendix 15: Country Specific Requirements ........................................... 161 
11.16. Appendix 16: Protocol Amendment History ............................................... 163 
12. REFERENCES ..................................................................................................... 180 
 
 
 

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LIST OF TABLES 
PAGE 
Table 1 
Schedule of Activities: Screening Assessments – Arm 1 - 
belantamab mafodotin and Arm 2 - Pom/Dex ......................................... 20 
Table 2 
Schedule of Activities: On-Treatment Assessments – Arm 1 - 
belantamab mafodotin ............................................................................ 22 
Table 3 
Schedule of Activities: On-Treatment Assessments – Arm 2 – 
Pom/Dex ................................................................................................ 27 
Table 4 
Schedule of Activities:  End of Treatment and Follow-Up 
Assessments – Arm 1 – belantamab mafodotin and Arm 2 – 
Pom/Dex ................................................................................................ 31 
Table 5 
Schedule of Activities: Ocular Sub Study ............................................... 34 
Table 6 
Hepatitis B (HBV) SoA – additional procedures ...................................... 35 
Table 7 
Hepatitis C (HCV) SoA – additional procedures ..................................... 36 
Table 8 
Risk Assessment and Mitigation Strategy............................................... 45 
Table 9 
Adequate Organ System Function ......................................................... 57 
Table 10 
Permitted Dose Reductions .................................................................... 69 
Table 11 
Dose Modifications Guidelines for Belantamab Mafodotin-
Related Adverse Events ......................................................................... 70 
Table 12 
General Dose Modification and Management Guidelines for 
Belantamab Mafodotin-Related Adverse Events Not Otherwise 
Specifieda ............................................................................................... 73 
Table 13 
Keratopathy Visual Acuity (KVA) Scale for Treatment-related 
Corneal Events ...................................................................................... 74 
Table 14 
Dose Modification for Belantamab Mafodotin Treatment based 
on the KVA scale (Table 13)................................................................... 75 
Table 15 
Dose Modifications Guidelines for Pomalidomide – Related to 
Hematologic Adverse Events ................................................................. 77 
Table 16 
Dose Modifications for Dexamethasone ................................................. 78 
Table 17 
Dose Modification Table for HBV+ Participants ...................................... 97 
Table 18 
Enhanced Pharmacokinetic and sBCMA Collection Schedule ................ 99 
Table 19 
Standard PK and sBCMA Collection Schedule ..................................... 100 

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Table 20 
Analysis Populations ............................................................................ 111 
Table 21 
Statistical Analytical Methods - Efficacy ............................................... 112 
Table 22 
Statistical Analytical Methods - Safety .................................................. 115 
Table 23 
Summary of PFS and OS analyses ...................................................... 117 
Table 24 
Stopping boundaries for OS ................................................................. 118 
Table 25 
Protocol-Required Safety and other Laboratory Assessments, 
including optional assessment1 ............................................................ 125 
Table 26 
Contraceptives Allowed During the Study............................................. 136 
 

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LIST OF FIGURES 
PAGE 
Figure 1 
Study Design Schema ............................................................................ 17 
Figure 2 
Treatment and Assessment Schema ...................................................... 18 
Figure 3 
Belantamab Mafodotin Mechanism of Action (MoA) ............................... 39 
Figure 4 
Liver Chemistry Stopping and Increased Monitoring Algorithm ............... 82 
Figure 5 
Liver Chemistry Increased Monitoring Algorithm with Continued 
Therapy for ALT ≥3xULN but <8xULN .................................................... 83 
Figure 6 
Ocular Sub-Study Schema ................................................................... 108 
 

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Protocol Summary 
1.1. 
Synopsis 
Protocol Title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and 
Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Low-
dose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple 
Myeloma (RRMM) (DREAMM 3) 
Short Title: Phase III Study of Single Agent Belantamab Mafodotin versus 
Pomalidomide plus Low-dose Dexamethasone in Participants with Relapsed/Refractory 
Multiple Myeloma 
Rationale: Multiple myeloma (MM) is an incurable malignancy which accounts for 1% 
of all cancers and for 10% of all hematologic malignancies.  A variety of drugs and 
combination treatments have been evaluated and found effective in treating MM. 
However, despite those treatment options, most, if not all, MM patients will ultimately 
develop resistance to existing therapies supporting the urgent need for new treatments. 
 
Immunomodulatory agents, such as lenalidomide and pomalidomide, are an important 
cornerstone of treatment for relapsed/refractory MM (RRMM). Pomalidomide 
administered with low-dose dexamethasone (pom/dex) is approved in the US, European 
Union (EU) and a number of other countries worldwide for patients with RRMM who 
have received at least two prior therapies including lenalidomide and bortezomib and 
have demonstrated disease progression on, or within 60 days of completion of, the last 
therapy. In the Phase III trial MM-003, which compared pom/dex with high-dose 
dexamethasone (HD) in this patient population, the median overall survival (OS, 12.7 
[95% confidence interval (CI): 10.4, 15.5] vs. 8.1 [95% CI: 6.9,10.8] months; hazard 
ratio (HR): 0.74 [95% CI: 0.56, 0.97]; p=0.0285) and progression-free survival (PFS, 4.0 
[95% CI: 3.6, 4.7] vs. 1.9 [95% CI: 1.9, 2.2] months; HR: 0.48 [95% CI: 0.39, 0.60]; 
p<0.0001) were significantly longer with pom/dex than with HD alone. An overall 
response rate (ORR) of 31% was achieved with pom/dex.  Pom/dex has been widely 
adopted globally as a treatment regimen for patients with advanced RRMM and is 
recommended in treatment guidelines.  
Belantamab mafodotin (GSK2857916) is a humanized (IgG1) immuno-conjugate which 
binds to BCMA, a target widely expressed on malignant plasma cells in MM. The parent 
anti-BCMA antibody is conjugated to the small molecule microtubule inhibitor 
monomethyl auristatin-F (MMAF), which is released inside the malignant cell after 
binding and internalization of the antibody.   
Single agent belantamab mafodotin has demonstrated to have a strong single-agent 
activity with a well-defined manageable safety profile in heavily pre-treated participants 
with RRMM (Q3W schedule via intravenous (IV) administration), based on final data 
from the First-Time-in-Human (FTIH) study BMA117159 (DREAMM-1) in participants 
who were refractory to at least one line of therapy and primary analysis data from the 
ongoing Phase II study 205678 (DREAMM 2)  in participants who have failed at least 3 

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prior lines of anti-myeloma therapy, including an anti-CD38 antibody, and who are 
refractory to an immunomodulatory agent and a proteasome inhibitor. 
In the FTIH DREAMM-1 study, as of the efficacy cut-off date of 31 August 2018, in the 
32 out of 35 participants in the Part 2 expansion cohort who were refractory to both 
immunomodulatory agents and proteasome inhibitors (PIs) and were treated with 
belantamab mafodotin (3.4 mg/kg IV), the ORR was 56% (95% CI: 37.7, 73.6) and 
median progression free survival (mPFS) was 7.9 months (95% CI: 2.3, Not estimable 
[NE]). In BMA117159, belantamab mafodotin demonstrated an acceptable safety profile. 
The most commonly reported adverse events (AEs) were cough, increased aspartate 
aminotransferase, and nausea, all of which were mostly mild or moderate (Grade 1 or 2), 
in addition to corneal events and thrombocytopenia, which are consistent with the known 
toxic effects of other MMAF-linked antibody-drug conjugates (ADCs) and were found to 
be manageable.  
The ongoing Phase II study 205678/DREAMM-2 is evaluating these two IV single agent 
doses (2.5 and 3.4 mg/kg) in participants 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 proteasome inhibitor.  A total of 194 participants 
received frozen drug product in the main cohort. The study met its primary endpoint for 
ORR. As of the cut-off date of 31 January 2020, ORRs were 31% (97.5% CI 21.7,43.6) 
in the 2.5 mg/kg arm and [35% (97.5% CI 24.8,47.0) in the 3.4 mg/kg arm. The median 
duration of response (DoR) was 11.0 months (95% CI: 4.2, not reported [NR]) at 2.5 
mg/kg and 6.2 months (95% CI: 4.8, NR) at 3.4 mg/kg. The mPFS was 2.8 months (95% 
CI: 1.6, 3.6) and 3.9 months (95% CI: 2.0, 5.8), respectively and the median OS was 13.7 
months (95% CI: 9.9, NR) at 2.5 mg/kg and 13.8 months (95% CI: 10.0, NR) at 3.4 
mg/kg. Primary analysis data from this study indicated no new safety signals, and the 
profile of adverse events was similar to the experience in the DREAMM-1 study for both 
arms. 
Further information on the effects of belantamab mafodotin are available in the 
Investigator’s Brochure.  
The efficacy and safety results from BMA117159 and primary analysis data from study 
205678 indicate that belantamab mafodotin is an effective single agent treatment option 
for patients with RRMM, with a novel mechanism of action (MOA). In binding to 
BCMA on malignant plasma cells, belantamab mafodotin initiates cell killing via a 
multimodal-mechanism, including delivering MMAF to BCMA-expressing MM cells, 
inducing apoptosis, enhancing antibody-dependent cellular cytotoxicity and antibody-
dependent cellular phagocytosis, and inducing immunogenic cell death. Further 
evaluation of single agent belantamab mafodotin is warranted in a randomized Phase III 
study against pom/dex, an established standard of care in RRMM. 

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Objectives and Endpoints: 
Objectives 
Endpoints 
Primary  
• 
To compare the efficacy with belantamab mafodotin 
vs pomalidomide plus low dose dexamethasone 
(pom/dex) in participants with relapsed/refractory 
multiple myeloma (RRMM) 
• 
PFS, defined as the time from the date of 
randomization until the earliest date of documented 
disease progression (according to IMWG Response 
Criteria) or death due to any cause 
Key Secondary 
• 
To compare the overall survival with belantamab 
mafodotin vs pom/dex in participants with RRMM 
• 
OS, defined as the time from randomization until 
death due to any cause 
Secondary 
• 
To compare other markers of efficacy of 
belantamab mafodotin vs pom/dex in participants 
with RRMM 
 
• 
ORR, defined as the percentage of participants with 
a confirmed PR or better per IMWG  
• 
Clinical benefit rate (CBR), defined as the 
percentage of participants with a confirmed minimal 
response (MR) or better per IMWG  
• 
DoR, defined as the time from first documented 
evidence of PR or better until PD per IMWG or 
death due to any cause among participants who 
achieve confirmed PR or better  
• 
TTR, defined as the time between the date of 
randomization and the first documented evidence of 
response (PR or better) among participants who 
achieve confirmed PR or better.  
• 
TTP, defined as the time from the date of 
randomization until the earliest date of documented 
PD (per IMWG Response Criteria) or death due to 
PD 
• 
To evaluate the safety and tolerability of 
belantamab mafodotin vs pom/dex in participants 
with RRMM  
• 
Incidence of adverse events (AEs) and changes in 
laboratory parameters  
• 
Ocular findings on ophthalmic exam 
• 
To evaluate the pharmacokinetic profile of 
belantamab mafodotin  
• 
Plasma concentrations of belantamab mafodotin, 
total monoclonal antibody (mAb), and cys-mcMMAF  
• 
To assess anti-drug antibodies (ADAs) against 
belantamab mafodotin  
• 
Incidence and titers of ADAs against belantamab 
mafodotin  
• 
To evaluate the tolerability of belantamab mafodotin 
vs pom/dex based on self-reported symptomatic 
adverse effects 
• 
Symptomatic adverse effects as measured by the 
PRO-CTCAE and OSDI  
• 
To evaluate and compare changes in symptoms 
and health-related quality of life (HRQOL) of 
belantamab mafodotin to pom/dex. 
• 
Health-related QOL as measured by EORTC QLQ-
C30, EORTC QLQ-MY20* and EORTC IL52*.  
• 
To assess Minimal Residual Disease (MRD) in 
participants who achieve ≥VGPR or better for 
belantamab mafodotin vs pom/dex 
• 
MRD negativity rate, defined as; the percentage of 
participants who are MRD negative by NGS method 
ADA= anti-drug antibodies; AE = adverse event; BCMA = B cell maturation antigen; cys-mcMMAF= cysteine 
maleimidocaproyl monomethyl auristatin-F;  DOR = duration of response;  EORTC = European Organisation for 
Research and Treatment of Cancer; EORTC IL52 = Disease Symptoms domain of EORTC QLQMY20;  EORTC 
QLQC30 = EORTC Quality of Life Questionnaire 30 item Core module; EORTC QLQMY20 EORTC Quality of Life 
Questionnaire 20 item Multiple Myeloma module; HCRU = health care resource utilization; HRQoL = health related 
quality of life; IMWG = International Myeloma Working Group; MRD = minimal residual disease; NGS = Next 
Generation Sequencing; ORR = overall response rate; OS = overall survival; OSDI = Ocular Surface Disease Index; 
PD = progressive disease; PFS = progression-free survival; pom/dex = pomalidomide/ dexamethasone; PR = partial 
response; PROCTCAE = Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events; 
QOL = quality of life; RRMM = relapsed/refractory MM; SAE = serious adverse event; TTP = time to progression; 

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Objectives 
Endpoints 
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 is a Phase III, open-label, randomized, multicenter study evaluating the 
efficacy and safety of single agent belantamab mafodotin compared to pom/dex in 
participants with RRMM.  
The study will include a screening period, study treatment period, and follow-up (see 
Figure 1). 
During screening participants will be evaluated for study eligibility per protocol as 
defined in the Inclusion and Exclusion criteria. Eligible participants must have been 
previously treated with at least two prior lines of therapy, including at least 2 consecutive 
cycles of both lenalidomide and a proteasome inhibitor (PI), (given separately or in 
combination) and must have documented progression (a) on, or within 60 days of 
completion of the last therapy or (b) must be non-responsive while on last treatment, 
where non-responsive is defined as not achieving at least Minimal Response (MR) after 2 
complete treatment cycles. In such cases lack of achieving of MR must be determined no 
earlier than at least 4 weeks after the last treatment. 
Following screening, participants will be centrally randomized in a 2:1 ratio to either 
Arm 1 (single agent belantamab mafodotin) or Arm 2 (pom/dex), as described in 
Intervention Groups and Duration. No cross-over will be allowed during the study until 
the final OS analysis.   
The study assessments will be performed during Screening, prior to the first dose of 
Cycle 1, and during each cycle of treatment. 
Upon permanent discontinuation of study treatment, participants will enter the follow-up 
phase: PFS follow-up for participants who discontinue study treatment but have not yet 
progressed and OS follow-up for participants with progressive disease (including those 
who were previously in PFS follow-up and have subsequently progressed). Participants 
are to follow the assessments as specified in the SoA.  
Number of Participants: 
Approximately 320 participants will be randomized in a 2:1 ratio, in favor of Arm 1. Arm 
1 (single agent belantamab mafodotin) will enroll approximately 214 participants and 
Arm 2 (pom/dex) will enroll approximately 106 participants. The randomization will be 
based on stage (International Staging System [ISS]), prior treatment with an anti-CD38 
agent (with a 40% global enrollment cap for participants with prior anti-CD38 treatment), 
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and number of prior lines of therapy (with a 55% global enrollment cap for participants 
with ≤3 prior lines) using a central Interactive Response Technology (IRT) system.    
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 are met. Additional participants that are enrolled in 
separate cohorts will not be included in the analysis portion of the study planned for the 
marketing authorization application, which is based on approximately 151 events. 
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: 
In this open-label randomized study comparing belantamab mafodotin vs pom/dex (see 
Figure 2 for a treatment and assessment schedule in both arms): 
Arm 1: Single agent Belantamab mafodotin  
Belantamab mafodotin will be administered intravenously at 2.5 mg/kg on Day 1 (D1) of 
a Q3W schedule (e.g., 21-day cycle).  The dose to be administered is based on actual 
body weight calculated at baseline.  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. The 
dose may be reduced to address toxicity according to protocol guidelines. 
Premedication (e.g., systemic corticosteroids) is not required unless deemed medically 
necessary by the investigator, in which case it should be administered according to 
institutional recommendations.  If an infusion-related reaction (IRR) occurs during 
administration, the infusion rate may be reduced or halted at the discretion of the 
investigator depending on the severity of the symptoms.   
Arm 2: Pomalidomide and low-dose dexamethasone (Pom/Dex) 
Pomalidomide will be administered orally at the approved starting dose of 4 mg daily on 
Days 1 to 21 of each 28-day cycle, with dexamethasone administered orally at a dose of 
40 mg once weekly (Days 1, 8, 15, and 22) as outlined in Section 5.3.2. For participants 
over 75 years old, dexamethasone should be administered at the lower dose of 20 mg 
once weekly (Days 1, 8, 15, and 22). 
End of Treatment and End of Study Definitions:  
Participants in both arms will be treated until disease progression, death, unacceptable 
toxicity, withdrawal of consent, lost to follow-up, or end of study, whichever comes first.   
The final analysis will occur when the planned 250 deaths for final OS analysis have 
occurred. If 250 OS events cannot be achieved, the final analysis will occur when all 
participants have died, are lost to follow up or have withdrawn consent. If OS is 
significant at 70% IF, no formal statistical testing will be conducted after 250 death 
events and OS data will continue to be collected until all participants have died, are lost 

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to follow up, or withdrawn consent, or for 2 years after the OS analysis at 70% IF, 
whichever occurs first.  
Following the final analysis, including any country-specific (expansion cohort) analysis, 
DREAMM-3 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 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 1 only), will be reported directly to GlaxoSmithKline (GSK). 
The end of study (EOS) is defined as the date when the last participant had their last visit 
(last subject last dose plus 70 days SAE reporting period). 

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Independent Data Monitoring Committee: 
An Independent Data Monitoring Committee (IDMC) will be employed for this study to 
review data at defined time points as outlined in the IDMC charter. The IDMC will be 
comprised of at least two physicians and one statistician external to GSK. 
 
1.2. 
Schema 
Figure 1 
Study Design Schema 
 
 
* Progression on or within 60 days of last treatment, or non-responsive while on last treatment (See IC. 4b) 
 
** Stratification based on International Staging System (ISS), number of prior lines of therapy and prior usage of 
anti-CD38 antibody treatment 
 
*** Until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent, lost to follow-up or end of 
study, whichever comes first. If at the end of OS follow-up, patients are still on treatment, PACT will be 
implemented and only safety data will be collected (See Section 9.3.1). 
 
**** includes follow-up for progression-free survival on subsequent line of therapy (PFS2) 
 
**** 

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Figure 2 
Treatment and Assessment Schema 
This chart represents an example of the planned treatment and assessment timepoints, but 
do not take into account any dose delays dose. Please refer to the Schedule of activities 
(SoA) (Section 2) for details on how visits are scheduled. 
 
2. 
SCHEDULE OF ACTIVITIES (SOA) 
All assessments planned for participants in Study 207495 are shown in the Time and 
Events Tables.  
Table 1: Screening Assessments – Both Arms  
Table 2: On-Treatment Assessments – Arm 1 – Belantamab mafodotin  
Table 3: On-Treatment Assessments – Arm 2 – Pom/Dex  
Table 4: End of Treatment and Follow Up Assessments – Both Arms  
Table 5: 
 
Table 6: Hepatitis B(HBV) SoA – additional procedures 
Table 7: Hepatitis C (HCV) SoA- additional procedures 
The details of these assessments are provided in footnotes to the tables, with more details 
provided in Section 9. Additional information on resuming study treatments after dose 
interruption/delay is provided in Section 7.4. 
For details on possible home healthcare and telemedicine approaches, please refer to 
Appendix 13 
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, 
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overdoses, prespecified ocular data (Arm 1 only),  and pregnancies will be reported 
directly to the Sponsor via paper forms (see Section 5.4, Section 7.7 and Section 9.3.1). 
For participant discontinuing treatment in the PACT phase, no end of treatment visit is 
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Table 1 
Schedule of Activities: Screening Assessments – Arm 1 - belantamab mafodotin and Arm 2 - Pom/Dex 
Screening Assessments – Arm 1 - belantamab mafodotin and Arm 2 - pom/dex 
Screening Study Assessments1,5 
Screen 
Notes 
Informed Consent 
X 
1. 
All Screening assessments must be performed within 28 days prior to first dose. Informed Consent must be 
signed before any study-specific assessments are performed. Screening Assessment do not need to be 
repeated on Cycle 1 Day 1 (C1D1) unless otherwise specified. 
2. 
Informed consent for optional genetics research must be obtained before collecting the sample. The sample 
will be collected at the first opportunity after a participant has met all eligibility requirements. 
3. 
Screening ocular examination will be performed by a qualified eye care specialist such as 
ophthalmologist/optometrist (Appendix 12, see Section 9.2.6 for list of ocular exam procedures).  
4. 
Perform only in women of child-bearing potential. Two serum pregnancy tests should be performed at 
screening. The first test should be performed within 10 to 14 days prior to first dose and the second test 
within 24 hours prior to administration of first dose. For questionable cases (child-bearing status), follicle-
stimulating hormone (FSH) and estradiol (as needed in women of non-childbearing potential only) should be 
performed at local lab (see Section 9.2.7 for more details).   
5. 
Refer to Appendix 2 for a comprehensive list of laboratory tests that must be collected for all participants and 
if analysed locally or centrally. 
6. 
If completed within 72 hours prior to the first dose, this assessment does not need to be repeated on C1D1  
7. 
eGFR as calculated by Modified Diet in Renal Disease (MDRD) formula (Appendix 10) 
8. 
Albumin/ creatinine ratio (spot urine preferably from first void). Urine dipstick for protein 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 with positive protein if urine dipstick protein quantification is not 
available. Albumin/creatinine will be performed at a local lab. If local testing is not available, then central 
testing will be performed. 
9. 
Refer to Table 6 for participants with positive serology for Hepatitis B and Table 7 for participants with 
positive serology for Hepatitis C. 
10. Single ECG on Screening, unless QTcF is prolonged, in which case triplicate ECGs are required.  To be 
performed after at least 5 min rest. 
11. Imaging of bones for lytic lesions by a method aligned with the institutional guidance (e.g. X-ray, CT, or MRI).  
Same modality used at Screening must be used throughout study.   
12. Imaging (i.e., CT, MRI, or PET-CT) is only required for participants with extramedullary disease (EMD) per 
local guidance. The same modality used at screening must be used throughout the study. Selected target 
lesion needs to be measured and followed over time.  Plasmacytoma measurements should be taken from 
the CT portion of the PET/CT, or MRI scans, or dedicated CT scans where applicable. For participants with 
Demography 
X 
Medical History, Disease History and 
Characteristics (includes substance abuse) 
X 
Prior anti-myeloma therapy (including radiation 
and transplants) 
X 
Physical Exam 
X 
Inclusion/Exclusion criteria  
X 
Past and current medical conditions 
X 
Concomitant Medication  
X 
Optional Genetics Consent2 
X 
Screening Safety Assessments1,5 
 
Ocular Exam3 
X 
ECOG Performance Status 
X 
Vital Signs (BP, HR, Body Temperature) 
X 
Weight and Height 
X 
Serum Pregnancy Test (WOCBP only)4 
X 
Hematology5 
X6 
Clinical chemistry5 
X6 
Estimated Glomerular Filtration (eGFR)7 
X6 
Urinalysis (dipstick) OR Spot Urine 
(albumin/creatinine ratio)8 
X6 
HBsAg, HBcAb, HCV tests9  
X 
12-lead ECG10 
X 
Screening Disease Evaluation1,5 
 
Skeletal Survey11 
X 
Beta2 microglobulin 
X 
UPEP 24 hr urine collection 
X6 
Urine immunofixation 
X6 
SPEP 
X6 

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Screening Assessments – Arm 1 - belantamab mafodotin and Arm 2 - pom/dex 
Screening Study Assessments1,5 
Screen 
Notes 
Serum Immunofixation 
X6 
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 perpendicular diameters of measured lesions (SPD). See also 
Section 9.1. and SRM for additional information.  
13. Only required for participant with IgD/E myeloma. 
14. 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, regardless of when the previous  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. 
15. Portion of the sample collected for disease assessment will be used for FISH testing, and MRD testing. Any 
remaining biopsy and aspirate sample will be used for biomarker research. 
16. BM biopsy is the preferred sample for these exploratory analyses. If for any reason BM biopsy is not 
obtainable, BM aspirate may be collected for BCMA expression and biomarker research 
17. Minimal residual disease (MRD) testing by NGS method.  
 
Extramedullary Disease (EMD) Assessment12 
X 
Serum Kappa, Lambda free Light chain, FLC 
ratio 
X6 
Calcium corrected for albumin (serum) 
X 
IgG, IgM, IgA 
X 
IgD/E, if applicable13 
X 
Bone Marrow (BM) Aspiration/Biopsy1,5 
 
BM (biopsy or aspirate) for disease assessment 
(percent plasma cells)15 
X 
BM aspirate for FISH testing14,15 
X 
BM biopsy for BCMA expression and biomarker 
research15,16 
X 
BM aspirate for baseline MRD testing15,17 
X 
Abbreviations: 
BCMA = B cell maturation antigen; BM = bone marrow;  BP = Blood pressure; cfDNA = Circulating free DNA; CT = Computed tomography; DNA = deoxyribonucleic acid; eGFR = 
Estimated glomerular filtration rate; ECG = Electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EMD = extramedullary disease;
 
; FISH = Florescent in situ hybridization; FLC = Free light chain; HBcAb = Hepatitis B core antibody; HBsAG = Surface antigen of Hepatitis B virus; HCV = Hepatitis C 
virus; HIV = Human Immunodeficiency Virus; Ig = Immunoglobulin; IHC = Immunohistochemistry; HR = Heart rate; MRD = Minimal residual disease; MRI = Magnetic resonance 
imaging; PET = Positron emission tomography; RNA = ribonucleic acid; SOI = start of infusion; SPEP = Serum protein electrophoresis; SRM = Study Reference Manual; UPEP = Urine 
protein electrophoresis; WOCBP = Women of child-bearing potential 
 
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Table 2 
Schedule of Activities: On-Treatment Assessments – Arm 1 - belantamab mafodotin 
On-Treatment Assessments – Arm 1 – belantamab mafodotin 
Study 
Assessments1,7 
C1D12 
 
Q3W 
(From 
Week 4, 
regardless 
of dosing) 
D1 of Each 
21-day 
Cycle (from 
C2-CX), if 
dosing3 
Notes 
 
ECOG Performance 
Status 
X 
X 
 
1. 
Assessments scheduled on days of dosing must be done prior to drug administration, unless otherwise 
specified.  All other assessments can be done ±3 days unless otherwise specified. The Q3W assessments 
must be carried out even if participant is not dosed, unless otherwise specified. All Q3W assessment days 
must be calculated from C1D1 irrespective of any changes in dosing cycle.  
2. 
Baseline disease evaluation assessments and ocular exam completed within the 28-day screening period prior 
to C1D1 do not need to be repeated on C1D1, unless otherwise specified. 
3. 
If no treatment is administered at Cycle visit, the following assessments do not need to be performed, unless 
clinically indicated: physical exam, vital signs, weight, pregnancy test, PK sample, ADA sample and soluble 
BCMA sample (except if collected with MRD assessment) 
4. 
AEs/SAEs will be collected from start of study treatment until at least 70 days after the last dose of study 
treatment.  All SAEs related to study participation (e.g., protocol mandated procedures, tests, or change in 
existing therapy) are to be collected from consent through OS follow-up. All AEs/SAEs will be followed until the 
event is resolved, stabilized, otherwise explained or the participant is lost to follow up (see Section 9.3). 
5. 
On C1D1 (first infusion) dosing day, vital signs must be assessed at pre-dose (within 30 minutes prior to SOI), 
within 15 mins after EOI, and 1-hour post EOI. On subsequent dosing days, vital signs must be assessed at 
pre-dose (within 30 minutes prior to SOI) and within 15 mins after EOI. On days where vital sign time points 
align with blood sampling time points, 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.  
6. 
On-treatment ocular exams to be performed up to 5 days prior to dosing from second cycle onwards. On-
treatment ocular exams to be performed Q3W prior to dosing, up to the 6th dose of belantamab mafodotin. At 
the time of the 6th dose of belantamab mafodotin, if there are no significant (KVA Grade 2 or above) treatment-
related ocular examinations findings, ocular symptoms, or vision changes, the frequency of ocular exams may 
decrease to once every 3 months until the end of treatment. If a participant subsequently develops vision 
Adverse Events4 
Ongoing 
Concomitant 
Medications 
Ongoing 
Safety Assessments 
Physical 
Examination 
X 
 
X3 
Vital Signs (BP, HR, 
Body Temperature)5 
X 
 
X3 
Ocular Exam 
 
X6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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On-Treatment Assessments – Arm 1 – belantamab mafodotin 
Study 
Assessments1,7 
C1D12 
 
Q3W 
(From 
Week 4, 
regardless 
of dosing) 
D1 of Each 
21-day 
Cycle (from 
C2-CX), if 
dosing3 
Notes 
 
Weight 
X 
 
X3 
changes or other ocular symptoms, the participant should be promptly evaluated by a qualified eye care 
specialist such as ophthalmologist/optometrist.  In case of persistent ocular exam findings, newly developed 
ocular symptoms or vision changes, the participants will have further exams, at least every cycle until 
resolution or baseline, or more frequently as clinically indicated by the qualified eye care specialist such as 
ophthalmologist/optometrist (Appendix 12). See Section 9.2.6 for full details of ocular exam procedures.   
7. 
Refer to Appendix 2 for a comprehensive list of laboratory tests that must be collected and whether analysed 
locally or centrally for all participants.  
8. 
If completed within 72 hours prior to the first dose, this assessment does not need to be repeated on C1D1  
9. 
eGFR as calculated by Modified Diet in Renal Disease (MDRD) formula (see Appendix 10). 
10. Albumin/creatinine ratio (spot urine, preferably from first void) to be performed every 6 weeks from C1D1 OR 
Urine dipstick for protein 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 ≥2+, or with positive protein if urine dipstick protein 
quantification is not available. Albumin/creatinine will be performed at a local lab. If local testing is not 
available, then central testing will be performed 
11. Perform only in women of child-bearing potential. The C1D1 pregnancy test is a serum test and should be 
within 24 hours prior to administration of first dose. Subsequent CXD1 pregnancy tests may be either serum or 
urine and each pregnancy test must be performed within 72 hours prior to dosing. 
12. To be assessed based on disease laboratory tests and imaging (if applicable) as outlined in this table.  
Response assessment is based on International Myeloma Working Group (IMWG) [Kumar, 2016].  
13. Disease evaluation (except imaging and skeletal survey) will be performed every 3 weeks (± 3 days) even if 
treatment is not administered. For participants who are discontinuing study intervention due to PD, the 
confirmation of PD 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 the disease progression 
before institution of any new anti-myeloma therapy. This may be performed at the EOT visit.  
14. Only if clinically indicated or if worsening clinical symptoms suggest skeletal PD. Imaging is not required if the 
PD is evident otherwise. Same modality used at Screening must be used throughout study. Imaging of bones 
for lytic lesions by a method aligned with the institutional guidance (e.g., X-ray, CT, or MRI).     
15. At time of first achieving unmeasurable M protein on SPEP/UPEP and at Q3W visit from week 4 until 
Hematology7 
X8 
X 
 
Clinical Chemistry7 
X8 
X 
 
eGFR9 
X8 
X 
 
Urinalysis (dipstick) 
or Spot Urine 
(albumin/creatinine 
ratio)10 
X8 
XQ6W 
 
Pregnancy Test 
(WOCBP only)11 
X 
 
X3 
Disease Evaluation Assessments13 
Response 
Assessment12 
 
X 
 
Skeletal Survey 
 
X14 
 
UPEP 24 hr urine 
collection 
X8 
X 
 
Urine 
Immunofixation 
 
X15 
 
SPEP 
X8 
X 
 
Serum 
immunofixation 
 
X15 
 
 
 
 
 
 
 
 
 
 
 

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On-Treatment Assessments – Arm 1 – belantamab mafodotin 
Study 
Assessments1,7 
C1D12 
 
Q3W 
(From 
Week 4, 
regardless 
of dosing) 
D1 of Each 
21-day 
Cycle (from 
C2-CX), if 
dosing3 
Notes 
 
Extramedullary 
disease assessment 
(by CT or MRI or 
PET/CT) 
 
X16 
 
suspected PD. 
16. Imaging (i.e., CT, MRI or PET-CT) is only required for participants with extramedullary disease Q12 weeks 
(e.g., Week 13, W25, W37, etc.) through 1 year and then as clinically indicated. The same modality used at 
screening must be used throughout the study. See Section 9.1 for more information on imaging, EMD 
measurement and follow-up, PD due to EMD. Refer also to the SRM for additional information. 
17. Only required for participants with IgD/E myeloma.  
18. For BCMA expression analysis by IHC and biomarker research at PD: BM biopsy is the preferred sample for 
these exploratory analyses, but if not obtainable, aspirate may also be used. Informed consent for the optional 
tissue sample must be obtained before collecting a sample.   
19. MRD testing to be performed at the time of first achieving response of VGPR or better, and repeated every 6 
months for 2 years, and then yearly until PD. In case of deepening of response from VGPR to CR, MRD 
sample should be collected at the time of CR assessment and repeated every 6 months for 2 years and then 
yearly until PD.  
20. At the time of suspected CR for confirmation of PC% <5% (always) or at time of suspected PD (only if not 
evident otherwise).  Bone marrow core biopsy is preferred.   
21. In participants achieving a CR, bone marrow biopsy to confirm sCR by IHC (κ/λ ratio). 
22. PET/CT required after first achieving MRD negativity by NGS, preferably within 42 days of testing negative 
23. Belantamab mafodotin administration on D1 of Cycle C2-CX ±3-days.  All scheduled cycle visits must be 
calculated from C1D1. Please refer to Section 7.6 in case a dose is delayed.  
24. See Section 7.1.1 for more detail on supportive Care information  
25. For pharmacokinetic sampling schedule, refer to Section 9.5. Pharmacokinetic samples are required according 
to the schedules for Standard and Enhanced PK collection for all participants receiving belantamab mafodotin 
(Table 18 and Table 19).  
26. Blood samples for ADA measurement in serum will be collected prior to the start of the infusion on dosing days 
at Cycles 1, 2, 6, 9, 12, and every 6 cycles thereafter (e.g., Cycle 18, Cycle 24, etc.).  
27. cfDNA samples to be collected pre-infusion on C1D1, and all MRD assessment timepoints.  
28. Soluble BCMA (serum): Collect sBCMA samples at the same PK timepoints as specified in Table 18 
(enhanced schedule) and Table 19 (standard schedule).  Additionally, sBCMA samples should be taken at 
Serum Kappa, 
Lambda free light 
chain, FLC ratio 
X8 
X 
 
IgG, IgM, IgA 
 
X 
 
IgD/E, if applicable17 
 
X 
 
Calcium corrected 
for albumin (serum) 
 
X 
 
Bone Marrow (BM) Aspiration/Biopsy 
Optional Tissue 
sample at PD: BM 
biopsy or aspirate 
for BCMA 
expression and 
biomarker research  
 
X18 
 
BM aspirate for 
MRD testing 
 
X19 
 
BM biopsy or 
aspirate for disease 
assessment 
(percent plasma 
cells) 
 
X20 
 
BM biopsy to 
assess sCR by IHC 
 
X21 
 
PET/CT upon 
achieving MRD 
negativity by NGS 
 
X22 
 

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On-Treatment Assessments – Arm 1 – belantamab mafodotin 
Study 
Assessments1,7 
C1D12 
 
Q3W 
(From 
Week 4, 
regardless 
of dosing) 
D1 of Each 
21-day 
Cycle (from 
C2-CX), if 
dosing3 
Notes 
 
Treatment 
every MRD assessment timepoint.   
29. Informed consent for optional genetic research must be obtained before collecting a sample. The sample will 
be collected at the first opportunity after a participant has met all eligibility requirements preferably on 
C1D1 
30. Only applicable for participants enrolled under the original protocol 
31. Only applicable for participants enrolled under protocol amendment 1 
   
Premedication (as 
needed) 
X 
 
X 
Belantamab 
mafodotin  
X 
 
X23 
Supportive Care 
Cooling eye 
masks24 
X 
 
X 
Preservative-free 
artificial tears24 
X 
 
X 
PK and ADA 
Pharmacokinetics25 
X 
 
X3 
Immunogenicity 
(ADA)26 
X 
 
X3 
Biomarkers and Genetics 
cfDNA (plasma)27 
X 
X MRD only 
 
Soluble BCMA28 
X 
X MRD only 
X3 
Optional Genetic 
Sample29 
X 
 
 
Health Outcomes  
PRO-CTCAE 
X 
X 
 
OSDI 
X 
X 
 
X 
X 
 
EORTC QLQ-C30 
X 
X 
 
EORTC IL5230 
X 
X 
 
EORTC QLQ-
MY2031  
X 
X 
 
X 
X(Q6W) 
 
X 
X(Q6W) 
 
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On-Treatment Assessments – Arm 1 – belantamab mafodotin 
Study 
Assessments1,7 
C1D12 
 
Q3W 
(From 
Week 4, 
regardless 
of dosing) 
D1 of Each 
21-day 
Cycle (from 
C2-CX), if 
dosing3 
Notes 
 
 
X(Q6W) 
 
X 
X 
 
 
Abbreviations: 
ADA = Anti-Drug Antibody; BP = Blood pressure; BM = bone marrow;  cfDNA – circulating free DNA; CR = Complete response; CT = Computed tomography; eGFR = Estimated 
glomerular filtration rate; ECOG PS= Eastern Cooperative Oncology Group Performance Status; EMD = extramedullary disease; EOI = End of Infusion; EORTC IL52 = Disease 
Symptoms domain of EORTC QLQ-MY20; 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;
 
;
; FLC = Free light chain;
HR = Heart rate;  
Ig = Immunoglobulin; IHC = Immunohistochemistry; MRD = Minimal residual disease; MRI = Magnetic resonance imaging; NGS = Next generation sequencing OS = Overall survival; 
OSDI = Ocular Surface Disease Index; PC = plasma cells; PD = Progressive disease; PET = Positron emission tomography; PFS = progression-free survival 
 
; PK = Pharmacokinetics; PRO-CTCAE = Patient-Reported Outcomes Version of the Common Term Criteria for 
Adverse Events; QID = 4 times a day; sCR = Stringent complete response; SAE = Serious adverse event; SOI = start of infusion; SPEP = Serum protein electrophoresis; SRM = Study 
Reference Manual; UPEP = Urine protein electrophoresis; VGPR = Very good partial response; WOCBP = Women of child-bearing potential 
 
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Table 3 
Schedule of Activities: On-Treatment Assessments – Arm 2 – Pom/Dex  
On-Treatment Assessments: Treatment Arm 2 (Pomalidomide/Dexamethasone) 
Study 
Assessments1,7 
C1D12  
Q3W (From 
Week 4, 
regardless 
of dosing) 
D1 of Each 
28-day 
Cycle (C2-
CX) if 
dosing3,4 
Notes 
ECOG Performance 
Status 
X 
X 
 
1. Assessments scheduled on days of dosing must be done prior to drug administration, unless otherwise specified. 
All other assessments can be done ±3 days unless otherwise specified. All Q3W assessments must be carried 
out even if participant is not dosed, unless otherwise specified. All Q3W assessment days must be calculated 
from C1D1 irrespective of any changes in dosing cycle. 
2. Baseline disease evaluation assessments and ocular exam completed within the 28-day screening period prior to 
C1D1 do not need to be repeated on C1D1, unless otherwise specified 
3. For Arm 2, treatment cycles are 28 days (see Figure 2).  
4. If no treatment is administered on a given visit, the following assessments do not need to be performed, unless 
clinically indicated: physical exam, vital signs, weight, hematology  
5. AEs/SAEs will be collected from the start of study treatment until at least 70 days after the last dose of study 
treatment.  All SAEs related to study participation (e.g., protocol mandated procedures, tests, or change in 
existing therapy) are to be collected from consent through OS follow-up. All AEs/SAEs will be followed until the 
event is resolved, stabilized, otherwise explained or the participant is lost to follow up (see Section 9.3).  
6. On-treatment ocular exams to be performed by a qualified eye care specialist such as 
ophthalmologist/optometrist every 6 months (±14 days) after C1D1 or as clinically indicated. See Section 9.2.6 for 
a list of ocular exam procedures.  
7. Refer to Appendix 2 for a comprehensive list of lab tests that must be collected and whether analysed locally or 
centrally for all participants.  
8. If completed within 72 hours prior to the first dose, this assessment need not be repeated on Day 1 of Cycle 1. 
9. Monitor hematology weekly for the first 8 weeks of treatment and every cycle thereafter. 
10. eGFR as calculated by Modified Diet in Renal Disease (MDRD) formula (see Appendix 10). 
11. Albumin/creatinine ratio (spot urine, preferably from first void) to be performed every 6 weeks from C1D1 OR 
Urine dipstick for protein 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 ≥2+, or with positive protein if urine dipstick protein 
quantification is not available. Albumin/creatinine will be performed at a local lab. If local testing is not available, 
then central testing will be performed. 
Adverse Events5 
Ongoing 
Concomitant 
Medications 
Ongoing 
Safety Assessments 
Physical 
Examination 
X 
 
X4 
Vital Signs (BP, HR, 
Body Temperature) 
X 
 
X4 
Ocular Exam6 
 
XQ6M 
 
Weight 
X 
 
X4 
Hematology7 
X8 
X 
X4,9 
Clinical Chemistry7 
X8 
X 
 
eGFR10 
X8 
X 
 
Urinalysis or Spot 
Urine for albumin/ 
creatinine ratio11 
X8 
XQ6W 
 
Pregnancy Test12 
X 
 
X 
REMS/Pregnancy 
prevention program 
registration13 
 
 
 
 
X 
 
 
 
 
X 
 
 
 
 

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On-Treatment Assessments: Treatment Arm 2 (Pomalidomide/Dexamethasone) 
Study 
Assessments1,7 
C1D12  
Q3W (From 
Week 4, 
regardless 
of dosing) 
D1 of Each 
28-day 
Cycle (C2-
CX) if 
dosing3,4 
Notes 
Disease Evaluation Assessments15 
12. Perform only in women of child-bearing potential. Pregnancy tests should be performed weekly during the first 4 
weeks (first cycle) and then every 4 weeks thereafter in women with regular menstrual cycles, or every 2 weeks in 
women with irregular menstrual cycles. The C1D1 pregnancy test is a serum test and should be within 24 hours 
prior to administration of first dose. Subsequent D1CX pregnancy tests should be performed within 72 hours prior 
to dosing and pregnancy tests may be either serum or urine. See Section 9.2.7 and Appendix 4 for more details.   
13. Applicable as required by local guidelines. Ensure counselling is completed and documented as required by 
applicable pregnancy prevention program. See Section 9.2.8 and SRM for full details. 
14. To be assessed based on disease laboratory tests and imaging (if applicable) as outlined in this table.  Response 
assessment is based on International Myeloma Working Group (IMWG) [Kumar, 2016].  
15. Disease evaluation (except imaging and skeletal survey) will be performed every 3 weeks (± 3 days) even if 
treatment is not administered. For participants who are discontinuing study intervention due to PD, the 
confirmation of PD 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 the disease progression 
before institution of any new anti-myeloma therapy. This may be performed at the EOT visit. 
16. Only if clinically indicated or if worsening clinical symptoms suggest skeletal PD.  Imaging is not required if the PD 
is evident otherwise. Same modality used at Screening must be used throughout study. Imaging of bones for lytic 
lesions by a method aligned with the institutional guidance (e.g., X-ray, CT, or MRI). 
17. At time of first achieving unmeasurable M protein on SPEP/UPEP and at Q3W visits from Week 4 until suspected 
PD. 
18. Imaging (i.e., CT, MRI or PET-CT) is only required for participants with extramedullary disease (EMD) Q12 weeks 
(e.g., Week 13, W25, W37, etc.) through 1 year and then as clinically indicated. The same modality used at 
screening must be used throughout the study.  See Section 9.1 for more information on imaging, EMD 
measurement and follow-up, PD due to EMD. Refer also to the SRM for additional information.  
19. Only required for participants with IgD/E myeloma.  
 
 
20. For BCMA expression analysis by IHC and biomarker research at PD: BM biopsy is the preferred sample for 
these exploratory analyses, but if not obtainable, aspirate may also be used. Informed consent for the optional
Response 
Assessment14 
 
X 
 
Skeletal Survey 
 
X16 
 
UPEP 24 hr urine 
collection 
X8 
X 
 
Urine 
Immunofixation 
 
X17 
 
SPEP 
X8 
X 
 
Serum 
immunofixation 
 
X17 
 
EMD assessment 
(by CT or MRI or 
PET/CT) 
 
X18 
 
Serum Kappa, 
Lambda free light 
chain, FLC ratio  
X8 
X 
 
IgG, IgM, IgA 
 
X 
 
IgD/E, if applicable19 
 
X 
 
 
 
 
Calcium corrected 
for albumin (serum) 
 
X 
 
 
 
 
 
 
 
 
 
 

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On-Treatment Assessments: Treatment Arm 2 (Pomalidomide/Dexamethasone) 
Study 
Assessments1,7 
C1D12  
Q3W (From 
Week 4, 
regardless 
of dosing) 
D1 of Each 
28-day 
Cycle (C2-
CX) if 
dosing3,4 
Notes 
Bone Marrow (BM) Aspiration/Biopsy 
Optional Tissue 
sample at PD: BM 
biopsy or aspirate 
for BCMA 
expression and 
biomarker research  
 
X20 
 
BM aspirate for 
MRD testing 
 
X21 
 
BM biopsy or 
aspirate for disease 
assessment 
(percent plasma 
cells) 
 
X22 
 
BM biopsy to assess 
sCR by IHC 
 
X23 
 
PET/CT upon 
achieving MRD 
negativity by NGS 
 
X24 
 
Treatment  
Thromboprophylaxis 
Ongoing25 
Pomalidomide26 
X 
 
X 
Dexamethasone26 
X 
 
X 
Dispense/Return 
Medication Diary27 
X 
 
X 
Biomarkers and Genetics 
cfDNA (plasma) 28 
X 
XMRD only 
 
Soluble BCMA29 
X 
X MRD only 
 
 
Optional Genetic 
X 
 
 
 

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On-Treatment Assessments: Treatment Arm 2 (Pomalidomide/Dexamethasone) 
Study 
Assessments1,7 
C1D12  
Q3W (From 
Week 4, 
regardless 
of dosing) 
D1 of Each 
28-day 
Cycle (C2-
CX) if 
dosing3,4 
Notes 
Sample30 
Health Outcomes 
PRO-CTCAE 
X 
X 
 
OSDI 
X 
X 
 
 
X 
X 
 
EORTC QLQ-C30 
X 
X 
 
EORTC IL5231 
X 
X 
 
EORTC QLQ-
MY2032 
X 
X 
 
X 
X(Q6W) 
 
X 
X(Q6W) 
 
 
X(Q6W) 
 
X 
X 
 
 
 
Abbreviations: 
BP = Blood pressure; BM = bone marrow;  cfDNA = Circulating free DNA; CR = Complete response; CT = Computed tomography; eGFR = Estimated glomerular filtration rate; ECOG 
PS= Eastern Cooperative Oncology Group Performance Status; EOI = End of Infusion; EMD = Extramedullary disease;  EORTC IL52 = Disease Symptoms domain of EORTC QLQ-
MY20; 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; 
 
 FLC = Free light chain; 
 HR = Heart rate;  Ig = Immunoglobulin; IHC = Immunohistochemistry; MRD = Minimal residual 
disease; MRI = Magnetic resonance imaging; NGS = Next generation sequencing; OS = Overall survival; OSDI = Ocular Surface Disease Index; PC = plasma cells; PD = Progressive 
disease; PET = Positron emission tomography; PFS = progression-free survival; 
 PRO-
CTCAE = Patient-Reported Outcomes Version of the Common Term Criteria for Adverse Events; REMS = Risk Evaluation and Mitigation Strategy; sCR = Stringent complete response; 
SAE = Serious adverse event; SOI = start of infusion; SPEP = Serum protein electrophoresis; SRM = Study Reference Manual; VGPR = Very good partial response; UPEP = Urine 
protein electrophoresis; WOCBP = Women of child-bearing potential 
 
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Table 4 
Schedule of Activities:  End of Treatment and Follow-Up Assessments – Arm 1 – belantamab mafodotin and Arm 
2 – Pom/Dex 
Schedule of Activities: End of Treatment and Follow-Up Assessments – Arm 1 – belantamab mafodotin and Arm 2 – pom/dex 
Study Assessments9 
End of 
Treatme
nt Visit1 
PFS 
Follow-
up2 
OS 
Follow-
up3 
Notes 
Physical Exam 
X 
X 
 
1. The End of Treatment (EOT) visit will occur within 30 days after last dose or before the start of any new anti-
myeloma therapy (whichever occurs first). 
2. PFS follow-up: Participants who discontinue study treatment for a reason other than PD, disease evaluations will 
continue to be performed at every 3 weeks (±3 days) from the last Q3W assessment visit until confirmed PD, 
death, start of a new anti-myeloma treatment, withdrawal of consent, lost to follow-up or end of the study 
whichever occurs first. Once participant progresses, move to OS follow-up. 
3. OS follow-up: After PD is documented, participants will be followed for survival and progression after subsequent 
anti-myeloma therapy (PFS2) by chart review, phone call, or any form of communication every 12 weeks (14-
day window) from the last Q3W assessment as referenced in 5.4. Participant does not need to come in for visit 
unless they are being followed for treatment-related ocular examination findings, ocular symptoms, or vision 
changes that are present at the end of study treatment.  Record the participant’s survival status and whether 
subsequent treatment for disease was given. If the final OS analysis occurs at the OS IA for efficacy (Section 
10.5), OS data will continue to be collected for all participants every 24 weeks until all have died, are lost to 
follow up or withdrawn consent, or for 2 years after the final OS analysis, whichever occurs first.  
4. AEs/SAEs will be collected up to at least 70 days after the last dose of study treatment.  All SAEs related to 
study participation (e.g., protocol mandated procedures, tests, or change in existing therapy) are to be collected 
from consent through OS follow-up. All AEs/SAEs will be followed until the event is resolved, stabilized, 
otherwise explained, or the participant is lost to follow-up.  
5. Concomitant medications administered after the End of treatment (EoT) should only be recorded for SAEs/AESIs 
as defined in Section 9.3.3. 
6. See Section 9.2.6 for list of ophthalmic exam procedures. 
7. ARM 1 ONLY: Participants with treatment-related ocular examination findings, ocular symptoms, or vision 
changes at the end of treatment will be followed at least every 3 months for up to 12 months, or until resolution to 
KVA Grade 1 or baseline, whichever comes first.  
8. Final pregnancy test (serum or urine) must be performed in women of childbearing potential at least 70 days of 
the last dose of belantamab mafodotin and at least 4 weeks after the last dose of pomalidomide/dexamethasone 
study treatment. Follow-up pregnancy assessment by telephone (for WOCBP only) should be performed 4 
months after the last dose of belantamab mafodotin study treatment. 
9. Refer to Appendix 2 for a comprehensive list of lab tests that must be collected for all participants and whether 
Safety 
Adverse Events4 
X 
X 
X 
Concomitant 
Medications5 
X 
X 
 
Ocular Exam6 
X 
X7 
X7 
ECOG Performance 
Status 
X 
X 
 
Vital Signs (BP, HR, 
Body Temperature) 
X 
 
 
Weight  
X 
 
 
Pregnancy Test8 
X 
 
 
Hematology9 
X 
X 
 
Clinical chemistry9 
X 
 
 
eGFR10 
X 
 
 
Urinalysis or Spot Urine 
(albumin/ creatinine 
ratio)11 
X 
 
 
ARM 2 ONLY 
Return Medication Diary12  
X 
 
 
PK/ADA – ARM 1 ONLY 
Pharmacokinetics (blood) 
for belantamab 
mafodotin13 
X 
 
 
Immunogenicity (ADA) 13 
X 
 
 
Biomarker 
Soluble BCMA (serum) 13  
X 
 
 
cfDNA (plasma) 
X 
 
 

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Schedule of Activities: End of Treatment and Follow-Up Assessments – Arm 1 – belantamab mafodotin and Arm 2 – pom/dex 
Study Assessments9 
End of 
Treatme
nt Visit1 
PFS 
Follow-
up2 
OS 
Follow-
up3 
Notes 
Disease Evaluation 
analysed locally or centrally. 
10. eGFR as calculated by the Modified Diet Renal Disease (MDRD) formula (see Appendix 10). 
11. Albumin/creatinine ratio (spot urine, preferably from first void) OR Urine dipstick for protein 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 ≥2+, or with positive protein if urine dipstick protein quantification is not available. 
Albumin/creatinine will be performed at a local lab. If local testing is not available, then central testing will be 
performed (first void). 
12. Participant diary will be used to keep a record of self-administered dexamethasone and pomalidomide 
13. Collect one PK sample (Arm 1 only), one ADA sample (Arm 1 only), and one sBCMA sample (Arm 1 and Arm 2) 
at end of treatment visit. Between 6 and 12 weeks after last dose of study treatment, and assuming no initiation 
of new anti-myeloma therapy, collect one PK (Arm 1 only), one ADA sample (Arm 1 only), and one sBCMA 
sample (Arm 1 and Arm 2). Sample may be collected at any planned follow-up visit. 
14. Imaging of bones for lytic lesions by a method aligned with the institutional guidance (e.g., X-ray, CT, or MRI). 
Only if clinically indicated, or if worsening clinical symptoms suggest skeletal PD. Imaging is not required if the 
PD is evident otherwise. Same modality used at Screening must be used throughout study. As clinical indicated, 
imaging is only required for participants with known extramedullary disease (EMD) either by CT, MRI, or PET/CT 
per local guidance. Same modality used at Screening must be used throughout study. See Section 9.1 for more 
information on imaging, EMD measurement and follow-up, PD due to EMD. Refer also to the SRM for additional 
information.  
15. As clinically indicated, imaging is only required for participants with known extramedullary disease (EMD) either 
by CT, MRI, or PET/CT per local guidance. Same modality used at Screening must be used throughout study. 
See Section 9.1 for more information on imaging, EMD measurement and follow-up, PD due to EMD. Refer also 
to the SRM for additional information. 
16. At time of first achieving unmeasurable M Protein in SPEP/UPEP and until suspected PD 
17. Only required for participants with IgD/E myeloma.  
18. To be assessed based on disease laboratory tests and imaging (if applicable) as outlined in this table. Response 
assessment is based on IMWG 2016 criteria.  
19. MRD testing to be performed by a central lab at the time of first achieving response of VGPR or better, and 
repeated every 6 months for 2 years and then yearly until PD. In case of deepening response from VGPR to CR, 
MRD sample should be collected at the time of CR assessment and repeated every 6 months for 2 years and 
then yearly until PD.   
20
Bone marrow core biopsy and/or aspirate for flow cytometry or immunohistochemistry (IHC); at the time of
Skeletal Survey14 
X 
X 
 
Imaging for EMD15 
X 
X 
 
UPEP 24 hr urine  
collection 
X 
X 
 
Urine immunofixation16 
X 
X 
 
SPEP 
X 
X 
 
Serum  
Immunofixation16 
X 
X 
 
Serum Kappa, lambda 
 free LC, FLC ratio 
X 
X 
 
Calcium corrected for 
albumin (serum) 
X 
X 
 
IgG, IgM, IgA 
X 
X 
 
IgD/E17 
X 
X 
 
Response  
Assessment18 
X 
X 
 
Bone Marrow (BM) Aspiration/Biopsy 
BM aspirate for MRD 
testing 
X19 
X19 
 
BM biopsy or aspirate 
for disease 
assessment (percent 
plasma cells) 
X20 
X20 
 
BM biopsy to assess 
sCR by IHC 
X21 
X21 
 
Optional Tissue Sample 
at PD: BM biopsy or 
aspirate for BCMA 
expression and 
biomarker research 
X22 
X22 
 
 
 
 
 

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Schedule of Activities: End of Treatment and Follow-Up Assessments – Arm 1 – belantamab mafodotin and Arm 2 – pom/dex 
Study Assessments9 
End of 
Treatme
nt Visit1 
PFS 
Follow-
up2 
OS 
Follow-
up3 
Notes 
Health Outcomes 
PRO-CTCAE 
X 
 
 
OSDI23 
X 
X 
X 
 
X 
 
 
EORTC-QLQ-C30 
X 
X24 
X25 
EORTC IL5226 
X 
X24 
X25 
EORTC QLQ-MY2027 
X 
X24 
X25 
X 
X24 
X25 
X 
X24 
 
X 
X24 
 
X 
 
 
Post-PD status 
Subsequent Anti–MM 
Treatment28 
 
X 
X 
Survival Status29 
 
 
X 
 
Abbreviations: 
ADA = Anti-Drug Antibody; BP = Blood pressure; BM = bone marrow;  cfDNA = Circulating free DNA; CR = Complete response; CT = Computed tomography; eGFR = Estimated 
glomerular filtration rate; ECOG PS= Eastern Cooperative Oncology Group Performance Status; EMD = Extramedullary disease;  EORTC IL52 = Disease Symptoms domain of 
EORTC-QLQ-MY20; 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; 
; 
; FLC = Free light chain; 
HR = Heart rate;  Ig = Immunoglobulin; 
IHC = Immunohistochemistry; MRD = Minimal residual disease; MRI = Magnetic resonance imaging; NGS = Next generation sequencing; OS = Overall survival; OSDI = Ocular Surface 
Disease Index; PC = plasma cells; PD = Progressive disease; PET = Positron emission tomography; PFS = Progression Free Survival; 
 
; PK = Pharmacokinetics; PRO-CTCAE = Patient-Reported Outcomes Version of the Common Term Criteria for Adverse Events; sCR = 
Stringent complete response; SAE = Serious adverse event; SOI = start of infusion;; SPEP = Serum protein electrophoresis; SRM = Study Reference Manual; VGPR = Very good 
partial response; UPEP = Urine protein electrophoresis 
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Table 6 
Hepatitis B (HBV) SoA – additional procedures  
Note: the procedures listed in this table apply ONLY to participants in screening and who have been enrolled and who have a positive serology for Hepatitis B; all procedures must be 
done as needed in addition to the required procedures for all participants detailed in Table 1 
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 study treatment and subsequently 
every 3 months, or if LFT elevations requiring increased monitoring or 
stopping criteria occurs, or for any clinical suspicion of hepatitis 
reactivation.  HBV-DNA testing will be performed at a local lab. If local 
testing is not available, then central testing will be performed 
3. 
For HBsAg+ participants, appropriate antiviral treatment per local 
guidance (e.g. tenofovir or entecavir) is started before starting study 
treatment, continues through to completion of study treatment 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 
 
 
 
 
 
 
 
 
 
 
 

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Table 7 
Hepatitis C (HCV) SoA – additional procedures  
Note: the procedures listed in this table apply ONLY to participants in screening and who have been enrolled and who have a positive serology for Hepatitis C; all procedures must be 
done as needed in addition to the required procedures for all participants detailed in Table 1 
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 study treatment and 
subsequently every 3 months, or if LFT elevations requiring 
increased monitoring or stopping criteria occurs, or for any clinical 
suspicion of hepatitis reactivation. HCV-RNA testing will be 
performed at a local lab. If local testing is not available, then 
central testing will be performed 
2.      Antiviral treatment should be given to participants with HCV 
before enrollment 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 enrollment. 
 
Treatment of active HCV  
 
 
 
 
 
X2 
 
 
 
 

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3. 
INTRODUCTION 
Multiple myeloma (MM) is an incurable malignancy and accounts for 1% of all cancers 
and for 10% of all hematologic malignancies [Moreau, 2017]. Worldwide, approximately 
103,000 new cases are diagnosed annually, and an estimated 32,110 new cases and 
12,960 deaths will occur in the United States in 2019 [Cowan, 2018; Siegel, 2019]. There 
have been significant advances in treatment for MM, including novel therapies like 
second and third -generation proteasome inhibitors (PIs), immunomodulatory drugs, and 
recent addition of monoclonal antibodies (mAbs) [National Comprehensive Cancer 
Network (NCCN), 2018; Moreau, 2017]. Those advances have contributed to incremental 
gains in PFS and OS, but most MM patients still relapse and ultimately develop 
resistance to existing therapies. Therefore, there is an urgent need to develop treatments 
with novel MOA which could potentially prevent the cross resistance to existing 
therapies [Kumar, 2004; Richardson, 2003; Richardson, 2006; Jagannath, 2008]. Details 
of the characteristics of belantamab mafodotin, nonclinical, and clinical activity are 
provided in the Investigator’s Brochure (IB) [GlaxoSmithKline Document Number 
2013N175128_08].  
3.1. 
Study Rationale 
Immunomodulatory drugs are an important cornerstone of treatment for patients with 
relapsed/refractory MM (RRMM).  These include lenalidomide and more recently 
pomalidomide. Pomalidomide administered with low-dose dexamethasone (pom/dex) is 
approved in the US, European Union (EU) and a number of other countries worldwide 
for patients with RRMM who have received at least two prior therapies including 
lenalidomide and bortezomib and have demonstrated disease progression on, or within 60 
days of completion of, the last therapy [e.g., POMALYST PI and Imnovid SmPC].   
Pom/dex has been previously studied in patients with relapsed MM refractory to 
lenalidomide and bortezomib in the Phase III trial MM-003, which compared pom/dex 
with high-dose dexamethasone (HD) [San Miguel, 2013]. The median overall survival 
(OS) (12.7 [95% CI: 10.4, 15.5] vs. 8.1 [95% CI: 6.9, 10.8] months; HR: 0.74 [95% CI: 
0.56, 0.97]; p=0.0285) and progression-free survival (PFS, 4.0 [95% CI: 3.6, 4.7] vs. 1.9 
[95% CI: 1.9, 2.2] months; HR: 0.48 [95% CI: 0.39, 0.60]; p<0.0001) were significantly 
longer with pom/dex than with HD alone. An overall response rate (ORR) of 31% was 
achieved with pom/dex (complete response [CR]: 1%; very good partial response 
[VGPR]: 5%; partial response [PR]: 26%). The most common Grade 3 to 4 hematological 
adverse events (AEs) were neutropenia (48% vs. 16%), anemia (33% vs. 37%), and 
thrombocytopenia (22% vs. 26%). Serious adverse events (SAEs; defined as Grade 5 
events requiring hospitalisation or resulting in disability or incapacity) occurred in 61% 
and 53% of participants in the pom/dex 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. 
Belantamab mafodotin (GSK2857916) is a first in class, antibody-dependent cellular 
cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug 
conjugate (ADC) that binds specifically to B-cell maturation antigen (BCMA), a target 

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present on mature B cells and on tumor cells in patients with MM [Tai, 2015; Tai, 2006].  
The antibody is conjugated to the microtubule inhibitor maleimidocaproyl monomethyl 
auristatin-F (mcMMAF) and is produced as an afucosylated form that generates an 
enhanced ADCC response.  As demonstrated in the FTIH study this novel mechanism of 
action can be reasonably expected to overcome cross resistance to existing therapies.    
Single agent belantamab mafodotin has demonstrated meaningful clinical benefit in two 
clinical studies conducted in heavily pre-treated participants with RRMM (Q3W schedule 
via IV administration); the first time in human (FTIH) study BMA117159 and the 
ongoing 205678/DREAMM 2 study evaluating single agent doses of 2.5 mg/kg and 
3.4 mg/kg. See Section 3.4, Human Experience with Belantamab Mafodotin, for details 
on efficacy and safety results from studies BMA117159/DREAMM-1 and 
205678/DREAMM-2.  
The efficacy and safety results from study BMA117159/DREAMM-1 and study 
205678/DREAMM-2 indicate that belantamab mafodotin is an effective single-agent 
treatment option for patients with RRMM, with a novel MOA. In binding to BCMA on 
malignant plasma cells, belantamab mafodotin initiates cell killing via a multimodal-
mechanism, including delivering MMAF to BCMA-expressing MM cells, inducing 
apoptosis, enhancing antibody-dependent cellular cytotoxicity and antibody-dependent 
cellular phagocytosis, and inducing immunogenic cell death. These data support further 
evaluation of single agent belantamab mafodotin in a randomized Phase III study against 
pom/dex, an established standard of care in RRMM participants. 
3.2. 
Background on BCMA and 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; Varfolomeev, 2004; Jiang, 2011].  BCMA is 
widely expressed on malignant plasma cells in all MM patients [Tai, 2015; Tai, 2006].  
The restricted expression profile of BCMA makes it a very good target for a therapeutic 
antibody with direct cell killing activity and 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 postulated to correlate with response to therapy and OS [Sanchez, 
2012]. 
BCMA has been validated as a therapeutic target in MM [Tai, 2015]. Study BMA117159 
demonstrated single-agent activity of belantamab mafodotin in heavily pre-treated MM 
participants.  Chimeric Antigen Receptor T-Cells (CAR-T) based therapies targeting 
BCMA have also demonstrated significant activity in MM [Cohen, 2016].  Other 
approaches utilizing bispecific antibodies (BiTe) have also entered development and have 
shown clinical activity [Topp, 2018].   

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3.3. 
Antibody-Drug Conjugate Belantamab Mafodotin  
Belantamab mafodotin binds to BCMA and kills MM cells via a multi-modal mechanism 
including delivery of cytotoxic, MMAF (cysteine maleimidocaproyl MMAF [cys 
mcMMAF]) to BCMA-expressing MM cells, thereby inducing apoptosis, enhancing 
antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis, 
and inducing immunogenic cell death (Figure 3) [Tai, 2014; Montes De Oca, 2019]. 
Exposure of dendritic cells to tumor cells undergoing immunogenic cell death is expected 
to result in an antigen-specific T-cell response, enhancing the immunogenic response 
against MM.  
Figure 3 
Belantamab Mafodotin Mechanism of Action (MoA) 
 
ADCC/ADCP=antibody-dependent cell-mediated cytotoxicity/antibody-dependent cellular phagocytosis, ADC=antibody 
drug conjugate, BCMA = B-cell maturation antigen 
3.4. 
Human Experience with Belantamab Mafodotin  
3.4.1. 
Clinical studies 
Single-agent belantamab mafodotin has demonstrated to have a strong single-agent 
activity with a well-defined manageable safety profile in heavily pre-treated participants 
with RRMM (Q3W schedule via IV administration).  Safety data for single-agent 
belantamab mafodotin were pooled (data as of 20 Sep 2019) for study 205678 
(DREAMM-2; NCT03525678) and supportive FTIH study BMA117159 (DREAMM-1; 
NCT02064387), by treatment cohorts of 2.5 mg/kg and 3.4 mg/kg. 

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FTIH study BMA117159/DREAMM-1 
In the FTIH DREAMM-1 study, which consisted of a dose escalation phase (Part 1, 
n=38) and a dose expansion phase (Part 2, n=35), as of the primary analysis cut-off date 
of 31 August 2018, a total of 73 participants with RRMM received at least 1 dose of 
belantamab mafodotin [GlaxoSmithKline Document Number 2013N175128_08; Trudel, 
2019].  
As of the efficacy cut-off date of 31 August 2018, a total of 35 participants were treated 
at the 3.4 mg/kg dose in Part 2 of the DREAMM-1 study. Participants were heavily pre-
treated: 57% of participants had 5 or more prior lines of therapy. The ORR was 60% 
(95% CI: 42.1, 76.1): comprised of PR, 6%; VGPR, 40%; CR, 9%; and stringent CR 
(sCR), 6%. The median duration of response (DoR) was 14.3 months (95% CI: 10.6, 
NR). The median PFS (mPFS) in this population was 12.0 months (95% CI: 3.1, not 
estimable [NE]). For participants refractory to both immunomodulatory agents 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, NE) [Trudel, 2019].  
Phase II study 205678/DREAMM-2 
The ongoing Phase II study 205678/DREAMM-2 is evaluating these two IV single agent 
doses (2.5 and 3.4 mg/kg) administered Q3W until disease progression in participants 
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 proteasome 
inhibitor.  A total of 194 participants received frozen drug product in the main cohort and 
24 participants received 3.4 mg/kg lyophilized drug product. The study met its primary 
endpoint for ORR in both the 2.5 mg/kg and 3.4 mg/kg frozen treatments. Primary 
analysis data from this study indicated no new safety signals, and the profile of adverse 
events was similar to the experience in the DREAMM-1 study for both arms. Both dose 
levels, 2.5 and 3.4 mg/kg, were shown to have a positive benefit/risk profile [Li, 2017; 
Lonial, 2020].  
As of the cut-off date of 31 January 2020, the ORR was 31% (97.5% CI 21.7,43.6) in the 
2.5 mg/kg and 35% (97.5% CI 24.8,47.0) in the 3.4 mg/kg frozen treatment. The median 
DoR was 11.0 months (95% CI: 4.2, NR) at 2.5 mg/kg and 6.2 months (95% CI: 4.8, NR) 
at 3.4 mg/kg. The mPFS in this population was 2.8 months (95% CI: 1.6, 3.6) and 3.9 
months (95% CI: 2.0, 5.8), respectively and the median Overall Survival (mOS) was 13.7 
months (95% CI: 9.9, NR) at 2.5 mg/kg and 13.8 months (95% CI: 10.0, NR) at 3.4 
mg/kg. Positive clinical activity was also demonstrated at the 3.4 mg/kg lyophilised dose 
[ORR 52% (97.5% CI 28.9,74.5)]. 
 

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3.4.2. 
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 20Sep2019) 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 3/4 AEs was comparable between belantamab 
mafodotin 2.5 mg/kg and 3.4 mg/kg cohorts. Adverse events 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). 
Single agent belantamab mafodotin 2.5 mg/kg was selected as the recommended dose 
based on comparable efficacy with a more favourable 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 
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 (data as of 31 Jan 2020), events in the Eye disorders system organ class 
(SOC) occurred in 78% of participants treated with belantamab mafodotin 2.5 mg/kg. 
The most common ocular AEs were keratopathy (71%, changes in corneal epithelium 
identified on eye exam, with or without symptoms), blurred vision (22%), and dry eye 
(13%). Decreased vision defined as Snellen-equivalent BCVA score worse than 20/50 in 
the better seeing eye was reported in 18% of participants receiving belantamab mafodotin 
2.5mg/kg. Severe vision loss defined as 20/200 or worse in the better seeing eye was 
reported in 1% of participants receiving belantamab mafodotin 2.5 mg/kg. 
The median time to onset of Grade 2 or above corneal findings (best corrected visual 
acuity or corneal examination) was 36 days (range: 19 to 143 days) in participants 
receiving belantamab mafodotin 2.5 mg/kg. The median time to resolution of these 
corneal findings was 91 days (range: 21 to 201 days). 
Participants with history of dry eye were more prone to develop corneal examination 
findings. Therefore, active management of dry eye symptoms prior to and during 
treatment is recommended (i.e. administration of preservative-free artificial tears). 

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The 
 of DREAMM-2 provided no evidence that corticosteroid eye drops 
are beneficial in preventing or mitigating corneal events. 
Thrombocytopenia 
In DREAMM-2 (data as of 31 Jan 2020), 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. The incidence of Grade 3 
bleeding events was low (2%), with no Grade 4 or 5 events reported in participants 
treated with belantamab mafodotin 2.5 mg/kg. 
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. 
Infusion-related reactions 
Infusion-related reactions (IRRs) are expected for biologic agents. In DREAMM-2 (data 
as of 31 Jan 2020), IRRs occurred in 21% of participants in the belantamab mafodotin 2.5 
mg/kg, which were Grade 1 - 3 in severity. 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%–27% of 
participants. One participant (2.5 mg/kg cohort) discontinued treatment due to IRRs 
(Grade 3 IRRs at first and second infusion). 
Additional information can be found in Section 5.3.1. 
3.4.3. 
Pharmacokinetics and Pharmacodynamics in Humans 
The pharmacokinetics of and pharmacodynamics belantamab mafodotin (antibody-drug 
conjugate, including the complex with soluble BCMA (sBCMA)), total monoclonal 
antibody (total mAb; including complex), and cys-mcMMAF were investigated in 
291 participants with RRMM following IV administration at doses from 0.03 to 4.6 
mg/kg Q3W in Study BMA117159 (n=73) and at doses of 2.5 or 3.4 mg/kg Q3W in 
Study 205678 (n=218).  
Maximum concentrations (Cmax) of belantamab mafodotin and total monoclonal 
antibody were observed at or shortly after the end of infusion (EOI), while 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 pharmacokinetics were well described by a linear, two-
compartment population model, with a time-varying decrease in clearance in a population 
pharmacokinetic analysis. At Cycle 1, belantamab mafodotin had a systemic clearance of 
0.92 L/day, steady-state volume of distribution of 10.8 L, and an elimination half-life of 
12 days in participants with RRMM in Study 205678. Over time, clearance was reduced 
CI

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by 28%, resulting in an elimination half-life of 14 days. The time to 50% change in 
clearance was approximately 50 days.  
No clinically significant differences in the pharmacokinetics 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 (eGFR ≥ 30 ml/min/1.73m2) or mild hepatic impairment (National Cancer 
Institute - Organ Dysfunction Working Group [NCI-ODWG] classification). Higher 
serum levels of 2-microglobulin, IgG, and soluble BCMA (sBCMA) and lower levels of 
albumin are associated with more advanced multiple myeloma or a higher multiple 
myeloma disease burden. Higher baseline IgG and sBCMA levels were associated with 
higher cys-mcMMAF central volume of distribution leading to lower cys-mcMMAF 
Cmax.   
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 cytochromes (CYP) P450. Cys-mcMMAF was an in vitro substrate of organic 
anion transporting polypeptides (OATP)1B1 and OATP1B3, multidrug resistance 
associated proteins (MRP)1, MRP2, and MRP3, a borderline substrate of bile salt export 
pump (BSEP), 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 Study BMA117159 and Study 205678.  All 
participants exhibited reductions in free sBCMA concentration at end of infusion 
compared to baseline at Cycle 1, with a return to near-baseline level by seven 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 Study 205678 and/or Study BMA117159 
found 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 corneal events and 
keratopathy and cys-mcMMAF Cmax was associated with thrombocytopenia. Probability 
of occurrence of dry eye, blurred vision, neutropenia and infusion related reaction 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. 
Additional information related to belantamab clinical PK, PD, and exposure-response 
relationships can be found in the Investigator’s Brochure [GlaxoSmithKline Document 
Number 2013N175128_08] 

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3.5. 
Benefit/Risk Assessment 
Additional information about the known and expected benefits and risks, detailed 
information of nonclinical and clinical findings information regarding warnings, 
precautions, contraindications, adverse events, and other pertinent information that may 
impact participant eligibility is provided in the belantamab mafodotin Investigator’s 
Brochure [GlaxoSmithKline Document Number 2013N175128_08] and pomalidomide 
and dexamethasone product labels, respectively.  
The following section outlines the risk assessment and mitigation strategy primarily for 
belantamab mafodotin in this protocol.  For pomalidomide and dexamethasone, the 
approved product labels should be referenced (see the Study Reference Manual [SRM] 
for details). 

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3.5.1. 
Risk Assessment 
The following table outlines the risk assessment and mitigation strategy for this protocol. Details on risks for pomalidomide and 
dexamethasone can be found in respective prescribing information; see Study Reference Manual (SRM). 
Table 8 
Risk Assessment and Mitigation Strategy 
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Study Treatment belantamab mafodotin  
Keratopathy (Changes to 
the corneal epithelium, 
potentially resulting in 
vision changes) 
Changes in corneal epithelium on ocular examination have been frequently 
observed with belantamab mafodotin such as superficial punctate 
keratopathy, microcyst-like changes, sub-epithelial haze, corneal erosions 
and corneal ulcers. These were most commonly associated with 
keratopathy (changes in the corneal epithelium upon examination), dry 
eyes, blurred vision 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 and no permanent loss of vision reported. 
Corneal ulcers or erosions are distinguished by the presence or absence of 
stromal involvement, respectively. The precise incidence has yet to be 
defined. The corneal defects (with or without stromal involvement) 
appeared as early as the second or third cycle but in most cases after 5 or 
more cycles of treatment 
Active monitoring of the corneal epithelium and visual acuity according to 
the SoA (Section 2).  
In the event of new-onset eye-related symptoms (such as pain, 
significant loss of visual acuity, or bothersome foreign body sensation), 
participants are to urgently seek medical attention by a qualified eye 
care specialist (appropriate testing includes slit lap examination [includes 
fluorescein staining] and measurement of visual acuity). Appropriate 
management should be initiated immediately as defined in Section 7.1.1. 
Recommendations for dose delays/reductions and treatment stopping 
guidance are provided in Section 7.6.2. 
Infusion related reaction 
(IRR) 
IRRs were reported in participants treated with belantamab mafodotin. Most 
IRRs observed were Grade 1 to 2 and manageable with treatment. 
Close monitoring for signs of IRR. 
Consider premedication for IRR in patients at risk. 
If an IRR occurs, follow guidance in Section 7.6.2.   
Thrombocytopenia 
Belantamab mafodotin may cause transient thrombocytopenia in some 
participants, which for most cases recovered between doses.  
In the pooled safety population of study 205678 which included participants 
treated with belantamab mafodotin 2.5 and 3.4 mg/kg, thrombocytopenia 
was noted in 46% of participants and ranged between Grade 1 to 4 in 
Routine hematologic monitoring as outlined in Section 2.  
Supportive therapy (including transfusions) is provided according to local 
medical practice 
Recommendations for dose reductions or treatment discontinuations are 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
severity 
outlined in Section 7.6.2. and Section 8.1. 
Other hematological 
effects 
Neutropenic events, including febrile neutropenia have been observed with 
treatment with belantamab mafodotin,  
In a study of belantamab mafodotin in combination with lenalidomide/ 
dexamethasone, two fatal cases of severe infections associated with 
neutropenia have been observed.    
Anemia is a common complication in the RRMM population and was 
frequently reported in the belantamab mafodotin clinical program. 
Routine hematologic monitoring as outlined in Section 2.    
Consider prophylactic antibiotics, per physician discretion and local 
institutional guidance, in participants with Grade 3-4 neutropenia  
Immediately hospitalize participants with febrile neutropenia  
Consider additional supportive treatment(s) per local practice (e.g., 
transfusion, growth factors).  
Recommendations for dose reductions or treatment discontinuations are 
outlined in Section 7.6.2. and Section 8.1. 
Nephrotoxicity 
Nonclinical safety experiments have demonstrated primary glomerular 
injury and tubular degeneration/regeneration (in rat and monkey). The 
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 chronic 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 one 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. 
Participants will be monitored for kidney function, including 
albumin/creatinine ratio. 
Participants will be educated about the need of maintaining adequate 
urinary output.   
Dose modification guidelines for increased serum creatinine and urinary 
albumin/creatinine ratio are outlined in Section 7.6.2. and Section 8.1. 
Pulmonary - Pneumonitis 
Nonclinical safety experiments have demonstrated the presence of 
progressive microscopic changes in the lungs (prominent alveolar 
macrophages associated with eosinophilic material; mixed perivascular 
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. 
Monitoring for clinical signs and symptoms potentially 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 11.3.3) and further treatment with belantamab mafodotin 
delayed (refer to protocol Section 7.6). 
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 Section 7.6. 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Immunosuppression 
In nonclinical 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. 
Participants who have active infection are excluded.  
Participants will be monitored for infections and those who develop 
infection will receive immediate treatment according to standard practice. 
Potential for Other 
Laboratory abnormalities 
Increased magnitude of aspartate aminotransferase (AST) relative to 
alanine aminotransferase (ALT) consistent with increased skeletal troponin I 
was observed in the single dose monkey study. Increased skeletal troponin 
I and/or creatine kinase and aldolase was observed in the rat 3-week study. 
Cases of elevated AST, lactate dehydrogenase (LDH) and creatine kinase 
(CK) alone or concomitant with no clear clinical correlate have been 
observed in clinical studies. 
Laboratory parameters will be monitored as outlined in the SoA (Section 
2).  
Participants with significant laboratory elevations (≥x3 ULN) should, 
where possible, have a sample sent for central testing of CK and LDH 
isoenzyme levels.  
Embryo-Fetal Toxicity 
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. 
Pregnancy testing outlined in the SoA. (Section 2) 
See Contraception requirements in Section 6.1 and Appendix 4. 
 
Impaired Male and Female 
Fertility 
In animal studies, belantamab mafodotin treatment has resulted in testicular 
toxicity and adverse effects on spermatogenesis. Reversibility of testicular 
toxicity is unknown at this time.  
Ovarian toxicity (luteinized non-ovulatory follicles) was observed in a 3-
week rat study (weekly dosing) and was not observed following 12 weeks 
off dose. In a 13-week rat study where drug was administered once every 3 
weeks, these changes were not observed. 
Men who may wish to father children in the future will be advised to have 
sperm samples frozen and stored before treatment. 
Women of childbearing potential who may desire offspring in the future 
will be counseled about the option of having eggs frozen before 
treatment. See Contraception requirements in Section 6.1 and Appendix 
4. 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Risks from Study Procedures 
Bone marrow 
aspiration/biopsy 
Pain, infection, bleeding may occur after the procedure 
Participants will be treated according to institution’s practice 
Incidental findings during 
image acquisition 
During the acquisition of imaging data (e.g., MRI, CT, PET), non-disease or 
clinically relevant abnormalities could be found by the radiographer 
performing the exams. 
Copies of all medical images that include non-disease, clinically relevant 
abnormalities will be shared with the site for storage 
Refer to the belantamab mafodotin Investigator’s Brochure for further information.  
 

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3.5.2. 
Benefit Assessment 
This study is being performed to study the efficacy and safety of single agent belantamab 
mafodotin compared to pom/dex, a global standard of care (SoC) for patients with 
RRMM who have been previously treated with at least two prior therapies, including 
lenalidomide and a proteasome inhibitor. This study population has a high unmet medical 
need as patients failing multiple lines of prior treatments do not have many therapeutic 
options left, and if response can be achieved with currently available drugs, it is usually 
of short duration. For pom/dex, based on available data, approximately a third of patients 
responded and the median PFS was 4.0 months [San Miguel, 2013].  
Belantamab mafodotin has demonstrated strong single-agent activity in two clinical 
studies conducted in heavily pre-treated participants with RRMM (Q3W schedule via IV 
administration). Based on the available data for the FTIH study BMA117159, as of the 
efficacy cut-off of 31 August 2018, participants receiving belantamab mafodotin at 3.4 
mg/kg had an ORR of 60% (95% CI: 42.1, 76.1) and a median PFS of 12.0 (95% CI: 3.1, 
NR) in a heavily pre-treated population (57% ≥5 prior lines of therapy) [Trudel, 2019; 
Trudel, 2018]. For participants refractory to both immunomodulators and proteasome 
inhibitors (N=32), the confirmed overall response rate was 56% (95% CI: 37.7%, 73.6%). 
In 205678/ DREAMM 2, both dose levels evaluated, 2.5 and 3.4 mg/kg, had a positive 
benefit/risk profile [Li, 2017; Lonial, 2020].  
Based on this profile, it is reasonable to hypothesize that the use of belantamab mafodotin 
as a single agent will provide an improved benefit compared to the combination regimen 
of pom/dex in this patient population. 
3.5.3. 
Overall Benefit: Risk Conclusion 
Taking into account the measures to minimize risks to participants in this study, the 
potential risks identified in association with belantamab mafodotin are justified by the 
anticipated benefits that may be afforded to participants with RRMM.   

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4. 
OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary  
• 
To compare the efficacy with belantamab mafodotin 
vs pomalidomide plus low dose dexamethasone 
(pom/dex) in participants with relapsed/refractory 
multiple myeloma (RRMM) 
• 
PFS, defined as the time from the date of 
randomization until the earliest date of documented 
disease progression (according to IMWG Response 
Criteria) or death due to any cause 
Key Secondary 
• 
To compare the overall survival with belantamab 
mafodotin vs Pom/Dex in participants with RRMM 
• 
OS, defined as the time from randomization until 
death due to any cause 
Secondary 
• 
To compare other markers of efficacy of 
belantamab mafodotin vs pom/dex in participants 
with RRMM 
 
• 
ORR, defined as the percentage of participants with 
a confirmed PR or better per IMWG  
• 
Clinical benefit rate (CBR), defined as the 
percentage of participants with a confirmed minimal 
response (MR) or better per IMWG  
• 
DoR, defined as the time from first documented 
evidence of PR or better until PD per IMWG or 
death due to any cause among participants who 
achieve confirmed PR or better  
• 
TTR, defined as the time between the date of 
randomization and the first documented evidence of 
response (PR or better) among participants who 
achieve confirmed PR or better.  
• 
TTP, defined as the time from the date of 
randomization until the earliest date of documented 
PD (per IMWG Response Criteria) or death due to 
PD 
• 
To evaluate the safety and tolerability of 
belantamab mafodotin vs pom/dex in participants 
with RRMM  
• 
Incidence of adverse events (AEs) and changes in 
laboratory parameters 
• 
Ocular findings on ophthalmic exam 
• 
To evaluate the pharmacokinetic profile of 
belantamab mafodotin  
• 
Plasma concentrations of belantamab mafodotin, 
total mAb, and cys-mcMMAF  
• 
To assess anti-drug antibodies (ADAs) against 
belantamab mafodotin  
• 
Incidence and titers of ADAs against belantamab 
mafodotin  
• 
To evaluate the tolerability of belantamab mafodotin 
vs pom/dex based on self-reported symptomatic 
adverse effects 
• 
Symptomatic adverse effects as measured by the 
PRO-CTCAE and OSDI 
• 
To evaluate and compare changes in symptoms 
and health-related quality of life (HRQOL) of 
belantamab mafodotin to pom/dex. 
• 
Health-related QOL as measured by EORTC QLQ-
C30, EORTC IL52* and EORTC QLQ-MY20* 
• 
To assess Minimal Residual Disease (MRD) in 
participants who achieve ≥VGPR or better for 
belantamab mafodotin vs pom/dex 
• 
MRD negativity rate, defined as; the percentage of 
participants who are MRD negative by NGS method 
Exploratory 
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Objectives 
Endpoints 
ADA= anti-drug antibodies; AE = adverse event; AUC = Area under the curve; 
;  BCMA 
= B cell maturation antigen; DOR = duration of response; 
; EORTC-
IL52 = Disease Symptoms domain of EORTC QLQMY20;  EORTC QLQC30 = European Organisation for Research 
and Treatment of Cancer Quality of Life Questionnaire 30 item Core module; EORTC QLQMY20 = European 
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Objectives 
Endpoints 
Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 20 item Multiple Myeloma module; 
 
 HRQoL = health related quality of life; IMWG = International Myeloma Working Group; KVA = Keratopathy 
Visual Acuity; MRD = minimal residual disease; NGS = Next Generation Sequencing;  ORR = overall response rate; 
OS = overall survival; OSDI = Ocular Surface Disease Index; PD = progressive disease; PFS = progression-free 
survival;
; pom/dex = 
pomalidomide/dexamethasone; PR = partial response; PROCTCAE = Patient Reported Outcomes version of the 
Common Terminology Criteria for Adverse Events; QOL = quality of life; RRMM = relapsed/refractory MM; SAE = 
serious adverse event;
; TTP = time to 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 participant 
enrolled under protocol amendment 1; 
 
5. 
STUDY DESIGN 
5.1. 
Overall Design 
This is a Phase III, open-label, randomized, multicentre study evaluating the efficacy and 
safety of single agent belantamab mafodotin compared to pom/dex in participants with 
RRMM. 
The study will include a Screening Period, a Study Treatment Period, and Follow-up 
(Section 1.2).  
During Screening, participants will be evaluated for study eligibility per protocol as 
defined in the Inclusion/Exclusion criteria (see Section 6).  Eligible participants must 
have been previously treated with at least two prior lines of therapy, including at least 2 
consecutive cycles of lenalidomide and a proteasome inhibitor (PI), (given separately or 
in combination) and must have documented progression (a) on, or within 60 days of 
completion of the last therapy or (b) Must be non-responsive while on last treatment, 
where non-responsive is defined as not achieving at least Minimal Response (MR) after 2 
complete treatment cycles. In such cases lack of achieving of at least MR must be 
determined no earlier than at least 4 weeks after the last treatment.  
Following Screening, approximately 320 participants will be centrally randomized in a 
2:1 ratio to either Arm 1 (single agent belantamab mafodotin) or Arm 2 (pom/dex), as 
described in Section 1.1. Participants will be stratified based on the following: previous 
treatment with anti-CD38 (Y/N), with a 40% global enrollment cap for participants with 
prior anti-CD38 treatment, stage (International Staging System [ISS]) (I/II or III), and 
number of prior lines of therapy (≤3 vs >3), with a 55% global enrollment cap for 
participants with ≤3 prior lines. Crossover to belantamab mafodotin arm will not be 
allowed until significant survival benefit is demonstrated on OS analysis. 
 
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 are met. Additional participants that are enrolled in 
separate cohorts will not be included in the analysis portion of the study planned for the 
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marketing authorization application, which is based on approximately 151 events. 
However, these additional participants will be included in country-specific supplemental 
analyses, as detailed in the country-specific Statistical Analysis Plan (SAP). 
During the Study Treatment Period, safety and disease assessments will be performed 
regularly according to the schedule of activities (Section 2) for each arm. Participants in 
both arms will be treated until PD, death, unacceptable toxicity, withdrawal of consent, 
loss to follow-up or end of OS follow-up, whichever comes first. End of OS follow-up is 
defined in Section 5.4.  Dose interruptions or reductions may be required following 
potential drug-associated toxicities. 
For participants who discontinue study treatment for reasons other than PD, disease 
evaluations will continue to be performed every 3 weeks (±3 days) until confirmed 
(documented) PD, death, start of a new anti-myeloma treatment, withdrawal of consent, 
or end of the study, whichever occurs first. In case of PD, participants will be followed to 
ascertain survival status and subsequent anti-myeloma therapy (PFS2), every 12 weeks 
(±14 days) until withdrawal of consent, lost to follow-up, death or the end of the study.  
Following the final analysis, includingany country-specific (expansion cohort) analysis, 
DREAMM-3 will move into the post analysis continued treatment (PACT) phase. 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 1 only) will be 
reported directly to GSK. 
The EOS is defined as the date when the last participant had their last visit (last subject 
last dose plus 70 days SAE reporting period). 
 
 
5.2. 
Scientific Rationale for Study Design 
The combination regimen of pom/dex has been previously studied in patients with 
relapsed MM refractory to lenalidomide and bortezomib in the Phase III trial MM-003, 
which compared pom/dex with high-dose dexamethasone (HD). The median overall 
survival (OS, 12.7 [95% CI: 10.4, 15.5] vs. 8.1 [95% CI: 6.9, 10.8] months; HR: 0.74 
[95% CI: 0.56, 0.97]; p=0.0285) and progression-free survival (PFS, 4.0 [95% CI: 3.6, 
4.7] vs. 1.9 [95% CI: 1.9, 2.2] months; HR: 0.48 [95% CI: 0.3; p<0.0001) were 
significantly longer with pom/dex than with HD alone. An overall response rate (ORR) of 
31% was achieved [San Miguel, 2013]. 
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Belantamab mafodotin has demonstrated strong single-agent activity in two clinical 
studies conducted in heavily pre-treated participants with RRMM (Q3W schedule via IV 
administration, see Section 3.4.1) and the results compare favourably with those of 
pom/dex above. 
In light of the efficacy data and acceptable safety/tolerability profile demonstrated to 
date, it is hypothesized that treatment with belantamab mafodotin will lead to greater 
patient benefit, as measured by progression-free survival (PFS) and overall survival (OS), 
compared to the SoC combination of pom/dex. The randomized two-arm design of this 
study will provide a comparison of the efficacy as measured by PFS and OS between the 
two treatment groups: Arm 1 receiving belantamab mafodotin and Arm 2 receiving the 
combination of pomalidomide with low dose dexamethasone. 
5.3. 
Justification for Dose 
5.3.1. 
Belantamab mafodotin – Arm 1 
The proposed belantamab mafodotin RRMM single agent dose of 2.5 mg/kg administered 
on a Q3W schedule was selected based on data from the FTIH BMA117159 study 
[Trudel, 2019; Trudel, 2018] and the primary analysis of the ongoing Phase II Study 
205678 (see Section 3.4).  
In the Phase I study BMA117159, as of the efficacy clinical cut-off date of 31 August 
2018, a total of 73 participants with RRMM have received at least 1 dose of belantamab 
mafodotin. In Part 1, 38 participants were enrolled at dose levels ranging from 0.03 
mg/kg to 4.6 mg/kg. In Part 2, a total of 35 participants with MM and 6 participants with 
NHL received at least 1 dose of 3.4 mg/kg belantamab mafodotin (RP2D).  In general, 
belantamab mafodotin has been well tolerated, with manageable toxicities. The most 
commonly reported individual treatment-related AEs were vision blurred (40%), dry eye 
(29%), fatigue (27%), AST increased, thrombocytopenia and nausea (19, 26% each), and 
chills (23%).  The most common SAEs reported were lung-associated infections and 
infusion-related reaction (IRR). 
A Bayesian logistic regression model (BLRM) was used to determine the dose-response 
relationship for both ORR and ≥Grade 2 corneal event rate (as determined by NCI-
CTCAE grading) based on data from all 73 participants with RRMM in BMA117159. 
The model showed that the posterior probability of observing an ORR ≥30% is 100% in 
the 3.4 mg/kg dose group and 83% in the 2.5 mg/kg dose group.  Similarly, the posterior 
probability of observing ≥Grade 2 corneal event rate is also higher in the 3.4 mg/kg dose 
group. Based on this analysis, these two doses (2.5 and 3.4 mg/kg) were selected for 
further evaluation. 
In the ongoing DREAMM-2 study, the two single agent doses (2.5 mg/kg and 3.4 mg/kg) 
are being studied via a two-arm, randomized design in participants 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.  Both dose levels, 2.5 and 3.4 
mg/kg, had a positive benefit/risk profile based on the primary efficacy and safety 
analysis (cut-off date of 21 June 2019) and updated analysis (cut-off 31 January 2020) 
[GlaxoSmithKline Document Number 2013N175128_08; Li, 2017; Lonial, 2020]. 

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Overall, there were no new safety signals identified in the 205678 study, and the profile 
of adverse events was similar to the experience in DREAMM-1 for both arms.  The dose 
of 2.5 mg/kg appeared to have a lower incidence of adverse events and less frequent dose 
delays and reductions, and it resulted in similar efficacy with 3.4 mg/kg dose as measured 
by ORR. 
In summary, the selection of the dose of 2.5 mg/kg Q3W for future single agent studies 
with belantamab mafodotin is based on the available data with single agent belantamab 
mafodotin in heavily pretreated patients with relapsed/refractory MM from 2 studies, 
DREAMM-1 (BMA117159) and DREAMM-2 (205678), which showed clinically 
meaningful efficacy with a manageable safety profile in a heavily pre-treated patient 
population.   
5.3.2. 
Starting dose of SOC (Pom/Dex) – Arm 2 
Pomalidomide will be administered orally at the approved starting dose of 4 mg daily on 
Days 1 to 21 of each 28-day cycle, with dexamethasone administered at a dose of 40 mg 
once weekly (Days 1, 8, 15, and 22), or at the lower dose of 20 mg once weekly (Days 1, 
8, 15, and 22). 
5.4. 
End of Study Definition 
A final analysis data cut-off (DCO) representing the end of data collection, prior to the 
EOS, is defined as the DCO date for the final analysis (see Section 10.5). Following the 
final 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 belantamab mafodotin [and/or 
study drug(s)] may continue to receive belantamab mafodotin [and/or study drug(s)] 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 complete the 70-day 
safety follow-up] and the EOS definition is reached.  
The final analysis will occur when the planned 250 deaths for final OS analysis have 
occurred. If 250 OS events cannot be achieved, the final analysis will occur when all 
participants have died, are lost to follow up or have withdrawn consent. If OS is 
significant at 70% IF, no formal statistical testing will be conducted after 250 death 
events and OS data will continue to be collected until all participants have died, are lost 
to follow up, or withdrawn consent, or for 2 years after the OS analysis at 70% IF, 
whichever occurs first.  
The end of study is defined when the last patient had their last visit (last subject last dose 
plus 70 days SAE reporting period). 
Cross-over to belantamab mafodotin will not be permitted.  
 

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6. 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.  
6.1. 
Inclusion Criteria 
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 Appendix 1, which 
includes compliance with the requirements and restrictions listed in the informed 
consent form (ICF) and in this protocol. 
2. Participants must be 18 or older, at the time of signing the informed consent.    
NOTE: In Republic of Korea, participants must be over 19 years of age inclusive, at 
the time of signing informed consent.  
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 
(Appendix 9). 
4. Histologically or cytologically confirmed diagnosis of MM as defined according to 
International Myeloma Working Group (IMWG), [Rajkumar, 2014], and: 
a. Has undergone autologous stem cell transplant (SCT), or is considered transplant 
ineligible, and 
b. Has received at least 2 prior lines of anti-myeloma treatments, including at least 2 
consecutive cycles of both lenalidomide and a proteasome inhibitor (given 
separately or in combination), AND  
i. 
Must have documented disease progression on, or within 60 days of, 
completion of the last treatment OR 
ii. 
Must be non-responsive while on last treatment, where non-responsive is 
defined as not achieving at least Minimal Response (MR) after 2 
complete treatment cycles. In such cases lack of achieving of at least MR 
must be determined no earlier than at least 4 weeks after the last 
treatment 
5. 
Has measurable disease with at least one of the following: 
a. Serum M-protein ≥0.5 g/dL (≥5 g/L)  
b. Urine M-protein ≥200 mg/24 hours  
c. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) 
and an abnormal serum FLC ratio (<0.26 or >1.65) 
6. Participants with a history of autologous SCT are eligible for study participation 
provided the following eligibility criteria are met: 
a. 
Transplant was >100 days prior to initiating study treatment 
b. 
No active infection(s) 
c. 
Participant meets the remainder of the eligibility criteria outlined in this 
protocol 
7. Adequate organ system functions as defined in Table 9 

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Table 9 
Adequate Organ System Function 
System 
Laboratory Values 
Hematologic 
Absolute neutrophil count (ANC) 
 
1.0x109/L 
Hemoglobin 
8.0 g/dL 
Platelets  
50x109/L 
Hepatic  
Total bilirubin 
≤1.5xULN (isolated bilirubin >1.5xULN is 
acceptable if bilirubin is fractionated and direct 
bilirubin <35%) 
ALT 
≤ 2.5xULN 
Renal 
Estimated glomerular filtration rate (eGFR)1 
Spot urine (albumin/creatinine ratios) 
30 mL/min/1.73 m2  
500 mg/g (56 mg/mmol) 
1. As calculated by Modified Diet in Renal Disease (MDRD) formula (Appendix 10). 
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 retest the participant, and the 
subsequent within range screening result may be used to confirm eligibility. 
 
8. Contraceptive use by men or women should be consistent with local regulations 
regarding the methods of contraception for those participating in clinical studies. 
a. 
Male Participants: 
Male participants are eligible to participate if they agree to the following during 
the intervention period and until 6 months* after the last dose of study 
intervention 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 depending on 
whether they are randomised to Arm 1 (belantamab mafodotin) or Arm 2 
(pom/dex), even if they have undergone a successful vasectomy:  
Agree to use a male condom throughout study treatment including the 6 
month* follow-up period even if they have undergone a successful vasectomy 
and a female partner to use an additional highly effective contraceptive 
method with a failure rate of <1% per year as described in Appendix 4 when 
having sexual intercourse with a pregnant woman or a woman of childbearing 
potential who is not currently pregnant. 
*Four weeks for male participants on Treatment Arm 2 (pom/dex). 
 

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b. 
Female Participants: 
A female participant is eligible to participate if she is not pregnant or 
breastfeeding, and at least one of the following conditions applies: 
• Is not a woman of childbearing potential (WOCBP) [Appendix 4] 
OR 
• Is a WOCBP and agrees to abide by the following: 
• Arm 1 (belantamab mafodotin): Use a contraceptive method that is highly 
effective (with a failure rate of <1% per year) which includes abstinence, 
preferably with low user dependency during the intervention period and for 4 
months after the last dose of study treatment. 
• Arm 2 (pom/dex): Due to pomalidomide being a thalidomide analogue with 
risk for embryo-fetal toxicity and prescribed under a pregnancy 
prevention/controlled distribution program, WOCBP participants will be 
eligible if they commit either to abstain continuously from heterosexual sexual 
intercourse or to use two methods of reliable birth control (one method that is 
highly effective), beginning 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. 
• Two negative pregnancy tests must be obtained prior to initiating therapy. The 
first test should be performed within 10-14 days and the second test within 24 
hours prior to prescribing pomalidomide therapy. 
• 
And agrees not to donate eggs (ova, oocytes) for the purpose of 
reproduction during this period.  
• 
The investigator should confirm the effectiveness of the 
contraceptive method(s) ahead of the first dose of study intervention. 
Additional requirements for pregnancy testing during and after study 
intervention are located in Appendix 4. 
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. 
9. All prior treatment-related toxicities (defined by National Cancer Institute- Common 
Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0, 2017) must be 
≤Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral 
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6.2. 
Exclusion Criteria 
Participants will not be eligible for inclusion in this study if any of the following criteria 
apply: 
1. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, 
organomegaly, endocrinopathy, myeloma protein, and skin changes); active plasma 
cell leukemia at the time of screening. 
2. Systemic anti-myeloma therapy or use of an investigational drug within <14 days or 
5 half-lives, whichever is shorter, before the first dose of study intervention.  
3. Prior treatment with an anti-MM monoclonal antibody within 30 days prior to 
receiving the first dose of study intervention.   
4. Prior BCMA-targeted therapy or prior pomalidomide treatment.  
5. Plasmapheresis within 7 days prior to the first dose of study intervention. 
6. Prior allogeneic stem cell transplant.  
NOTE – Participants who have undergone syngeneic transplant will be allowed only 
if no history of, or currently active, GvHD. 
7. Any major surgery within the last 4 weeks. 
8. Presence of active renal condition (infection, requirement for dialysis or any other 
condition that could affect participant’s safety).  Participants with isolated 
proteinuria resulting from MM are eligible, provided they fulfil criteria included in 
Table 9 
9. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other 
conditions (including lab abnormalities) that could interfere with participant’s safety, 
obtaining informed consent, or compliance with study procedures.  
10. History of (non-infectious) pneumonitis that required steroids, or current 
pneumonitis.  
11. Evidence of active mucosal or internal bleeding. 
12. Current unstable liver or biliary disease per investigator assessment defined by the 
presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal 
or gastric varices, persistent jaundice, or cirrhosis. 
NOTE: Stable chronic liver disease (including Gilbert’s syndrome or 
asymptomatic gallstones) or hepatobiliary involvement of malignancy is 
acceptable if participant otherwise meets entry criteria. 
13. Participants with previous or concurrent malignancies other than multiple myeloma 
are excluded, unless the second malignancy has been considered medically stable for 
at least 2 years. The participant must not be receiving active therapy, other than 
hormonal therapy for this disease. NOTE – Participants with curatively treated non-
melanoma skin cancer are allowed without a 2-year restriction.  
14. Evidence of cardiovascular risk including any of the following: 

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a. Evidence of current clinically significant uncontrolled arrhythmias, 
including clinically significant electrocardiogram (ECG) abnormalities 
including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular 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 (Appendix 11) 
d. Uncontrolled hypertension. 
15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs 
chemically related to belantamab mafodotin, pomalidomide, dexamethasone or any 
of the components of the study intervention. 
16. Pregnant or lactating female. 
17. Active infection requiring treatment. 
18. Known human immunodeficiency virus (HIV), 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/uL 
• 
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 7.5.3, Drug 
Interactions) 
19. Patients with Hepatitis B will be excluded unless the following criteria can be met 
Serology 
Screening 
During Study Treatment 
HbcAb+, 
HbsAg- 
• HBV DNA undetectable 
• Monitoring per protocol 
(Section 2) 
• Antiviral treatment 
instituted if HBV DNA 
becomes detectable 
HBsAg+ at 
screen or 3 
months prior to 
first dose of 
study treatment  
• HBV DNA undetectable 
• Highly effective antiviral treatment 
started ≥4 weeks prior to first dose 
of study treatment 
• Baseline imaging per protocol 
(Section 2) 
• Participants with cirrhosis are 
excluded 
• Japan only: Must test HBeAg and 
HBeAb  
• Table of Antiviral 
treatment maintained 
throughout study 
treatment 
• Monitoring and 
management per 
protocol (Section 2) 

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Note: Presence of HBsAb indicating previous vaccination will not exclude a participant  
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. 
 
 
 
20. Positive hepatitis C antibody test result or positive hepatitis 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: 
• 
Hepatitis C RNA test negative at Screening 
• 
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.  
Hepatitis RNA is optional and participants with negative Hepatitis C antibody 
test are not required to also undergo Hepatitis C RNA testing.  
21.  Participants unable to tolerate thromboembolic prophylaxis  
22. Current corneal epithelial disease except for mild punctate keratopathy 
6.3. 
Lifestyle Considerations 
6.3.1. 
Contact Lenses 
Contact lenses are prohibited in participants randomized to Arm 1 (belantamab 
mafodotin) while the participant is receiving belantamab mafodotin. Following 
discontinuation of belantamab mafodotin treatment, contact lens use may be restarted 
after the qualified eye care specialist such as ophthalmologist/optometrist (Appendix 12) 
confirms there are no other contraindications.   
6.3.2. 
Tobacco 
Pomalidomide/dexamethasone arm only:  Cigarette smoking reduced pomalidomide 
AUC by 32% to 50% due to CYP1A2 induction.  Participants who use tobacco products 
should be advised that smoking may reduce the efficacy of pomalidomide. [POMALYST 
PI] and [Imnovid SmPC]. 
6.3.3. 
Other Lifestyle Considerations  
In Arm 2, participants must not donate blood during treatment with pomalidomide and 
for 4 weeks following discontinuation of study treatment, as transfused blood might be 
given to a pregnant female whose fetus must not be exposed to pomalidomide.   

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6.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study 
but are not subsequently enrolled. 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.  Rescreened participants must be assigned a new unique participant 
number that is different from the initial number. Rescreening of a participant more than 
once requires discussion with the Medical Director. Refer to the SRM for further details. 
7. 
STUDY INTERVENTION 
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, or medical device(s) intended to be administered to a study participant according 
to the study protocol. 

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7.1. 
Study Intervention(s) Administered 
ARM Name 
Arm 1 
Arm 2 
Intervention 
Name 
belantamab mafodotin 
(GSK2857916) 
pom/dex (Pomalidomide plus low dose 
Dexamethasone) 
Type  
Experimental treatment 
Active comparator  
Dose 
Formulation 
Powder for solution for infusion 
Pomalidomide: capsule 
Dexamethasone: tablet 
Dosage Level(s) 2.5 mg/kg on day 1 of every 21-day 
cycle 
Pomalidomide – 4 mg daily on Days 1 -
21 of each 28-day cycle  
Dexamethasone – 40 mg or at lower 
20 mg doseb once weekly (Days 1, 8, 
15, and 22)  
Route of  
Administration 
Intravenous solution over at least 
30 minutesa 
Oral 
Dosing 
instructions 
Reconstitute belantamab mafodotin 
for injection 100 mg/vial with 2.0 mL 
of water for injection (WFI), sterile 
Dilute belantamab mafodotin in 
normal 0.9% saline to the 
appropriate concentration, per the 
investigator’s brochure, for the 
dose. Doses of belantamab 
mafodotin are to be administrated 
as an IV infusion via an infusion 
pump. See Investigator’s Brochure 
for compatible administration 
materials. 
Refer to labels for dosing instructions 
[e.g. POMALYST PI; Imnovid SmPC] 
a. 
Infusions may be prolonged in the event of an infusion reaction. If multiple participants experience clinically 
significant infusion reactions, the infusion rate may be slowed for all future administrations of study treatment(s) 
for all participants. Should this global change in infusion rate be required, it will be communicated to the sites in 
writing. 
b. 
For participants >75 years old 
 
7.1.1. 
Supportive Care Guidelines for Belantamab Mafodotin – Arm 1 
Corneal events, which commonly manifest as superficial keratopathy, have been 
observed with antibody drug conjugates, including those conjugated to MMAF [Eaton, 
2015].  
Sites are required to establish a close collaboration with a qualified eye care specialist 
such as ophthalmologist/optometrist (Appendix 12) who will be responsible for assessing 
participants and managing those who develop corneal examination findings in close 
communication with GSK Medical Director.  
Please refer to Section 9.2.6.1 for ocular examinations, procedures and assessment 
schedule for participants in arm 1. 

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Prophylactic preservative-free artificial tears should be administered in each eye at least 4 
to 8 times daily, beginning on Cycle 1 Day 1 until EOT.  In the event of ocular symptoms 
(e.g., dry eyes), the use of artificial tears may be increased up to every 2 hours as needed.  
Corticosteroid eye drops are not required as prophylaxis but can be used therapeutically if 
clinically indicated as per discretion of an eye-care specialist. If steroid eye drops are 
deemed medically necessary and prescribed, intraocular pressure must be monitored if 
used for >7 days. Allow at least 5-10 minutes between administration of artificial tears 
and steroid eye drops (if administered).  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.   
On the day of infusion, at the discretion of the participant and the investigator, the 
following may be considered:  
• Beginning with the start of each belantamab mafodotin infusion, participants may 
apply cooling eye masks for approximately 1 hour or as much as tolerated.   
• Participants may continue using the cooling eye mask beyond the first hour for up 
to 4 hours. Further use beyond 4 hours is at the participant’s discretion. 
In treatment arm 1, participants must avoid the use of contact lenses during the study.  
See Section 6.3 for further details. 
7.1.2. 
Supportive Care Guidelines for Pom/Dex – Arm 2 
Thromboembolic monitoring and prophylaxis are recommended as per institutional 
guidelines in participants in Arm 2 (pom/dex) based on assessment of risk factors 
[POMALYST PI; Imnovid SmPC]. Please refer to Section 7.6.2.2 for dose modification 
guidelines for pomalidomide- and dexamethasone-related adverse events.   
7.2. 
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 Study Reference Manual.  
Under normal conditions of handling and administration, study intervention is not 
expected to pose significant safety risks to site staff.  Take adequate precautions to avoid 

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direct eye or skin contact and the generation of aerosols or mists. In the case of 
unintentional occupational exposure notify the monitor, Medical Director and/or GSK 
study contact. 
A Material Safety Data Sheet (MSDS)/equivalent document describing occupational 
hazards and recommended handling precautions either will be provided to the 
investigator, where this is required by local laws, or is available upon request from GSK. 
In the case of unintentional occupational exposure notify the monitor, Medical Director, 
or GSK study contact. 
7.3. 
Measures to Minimize Bias: Randomization and Blinding 
The Sponsor will supply a range of unique numbers to each site and participants eligible 
for enrolment will be assigned a unique Participant Number by the site. 
All participants will be centrally randomized using central Interactive Response 
Technology (IRT). 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. 
Participants will be assigned to study treatment in accordance with the randomization 
schedule. 
This is an open-label study; therefore, no blinding of treatment identity is needed for 
either belantamab mafodotin or pom/dex arm. However, to ensure trial integrity steps will 
be taken to restrict access to key information while the study is ongoing and prevent data 
aggregation except for where specified in the protocol. 
Upon completion of all the required screening assessments, eligible participants will be 
registered via an Interactive Response Technology (IRT), by the investigator or 
authorized site staff. The IRT system allows study sites to register and randomize 
participants, and also records stratification information. 
The following information for stratification must be entered into the system to obtain the 
treatment assignment: 
• previous treatment with anti-CD38 therapy (Y/N) 
• ISS I/II or III 
• number of prior lines of therapy (≤3 vs >3) 
Randomization will be done centrally using a randomization schedule, which will assign 
participants in a 2:1 ratio to: 
• Arm 1: 2.5 mg/kg IV Q3W  
• Arm 2: pomalidomide 4 mg orally daily on Days 1 to 21 Q4W (28-day cycle)/ 
dexamethasone 40 mg once weekly (Days 1, 8, 15, and 22) Q4W (28-day cycle) 

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For participants >75 years old, dexamethasone 20 mg once weekly (Days 1, 8, 15, 
and 22) Q4W (28-day cycle) 
Once a randomization number has been assigned it must not be re-assigned even in cases 
of errors. 
Every attempt should be made for Dosing (C1D1) to occur on the same day as 
randomisation call, or as early as possible after the call where for logistical reason same 
day dosing is not possible. 
Returned study intervention should not be re-dispensed to the participants. 
Study Specific User Guide for IRT system will be provided to the study site in the SRM. 
For each country specific expansion cohort, a separate randomization schema will be 
utilized.  
7.4. 
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 and reported in the 
electronic case report form (eCRF). 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. Study intervention start and 
stop dates, including dates for study intervention delays and/or dose reductions will also 
be recorded in the eCRF.  
Belantamab mafodotin is to be administered as an IV infusion, via an infusion pump.  
Premedication is not required prior to infusion unless deemed medically necessary by the 
investigator, in which case it should be administered according to institutional 
recommendations.  
For pom/dex, when participants self-administer study intervention(s) at home, 
compliance with pom/dex 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 eCRF.  A record of the number of pom/dex 
capsules or tablets dispensed to and taken by each participant must be maintained and 
reconciled with study intervention and compliance records. Treatment start and stop 
dates, including dates for treatment delays and/or dose reductions will also be recorded in 
the eCRF.  
7.5. 
Concomitant Therapy 
Any medication or vaccine (including over-the-counter or prescription medicines, 
vitamins, and/or herbal supplements) that the participant is receiving at the time of 
enrollment or receives during the study must be recorded in the eCRF along with: 
• 
reason for use 
• 
dates of administration including start and end dates 

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• 
dosage information including dose and frequency 
The Medical Director should be contacted if there are any questions regarding 
concomitant or prior 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 End of Treatment 
(EoT) visit. Concomitant medications administered after the EoT visit should be recorded 
for SAEs/AESIs as defined in Section 9.3. Any concomitant medication(s), including 
non-prescription medication(s) and herbal product(s), taken during the study will be 
recorded in the source records and eCRF.  Additionally, a complete list of all prior anti-
myeloma therapies will be recorded in the eCRF. 
If future changes are made to the list of permitted/prohibited medications, formal 
documentation in the form of a letter will be provided by GSK and stored in the study 
file. The SRM will be updated to include this information.  
7.5.1. 
Permitted Medication(s) 
Participants should receive full supportive care during the study, including transfusions of 
blood products, growth factors, and treatment with antibiotics, anti-emetics, antidiarrheal, 
and analgesics, as appropriate.  Concomitant therapy with bisphosphonates is allowed.  
Participants may receive local irradiation for pain or stability control. Thromboembolic 
monitoring and prophylaxis is recommended as per institutional guidelines in participants 
in Arm 2 (pom/dex) based on assessment of risk factors [POMALYST PI; Imnovid 
SmPC].  
While on study, a participant who is diagnosed with an unrelated malignancy that can be 
addressed by local therapy 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. 
7.5.2. 
Prohibited Medication(s) 
Chronic treatment with oral steroids other than study medication is prohibited while the 
participant is on study, unless for treatment of acute complications related to study 
treatment, including prophylaxis and/or management of IRR, or exacerbations of chronic 
conditions (no longer than 7 days).  Inhaled steroids are allowed for management of 
asthma or COPD exacerbations.  Chronic low dose replacement therapy (less ≤10 mg/day 
prednisolone) is allowed in participants with adrenal insufficiency.  
Administration of live or live-attenuated vaccines is contraindicated 30 days prior to the 
first dose of study treatment and while on study treatment. Use of live or live-attenuated 
vaccines is further contraindicated for at least 70 days following the last dose of 
belantamab mafodotin.  Killed or inactivated vaccines may be administered; however, the 
safety and response to such vaccines cannot be predicted. 
For guidance on prohibited concomitant medications with pomalidomide and 
dexamethasone usage see the relevant package insert in the SRM. 

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Other prohibited therapies for all participants 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 proteasome 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 
7.5.3. 
Drug Interactions 
For participants enrolled in Arm 1: Elimination pathways for belantamab mafodotin and 
cys-mcMMAF have not been characterized in humans. However, cys-mcMMAF was 
shown to be a substrate of P-gp and OATP transporters, and to be a poor substrate of 
CYP enzymes in vitro. Caution should be exercised when belantamab mafodotin is 
combined with strong inhibitors of P-gp, and strong inhibitors of OATP should be 
avoided unless considered medically necessary. Additional information is provided in the 
SRM. Anti-HIV and anti-microbials that are OATP inhibitors (list provided below; list 
covering other classes of drugs) are thus prohibited unless considered medically 
necessary. Preferably alternative antimicrobials and anti-HIV drugs would need to be 
prescribed to these patients.   
 For guidance on drug interactions with pomalidomide and dexamethasone usage see the 
relevant package insert in the SRM. 
 
• 
OATP inhibitors:  Prohibited unless considered medically necessary 
• 
Anti-HIV drugs: atazanavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir 
• 
Anti-HCV drugs: simeprevir, telaprevir 
• 
Antibiotics drugs: clarithromycin, erythromycin, rifampin/rifampicin 
• 
Antifungals drugs: itraconazole 
• 
Others: cyclosporine, eltrombopag, gemfibrozil 
 
7.6. 
Dose Modification and Delay 
Dose delays and reductions are permitted throughout the study as described below. 
After Cycle 1, participants may have their dose delayed or reduced for toxicities 
according to the recommendations.   
Dosing delays to the next cycle are permitted in the case of medical/surgical events or for 
logistical reasons not related to study therapy (e.g., elective surgery, unrelated medical 
events, participant vacation, and/or holidays, but not for participants’ decision to delay 
treatment).   

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The reason for any dose delay must be documented in the participant’s eCRF and clinic 
record.  
7.6.1. 
Dose Adjustments Due to Body Weight  
7.6.1.1. 
Belantamab mafodotin – Arm 1 
The actual body weight in kg at baseline (assessed on Cycle 1 Day 1 prior to dosing) will 
be used for dose calculation of belantamab mafodotin in all participants during the 
treatment period.  However, if the change of body weight is greater than 10%, the dose 
must be recalculated based on the actual body weight at the time of dosing. 
7.6.1.2. 
Pom/Dex – Arm 2 
Pomalidomide is administered at a fixed dose level, with no adjustments for body weight 
as indicated in pomalidomide product labels [e.g. POMALYST PI; Imnovid SmPC].  
Dexamethasone is administered at a fixed dose level, with no adjustments for body 
weight. 
7.6.2. 
Dose Modifications 
7.6.2.1. 
Belantamab mafodotin – Arm 1 
Table 10 details the permitted dose modifications of belantamab mafodotin.  Table 11 
and Table 12 contain dose modification guidance for drug-related AEs.   
See Table 13 for grading of corneal events (Keratopathy Visual Acuity [KVA] scale) and 
Table 14 for dose modification guidelines for belantamab mafodotin treatment based on 
the KVA scale. 
Table 10 
Permitted Dose Reductions 
Starting dose 
Dose reduction 
2.5 mg/kg 
1.9 mg/kg 
If the participant cannot tolerate the drug after the allowed dose reduction of belantamab 
mafodotin, he or she must discontinue treatment for lack of tolerability. 
In case of full resolution of symptoms which lead to dose reduction, further treatment at 
the previous dose level may be considered by the investigator.  
If a dose is delayed, the participant should wait for the next scheduled dose to resume 
treatment. In individual cases where in the judgment of the Investigator waiting a full 
cycle to resume treatment after delay (skipping dose) related to toxicity which has 
resolved would be detrimental to the participant’s health, the PI should contact the 
CCI

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Medical Director to discuss an earlier re-start. An earlier re-start may be considered only 
for participants who have recovered from toxicity to at least ≤Grade 1. The dosing with 
belantamab mafodotin cannot occur more frequently than every 21 days (±3-day 
window). In such cases, efficacy and safety assessments must remain every 3 weeks in 
line with initial efficacy and safety assessments on study, which may result in 2 separate 
visits (1 for dosing, 1 for disease assessments). Evaluations associated with a dose would 
be entered into the eCRF under the next scheduled cycle.  
Resuming treatment with belantamab mafodotin will be possible with or without dose 
reduction after the toxicity has resolved to Grade 1 or less.  
Table 11 
Dose Modifications Guidelines for Belantamab Mafodotin-Related 
Adverse Events  
Toxicity 
Grade/description 
of toxicity 
Recommendations 
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 current 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 with a 
dose reduction 
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 resolutiona 

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Toxicity 
Grade/description 
of toxicity 
Recommendations 
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)  
Grade 3 
• 
No bleeding: continue treatment with 1 dose 
level reduction. Consider reverting to previous 
dose once thrombocytopenia recovered to Grade 
2 or less  
• 
With bleeding: withhold the dose, continue 
treatment after recovery with 1 dose level 
reduction 
• 
Consider additional supportive treatment (e.g., 
transfusion), as clinically indicated and per local 
practice. 
Grade 4 
• 
Withhold the dose. Consider restarting with 1 
dose level reduction 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 1 dose level reduction may be 
considered after discussion with the Medical 
Director 
Febrile neutropenia 
 
Graded according to NCI 
CTCAE criteria 
 
Grade 3-4 
 
(Defined as: single 
temp of 38.3oC, or 
sustained 38oC for 
>1 hr AND ANC 
<1.0x109/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 a dose reduction of 
belantamab mafodotin, if neutropenia was drug 
related 
Neutropenia without fever 
 
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 

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Toxicity 
Grade/description 
of toxicity 
Recommendations 
<1.0x109/L), consider dose reduction of 
belantamab mafodotin by 1 level 
Infusion Reactionb 
Grade 2 
• 
Stop the infusion, provide medical treatment and 
continue at half the original infusion 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 pre-medicated 
Grade 4 
• 
Permanently discontinue from treatment 
Pneumonitis 
Grade 2 
• 
Withhold treatment with belantamab mafodotin  
• 
Upon recovery, restart treatment with 1 dose level 
reduction.   
• 
If patient is already at the lowest dose level (1.9 
mg/kg), then rechallenge with the same dose 
must be discussed with the Medical Director 
Grade 3-4 
• 
Permanently discontinue from treatment 
a. 
Further treatment may be allowed on case by case basis after discussion with Medical Director who may consult 
GSK’s nephrotoxicity panel. 
b. 
If symptoms resolve within one hour of stopping infusion, the infusion may be restarted at 50% of the original 
infusion rate (e.g., from 100 mL/hr to 50 mL/hr).  Otherwise dosing will be held until symptoms resolve and the 
participant must be pre-medicated for the next scheduled dose. 
 
 

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Table 12 
General Dose Modification and Management Guidelines for 
Belantamab Mafodotin-Related Adverse Events Not Otherwise 
Specifieda 
Severity 
Management 
Follow-up 
Grade 1 
• 
Administer symptomatic 
treatment as appropriate 
• 
Continue study drug(s)a 
• 
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 drugb, or consider dose reduction  
• 
If recovery takes >3 weeks- consult GSK medical 
director (MD)  
• 
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 dose reduction.   
• 
Consider consultation with GSK MD.     
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 or reduced 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 
GSK MD it is agreed that benefits outweigh the risks 
for a given participant 
 
a. 
Treatment-related decisions can be made based on local laboratory results if central results are not available or 
delayed. 
b. 
In case a dose is delayed, the participant should wait for the next scheduled dose to resume treatment 
 

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Table 13 
Keratopathy Visual Acuity (KVA) Scale for Treatment-related Corneal 
Events 
 
Grade per KVA scale 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Corneal 
Events 
 
Corneal 
examination 
finding(s) 
Mild superficial 
keratopathya 
Moderate 
superficial 
keratopathyb 
Severe superficial 
keratopathyc 
Corneal 
epithelial 
defectd 
Change in 
Snellen-
equivalent 
BCVAe,f,g 
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 
a. 
Mild superficial keratopathy: Mild superficial punctate keratopathy (documented worsening from baseline), 
with or without symptoms. 
b. 
Moderate superficial keratopathy: Any/ or a combination of: moderate superficial punctate keratopathy, 
patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity. 
c. 
Severe superficial keratopathy: any/ or a combination of: severe superficial punctate keratopathy, diffuse 
microcyst-like deposits, sub-epithelial haze (central), or a new central stromal opacity. 
d. 
Corneal epithelial defect such as corneal ulcers (with underlying stromal infiltration). 
e. 
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 PI’s assessment of benefit vs. risk based on corneal exam findings following a discussion 
with the qualified eye care specialist such as ophthalmologist/optometrist. 
f. 
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. 
g. 
If a participant has cataract surgery the BCVA should be re-baselined and visual acuity assessed from 
the new baseline value. 
BCVA- best corrected visual acuity 
 

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Table 14 
Dose Modification for Belantamab Mafodotin Treatment based on 
the KVA scale (Table 13) 
Grade per KVA 
scale 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Recommended 
Dosage 
Modificationsa 
Continue treatment 
at current dose. 
Withhold 
belantamab 
mafodotin until 
improvement in 
both corneal 
examination 
findings and 
changes in BCVA 
to Grade 1 or 
better and resume 
at current dose. 
 
Withhold 
belantamab 
mafodotin until 
improvement in 
both corneal 
examination 
findings and 
changes in BCVA 
to Grade 1 or 
better and resume 
at reduced doseb. 
Consider 
permanent 
discontinuation of 
belantamab 
mafodotin.  
 
If based on benefit 
risk assessment, 
treatment of 
belantamab 
mafodotin is being 
considered, 
withhold treatment 
until improvement 
in both corneal 
examination 
findings and 
change in BCVA to 
Grade 1 or better 
and resume at 
reduced doseb. 
 
 
a. 
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. 
b. 
If already on 1.9 mg/kg, participant continues treatment at same dose.  
 
 
7.6.2.2. 
Pom/Dex – Arm 2 
Dose interruptions and reductions are permitted per pomalidomide and dexamethasone 
labels [e.g. POMALYST PI; Imnovid SmPC].  Guidance from the most recent applicable 
labels, together with any additional institutional guidance that may apply, should be 
followed.  
Pom/dex may be resumed upon recovery during the ongoing cycle. A cycle will be 
defined as 28 days, with pomalidomide dosed on Days 1-21 followed by 7 days off 
treatment and dexamethasone once weekly (Days 1, 8, 15, and 22). This cycle length and 
dosing durations are irrespective of start or duration of pom/dex use. Missed doses will 
not be made up. For example: 
• Scenario 1: Delayed pom/dex start: Pom/dex is not started on D1 of a new cycle 
due to an AE. If recovery occurred on any day between D1-21 of this cycle. 
Pom/dex can be resumed and continued until D21.  

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• Scenario 2: Pom/dex interrupted due to AE midcycle: If the AE recovers before 
D21, the treatment with pom/dex may be resumed for the remaining days of the 
21 days of that cycle. The D1 for this given cycle remains the same date (from 
before interruption).   
• Scenario 3: Pom/dex use interrupted due to AE which did not recover during D1-
D21:  In this case a participant would not receive pom/dex for remaining (or all) 
days of this cycle. Pom/dex would be skipped for the entire cycle (D1-D28) and 
would be resumed on D1 of the following cycle, assuming the participant has 
recovered and can be dosed.  
The maximum number of doses of dexamethasone per Cycle is four; on Day 1, Day 8, 
Day 15 and Day 22. Missed doses will not be made up. In case of an AE that in the 
judgment of investigator is related to dexamethasone, the cycle may continue only with 
pomalidomide administration until the participant has recovered and can receive 
dexamethasone at full or reduced dose.  
Efficacy and safety assessments must remain every 3 weeks after the previous efficacy 
and safety assessments which may result in 2 separate visits (1 for dosing and 1 for 
disease assessments).   
Treatment with pom/dex will continue until disease progression or unacceptable toxicity. 
• To initiate a new cycle of pomalidomide, the neutrophil count must be ≥ 1 x 
109/L, and the platelet count must be ≥ 50,000 per mcL (≥ 50 x 109/L). 
• In case of neutropenia, the physician should consider the use of growth factors. 
• For other Grade 3 or 4 adverse reactions judged to be related to pomalidomide, 
hold treatment and restart treatment at 1 mg less than the previous dose when 
adverse reaction has resolved to ≤ Grade 2 at the physician’s discretion. 
• If adverse reactions occur after dose reductions to 1 mg, then the medicinal 
product should be discontinued. 
• Pomalidomide interruption or discontinuation should be considered for Grade 2-3 
skin rash. Pomalidomide must be discontinued for angioedema, Grade 4 rash, 
exfoliative or bullous rash, and should not be resumed following discontinuation 
for these reactions (see local label for further details). 
• If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) 
are co-administered with pomalidomide, reduce the dose of pomalidomide by 
50%. 
See Table 15 for dose modifications guidelines for pomalidomide-related AEs. Table 16 
details recommended dose modifications for dexamethasone-related AEs. The relevant 
local prescribing information should be reviewed for further details and adhered to if 
more conservative than protocol guidance. 
 

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Table 15 
Dose Modifications Guidelines for Pomalidomide – Related to 
Hematologic Adverse Events  
Toxicity 
Dose Modification 
Neutropenia 
ANC < 500 per mcL (< 0.5 x 109/L) 
or Febrile neutropenia (fever ≥ 38.5˚C and ANC 
< 1,000 per mcL [<1 x 109/L]) 
 
Interrupt pomalidomide treatment, follow CBC weekly 
 
 
ANC return to ≥1 x 109/L 
Resume pomalidomide treatment at 3 mg daily 
For each subsequent drop < 500 per mcL (< 0.5 
x 109/L) 
 
Interrupt pomalidomide treatment 
Return to ≥ 500 per mcL or to ≥1 x 109/L 
Resume pomalidomide treatment at 1 mg less than the 
previous dose 
Thrombocytopenia 
Platelet count < 25,000 per mcL (<25 x 109/L) 
Interrupt pomalidomide treatment, follow CBC weekly 
Platelet count returns to > 50,000 per mcL (≥50 x 
109/L) 
Resume pomalidomide treatment at 3 mg daily 
For each subsequent drop < 25,000 per mcL (< 
25 x 109/L) 
 
Interrupt pomalidomide treatment 
Return to ≥ 50,000 per mcL (≥50 x 109/L) 
Resume pomalidomide treatment at 1 mg less than the 
previous dose 
ANC – Absolute Neutrophil Count; CBC – Complete Blood Count. mcL = microliter 

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Table 16 
Dose Modifications for Dexamethasone 
Toxicity 
Dose Modification 
Dyspepsia = Grade 1-2 
 
 
Dyspepsia ≥Grade 3 
Maintain dose and treat with histamine (H2) blockers or 
equivalent. Decrease by one dose level if symptoms 
persist.  
Interrupt dose until symptoms are controlled. Add H2 
blocker or equivalent and decrease one dose level when 
dose restarted.  
Edema ≥Grade 3  
 
Use diuretics as needed and decrease dose by one dose 
level.  
Confusion or mood alteration ≥Grade 2 
Interrupt dose until symptoms resolve. When dose 
restarted decrease dose by one dose level. 
Muscle weakness ≥Grade 2  
 
Interrupt dose until muscle weakness ≤ Grade 1. Restart 
with dose decreased by one level. 
Hyperglycemia ≥Grade 3  
 
Decrease dose by one dose level. Treat with insulin or 
oral hypoglycaemic agents as needed  
Acute pancreatitis  
 
Discontinue patient from dexamethasone treatment 
regimen.  
Other ≥Grade 3 dexamethasone-related 
adverse events  
 
Stop dexamethasone dosing until adverse event resolves 
to ≤ Grade 2. Resume with dose reduced by one level.  
 
Dexamethasone dose reduction levels:  
• ≤ 75 years of age.  
o Starting dose 40 mg, dose level -1 20 mg, dose level -2 10 mg, on Days 1, 
8, 15 and 22 of each 28-day treatment cycle. 
o At investigator discretion, if a participant ≤ 75 years of age has 
comorbidities that may result in excessive toxicity with a 40 mg starting 
dose of dexamethasone, a starting dexamethasone dose of 20 mg may be 
used, as described below.  
• > 75 years of age. 
o Starting dose 20 mg, dose level -1 12 mg, dose level -2 8 mg, on Days 1, 
8, 15 and 22 of each 28-day treatment cycle. 
If recovery from toxicities is prolonged beyond 14 days, then the dose of dexamethasone 
will be decreased by one dose level. 
7.7. 
Continued Access to Study Intervention after the End of the 
study 
Study participants that continue to benefit from study intervention beyond the DCO date 
will continue to have access to study intervention until the EOS as defined in Section 5.4. 
There is no planned intervention following the EOS. 

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The investigator is responsible for ensuring that consideration has been given to the post-
study care of the participant’s medical condition. 
Refer to the SoA (Section 2) for follow-up assessments of participants who are to be 
followed for disease progression and survival after they permanently discontinue from 
study drugs until the DCO date and to Section 9.3.1 for follow-up assessments from the 
DCO date to the EOS. 
7.7.1. 
Continued Access to Study Intervention After Final Data Cut-off 
prior to EOS 
Participants receiving belantamab mafodotin or pomalidomide/dexamethasone at the time 
of the final analysis may continue to receive belantamab mafodotin or 
pomalidomide/dexamethasone, if in the opinion of their treatment physician, they are 
continuing to derive clinical benefit from continued treatment, and they do not meet a 
protocol-defined treatment discontinuation criteria (Section 8.1). Study treatment will 
continue until a study discontinuation (see Protocol Section 8.1) as assessed by the 
investigator has been met. 
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, overdoses and pregnancy while receiving belantamab mafodotin or 
pomalidomide/dexamethasone.  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 t in 
accordance with Section 9.3.1. Pre-specified ocular data (Arm 1 only) (see SRM) will be 
reported as outline in Section 9.3.1. 
During the PACT phase, recording and follow up of SAEs, AEs leading to treatment 
discontinuation, overdose, pregnancy and pre-specified ocular data (Arm 1 only) will be 
done via paper forms (see SRM for details). For dispensing of study treatment and 
maintaining drug accountability in the PACT phase please refer to the SRM. All other 
assessments will revert to standard of care at their site. 
 

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8. 
DISCONTINUATION CRITERIA 
8.1. 
Discontinuation of Study Intervention 
Participants will receive study treatment until disease progression, withdrawal of consent, 
death, unacceptable toxicity (including but not restricted to meeting stopping criteria for 
significant toxicity as outlined in Section 8.2), loss to follow-up, or end of study (Section 
5.4). 
Study treatment must be permanently discontinued for any of the following reasons: 
• 
disease progression or unacceptable toxicity (including protocol-defined safety 
stopping criteria 
• 
pregnancy 
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 
• 
concurrent illness that prevents further administration of study treatment(s) 
• 
participant is lost to follow-up  
• 
study is closed or terminated 
The primary reason that study treatment was permanently discontinued must be 
documented in the participant’s medical records and electronic case report form (eCRF)  
If the participant voluntarily discontinues from treatment due to toxicity, AE must be 
recorded as the primary reason for permanent discontinuation on the eCRF.   
Once a participant has permanently discontinued from study treatment, the participant 
will continue to be followed until the end of study.  
All participants who discontinue from study treatment for any reason other than 
confirmed progression or death will be followed up for PFS, OS, and progression after 
subsequent anti-myeloma therapy (PFS2) as specified in the SoA (see Section 2).  

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PFS Follow-up: 
All participants who permanently discontinue study treatment in the absence of disease 
progression will remain in the study and will be followed for progression according to the 
protocol schedule until (whichever comes first): 
• 
Progression is documented, or  
• 
New anti-myeloma therapy is initiated, or 
• 
Lost to follow-up, or 
• 
Withdrawal of consent, or 
• 
Death occurs, or  
• 
End of OS follow-up (Section 5.4) 
 
OS Follow-up: 
All participants who permanently discontinue study treatment and have experienced 
disease progression or have started new anti-myeloma therapy will be followed for 
survival and progression after new anti-myeloma therapy until the end of OS follow-up 
as described in Section 5.4 
8.2. 
Safety Stopping Criteria 
8.2.1. 
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 4 and Figure 5. 

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Figure 4 
Liver Chemistry Stopping and Increased Monitoring Algorithm 
 
 

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Figure 5 
Liver Chemistry Increased Monitoring Algorithm with Continued 
Therapy for ALT ≥3xULN but <8xULN 
 
 
Liver Safety Required actions and Follow up Assessments Section can be found in 
Appendix 6 and Appendix 7. 
8.2.1.1. 
Study Intervention Restart or Rechallenge after liver stopping criteria 
met 
If participant meets liver chemistry stopping criteria do not restart/rechallenge participant 
with study intervention unless: 
• GSK Medical Governance approval is granted 
• Ethics and/or IRB approval is obtained, if required, and 
• Separate consent for intervention restart/rechallenge is signed by the participant 
Refer to Appendix 6 and Appendix 7 for details.  
If GSK Medical Governance approval to restart/rechallenge participant with study 
treatment is not granted, then participant must permanently discontinue study treatment 
and may continue in the study for protocol-specified follow up assessments. 

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8.2.2. 
Allergic and Anaphylactic Reaction Stopping Criteria 
All participants will be monitored carefully for evidence of allergic response.  A 
participant that exhibits signs or symptoms of severe hypersensitivity or anaphylaxis will 
receive appropriate medical treatment and permanently discontinue study treatment but 
will continue in the study.  
8.2.3. 
Corneal Event Stopping Criteria 
Belantamab mafodotin dose modifications and stopping criteria for treatment-related 
corneal events should be based on the guidelines of Keratopathy Visual Acuity (KVA) 
Scale (see Table 13 and Table 14)  Grade 4 belantamab mafodotin treatment-related 
corneal events (Table 13) according to the Keratopathy Visual Acuity (KVA) Scale must 
be discussed in detail between the Principal Investigator, site qualified eye care specialist 
such as ophthalmologist/optometrist (Appendix 12) , and GSK Medical Director or 
delegate, in order to determine whether the participant should be allowed to continue 
treatment with belantamab mafodotin, or permanently discontinue treatment (Table 13). 
The decision will be documented in study files, together with individual assessment of 
risk-benefit. 
8.2.4. 
Infusion-Related Reactions Stopping Criteria 
Premedication is not required prior to 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. 
Infusion-related reactions should be managed by guidelines provided in Table 11. A 
participant that experiences a Grade 4 IRR must permanently discontinue study treatment 
but will continue in the study. 
8.3. 
Participant Discontinuation/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, behavioural, 
compliance or administrative reasons.  
At the time of discontinuing from the study, if possible, an End of Treatment visit should 
be conducted. See SoA for data to be collected at the time of study discontinuation and 
follow-up and for any further evaluations that need to be completed. 
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. 
The status of ongoing, withdrawn (from the study), and “lost to follow-up” patients at the 
time of an OS analysis should be obtained by the site personnel by checking the patients 
notes, hospital records, contacting the patients current physician, and checking publicly 
available death registries.  

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Withdrawn participants will not be replaced.  
8.4. 
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.  
Discontinuation of specific sites or of the study as a whole are handled as indicated in 
Appendix 1. 
 
9. 
STUDY ASSESSMENTS AND PROCEDURES 
A signed, written informed consent form must be obtained from the participant prior to 
any study-specific procedures or assessments being performed.   
A list of clinical laboratory tests is displayed in Appendix 2. 
Whenever vital signs, 12-lead ECGs and blood draws are scheduled for the same nominal 
time, the assessments should 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.   
Study procedures and the timing of each assessment is listed in the SoA (Section 2).  Key 
assessments to be performed are listed below, with more detailed information provided 
for specific assessments in the SRM, Ocular Reference Manual (ORM) and Q2 Lab 
Manual:  
• 
Study procedures and their timing are summarized in the SoA (Section 2).  
• 
Protocol waivers or exemptions are not allowed.  

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• 
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 criterion listed in Section 6.1 and Section 6.2 
• 
Immediate safety concerns should be discussed with the sponsor immediately 
upon occurrence or awareness to determine if the participant should continue or 
discontinue study intervention. 
• 
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. 
• 
Visit Windows: 
o 
Baseline disease assessments must be completed with 28 days prior to 
dosing start unless otherwise specified.  Refer to SoA (Section 2).  
o 
Every effort should be made for C1D1 to occur on the same day as the 
randomisation call is made, or as soon as possible after. 
o 
Screening assessments performed within the permitted time do not need 
to be repeated on C1D1 unless otherwise specified. 
o 
Safety labs completed within 72 hours of first dose do not need to be 
repeated on C1D1. 
o 
Screening pregnancy testing must be completed within 10-14 days (first 
test) and within 24 hours (second test) prior to first dose. 
o 
Post screening pregnancy testing should occur within 72h prior to 
dosing.   
o 
On study visits, including dosing C2-CX, have a ±3-day window. 
o 
After C1D1, on-study ocular exams should be performed within 5 days 
prior to dosing.  
o 
PFS follow-up visits have a ±3-day window. 
o 
OS follow-up visits have a ±14-day window and can be conducted by 
phone call, or other form of communication. 
o 
The timing and number of planned study assessments, including biomarker assessments, 
may be altered during the course of the study based on newly available data (e.g., to 
CCI

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obtain data closer to the time of peak plasma concentrations) to ensure appropriate 
monitoring.  
Any changes in the timing or addition of time points for any planned study assessments 
must be documented and approved by the relevant study team member and then archived 
in the sponsor and site study files but will not constitute a protocol amendment. The 
IRB/IEC will be informed of any safety issues that require alteration of the safety 
monitoring scheme or amendment of the ICF. 
For details on possible alternative health care approaches, please refer to Appendix 13 
9.1. 
Efficacy Assessments 
Standard disease assessments for RRMM will include the following assessments: 
• 
UPEP, Urine Immunofixation (24 hr urine collection for urine M-protein)  
• 
SPEP, Serum immunofixation for serum M protein 
• 
Calcium corrected for albumin 
• 
Quantitative Ig (IgG, IgM, IgA)   
• 
IgD, IgE (only in participants with IgD or IgE myeloma)  
• 
Serum Kappa, lambda free LC, FLC ratio  
• 
Bone marrow:  
• 
at screening: biopsy and/or aspirate for baseline analysis (disease assessment, 
FISH, MRD);  
• 
at the first time of achieving VGPR, repeated every 6 months for 2 years and 
then yearly until PD: aspirate to assess MRD  
• 
at the time of suspected CR for cases of deepening response from VGPR to 
CR, or achieving CR without prior VGPR, repeated every 6 months for 2 
years and then yearly until PD: aspirate to assess MRD 
• 
at the time of suspected CR: biopsy (preferred) or aspirate to assess % of 
plasma cells 
• 
Additional bone marrow testing if CR is achieved: biopsy for 
immunohistochemistry (IHC) to confirm sCR  
• 
Imaging of extramedullary disease (only in participants with extramedullary 
disease) 
• 
PET/CT is required for participants after first achieving MRD-by NGS, 
preferably within 42 days after receiving data showing MRD negativity (Section 
2) 
• 
Physical examination (as indicated for palpable/superficial lesions) 
• 
Skeletal surveys at screening and as clinically indicated 

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Response evaluation will be performed according to the IMWG Uniform Response 
Criteria for Multiple Myeloma [Kumar, 2016]. Response will be assessed by the 
Investigators. A pre-specified audit by an Independent Review Committee (IRC) will be 
used to support the Investigator-assessed responses.  
Baseline serum/urine disease assessment and baseline imagining will be completed 
during screening period (within 28 days prior to the first dose of study treatment). On 
study serum and urine-based assessments (including M-protein, FLC, SPEP, UPEP ± 
immunofixation and calcium corrected for albumin) will be performed every 3 weeks 
from first dose of study intervention as detailed in the SoA (Section 2). Details for the 
preparation and shipment of samples for central laboratory assessments will be provided 
in the Lab Manual. 
In participants with extramedullary disease, the disease assessments must include 
imaging (e.g., CT, MRI, or PET-CT) and should be performed as described in the SoA 
(Section 2). The same modality should be used throughout the study and include physical 
examination (as indicated for palpable/superficial lesions). Selected target lesion needs to 
be measured and followed over time. Whole body MRI is also acceptable, if it can be 
repeated over time. 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. If the last radiographic assessment 
occurred ≥8 weeks prior to the participants’ withdrawal from study treatment, and PD has 
NOT been documented, a new assessment for extramedullary disease should be obtained 
at the end of treatment (EOT) visit. If participant continues in PFS follow-up, perform 
scans for extramedullary disease as clinically indicated. Plasmacytoma measurements 
should be taken from the CT portion of the PET/CT, or MRI scans, or dedicated CT scans 
when 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 (SPD). This may 
be performed at the EOT visit. Digital copies of all scans must be maintained at 
Investigator site as source document.  
Targeted next generation sequencing (NGS) will be used to assess minimal residual 
disease (MRD) status utilizing a central testing lab. MRD testing should take place as 
described in Section 2. Response evaluation will be performed according to the IMWG 
criteria [Kumar, 2016]. For participants who are MRD negative by NGS (10-5), a CT-PET 
will be performed at the time of confirming MRD negativity.  
All response assessments on study must be performed on a calendar schedule and must 
not be affected by dose interruptions/delays.   
For participants who are discontinuing study intervention due to PD, the confirmation 
must be performed from a different sample collection performed either on the same day, 
or preferably within 14 days of the original disease progression before initiation of any 
new anti-myeloma therapy. The assessments will be performed during End of Treatment 
Visit (Table 4) for the SoA of anti-myeloma activity. 
If the last imaging assessment was greater than or equal to 8 weeks prior to the 
participant’s discontinuation from study treatment and progressive disease has not been 

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documented, a new disease assessment must be obtained at the time of discontinuation 
from study treatment. 
9.1.1. 
Independent Review Committee 
Independent Review Committee (IRC) responses will be utilized to assess efficacy 
endpoints of the study for a pre-specified random sample, or full IRC if audit meets the 
required threshold, as supportive information to the investigator-assessed responses. 
Independent Review Committee (IRC) responses will be utilized to assess efficacy 
endpoints of the study for a pre-specified random sample, or full IRC review if audit 
meets the required threshold, as supportive information to the investigator-assessed 
responses. All laboratory parameters and lesion measurements used to assess participant 
response will be shared with the IRC and will be used to assess their responses, according 
to the IMWG criteria. Additional information can be found in Appendix 1 and in the IRC 
Charter. 
9.2. 
Safety Assessments 
Planned time points for all safety assessments are provided in the SoA (Section 2). 
9.2.1. 
Physical Examinations 
A complete physical examination will include, at a minimum, assessments of the head, 
eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), 
lymph nodes, and extremities.  Height (only at screening) and weight will also be 
measured and recorded (see SoA, Section 2). 
Investigators should pay special attention to clinical signs related to previous serious 
illnesses. 
9.2.2. 
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 where vital sign time points align with blood sampling time points, 
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. 
9.2.2.1. 
Belantamab Mafodotin Infusions 
Monitoring intervals: Vital signs must be monitored at designated time points related to 
drug infusion as specified in the SoA (see Section 2).  In general, participants must also 
be monitored for at least 1 hour after the completion of the first infusion and may be 
discharged if considered clinically stable and all other study procedures have been 
completed.  For subsequent infusions, participants may be discharged after the infusion 
has been completed if considered clinically stable and all other study procedures have 
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9.2.3. 
Electrocardiograms 
Single 12-lead ECG will be obtained as outlined in the SoA (see Section 2) using an ECG 
machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc 
intervals. All ECGs must be performed by qualified personnel at the site after the 
participant has at least a 5-minute rest.   
The QT interval must be corrected for heart rate by Fridericia’s formula (QTcF). 
9.2.4. 
ECOG Performance Status 
Participants performance status will be assessed at Screening and then as specified in the 
SoA (Section 2), using the Eastern Cooperative Oncology Group (ECOG) scale, provided 
in Appendix 9. 
9.2.5. 
Clinical Safety Laboratory Assessments 
Refer to Appendix 2 for a list of clinical laboratory tests to be performed and to the SoA 
(see Section 2) for the timing and frequency. Details for the preparation and shipment of 
samples will be provided in the SRM / Lab 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 eCRF. 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. 
All laboratory tests with values considered clinically significantly abnormal during 
participation in the study or within 70 days after the last dose of either study intervention 
should be repeated until the values return to normal or baseline or are no longer 
considered significantly abnormal by the investigator or medical director.  
If such values do not return to normal/baseline within a period of time judged reasonable 
by the investigator, the etiology should be identified and the sponsor notified. 
All protocol-required laboratory assessments, as defined in Appendix 2, must be 
conducted in accordance with the laboratory manual and the SRM.  
Asymptomatic elevations of lactate dehydrogenase (LDH) and creatine kinase (CK) and 
AST have been observed in study BMA117159.  Participants with significant elevations 
(≥x3 ULN) should, where possible, have a sample sent for central testing of CK and LDH 
isoenzyme levels. 
9.2.6. 
Ocular Examinations and Procedures 
Study sites must establish a close collaboration with a qualified eye care specialist such 
as ophthalmologist/optometrist who will be responsible for assessing participants while 
they are on study and managing participants who develop belantamab mafodotin 
treatment-related ocular symptoms or vision changes. Management of such participants 
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qualified eye care specialist. Participants will be assessed by a qualified eye care 
specialist such as ophthalmologist/optometrist at screening/baseline in both arms.  
A full screening/baseline ophthalmic examination for all participants must include for 
both eyes (OU): 
1. Best corrected visual acuity. (Snellen-equivalent BCVA must be recorded in the 
eCRF.) 
2. Documentation of manifest refraction and the method used to obtain best 
corrected visual acuity. 
3. Current glasses prescription (if applicable). 
4. Anterior segment (slit lamp) examination with focus on the cornea and lens, 
including fluorescein staining of the cornea 
5. Intraocular pressure measurement 
6. Dilated funduscopic exam 
The on treatment and follow-up ophthalmic exam should be performed for both eyes 
(OU) as described below and in the SoA (Section 2):  
1. Best corrected visual acuity. (Snellen-equivalent BCVA must be recorded in the 
eCRF.) 
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)  
5. Dilated fundoscopic exam (if clinically indicated)  
The end of treatment and last follow-up ophthalmic exam, if required, should match the 
screening/baseline exam.  
Additional examinations should be performed at the discretion of the qualified eye care 
specialist.  
9.2.6.1. 
Treatment Arm 1 – belantamab mafodotin 
Participants will be assessed by a qualified eye care specialist such as 
ophthalmologist/optometrist (Appendix 12) at screening/baseline and then Q3W prior to 
dosing 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 (Grade 2 or above) ocular examinations findings, 
patient’s symptoms or vision changes at the time of the sixth dose exam, 

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participants may have their ophthalmologic exams decreased to once every 3 
months.  
• If a participant subsequently develops vision changes or other ocular symptoms, 
the participant should be promptly evaluated by the qualified eye care specialist.  
• In case of persistent ocular exam findings, newly developed ocular symptoms or 
vision changes, the participants will have further ocular exams, at least every 
cycle until resolution or baseline, or more frequently as clinically indicated by the 
qualified eye care specialist. 
Participants with a belantamab mafodotin treatment-related ocular AEs at the End of 
Treatment Visit will be followed by the qualified eye care specialist at least every 3 
months according the schedule in the SOA (Section 2) until either: resolved to Grade 1 or 
baseline, or up to 1 year (whichever comes first). These examinations are referred to as 
“follow-up visits.”  
9.2.6.2. 
Treatment Arm 2 – pom/dex 
Examinations should be performed as described above at screening/baseline and then as 
described in the SoA (Section 2). 
9.2.7. 
Pregnancy Tests (WOCBP only)  
Two highly sensitive serum pregnancy tests should be performed at screening.  The first 
test should be performed within 10 – 14 days and the second test within 24 hours before 
the first dose of study intervention. Subsequent pregnancy tests may be either serum or 
urine. 
For all WOCBP enrolled in Arm 1, belantamab mafodotin, pregnancy tests must be 
conducted within 72 hours prior to dosing. 
For all WOCBP enrolled in Arm 2, pom/dex therapy, pregnancy tests should be 
conducted weekly during the first 4 weeks of use, then every 4 weeks thereafter in 
women with regular menstrual cycles or every 2 weeks in women with irregular 
menstrual cycles within 72 hours prior to dosing [e.g. POMALYST PI; Imnovid SmPC].  
Additional pregnancy testing should be performed according to the Schedule of Activities 
(Section 2) during the treatment period, at EoT Visit and at least 70 days after the last 
dose of study treatment (belantamab mafodotin arm) or at least 4 weeks after the last dose 
of study treatment (pom/dex treatment arm) and as required locally. Follow-up pregnancy 
assessment by telephone (for WOCBP only) should be performed 4 months after the last 
dose of belantamab mafodotin study treatment.  
 
Pregnancy testing and counselling will be performed whenever a menstrual cycle is 
missed, or when pregnancy is otherwise suspected, or if there is any abnormality in a 
female participant’s menstrual bleeding. 
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9.2.8. 
Pomalidomide Risk Evaluation and Mitigation Strategy (REMS) 
/Pregnancy Prevention/Controlled Distribution Program 
Pomalidomide is a thalidomide analogue, which is a known human teratogen.  Because of 
the embryo-fetal risk, pomalidomide is available only through a pregnancy 
prevention/controlled distribution program.  
Participants receiving pomalidomide must register with the appropriate pregnancy 
prevention/controlled distribution program in place (see SRM for details). Ensure 
counselling is completed and documented as required by applicable pregnancy prevention 
program. Acceptable contraception methods need to be aligned to regulatory 
guidelines/regulations for respective countries and as outlined in the local label (as 
applicable). Contraception and pregnancy testing timelines and frequencies must be 
within the regulatory guidelines/regulations for the respective country.  
9.3. 
Adverse Events and Serious Adverse Events 
The definitions of an AE or SAE can be found in Appendix 3. 
Adverse events will be coded using the standard MedDRA and grouped by system organ 
class.  Adverse events will be graded by the investigator according to the NCI-CTCAE, 
(version 5.0).    
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 (see Section 8).  
9.3.1. 
Time Period and Frequency for Collecting AE and SAE 
Information 
• 
All SAEs will be collected from the start of intervention until at least 70 days 
following discontinuation of either Arm 1 or Arm 2 study treatment regardless of 
initiation of a new myeloma therapy or transfer to hospice at the time points 
specified in the SoA (Section 2).  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 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 intervention until at least 70 days 
following discontinuation of either Arm 1 or Arm 2 study treatment regardless of 
initiation of a new myeloma therapy or transfer to hospice at the time points 
specified in the SoA (Section 2). 
• 
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 case report form (CRF) not the AE section. 

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• 
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 Appendix 3. The 
investigator will submit any updated SAE data to the sponsor within 24 hours of it 
being available. 
• 
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 1 only) via paper forms, emails 
(preferably), and fax which will be reported directly to GSK (see SRM for details). 
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 
(see SRM for details). 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 three 
weeks (and prior to the next belantamab mafodotin infusion if dosing), until 
resolution (KVA Grade 1 or baseline). After resolution, the ocual 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:  

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• 
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 months 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. 
• 
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. Refer to SRM for 
additional information. 
 
9.3.2. 
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 Appendix 3. 
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.  
9.3.3. 
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, will be 
followed until the event is resolved, stabilized, otherwise explained, or the participant is 
lost to follow-up (as defined in Section 8.4). Further information on follow-up procedures 
is given in Appendix 3. 
9.3.4. 
Regulatory Reporting Requirements for SAEs 
• 
Prompt notification by the investigator to the sponsor of a 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 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 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 a SAE or other 
specific safety information e.g., summary or listing of SAEs) from the sponsor will 
review and then file it along with the Investigator’s Brochure and will notify the 
IRB/IEC, if appropriate according to local requirements. 

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9.3.5. 
Adverse Events of Special Interest 
Adverse events of special interest (AESI) for belantamab mafodotin are corneal events, 
thrombocytopenia and infusion-related reactions. The severity of all AESI will be graded 
utilizing the National Cancer Institute – Common Toxicity Criteria for Adverse Events 
(version 5.0). Guidelines for dose modifications and interruptions for management of 
common toxicities associated with the study treatment are provided in Section 7.6.  
9.3.6. 
Pregnancy 
Investigators must not collect pregnancy information for female participants known to be 
pregnant during the screening phase or before exposure to study treatment. 
The need for a screening pregnancy test depends on whether a female participant is of 
childbearing potential or non-childbearing potential and as described in Section 2.  
Details of all pregnancies in female participants will be collected after the start of study 
treatment and for 4 months following the last dose of belantamab mafodotin, or 4 weeks 
for pomalidomide.  
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 or 4 weeks for pomalidomide. This applies only to male participants who 
receive study intervention. 
If a pregnancy is reported, the investigator must inform GSK within 24 hours of learning 
of the pregnancy and must follow the procedures outlined in Appendix 4. 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, and ectopic pregnancy) are considered SAE. 
9.3.7. 
Cardiovascular and Death Events 
For any cardiovascular events detailed in Appendix 3 and all deaths, whether or not they 
are considered SAEs, specific Cardiovascular (CV) and Death sections of the CRF will 
be required to be completed.  These sections include questions regarding cardiovascular 
(including sudden cardiac death) and non-cardiovascular death.  
The CV eCRFs are presented as queries in response to reporting of certain CV MedDRA 
terms.  The CV information should be recorded in the specific cardiovascular section of 
the eCRF within one week of receipt of a CV Event data query prompting its 
completion.   
The Death eCRF is provided immediately after the occurrence or outcome of death is 
reported. Initial and follow-up reports regarding death must be completed within one 
week of when the death is reported. 
9.3.8. 
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. 

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Participants should be monitored according to SoA (Table 6). 
 
Participants who experience clinically significant elevations in liver chemistry should 
follow protocol liver event monitoring and stopping criteria, and careful evaluation 
should be immediately initiated for evaluation of etiology including HBV DNA testing.  
 
Table 17 
Dose Modification Table for HBV+ Participants 
Toxicity 
Grade/description 
of toxicity 
Recommendations 
Hepatitis B reactivation 
Detectable HBV 
DNA 
• 
Immediate (within 1 week) consult with local 
specialist to institute/modify treatment and 
monitoring 
• 
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. 
 
9.4. 
Treatment of Overdose 
There is no specific antidote for an overdose of belantamab mafodotin.  GSK does not 
recommend a specific treatment for an overdose of belantamab mafodotin. 
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 absence of the overdose.  
• Obtain a plasma sample for PK analysis and a blood sBCMA sample if requested 
by the GSK Medical Director (determined on a case-by-case basis). 
• Document the quantity of the excess dose as well as the duration of the 
overdosing in the eCRF. 
• 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. 
In the event of overdose with pomalidomide, supportive care is advised as indicated in 
the product information for pomalidomide [e.g. POMALYST PI; Imnovid SmPC]. 

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In the event of overdose with dexamethasone, supportive and symptomatic therapy are 
advised, which may include gastric lavage or emesis. 
9.5. 
Pharmacokinetics 
9.5.1. 
Blood Sample Collection for Pharmacokinetics 
Blood samples for pharmacokinetic (PK) analysis of belantamab mafodotin, total 
antibody, and cys-mcMMAF will be collected from participants in Arm 1 at the visits 
indicated in the SOA (Section 2) either via an Enhanced PK schedule (Table 18) or via a 
Standard PK schedule (Table 19).  Participants in Arm 1 will undergo additional PK 
sampling at timepoints specified in Table 18 for enhanced PK analysis until evaluable 
samples are available for approximately 25% of participants. These additional 
assessments will be collected during Cycle 1 and Cycle 3. All North East Asian 
participants must follow the enhanced PK schedule in Table 18 Table 17. 
In addition to the PK schedule outlined in Table 18 and Table 19, for participants of the 
ocular sub study, a single PK sample will be collected prior to the first infusion following 
the dosing hold (see Section 9.12). 
Following a liver stopping event a blood sample for pharmacokinetic (PK) analysis and a 
blood sample for sBCMA will be obtained within 70 days after the last belantamab 
mafodotin dose (see Appendix 6) 
Collection of a soluble BCMA (sBCMA) sample (Section 9.8.1) is required for each PK 
sample. 
Pharmacokinetic and accompanying sBCMA sample collection may be terminated when 
sufficient data have been collected. 
All PK, sBCMA, and ADA samples once collected (regardless of dosing) will be 
analyzed if the sample date and time have been recorded. 

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Table 18 
Enhanced Pharmacokinetic and sBCMA Collection Schedule   
Cycle/Day 
Sample Timepoint 
Notes 
C1D1 
Predose 
Within 0-30 min prior to SOI (sBCMA also 
collected in Arm 2) 
EOI 
Within 0-30 after EOI 
2 h after SOI 
Within 15 min of SOI + 2 h  
C1D2 
24 h after SOI 
Within 2 h of SOI + 24 h  
C1D4  
Anytime 
Within 24 h of SOI + 72 h  
C1D8 – C1D15 
Anytime 
One sample on any study day between Day 8 
and 15 in the cycle, inclusive 
C1D22 
Anytime 
Collect only if the dose for the next cycle is 
delayed; collect within 2 days of Day 22   
C2D1 
Predose 
Within 0-30 min prior to SOI  
EOI 
Within 0-30 min after EOI  
C3D1 
Predose 
Within 0-30 min prior to SOI  
EOI 
Within 0-30 min after EOI  
2 h after SOI 
Within  15 min of SOI + 2 h  
C3D2 
24 h after SOI 
Within  2 h of SOI + 24 h  
C3D4 
Anytime 
Within  24 h of SOI + 72 h  
C3D8 – C3D15 
Anytime 
One sample on any study day between Day 8 
and Day 15 in the cycle, inclusive  
C3D22 
Anytime 
Collect only if the dose for the next cycle is 
delayed; collect within  2 days of Day 22  
C4D1, C6D1  
Predose 
Within 0-30 min prior to SOI  
EOI 
Within 0-30 min after EOI  
C9D1, C12D1 
Predose 
Within 0-30 min prior to SOI  
Every 6 cycles 
(C18D1, etc.) 
Predose 
Within 0-30 min prior to SOI  
EOT 
Anytime 
At End of Treatment visit (sBCMA also 
collected in Arm 2) 
FU 
Between 6 and 12 weeks after last 
dose of study treatment and before 
initiation of new anti-myeloma 
therapy 
Collect one PK, one ADA, and one sBCMA 
sample. Sample may be collected at any 
planned follow-up visit 
MRD 
MRD assessment timepoints 
sBCMA only (Arm 1 & Arm 2) 
SOI = start of infusion; EOI = end of infusion; EOT = end of treatment 
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Table 19 
Standard PK and sBCMA Collection Schedule  
Cycle/Day 
Sample Timepoint 
Notes 
C1D1 
Predose 
Within 0-30 min prior to SOI (sBCMA also 
collected in Arm 2) 
EOI 
Within 0-30 min after EOI 
C1D2 
24 h after SOI 
Within  2 h of SOI + 24 h 
C2D1 
Predose 
Within 0-30 min prior to SOI 
EOI 
Within 0-30 min after EOI 
C3D1 
Predose 
Within 0-30 min prior to SOI 
EOI 
Within 0-30 min after EOI 
C3D2 
24 h after SOI 
Within  2 h of SOI + 24 h 
C4D1, C6D1  
Predose 
Within 0-30 min prior to SOI 
EOI 
Within 0-30 min after EOI 
C9D1, C12D1 
Predose 
Within 0-30 min prior to SOI 
Every 6 cycles 
(C18D1, etc.) 
Predose 
Within 0-30 min prior to SOI 
EOT 
Anytime 
At End of Treatment visit (sBCMA also 
collected in Arm 2) 
FU 
Between 6 and 12 weeks after last 
dose of study treatment and 
before initiation of new anti-
myeloma therapy 
Collect one PK, one ADA, and one sBCMA 
sample. Sample may be collected at any 
planned follow-up visit 
MRD 
MRD assessment timepoints 
sBCMA only (Arm 1 & Arm 2) 
SOI = start of infusion; EOI = end of infusion; EOT = end of treatment 
Each PK sample must be collected as close as possible to the planned time relative to the 
start of the infusion (which is 0 h) administered to the participant on PK days.  The actual 
date and time of each blood sample collection will be recorded. 
Details on PK blood sample collection, processing, storage, and shipping procedures are 
provided in the Lab Manual. 
9.5.2. 
Pharmacokinetic Sample Analysis 
Plasma analysis will be performed under the control of by GSK or its designee, the 
details of which will be included in the SRM.  Concentrations of belantamab mafodotin, 
total antibody, 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, total antibody, and cys-
mcMMAF, any remaining plasma may be analyzed for other compound-related 
metabolites and the results reported under a separate GSK protocol. 
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9.6. 
Pharmacodynamics 
Pharmacodynamic biomarker parameters may be evaluated in this study.  See Section 9.8 
for further details. 
9.7. 
Genetics 
A 6 mL blood sample for DNA isolation will be collected from participants who have 
consented to participate in the genetics analysis component of the study. Participation is 
optional. Participants who do not wish to participate in the genetic research may still 
participate in the study. 
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. 
See Appendix 5 for information regarding genetic research. Details on processes for 
collection and shipment and destruction of these samples can be found in the SRM/Lab 
Manual. 
9.8. 
Biomarkers 
Biomarker research is part of this study and will involve peripheral blood (serum and 
plasma) and bone marrow. Soluble BCMA (sBCMA) and cfDNA analysis will be 
assessed with their relationship to response to belantamab mafodotin. Any blood, serum, 
and bone marrow samples collected during this study may be used to measure novel 
biomarkers (including DNA, RNA, and protein-based measurements) to identify factors 
associated with the biological and clinical responses to belantamab mafodotin.  If 
relevant, this approach may be extended to include the identification of biomarkers 
associated with AEs.  Unless stated otherwise, these investigations may be performed 
irrespective of whether a response to belantamab mafodotin is observed.  
Samples will be collected at the time points indicated in the SoA (Section 2).  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.  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. Additionally, novel biomarkers involving RNA analysis, DNA analysis, 
or protein analysis may also be incorporated, as data warrants.  These analyses may 
include but not be limited to: 
• 
Bone marrow BCMA expression by IHC and/or RNA analysis performed on 
bone marrow biopsy or aspirate 
• 
Bone marrow biopsy or aspirate may be evaluated for any DNA/RNA changes 
correlating with response 
• 
Measurements of the serum levels of soluble BCMA (sBCMA)  
• 
Soluble factors, including circulating plasma cell-free DNA (cfDNA). 
 

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9.8.3. 
RNA Transcriptome Research 
Transcriptome studies may be conducted using microarray, and/or alternative equivalent 
technologies, which facilitates the simultaneous measurement of the relative abundances 
of thousands of ribonucleic acid (RNA) species resulting in a transcriptome profile for 
bone marrow samples. This will enable the evaluation of changes in transcriptome 
profiles that may correlate with biological response relating to response to belantamab 
mafodotin.  
The same samples may also be used to confirm findings by application of alternative 
technologies. 
9.8.4. 
RNA Expression Research of a Subset of RNA Species 
RNA expression studies may be conducted using quantitative reverse transcriptase 
polymerase chain reaction (RT-qPCR), and/or alternative equivalent technologies, which 
can facilitate the simultaneous measurement of the relative abundances of RNA species 
resulting in a RNA expression profile for bone marrow samples. The RNAs assayed may 
be those involved with the pathogenesis of multiple myeloma or in the participant’s 
response to belantamab mafodotin. In addition, continuing research may identify other 
proteins or regulatory RNAs that may be involved in the response to belantamab 
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mafodotin or the pathogenesis of multiple myeloma. The RNAs that code for these 
proteins and/or regulatory RNAs may also be studied. This will enable the evaluation of 
changes in RNA expression profiles that may correlate with biological response relating 
to response to belantamab mafodotin. 
9.9. 
Immunogenicity Assessments 
Serum samples for determination of anti-belantamab mafodotin antibodies (anti-drug 
antibody; ADA) will be taken from all participants in this study at the time-points 
specified in the SoA (Section 2). Additionally, serum samples should be collected at the 
final visit from participants who discontinued study intervention or were withdrawn from 
the study. ADA sample collection may be terminated when sufficient data have been 
collected. These samples will be tested by the Sponsor or Sponsor’s designee.   
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 belantamab, and the linker-payload portion of belantamab mafodotin. Plasma 
samples for the determination of belantamab mafodotin and total antibody plasma 
concentrations will be collected at the same time points (see SoA) as the immunogenicity 
samples. The plasma concentration results will enable interpretation of the anti-drug 
antibody data.   
Details of sample preparation, storage, and analysis will be provided in the Lab Manual.  
9.10. 
Health Economics 
 will be assessed in this study and reported by 
participants using a questionnaire to be completed at each study visit. Parameters to be 
measured include:  
• 
Number of office/outpatient/hospital clinic visits by specialty 
• 
Number of emergency room/urgent care facility visits 
• 
Number and duration of in-patient hospitalization (total nights, including 
duration by wards [intensive care unit vs. general ward]) 
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For further details, see the SRM. The questionnaire will be administered to participants in 
different regions based on the availability of translated versions. The data collected in the 
eCRF may be used to conduct exploratory economic analyses. 
9.11. 
Patient-Related Outcomes 
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, or due to site restrictions or the PI or site feels it is in the best interest of the 
participant not to come to the site. Participants who are not able to complete the 
questionnaire on their own and require assistance should have the questionnaires 
administered to them in an interview format. The interview may be administered by the 
site staff (or delegate) or a third party over the telephone. If the Interviewer-Administered 
format is used, the questionnaires should be read to the participants verbatim, and 
participant responses should be recorded directly without any interpretation.  For further 
details, refer to the SRM.  
The questionnaires will be administered to participants in different regions based on the 
availability of translated versions. 
Participants enrolled under the original protocol and who completed the EORTC IL52 
questionnaires will continue to do so. Participant enrolled under protocol amendment 1 
will complete the EORTC QLQ-MY20 questionnaire. All participants will complete the 
 at the required study visits. 
9.11.1. 
Patient Reported Outcome 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 Common Terminology 
Criteria for Adverse Events (CTCAE), the standard lexicon for adverse event 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 subset of items selected from the PRO-CTCAE 
Version 1.0 Item library will be administered.   
The PRO-CTCAE will be administered as noted in the SoA (Section 2) to participants in 
different regions based on the availability of translated versions. 
9.11.2. 
Visual Function Questionnaire 
The impact of potential ocular change in vision on function and health-related quality-of-
life will be assessed with the use of the OSDI visual function questionnaire.  All 
participants will use the Self-Administered version of the questionnaire, unless their 
vision 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 
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assistance must use an Interviewer Administered format.  If the Interviewer Administered 
format is being used, it must be read to the participants verbatim, and participant 
responses must be recorded directly without any interpretation.  For any additional 
assessments conducted via telephone (either during participation in the treatment period 
or during Follow-up), the Interviewer Administered format must be used.  
The OSDI will be administered as noted in the SoA (Section 2) to participants in different 
regions based on the availability of translated versions. 
9.11.2.1. 
The Ocular Surface Disease Index 
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to assesses 
both the frequency of dry eye symptoms and their impact on vision-related functioning 
[Schiffman, 2000; Dougherty, 2011].  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. 
9.11.3. 
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 five functional scales (Physical, Role, 
Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and 
Nausea/Vomiting), a Global Health Status/QoL scale, and six 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 Health-Related Qualify of Life (HRQoL), whereas 
a high score for symptom scales and single items represents significant symptomatology 
[Proskorovsky, 2014]. 
9.11.4. 
European Organization for Research and Treatment of Cancer 
Multiple Myeloma Module 20 (EORTC QLQ MY20) and EORTC 
IL52 
The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQ-
MY20) is a supplement to the QLQ-C30 instrument used in patients with multiple 
myeloma [Aaronson, 1993; Cocks, 2007].  It includes four scales (Disease Symptoms, 
Body Image, Future Perspective, and Side Effects. For the EORTC IL52, only the 
Disease Symptoms domain of the QLQ-MY20 will be administered, which includes bone 
aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing 
with activity. For both, the QLQ-C30 and QLQ-MY20, domain scores are averaged and 
transformed linearly to a score ranging from 0–100. A high score for Disease Symptoms 
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10. 
STATISTICAL CONSIDERATIONS 
10.1. 
Statistical Hypotheses 
Primary endpoint PFS 
The primary efficacy analysis will be the comparison of the distribution of PFS between 
the two treatment groups. Assuming proportional hazards for PFS, the following 
statistical hypothesis will be tested to address the primary efficacy objective at one-sided 
alpha level of 2.5%: 
 
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H01: Θ1  ≥1   VS.   HA1: Θ1 < 1 
 
where, 
 is the PFS HR (belantamab mafodotin arm vs. pom/dex arm). 
Key secondary endpoint OS 
Assuming proportional hazards for OS, the following statistical hypotheses will be tested 
at one-sided alpha level of 2.5% if PFS is statistically significant: 
H02: Θ2  ≥1   VS.   HA2: Θ2 < 1 
 
where, 
 is the OS HR (belantamab mafodotin arm vs. pom/dex arm). 
10.2. 
Sample Size Determination 
Primary Endpoint PFS 
Based on available data from literature, the median PFS in the pom/dex arm is expected 
to be around 4 months [San Miguel, 2013]. It is expected that treatment with belantamab 
mafodotin will result in a 43% reduction in the hazard rate for PFS, i.e. an expected HR 
of 0.57 (corresponding to an increase in median PFS from 4 months to 7 months under 
the exponential model assumption). 
The final PFS analysis will be conducted after observing approximately 151 events and 
the first 320 randomized subjects have been followed for a minimum of 4 months. With 
151 events, the study has a power of 90% to detect a hazard ratio of 0.57 at 1-sided alpha 
of 0.025 (corresponding to a critical value of 0.713 for the hazard ratio). This calculation 
assumes participants randomized to the two treatment arms in a 2:1 ratio. Assuming that 
enrolment will continue for approximately 20 months at a uniform rate of 16 participants 
per month, a total of 320 participants will be randomized in a 2:1 ratio to receive single 
agent belantamab mafodotin or pom/dex. It is estimated that the targeted 151 PFS events 
will be observed approximately 23 months after the first participant is randomized based 
on a lognormal cure rate model [Chen, 2016]. These calculations were made using the 
software package East 6.5 and a proprietary SAS macro. 
Power for Analysis of Key Secondary Endpoint OS 
OS, as the key secondary endpoint, will be formally statistically tested, provided that the 
primary endpoint PFS is statistically significant. Based on available data from literature, 
the median OS in the pom/dex arm is expected to be around 13 months [San Miguel, 
2013]. It is hypothesized that treatment with belantamab mafodotin will result in a 32% 
reduction in the hazard rate for OS, i.e., an expected HR of 0.68 (which corresponds to an 
increase in median OS to 19 months under the exponential model assumption). In order 
to ensure 80% power to test the null hypothesis: OS HR = 1, versus the specific 
alternative hypothesis: OS HR = 0.68, a total of 250 deaths need to be observed. This 
calculation assumes analysis by a one-sided log-rank test at the overall 2.5% level of 
significance, participants randomized to the two treatment arms in a 2:1 allocation ratio, 
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function [Lan, 1983] using information fractions of (0.4, 0.7, 1). Based on the same 
number of participants that are planned to be enrolled in this study to provide sufficient 
power for the primary endpoint, it is estimated that these 250 deaths will be observed 
approximately >60 months after the randomization date of the first participant under HA2 
(assuming a similar loss to follow-up, i.e. 5% per year). Therefore, the cut-off date for the 
final analysis of OS will be approximately 35 months after the cut-off date for the final 
analysis of PFS. These calculations were made using the software package East 6.5 and a 
proprietary SAS macro. 
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, which is based 
on approximately 151 events. However, these additional participants will be included in 
country-specific supplemental analyses, as detailed in country specific Statistical 
Analysis Plan (SAP), requested by the applicable regulatory authorities concerned.  
10.3. 
Populations for Analyses 
For purposes of analysis, the populations are defined in Table 20: 
Table 20 
Analysis Populations 
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 and strata to which the participant was randomized 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. 
mITT (modified ITT) 
All participants who have received at least 2 lines of prior therapies; 
randomized and received at least one dose of study treatment (participant 
randomized to the belantamab mafodotin arm but received pom/dex will 
be excluded and vice versa); with measurable disease at baseline.  
Safety 
All randomized participants who take at least 1 dose of study intervention. 
Participants will be analyzed according to the intervention they actually 
received. 
Pharmacokinetic 
The Pharmacokinetic Population will consist of those participants in Safety 
Population from whom at least one PK sample has been obtained and 
analyzed.  This population will be the primary population for PK analyses. 
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10.4. 
Statistical Analyses 
Statistical analyses (both interim and final) will be performed by the sponsor or under the 
authority of the sponsor.  A general description of the statistical methods to be used to 
analyze the efficacy and safety data is outlined below.  Specific details will be provided 
in the SAP. 
10.4.1. 
Efficacy Analyses 
Analysis of efficacy endpoints will be based on Investigator-assessed confirmed response 
and dates per IMWG [Kumar, 2016] criteria with the ITT population unless otherwise 
specified. 
The primary analysis based on Investigator-assessed responses will be supported by a 
pre-specified analysis based on IRC-assessed responses in a randomly selected subset of 
ITT population. Details of the audit are described in the IRC Audit plan, including sample 
size calculation for the IRC audit, random sampling process, the methods to summarize 
and analyse the data from the sample-based IRC assessment, and assessment of the bias 
from investigator responses.  Appropriate subgroup analyses may be performed if data 
permits, e.g., the primary endpoint PFS may be analyzed by age (<65 years, ≥65 years), 
sex (Female, Male), ethnicity (Hispanic, non-Hispanic), race groups (American Indian or 
Alaskan Native, Asian, Black, Native Hawaiian or Other Pacific Islander, White, Mixed 
Race), region (North America, Europe, North-East Asian [consisting of Japan, China and 
Republic of Korea], etc.), prior anti-myeloma therapy and other baseline characteristics.  
The analytical methods planned for each endpoint are described in Table 21. 
Table 21 
Statistical Analytical Methods - Efficacy 
Endpoint 
Statistical Analysis Methods 
Primary 
PFS is the primary endpoint of this study; it is defined the time from randomization 
until the earliest date of PD, or death due to any cause. Determination of dates of 
PFS event and dates for censoring is provided in the SAP. 
Final PFS analysis will be conducted at the time of observing approximately 151 
PFS events and the first 320 randomized subjects have been followed for a 
minimum of 4 months. 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 (1982). The distribution of PFS 
will be compared between the two treatment arms using log-rank test stratified by 
randomization stratification factors at one-sided alpha level of 0.025. 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. HR and corresponding 95% CI will be estimated 
from Cox proportional hazard model stratified by randomization factors with 
treatment arm as the sole explanatory variable. If the proportional hazard 
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Endpoint 
Statistical Analysis Methods 
conducted in addition as appropriate. 
The hypothesis testing decision of the primary endpoint PFS will be based on ITT 
population, investigator-assessed response per IMWG 2016 and primary censoring 
rule defined in the SAP. Investigator-assessed response will be supported by IRC-
assessed responses in a randomly selected subset of the ITT population.  
Additional analyses of PFS based on alternative censoring rules will also be 
performed. The analyses will only include Kaplan-Meier estimates, Cox proportional 
hazards model stratified by randomization factors.  Details are provided in the SAP. 
Analyses of PFS will also be performed based on mITT population and investigator 
assessed response. The analyses will only include Kaplan-Meier estimates, Cox 
proportional hazards model stratified by randomization factors. Details are provided 
in the SAP. 
Subgroup PFS analysis by randomization stratification factors will be conducted at 
final PFS analysis based on ITT population only.  Details are provided in the SAP. 
Key 
Secondary 
Overall Survival (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 of 
last contact.  
Provided that PFS is significant, OS analysis will be conducted at planned analysis 
using similar approach as for the final PFS analysis (i.e. Kaplan-Meier estimates, 
stratified log-rank test, Cox proportional hazards model stratified by randomization 
factors, and examination of non-proportional hazards effect).  
The hypothesis testing and boundary crossing decision of the key secondary 
endpoint OS will be based on ITT population. 
Analyses of OS will also be performed based on mITT population. The analyses will 
only include Kaplan-Meier estimates, Cox proportional hazards model stratified by 
randomization factors. Details are provided in the SAP. 
Subgroup OS analysis by randomization factors will be conducted at final OS 
analysis based on ITT population.  Details are provided in the SAP. 
Secondary 
At final PFS/OS analysis, 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).  
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 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 95% CI for the difference will be calculated.  
CBR, defined as the percentage of participants with a confirmed minimal response 
(MR) or better. 
DOR is defined as the time from first documented evidence of PR or better until the 
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Endpoint 
Statistical Analysis Methods 
participants who achieve a response (i.e., confirmed PR or better). 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 (1982). 
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).  
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 Best 
Overall Response (BOR).  
TTP is defined as the time from randomization until the earliest date of PD, 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 approaches of Kaplan-Meier estimates, Cox 
proportional hazards model stratified by randomization factors.  
MRD negativity rate is defined as the proportion of participants who are MRD 
negative as assessed by NGS. For analysis purposes, participants in the ITT 
population without MRD assessment will be considered as having positive MRD. 
The MRD negativity rate will be summarized by treatment arm. Corresponding 95% 
exact Cis will also be provided. 
Analyses of ORR, CBR, DoR, TTR, and TTP will be performed based on 
investigator-assessed response for ITT population. 
 
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10.4.2. 
Safety Analyses 
All safety analyses will be performed on the Safety Population and are described in Table 
22.  
Table 22 
Statistical Analytical Methods - Safety 
Endpoint 
Statistical Analysis Methods 
Secondary 
Adverse Events: 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, 
regardless of initiation of a new myeloma therapy, until the participant withdraws consent 
for study participation.AEs will be recorded using standard medical terminology and 
graded according to the NCI-CTCAE, Version 5.0. For AE reporting, the verbatim term 
used in the CRF by investigators to identify adverse events will be coded using the latest 
version of Medical Dictionary for Regulatory Activities (MedDRA) coding dictionary [NCI, 
2010]. 
Adverse events 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. Adverse events, if listed in 
the NCI-CTCAE (version 5.0) will be summarized by the maximum grade. 
Characteristics (e.g., number of occurrences, action taken, grade, etc.) of the following 
toxicity 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 laboratory values and changes 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. 
Other Safety Measures: Data for vital signs 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 the SAP. 
 
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10.4.4. 
Other Analyses 
10.4.4.1. 
Biomarker Analyses 
Biomarker exploratory analyses will be described in the reporting and analysis plan. 
10.4.4.2. 
Pharmacokinetic Analyses 
Concentration-Time Data: Linear and semi-logarithmic individual concentration-time 
profiles and mean and median profiles (when appropriate) will be plotted for belantamab 
mafodotin, total mAb, and cys-mcMMAF.  Concentrations of belantamab mafodotin, 
total mAb, and cys-mcMMAF will be listed for each participant and summarized (when 
appropriate) by planned time point.  
Derived Pharmacokinetic Parameters: Pharmacokinetic analyses will be the 
responsibility of Clinical Pharmacokinetics/Modelling and Simulation, GSK. 
Plasma belantamab mafodotin, total mAb, and cys-mcMMAF concentration-time data 
may be combined with data from other studies and will be analyzed using a population 
pharmacokinetic approach.  The initial analysis will use the current population 
pharmacokinetic model to generate post hoc belantamab mafodotin pharmacokinetic 
parameter estimates for the individual participants in Arm 1 of Study 207495.  Based on 
the individual post hoc parameter values, dosing information, and sample collection 
times, belantamab mafodotin plasma concentrations at the time of sample collection will 
be predicted for each participant.  Model evaluation will consist of comparison of model-
predicted and observed concentrations.  If necessary, model estimation will be performed.  
Results of this analysis may be provided in a separate report. 
For participants who undergo enhanced pharmacokinetic sampling, noncompartmental 
analysis to generate selected pharmacokinetic parameter values (Cmax, tmax, AUC(0-), 
Ctrough) may be performed at Cycle 1 and Cycle 3, data permitting. 
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 and dose level. 
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GSK CPMS analysts 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 each interim analysis) throughout the trial for population 
PK model development/refinement.  
North East Asia country PK analyses will be completed at the time of the final analysis 
for each country-specific expansion cohort and may be provided in a separate report. 
10.4.4.3. 
Pharmacokinetic/Pharmacodynamic Analyses 
If deemed appropriate and if data permit, exposure-response relationships between 
belantamab mafodotin and/or cys-mcMMAF exposure (e.g., dose, dose intensity, 
concentration, Cmax, or AUC) and clinical activity and/or toxicity (e.g., response, 
corneal events) may be explored using population methods. If data permit, the effects of 
covariates may be explored. Results of this analysis may be provided in a separate report. 
10.5. 
Planned Analyses 
Table 23 summarizes the planned interim and / or final analyses for PFS and OS. 
Table 23 
Summary of PFS and OS analyses  
Analyses Timing 
from 
Randomization 
Planned PFS analyses 
Planned OS analyses 
~25 months 
PFS final 
~151 PFS events and the first 320 randomized 
subjects have been followed for a minimum of 4 
monthsc 
OS IA for efficacya 
~100 OS events 
~40% OS information 
fraction 
~48months 
N/A 
OS IA for efficacya 
~175 OS events 
~70% OS information 
fraction 
>60 months 
N/A 
OS finalb 
~250 OS events 
a. 
Provided that final PFS analysis is significant. 
b. 
If PFS is significant and null hypothesis is not rejected at the 2nd OS IA for efficacy. 
c. 
First dose of 320th subject happens around 21 months 
 
 
Planned Analyses for Key secondary endpoint OS 
The key secondary efficacy endpoint, OS, will be compared between the 2 treatment 
arms (belantamab mafodotin arm vs pomalidomide/ dexamethasone arm) using a group 
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time of PFS final (~40% information), one interim analysis at ~70% information and one 
final at 100% information. The boundary for declaring superiority of belantamab 
mafodotin arm over pomalidomide/ dexamethasone arm is based on a Lan-DeMets 
(O’Brien-Fleming) alpha spending function [Lan, 1983] with overall alpha = 0.025, one-
tailed, and will be adjusted based on actual observed number of deaths (actual 
information fraction).  
At the first OS interim analysis (~40% OS information fraction), the study will not be 
stopped regardless of the results. GSK will continue to collect the OS data to conduct the 
2nd OS interim analysis to test for efficacy at ~70% OS information fraction. 
At the OS interim analysis for efficacy (~70% OS information fraction) (Table 23), 
assuming 175 events are observed, if the calculated p<0.0073 (corresponding to 
HR<0.676), it would be  considered that the efficacy boundary is crossed and the OS 
analysis would be significant. 
A hierarchical testing procedure will be adopted and the OS interim/final analysis for 
efficacy will only be performed if the primary efficacy endpoint PFS is statistically 
significant at PFS final analysis [Bretz, 2009; Li, 2017]. The testing procedures are 
detailed as follows: 
Step 1: Test PFS at the final PFS analysis. If significant, go to Step 2 and overall one-
sided alpha of 0.025 will be carried forward to test for OS; if not significant, stop testing; 
Step 2: Test OS at the first OS interim analysis (at the same time of PFS final, ~40% OS 
information fraction) for efficacy (cumulative one-sided alpha spent for OS = 0.0004); 
Step 3: Test OS at the 2nd OS interim analysis for efficacy (~70% information fraction). If 
significant, stop testing; if not significant, go to Step 4 (cumulative one-sided alpha spent 
for OS = 0.0074); 
Step 4: Test OS at the time of the final OS analysis (cumulative one-sided alpha spent for 
OS = 0.025). 
Table 24 
Stopping boundaries for OS 
Information 
fraction 
N of events 
Cum. alpha 
Spent 
Efficacy 
Boundary  
(p-value) 
Efficacy 
Boundary  
(HR) 
Boundaries crossing 
probabilities (incremental) 
Under H0 
 
Under H1 
0.4 
100 
0.0004 
0.0004* 
0.491* 
0.04% 
 
5.8% 
0.7 
175 
0.0074 
0.0073 
0.676 
0.7% 
 
41.2% 
1 
250 
0.0250 
0.0227 
0.765 
1.8% 
 
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*: The threshold will be is used for the 1st OS analysis, however, the study will not be stopped for efficacy 
regardless of the results. GSK will continue to collect the OS data to conduct the 2nd OS interim analysis to 
test for efficacy at ~70% OS information fraction.   
 
If OS is significant at 70% IF, OS data will continue to be collected until final analysis: 
defined as all participants have died, are lost to follow up, or withdrawn consent, or for 2 
years after the OS analysis at ~70% IF, whichever occurs first. Analysis of OS will be 
performed using only Kaplan-Meier method and stratified Cox proportional hazards 
model. 
10.5.1. 
Independent Data Monitoring Committee  
An Independent Data Monitoring Committee (IDMC) consisting of at least 2 physicians 
and one statistician as defined in the IDMC Charter will review data at defined time 
points. Additional details, including the list of outputs supporting decision making at the 
interim analysis, will be provided in the IDMC charter.    
The first IDMC safety review meeting is planned when approximately 60 participants 
have been on study for at least 8 weeks. Subsequent IDMC safety review meeting is 
planned approximately every 6 months hereafter. 

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11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations 
11.1.1. 
Regulatory and Ethical Considerations 
• 
This study will be conducted in accordance with the protocol and with: 
o Consensus ethical principles derived from international guidelines including 
the Declaration of Helsinki and Council for International Organizations of 
Medical Sciences (CIOMS) International Ethical Guidelines 
o Applicable ICH Good Clinical Practice (GCP) Guidelines 
o Applicable laws and regulations 
• 
The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant 
documents (e.g., advertisements) must be submitted to an IRB/IEC by the 
investigator and reviewed and approved by the IRB/IEC before the study is initiated.  
• 
Any amendments to the protocol will require IEC/IRB approval before 
implementation of changes made to the study design, except for changes necessary to 
eliminate an immediate hazard to study participants.  
• 
The investigator will be responsible for the following: 
o 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/EC 
o Notifying the IRB/IEC of SAE or other significant safety findings as required 
by IRB/IEC procedures 
o Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 
536/2014 for clinical studies (if applicable), and all other applicable local 
regulations 
11.1.2. 
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. 
11.1.3. 
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.  

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• 
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.  
11.1.4. 
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.  
• 
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. 
11.1.5. 
Committees Structure 
Details on the IDMC structure will be defined in the IDMC charter and as noted in 
Section 10.5.1. 
An IRC will be utilized to perform a pre-specified audit of the investigator-assessed 
response and progression. Further details on the IRC process will be defined in the IRC 
charter. Results from the IRC audit will not be provided to the investigative sites.  
 
Participant data to be shared with the IRC may include the following: 
Laboratory data 
• Serum M protein electrophoresis (SPEP) and immunofixation results 
• 24-hour Urine M protein electrophoresis (UPEP) and immunofixation results  
• Serum free light chain (FLC) values including kappa and lambda values, 
kappa/lambda ratio, difference between kappa and lambda [dFLC] 
 
 

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Imaging data  
• Extramedullary lesions identified at Baseline (longest diameter, longest 
perpendicular diameter, sum of product of diameters [SPD]) 
• New extramedullary lesions 
• Skeletal lytic lesions 
Bone marrow aspirate/biopsy data 
•  Bone marrow plasma cell percentage (BMPC%)  
• Absence of plasma cell clonality in bone marrow (per k/l ratio by IHC) 
• Minimal Residual Disease (MRD) by NGS (10-5) 
 
11.1.6. 
Dissemination of Clinical Study Data 
For studies conducted in the EU under Regulations EU 536/2014: Consider whether 
submission of results of the clinical study will be delayed more than one year after the 
end of trial and provide substantiated reasons. Provide justification if a single summary of 
results report will not be submitted for all study treatments used in the clinical study. 
• 
Disclosure of 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 US 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 clinical study report.  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 protocol and results summary 
and for development of a manuscript for publication for this study will be in 
accordance with GSK Policy. 
• 
GSK intends to make anonymized patient-level data from this trial available to 
external researchers for scientific analyses or to conduct further research that can 
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provided by trial participants are used to maximum effect in the creation of 
knowledge and understanding 
• 
A manuscript will be progressed for publication in the scientific literature if the 
results provide important scientific or medical knowledge. 
11.1.7. 
Data Quality Assurance 
• 
All participant data relating to the study will be recorded on printed or electronic 
CRF 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.  
• 
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.  
• 
Monitoring details describing strategy (e.g., risk-based initiatives in operations and 
quality such as Risk Management and Mitigation Strategies and Analytical Risk-
Based Monitoring), 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.  
• 
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, International Conference on 
Harmonization Good Clinical Practice (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 Clinical 
Study Report (CSR)/equivalent summary (except for 15 years in the US, China 
including Hong Kong SAR (Special Administrative Region)), 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.  
• 
GSK will retain records for 30 Years after date of study report (or date of termination 
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11.1.8. 
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 reported on the CRF or 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. 
• 
Definition of what constitutes source data can be found in the SRM. 
11.1.9. 
Study and Site Closure 
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: 
• 
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 recruitment of participants by the investigator 
• 
Discontinuation of further study intervention development 
11.1.10. 
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. 
 

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11.2. 
Appendix 2: Clinical Laboratory Tests 
• 
The tests detailed in Table 25 are identified as being performed at either local or 
central laboratory. 
• 
For response assessments, local laboratory results are only required in the event that 
the central laboratory results are not available in time for response evaluation. If a 
local sample is required, it is important that the sample for central analysis is 
obtained at the same time.  
• 
Protocol-specific requirements for inclusion or exclusion of participants are detailed 
in Section 6 of the protocol. 
• 
Pregnancy testing for WOCBP (for definition see Section 11.4.1)   Note that for 
questionable cases (child-bearing potential), FSH and estradiol will be performed, as 
needed. 
• 
Screening Pregnancy (serum) testing, all participants (Section 6.1 [Inclusion 
Criteria] for screening pregnancy criteria). 
• 
Post screening for participants in Arm 1, belantamab mafodotin therapy, 
pregnancy testing (urine or serum as required by local regulations) will be 
conducted at every cycle during intervention.  
• 
Post screening for participants in Arm 2, pom/dex therapy, pregnancy tests will 
be performed weekly during the first month (first cycle) and then once every 
cycle thereafter in women with regular menstrual cycles, or every 2 weeks in 
women with irregular menstrual cycles. Pregnancy tests may be either serum or 
urine.  
• 
Pregnancy testing (urine or serum as required by local regulations) will be 
conducted at the end of relevant systemic exposure (at least 70 days [belantamab 
treatment] or at least 4 weeks [pomalidomide treatment].  
• 
Additional serum or urine pregnancy tests may be performed at any time during 
the study, as determined necessary by the investigator or required by local 
regulations, to establish the absence of pregnancy at any time during the 
participant's participation in the study. 
 
Table 25 
Protocol-Required Safety and other Laboratory Assessments, 
including optional assessment1 
Laboratory 
Assessments 
Parameters 
Hematology2 
Platelet Count8  
RBC Indices: 
MCV 
MCH 
Reticulocyte Count 
MCHC 
WBC count with 
Differential: 
Neutrophils8 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
Red Blood Cell (RBC) 
Count 
White Blood Cell (WBC) 
count (absolute) 
Hemoglobin8 
Hematocrit 

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Laboratory 
Assessments 
Parameters 
Clinical 
Chemistry2,3 
Blood urea 
nitrogen (BUN) 
Potassium 
Aspartate 
Aminotransferase (AST) 
Total and direct 
bilirubin8 
 
Creatinine 
Sodium 
Alanine Aminotransferase 
 (ALT)8 
Total Protein 
 
Chloride 
Uric Acid 
Total bicarbonate or Total 
CO2 or CO2CP 
Gamma Glutamyl 
transferase (GGT) 
Magnesium 
Phosphorous 
Creatine kinase (CK) 
Lactate 
Dehydrogenase 
(LDH) 
Glucose 
(nonfasting)  
Calcium 
Alkaline phosphatase 
Albumin 
Estimated 
glomerular 
filtration Rate 
(eGFR)8 
Thyroid 
Stimulating 
Hormone 
(TSH) 
T4 
 
Urine Tests2,8 
• 
Optional Urine dipstick5    OR 
• 
Spot urine (creatinine/albumin ratio)5  
Other Safety 
Laboratory Tests 
• Highly sensitive serum human chorionic gonadotropin (hCG)2 pregnancy tests (as 
needed for women of childbearing potential) at screening.  Subsequent pregnancy 
tests may be urine or serum. 
• Follicle stimulating hormone (FSH) and estradiol (as needed in women of non-
childbearing potential; for additional details see Appendix 4)2 
• Hepatitis B surface antigen (HBsAg) – screening ONLY2,8 
• Hepatitis B core antibody (HBcAb) – screening ONLY2,8 
NOTE: Please refer to Table 6 regarding Hepatitis B DNA testing.2,4 
• HBeAG and HBeAb2 – Japan ONLY 
• Hepatitis C (Hep C antibody): - screening ONLY2,8 
NOTE: Please refer to Table 7 regarding Hepatitis C RNA testing2,4. 
• LDH and CK isoenzymes4, 7 
PK/ADA (not 
performed at 
screening) 
• 
Belantamab mafodotin pharmacokinetics (PK)4 
• 
Anti-Drug Antibodies (ADA)4 to belantamab mafodotin 
Optional Testing 
• 
Gx4 
• 
Tissue sample at PD for BCMA (BM biopsy) or bone marrow aspirate for 
biomarker research4 
Biomarker 
Measurements 
• 
cfDNA (plasma)4 
• 
soluble BCMA (sBCMA)4 – serum 
• 
Remaining portion of bone marrow sample (biopsy or aspirate) collected at 
baseline/screening will be used for biomarker research4 
• 
Remaining portion of optional bone marrow sample (biopsy or aspirate) collected 
at PD will be used for biomarker research4 
Disease 
Evaluation 
Laboratory Tests 
• 
Urine Protein Electrophoresis (UPEP)4,8 
• 
Serum Protein Electrophoresis (SPEP)4,8 
• 
Urine immunofixation4 
• 
Serum immunofixation4 
• 
24-hour urine collection for M-protein4,8 
• 
Serum Kappa, lambda free LC, FLC ratio4,8 

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Laboratory 
Assessments 
Parameters 
• 
Beta2 microglobulin4 
• 
IgG4, IgM4, IgA4 (IgD and IgE ONLY for participants with IgD/E myeloma)4 
• 
Calcium corrected for albumin (serum)4 
Bone Marrow 
Aspiration/Biopsy 
• 
MRD testing4 
• 
Disease assessment (percent plasma cells)2, 4 
• 
To confirm sCR (IHC)4,6 
• 
FISH testing to be performed locally at least for: t(4;14), t(14;16), amp(1q), 
del(1p) and del(17p13). If patient is known to have previously tested positive for 
t(4;14),or  t(14;16),  FISH testing for those translocations does not need to be 
repeated, as results from previous tests are acceptable regardless of when those 
tests were performed. Other 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. 
• 
BCMA IHC assessment4 
The results of each test performed by a Local Laboratory must be entered into the eCRF. Central laboratory 
data will be sent directly to GSK.  
1. 
Other lab tests maybe completed as needed. 
2. 
Performed by local lab. 
3. 
Details of liver chemistry stopping criteria and required actions and follow-up assessments after liver stopping or 
monitoring event are given in Section 8.1 and Appendix 6 All events of ALT 3 × upper limit of normal (ULN) and 
bilirubin 2 × ULN (>35% direct bilirubin) or ALT 3 × ULN and international normalized ratio (INR) >1.5, if INR 
measured, which may indicate severe liver injury (possible Hy’s Law), must be reported as an SAE (excluding 
studies of hepatic impairment or cirrhosis). 
4. 
Performed by central lab 
5. 
Urine dipstick for protein 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 visit), or ≥2+ (during study treatment), or 
with positive protein if urine dipstick protein quantification is not available. Albumin/creatinine will be performed at 
a local lab. If local testing is not available, then central testing will be performed (first void).   
6. 
Results from tests to confirm sCR will be collected and stored by third party vendor. 
7. 
Participants with significant elevations (≥x3 ULN) 
8. 
Assessments critical for eligibility  
 

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11.3. 
Appendix 3: Adverse Events: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting 
11.3.1. 
Definition of AE 
AE Definition 
• 
An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of a study intervention, whether or not considered related to 
the study intervention. 
• 
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 intervention. 
 
Events Meeting the AE Definition 
• 
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) 
or other safety assessments (e.g., ECG, 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 intervention 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 
intervention or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should 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 fulfill 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. 
• 
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Events NOT Meeting the AE Definition  
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. 
 
11.3.2. 
Definition of SAE 
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). 
A SAE is defined as any untoward medical occurrence that, at any dose: 
Results in death 
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. 
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 fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE 
should be considered serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen from 
baseline is not considered an AE. 
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 

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everyday life functions but do not constitute a substantial disruption. 
Is a congenital anomaly/birth defect 
Other situations: 
• 
Medical or scientific judgment should 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 should 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. 
Is associated with liver injury and impaired liver function defined as: 
• ALT 3 x ULN and total bilirubin* 2 x ULN (>35% direct), or 
• ALT 3 x ULN and 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 x ULN 
and total bilirubin 2 x 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 Appendix 6 for liver chemistry follow-up procedures. 
 
11.3.3. 
Definition of Cardiovascular Events 
Cardiovascular Events (CV) Definition: 
Investigators will be required to fill out the specific CV event page of the 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 

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Cardiovascular Events (CV) Definition: 
• 
Deep venous thrombosis/pulmonary embolism 
• 
Revascularization 
 
11.3.4. 
Recording and Follow-Up of AE and SAE 
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 
according to the National Cancer Institute Common Terminology Criteria for Adverse 
Events (NCI-CTCAE) Version 5.0 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)1. 
 Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
ADL2. 
Grade 4: Life-threatening consequences; urgent intervention indicated. 
 Grade 5: Death related to AE.  
1Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc. 

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AE and SAE Recording 
2 Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, 
taking medications, and not bedridden. 
 
Assessment of Causality 
• 
The investigator is obligated to assess the relationship between study intervention 
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 intervention 
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. 
 

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11.3.5. 
Reporting of SAE to GSK 
SAE Reporting to GSK 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 show evidence within 
the eCRF (e.g., check review box, signature, etc.) of review and verification of the 
relationship of each SAE to IP/study participation (causality).  
• 
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) or to the medical director/SAE coordinator by telephone. 
• 
Contacts for SAE reporting can be found in the Study Reference Manual. 
 
SAE Reporting to GSK via Paper CRF 
• 
Facsimile transmission of the SAE paper CRF is the preferred method to transmit 
this information to the medical director/SAE coordinator. 
• 
In rare circumstances and in the absence of facsimile equipment, notification by 
telephone is acceptable with a copy of the SAE data collection tool sent by overnight 
mail or courier services  
• 
Initial notification via telephone 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 Study Reference Manual. 
 
 

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11.4. 
Appendix 4: Contraceptive Guidance and Collection of 
Pregnancy Information 
11.4.1. 
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.  
For questionable cases (child-bearing status), follicle-stimulating hormone (FSH) and 
estradiol (as needed in women of non-childbearing potential only) should be performed at 
local lab (see Appendix 2).   
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 the participant’s 
medical records, medical examination, or medical history interview. 
3. 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 hormonal replacement therapy (HRT). However, in the absence 
of 12 months of amenorrhea, confirmation with more than one FSH measurement 
is required.  
• Females on HRT and whose menopausal status is in doubt will be required to use 
one 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 enrollment. 
 

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11.4.2. 
Contraception Guidance 
Use of belantamab mafodotin in pregnant women may cause fetal harm and there is the 
potential for embryo-fetal risk when prescribing pomalidomide. Pomalidomide is 
available only through a pregnancy prevention/controlled distribution program.    
Participants receiving pomalidomide must register with any pregnancy 
prevention/controlled distribution program in place locally where applicable (see SRM 
for details).  Acceptable contraception methods need to be aligned to regulatory 
guidelines/regulations for respective countries and as outlined in the local label (as 
applicable). Contraception and pregnancy testing timelines and frequencies must be 
within the regulatory guidelines/regulations for the respective country.  See Section 6.1 
for further details. 
Contraceptives allowed during the study for both treatment arms are presented in Table 
26. 

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Table 26 
Contraceptives Allowed During the Study 
CONTRACEPTIVESa ALLOWED DURING THE STUDY INCLUDE: 
Highly Effective Methodsb,c That Have Low User Dependency  
• 
Implantable progestogen-only hormone contraception associated with inhibition of ovulationc, d 
• 
Intrauterine device (IUD)d 
• 
Intrauterine hormone-releasing system (IUS)c, d 
• 
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 Methodsb,c That Are User Dependent 
• 
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition 
of ovulationc 
• Orale 
• intravaginal 
• transdermal 
• injectable 
• 
Progestogen-only hormone contraception associated with inhibition of ovulationc 
• 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 
a) 
Contraceptive use by men or women should be consistent with local regulations regarding the use of 
contraceptive methods for those participating in clinical studies.  Consult the local label for additional guidance 
on contraceptive use when using pomalidomide. If local label has stricter requirements, the local label 
should take precedence. 
b) 
Failure rate of <1% per year when used consistently and correctly. Typical use failure rates differ from those 
when used consistently and correctly. 
c) 
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. 
d) 
Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at 
the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in 
patients with neutropenia. (Imnovid SmPC). 
e) 
Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking 
pomalidomide and dexamethasone, combined oral contraceptive pills are not recommended (Imnovid 
SmPC). Consult pomalidomide pregnancy prevention program / product information for recommended 
contraception.  
Note: Periodic abstinence (calendar, sympto-thermal, post-ovulation methods), withdrawal (coitus interruptus), 
spermicides only, and lactational amenorrhoea 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) 

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11.4.3. 
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 last dose of belantamab mafodotin treatment (Arm 1) or at least 4 weeks after 
the last dose of pomalidomide treatment (Arm 2). This applies only to male participants 
who receive study intervention. 
• 
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 during the pregnancy and post delivery to 
determine the outcome of the pregnancy. Information on the status of the mother and 
child will be forwarded to GSK. 
• 
For Arm 1 follow-up will be no longer than 6 to 8 weeks following the estimated 
delivery date. For participants in Arm 2, follow-up will be up to 1 year for infant 
follow-up. 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 last 
dose of belantamab mafodotin treatment (Arm 1) or 4 weeks after the last dose of 
pomalidomide treatment (Arm 2). 
• 
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. For participants in Arm 2, follow-up 
will be up to 1 year for infant follow-up.   
• 
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 AE or SAE, any pregnancy 
complication or elective termination of a pregnancy 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 intervention by the investigator, will be reported to 
GSK as described in Appendix 3. While the investigator is not obligated to actively 

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seek this information in former study participants, he or she may learn of an SAE 
through spontaneous reporting.  
• 
In compliance with REMS requirements, pregnancy information on any female 
participant enrolled in Arm 2 (pom/dex therapy) in the US must be reported to 
Celgene Corporation at 1-888-423-5436 or FDA at 1-800-332-1088 or 
www.fda.gov/medwatch. Notification to other program which may be in place 
locally will be detailed in the SRM.  
Any female participant who becomes pregnant while participating in the study will 
discontinue study intervention. 

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11.5. 
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 IRB/IEC allow, a blood sample will be collected for DNA 
analysis 
• 
DNA samples will be used for research related to belantamab mafodotin or multiple 
myeloma 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 multiple myeloma. Genetic research may consist of the analysis 
of one 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 clinical study report 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 multiple myeloma continues but no longer than 15 
years after the last participant last visit or other period as per local requirements. 

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11.6. 
Appendix 6: Liver Safety: Required Actions and Follow-up 
Assessments and Study Intervention 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 and required follow up assessments  
Liver Chemistry Stopping Criteria 
ALT-absolute 
ALT  8xULN 
ALT Increase 
ALT  5xULN but <8xULN persists for 2 weeks 
ALT  3xULN but <5xULN persists for 4 weeks 
Bilirubin1, 2 
ALT  3xULN and bilirubin  2xULN (>35% direct bilirubin)  
INR2  
ALT  3xULN and INR>1.5, if INR measured 
Cannot 
Monitor 
ALT  5xULN but <8xULN and cannot be monitored weekly for 2 weeks 
ALT  3xULN but <5xULN and cannot be monitored weekly for 4 weeks 
Symptomatic3 
ALT  3xULN associated with symptoms (new or worsening) believed to be related to 
liver injury or hypersensitivity 
Required Actions and Follow up Assessments 
Actions 
Follow Up Assessments 
• 
Immediately discontinue study intervention  
• 
Report the event to GSK within 24 hours 
• 
Complete the liver event CRF and complete an 
SAE data collection tool if the event also meets 
the criteria for an SAE2 
• 
Perform liver event follow up assessments  
• 
Monitor the participant until liver chemistries 
resolve, stabilize, or return to within baseline 
(see MONITORING below) 
• 
Do not restart/rechallenge participant with 
study intervention unless allowed per protocol 
and GSK Medical Governance approval is 
granted (See below) 
• 
If restart/rechallenge not allowed or not 
granted, permanently discontinue study 
intervention and continue participant in the study 
• 
Viral hepatitis serology4 
• 
Obtain INR and recheck with each liver 
chemistry assessment until the transaminases 
values show downward trend 
• 
Obtain blood sample for pharmacokinetic (PK) 
analysis and a blood sample for sBCMA, if it 
can be obtained within 70 days after last dose5 
• 
Serum creatine phosphokinase (CPK) and 
lactate dehydrogenase (LDH) gamma glutamyl 
transferase [GGT], glutamate dehydrogenase 
[GLDH], and serum albumin. 
• 
Fractionate bilirubin, if total bilirubin2xULN 
• 
Obtain complete blood count with differential to 
assess eosinophilia 
• 
Record the appearance or worsening of clinical 
symptoms of liver injury, or hypersensitivity, on 

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Liver Chemistry Stopping Criteria 
for any protocol specified follow up assessments 
MONITORING: 
If ALT 3xULN AND total bilirubin 2xULN or 
INR >1.5:  
  
• Repeat liver chemistries (include ALT, AST, 
alkaline phosphatase, bilirubin and INR) and 
perform liver event follow up assessments within 
24 hrs 
• 
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 <2xULN and INR 
1.5): 
• 
Repeat liver chemistries (include ALT, AST, 
alkaline phosphatase, bilirubin and INR) and 
perform liver event follow up assessments within 
24-72 hrs  
• 
Monitor participants weekly until liver chemistries 
resolve, stabilize or return to within baseline 
the AE report form 
• 
Record use of concomitant medications on the 
concomitant medications report form including 
acetaminophen, herbal remedies, other over 
the counter medications. 
• 
Record alcohol use on the liver event alcohol 
intake case report form (CRF) page 
If ALT 3xULN AND total bilirubin 2xULN 
or INR >1.5 obtain the following in addition to 
the assessments listed above  
• 
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 HPLC assay 
(quantifies potential acetaminophen 
contribution to liver injury in participants with 
definite or likely acetaminophen use in the 
preceding week [James, 2009]). NOTE: not 
required in China  
• 
Liver imaging (ultrasound, magnetic 
resonance, or computerised tomography) and 
/or liver biopsy to evaluate liver disease; 
complete Liver Imaging and/or Liver Biopsy 
CRF forms. 
• Liver biopsy may be considered and discussed 
with local specialist if available, for instance: 
o In patients when serology raises the 
possibility of autoimmune hepatitis (AIH) 
o In patients when suspected DILI 
progresses or fails to resolve on 
withdrawal of study intervention 
o In patients with acute or chronic atypical 
presentation:  
• 
If liver biopsy conducted complete liver biopsy 
form 
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  3xULN and bilirubin  2xULN. 
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  3xULN and bilirubin  2xULN (>35% direct bilirubin) or ALT  3xULN 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); and the threshold value stated will not apply to participants receiving 
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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; HBsAg and HBcAb; 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 or Hepatitis E RNA, For Hepatitis B patients, obtain Hepatitis B-DNA 
5. PK sample and associated sBCMA sample may not be required for participants known to be non-GSK comparator 
interventions.  Record the date/time of the PK/sBCMA blood sample draw and the date/time of the last dose of 
study intervention prior to PK/sBCMA 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.   

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Liver chemistry increased monitoring criteria with continued therapy 
Liver Chemistry Increased Monitoring Criteria – Liver Monitoring Event 
Criteria 
Actions 
 
ALT 5xULN and <8xULN and bilirubin 
<2xULN without symptoms believed to be 
related to liver injury or hypersensitivity, 
and who can be monitored weekly for 2 
weeks. 
OR 
ALT 3xULN and <5xULN and bilirubin 
<2xULN 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, 
bilirubin) until they resolve, stabilise 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 5xULN and <8xULN to 
≥3xULN but <5xULN, continue to monitor liver 
chemistries weekly.  
• 
If, after 4 weeks of monitoring, ALT <3xULN and 
bilirubin <2xULN, monitor participants twice monthly 
until liver chemistries normalize or return to within 
baseline. 
 

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11.7. 
Appendix 7: 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/Independent Ethics Committee (IRB/IEC) 
approval is obtained, if required and 
• Separate ICF for study intervention restart/rechallenge is signed by the 
participant and participant is informed of any associated risks 
 
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. 
11.7.1. 
Rechallenge Following Liver Stopping Events that are Possibly 
Related to Study Intervention 
Following drug-induced liver injury, 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 one 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 >2xULN with initial liver injury (direct bilirubin >35% of 
total) 
• ongoing severe liver injury defined by: ALT ≥3xULN, bilirubin ≥2xULN (direct 
bilirubin >35% of total), or INR>1.5 
• serious adverse event or fatality has earlier been observed with drug rechallenges 
[Hunt, 2010; Papay, 2009] 
• evidence of drug-related preclinical liability (e.g. reactive metabolites; 
mitochondrial impairment) [Hunt, 2010]. 
Rechallenge refers to resuming study intervention following study intervention 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 favourable. 
 
 

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Approval by GSK for rechallenge with study intervention can be considered where: 
• 
The Principal Investigator (PI) requests consideration of rechallenge with study 
intervention for a participant who is receiving compelling benefit with study 
intervention that exceeds risk, and no effective alternative therapy is available.   
• 
IRB/IEC approval for rechallenge with study intervention has been obtained.    
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 intervention 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 intervention.  Documentation of informed consent must be 
recorded in the study file.   
• 
Study intervention must be administered at the dose specified by GSK. 
• 
Participants approved by GSK for rechallenge with study intervention 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 intervention rechallenge, participant meets protocol-defined liver 
chemistry stopping criteria, study intervention should be permanently discontinued.  
• 
GSK Medical Director, and the IRB/IEC as required, must be informed of the 
participant’s outcome following study intervention rechallenge.  
• 
GSK to be notified of any adverse events.  
 
11.7.2. 
Restart Following Transient Resolving Liver Stopping Events Not 
Related to Study Intervention 
Restart refers to resuming study intervention 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 intervention restart can be considered where: 
• 
Principal Investigator requests consideration for study intervention 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 x baseline and ALT 
<3xULN). 

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• 
Possible study intervention-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 
intervention 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 intervention-related liver injury cannot be excluded, the guidance 
on rechallenge will apply. 
• 
There is no evidence of alcohol-related hepatitis. 
• 
IRB/IEC approval of study intervention restart must be obtained, as required. 
If restart of study intervention is approved by GSK in writing: 
• 
The participant must be provided with a clear description of the possible benefits and 
risks of study intervention administration, including the possibility of recurrent, more 
severe liver injury or death.   
• 
The participant must also provide signed informed consent specifically for the study 
intervention restart.  Documentation of informed consent must be recorded in the 
study file.   
• 
Study intervention must be administered at the dose specified by GSK. 
• 
Participants approved by GSK for restart of study intervention 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 
intervention restart, study intervention should be permanently discontinued.  
• 
GSK Medical Director, and the IRB/IEC must be informed of the participant’s 
outcome following study intervention restart.  
• 
GSK to be notified of any adverse events.  
 
 
 

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11.8. 
Appendix 8: Abbreviations and Trademarks 
Abbreviations 
ADA  
Anti-drug antibody 
ADC 
Antibody drug conjugate 
ADL 
Activities of Daily Living 
ADCC 
Antibody dependent cellular cytotoxicity 
ADCP 
Antibody-dependent cellular phagocytosis 
AE 
Adverse event 
AESI 
Adverse event of special interest 
ALT 
Alanine aminotransferase or Alanine transaminase 
ANC 
Absolute neutrophil count 
AST 
Aspartate aminotransferase or Aspartate transaminase 
AUC 
Area under the curve 
BCMA 
B cell maturation antigen 
BCVA 
Best corrected visual acuity 
BM 
Bone marrow 
BOR 
Best overall response 
BP 
Blood pressure 
BSEP 
Bile salt export pump 
C 
Cycle 
C1D1 
Cycle 1 Day 1 
CBR 
Clinical benefit rate 
cfDNA 
Cell free deoxyribonucleic acid 
CI 
Confidence interval 
CK 
Creatine kinase 
CL 
Clearance 
Cmax 
Maximum observed concentration 
CO2 
Carbon dioxide 
CO2CP 
Carbon dioxide combining power 
CR 
Complete response 
CTCAE 
Common Terminology Criteria for Adverse Events 
CT 
Computed tomography 
Ctau 
Trough concentration 
Ctrough 
Concentration at trough 
CV 
Cardiovascular  
CV% 
Percent coefficient of variation 
CYP 
Cytochrome P450 
cys-mcMMAF 
cysteine maleimidocaproyl monomethyl auristatin-F; 
CX 
Cycle and number (any, unspecified) 
DILI 
Drug induced liver injury 
DNA 
Deoxyribonucleic acid 
DOR 
Duration of response 
ECG 
Electrocardiogram 
CCI

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ECOG (PS) 
Eastern Cooperative Oncology Group (Performance Status) 
eCRF 
Electronic case report form 
eGFR 
Estimated glomerular filtration rate 
ER 
Endoplasmic reticulum 
EMA 
European Medicines Agency 
EMD 
Extramedullary disease 
EOI 
End of infusion 
EORTC IL52 
European Organisation for Research and Treatment of 
Cancer - Disease Symptoms domain of EORTC-QLQ-
MY20 
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 
EOS 
End of study 
EU 
European Union 
FDA 
Food and Drug Administration 
FISH 
Florescent in situ hybridization 
FLC 
Free light chain 
FSH 
Follicle stimulating hormone 
FTIH 
First Time in Human  
g 
Gram  
GSK 
GlaxoSmithKline 
GVHD 
Graft-Versus-Host Disease  
h 
Hour  
HBcAb 
Hepatitis B core antibody 
HBeAb 
Hepatitis B e antibody 
HBeAg 
Hepatitis B e antigen 
HBsAg 
Hepatitis B surface antigen 
HBV 
Hepatitis B virus  
HCV 
Hepatitis C virus 
HD 
High Dose Dexamethasone 
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 
ICH GCP 
International Conference on Harmonization Good Clinical 
Practice 
CCI
CCI

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IDMC 
Independent Data Monitoring Committee 
IEC 
Independent Ethics Committee 
IF 
Information fraction 
Ig 
Immunoglobulin 
IgA 
Immunoglobulin A 
IgG 
Immunoglobulin G 
IgG1 
Immunoglobulin G1 
IgM 
Immunoglobulin M 
IHC 
Immunohistochemistry  
IL-# 
Interleukin-# 
IMWG 
International Myeloma Working Group 
INR 
International normalization ratio 
IRC 
Independent Review Committee 
IRB 
Institutional Review Board 
IRR 
Infusion-related reaction 
IRT 
Interactive Response Technology 
ISS 
International Staging System 
IV 
Intravenous 
kg 
Kilogram 
KVA 
Keratopathy Visual Acuity 
z 
Terminal phase elimination rate constant 
L 
Liter 
LDH 
Lactate dehydrogenase 
LVEF 
Left ventricular ejection fraction 
mAb 
Monoclonal antibody 
mcL 
microliter 
mcMMAF 
maleimidocaproyl monomethyl auristatin-F; 
MD 
Medical director 
MDRD 
Modified Diet in Renal Disease 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
g 
Microgram 
uL 
Microliter 
min 
Minute  
mIU 
Milli-international unit 
mL 
Milliliter 
mm 
Millimeter 
MM 
Multiple myeloma 
MMAF 
Microtubular inhibitor monomethyl auristatin-F 
MOA 
Mechanism of action 
mOS 
Median overall survival 
MR 
Minimal response 
MRD 
Minimal residual disease 
MRI 
Magnetic resonance imaging 
MRP 
Multidrug resistance associated protein 
MSDS 
Material Safety Data Sheet 

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msec 
Millisecond  
MTD 
Maximum tolerated dose 
MUD 
Maximum utility dose 
NCI 
National Cancer Institute 
NCI-CTCAE 
National Cancer Institute- Common Toxicity Criteria for 
Adverse Events 
NCI-ODWG 
National Cancer Institute - Organ Dysfunction Working 
Group 
NE 
Not estimable 
NGS  
Next generation sequencing 
NIH 
National Institute of Health (in the United States) 
NK 
Natural killer (cell) 
nm 
Nanometer 
NR 
Not reported 
NYHA 
New York Heart Association 
OATP 
Organic-anion-transporting polypeptide 
ORR 
Overall response rate 
OS 
Overall survival 
OSDI 
Ocular Surface Disease Index 
OTC 
Over the counter 
OU 
Both Eyes 
PACT 
Post analysis continued treatment 
PCR 
Polymerase chain reaction 
PD 
Progressive disease 
PET 
Positron emission tomography 
PFS 
Progression-free survival 
PFS2 
Progression-free Survival on Subsequent Line of Therapy 
pg 
Picogram 
P-gp 
P-glycoprotein 
PI 
Principal Investigator 
PK 
Pharmacokinetic(s) 
pmol 
Picomole 
POEMS 
Polyneuropathy, organomegaly, endocrinopathy, 
monoclonal gammopathy, and skin changes 
pom/dex 
Pomalidomide plus Low-Dose Dexamethasone  
PRO-CTCAE 
Patient-Reported Outcome Version of the Common 
Toxicity Criteria for Adverse Events 
PR 
Partial response 
Q3W 
Every three weeks 
QID 
Four times a day 
QTc 
Corrected QT interval 
RCE 
Recurrent corneal erosion(s) 
RIBA 
Recombinant immunoblot assay 
RP2D 
Recommended Phase 2 Dose 
RNA 
Ribonucleic acid 
RO 
Receptor occupancy 

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RRMM 
Relapsed/refractory multiple myeloma 
SAE 
Serious adverse event 
SAS 
Statistical Analysis System 
sBCMA 
Soluble B cell maturation antigen 
sCR 
Stringent complete response 
sCRS 
Severe cytokine release syndrome 
SCT 
Stem cell transplant 
SD 
Stable disease 
SEB 
Staphylococcal enterotoxin B 
sec 
Second 
SoA 
Schedule of Activities 
SoC 
Standard of care 
SOC 
System organ class 
SOI 
Start of infusion 
SOP 
Standard Operating Procedure 
SPD 
Sum of the Products of the maximal perpendicular 
Diameters of measured lesions 
SPEP 
Serum protein electrophoresis 
SRM 
Study Reference Manual 
t1/2 
Terminal phase half-life 
tlast 
Last time point where the concentration is above the limit of 
quantification 
TLS  
Tumor lysis syndrome  
tmax 
Time to Cmax 
TNF 
Tumor necrosis factor 
TSH 
Thyroid stimulating hormone 
TTP 
Time to progression 
TTR 
Time to response 
UK 
United Kingdom 
ULN 
Upper limit of normal 
UPEP 
Urine protein electrophoresis 
US 
United States 
USA 
United States of America 
USP 
United States Pharmacopeia 
V 
Volume of distribution 
VGPR 
Very good partial response 
WBC 
White blood cell 
 
CCI

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Trademark Information 
Trademarks of the GSK group of 
companies 
 
Trademarks not owned by the GSK 
group of companies 
NONE 
 
IMNOVID 
 
 
MedDRA 
 
 
POMALYST 
 
 
PureVision 

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Grade 
Descriptions 
Source: Oken, 1982. 

CCI - This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected 
by third party copyright laws and therefore have been excluded.

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11.10. 
Appendix 10: Modified Diet in Renal Disease (MDRD) 
The MDRD formula for calculating the estimated glomerular filtration rate (eGFR) is as 
follows: 
eGFR = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) 
where, GFR is expressed in mL/min/1.73 m2, SCr is serum creatinine expressed in mg/dL, 
and age is expressed in years.  
The link below will auto-calculate the creatinine clearance:  
http://nephron.org/cgi-bin/MDRD_GFR/cgi 

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11.11. 
Appendix 11: NYHA Functional Classification System 
The New York Heart Association (NYHA) Functional Classification: Class I, II, III or IV 
Heart Failure [The Criteria Committee of the New York Heart Association (NYHA), 
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 
NYHA Functional Classification for Heart Failure 
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. 
Source: NYHA. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th Ed. Boston, 
MA: Little, Brown & Co. 1994. 253-256. 
 

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11.12. 
Appendix 12: Eye Care Specialist’s Qualifications and 
Requirements 
For examiners with a degree in optometry or ophthalmology, those involved in eye 
evaluations in the protocol must be able to provide comprehensive eye care to patients, 
ranging from routine check-ups to treatment and ongoing management of visual disease. 
This includes, as a minimum, the ability to perform the following activities:  
• Comprehensive eye exams  
• 
Visual acuity with manual refraction tests and analysis of results 
• Slit lamp tests and analysis of results  
• Intraocular pressure examination 
• Dilated fundoscopic examination 
• Diagnosis and treatment of ocular issues and diseases such as keratopathy or 
glaucoma 
Qualified eye care specialists, including optometrist, will also be able to communicate 
with patients on the effect of belantamab mafodotin on eye. 

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11.13. 
Appendix 13: 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 SoA (Section 2) and include:  
• History-taking to elicit signs and symptoms relevant to clinical features of 
multiple myeloma, and adverse events of study medications  
• Collection of blood and urine samples including:  
o Safety assessments which may include routine blood and urine 
sampling 
o PK and ADA specimen collection 
o Efficacy assessments to be sent to central lab 
o Biomarker, immunogenicity and genetic assessments 
o 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. Please refer to the SRM/lab manual for sample collection and storage 
requirements. 
• Measurement of vital signs (BP, heart rate, body temperature) and weight. 
• Delivery/Administration of oral study medication or direct to patient service 
• Identification and reporting of concomitant medications. 
• Dosing diary review for medication compliance. 
• The Home Health visit may be combined with Telemedicine visit with the PI 
(see below) 
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.  
It is strongly recommended that all participants should have at least one onsite visit per 
treatment cycle to also allow assessments that cannot be done via home health to be 
performed.  
The participant should be informed of any potential risks associated with Home 
Healthcare and sign a revised or additional Informed Consent Form if required. 
IRB/Ethics committee 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 Exam) 
Where applicable country and local regulations and infrastructure allow, protocol-
required eye exams 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 exams, must 
follow the schedule provided in the SoA (Section 2) and include:  
• Best corrected Visual Acuity (VA)*  
• Slit lamp exam  
• Tonometry   
• Ophthalmoscopy   
The participant should be informed of any potential risks associated with Home 
Healthcare Ophthalmologic exams and sign a revised Informed Consent Form if required. 
IRB/Ethics committee should be informed and/or approve of this change in approach and 
the process documented in study files. 
* Note: Pinhole can be used for assessment of BCVA at patient’s home when the 
examiner does not have the opportunity to perform refraction. Note: Rosenbaum pocket 
eye screener chart (i.e. near VA chart) should only be assessed if space doesn’t allow for 
distance-chart e.g. in participants’ home. 
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 Informed Consent Form if required. IRB/Ethics committee 
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 (PRO) Administration 
 Where applicable country and local regulations and infrastructure allow, remote PRO 
administration may be permitted.  Remote PRO administration is defined administration 
of protocol PROs by a qualified third party over the telephone. 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 Informed Consent Form if required. IRB/Ethics 
committee should be informed and/or approve of this change in approach and the process 
documented in study files. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11.14. 
Appendix 14: 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 to 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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11.15. 
Appendix 15: Country Specific Requirements 
Inclusion / Exclusion Criteria: 
• In 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 Germany, the following additional exclusion criteria applies:  Availability of a 
standard-of-care treatment that, in the Investigator’s opinion, represents a superior 
benefit-risk for the patient than participation in this clinical trial (e.g. triple-drug 
regimen). 
• In France, the following additional exclusion criteria applies:  Availability of a 
standard-of-care treatment that, in the Investigator’s opinion, represents a superior 
benefit-risk for the patient than participation in this clinical trial (e.g. anti-CD38 
containing regimen for a patient who has not been previously treated with anti-
CD38) 
• In Japan, Hepatitis B participants who are HBsAb+ are eligible for inclusion in 
this study if after assessing HBeAg, HBeAb, and HBV DNA, HBV DNA is 
undetectable. If a potential participant is 18 or 19 years of age, signed informed 
consent from the participants’ legally acceptable representative must be obtained, 
as well as from the participant himself/herself.  
• In China, Hepatitis B participants who are HBsAb+ are eligible for inclusion in 
this study if HBV DNA is undetectable.  
Adverse Events 
• For all studies conducted in China, SAEs will be collected from signing of the 
ICF and NOT from the start of treatment. 
Ocular Examinations 
• In France, all ocular examinations required per protocol will be conducted only 
by an ophthalmologist. 
Other Assessments: 
• In China, the following assessment with not be performed as a follow-up to 
bilirubin or INR meeting Liver Chemistry stopping criteria: Serum 
acetaminophen adduct HPLC assay. 
• In China, the following samples will not be collected: bone marrow biopsy 
sample for BCMA IHC, BM aspirate for exploratory endpoints, cfDNA and 
pharmacogenetic samples.  
• In China, MRD sample collection and assessment will not be performed until 
approval from OHGRA is obtained. 

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Contraception Guidance: 
Of the contraceptive methods defined in Table 26 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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CI

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11.16. 
Appendix 16: Protocol Amendment History  
The Protocol Amendment Summary of Changes table for the current amendment is 
located directly before the Table of Contents (TOC).  
Amendment 4: (20-Apr-2022) 
Overall Rationale for the Amendment:  
This protocol amendment is being introduced following the re-estimation of study 
completion timeframe based on the current rate of accrual of PFS events being slower 
than originally anticipated. 
This protocol amendment revises the power for PFS Final Analysis from 95.6% to at-
least 90%, allowing the PFS final analysis to be triggered when at least 151 events are 
accrued and the first 320 randomized subjects have been followed for a minimum of 4 
months, with an anticipated median follow-up of approximately 10 months by the time 
151 PFS events accrue.  
The PFS futility Interim Analysis is removed as this would coincide with the updated 
PFS Final analysis. 
The two interim and one final planned OS analyses remain unchanged.  
Section # and Name  
Description of Change  
Brief Rationale  
Section 1.1 Synopsis  
Revised the number of events required 
for PFS analysis 
Added clarification around post analysis 
continued treatment (PACT) phase and 
definition of end of study   
To support delivering PFS analyses projections 
within a reasonable timeframe  
To ensure patients benefiting from study 
treatment will be allowed to continue on study 
treatment after end of OS Follow-Up 
Section 1.2 Schema 
Added clarification around PACT phase To ensure patients benefiting from study 
treatment will be allowed to continue on study 
treatment after end of OS Follow-Up 
Section 2 Schedule of 
Activities  
Added clarification around PACT phase 
Updated clarification for disease 
assessment evaluation window 
 
Updated BM biopsy/aspirate collection 
requirements 
To ensure patients benefiting from study 
treatment will be allowed to continue on study 
treatment after end of OS Follow-Up  
To ease testing burden for sites  
To ease testing burden for sites and to align with 
program language  
Section 5.1 Overall Design  Added clarification around PACT phase 
and end of study   
Revised the number of events required 
for PFS analysis 
To ensure patients benefiting from study 
treatment will be allowed to continue on study 
treatment after end of OS Follow-Up and 
country-specific (expansion cohort) analyses 
To support delivering PFS analyses projections 
within a reasonable timeframe  
Section 5.4 End of Study 
Definition 
Added clarification around PACT phase 
and end of study   
To ensure patients benefiting from study 
treatment will be allowed to continue on study 
treatment after end of OS Follow-Up 
Section 7.7 Intervention 
Added clarification around PACT phase To ensure patients benefiting from study 

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Section # and Name  
Description of Change  
Brief Rationale  
after the End of OS Follow-
up 
and end of study   
treatment will be allowed to continue on study 
treatment after end of OS Follow-Up 
Section 8.1  Discontinuation 
of Study Intervention 
Replaced End of Study with End of OS 
follow-up 
Due to change in definition of End of Study 
Section 9.1 Efficacy 
Assessments 
Updated clarification for disease 
assessment evaluation window  
To ease testing burden for sites and to align with 
program language  
Section 9.3 Adverse Events 
and Serious Adverse 
Events 
Added clarification around PACT phase 
and end of study  
To ensure patients benefiting from study 
treatment will be allowed to continue on study 
treatment after end of OS Follow-Up 
Section 9.5 
Pharmacokinetics 
Added clarification that PK and 
accompanying sBCMA sample collection 
may be terminated when sufficient data 
have been collected 
To ease testing burden for sites 
Section 9.8 Biomarkers 
Updated BM biopsy/aspirate collection 
requirements 
Added clarification that PK and 
accompanying sBCMA sample collection 
may be terminated when sufficient data 
have been collected 
To ease testing burden for sites and to align with 
program language  
To ease testing burden for sites 
Section 9.9 Immunogenicity 
Assessments 
Added clarification that ADA sample 
collection may be terminated when 
sufficient data have been collected 
To ease testing burden for sites 
Section 10.2 Sample Size 
Determination 
Remove PFS IA  
Revision of power for PFS Final Analysis 
from 95.6% to at least 90%  
Revised the number of events and 
months of follow-up required for PFS 
analysis 
The new proposed PFS Final analysis will 
supersede the PFS futility Interim Analysis as 
the two analyses are expected to happen at 
about the same timeframe. 
To support delivering PFS analyses projections 
within a reasonable timeframe 
To support delivering PFS analyses projections 
within a reasonable timeframe   
Section 10.4 Statistical 
Analyses 
Revised the number of events and 
months of follow-up required for PFS 
analysis 
To support delivering PFS analyses projections 
within a reasonable timeframe  
Section 10.5 Planned 
Analyses  
Remove PFS IA 
Revised the number of events and 
months of follow-up required for PFS 
analysis 
The new proposed PFS Final analysis will 
supersede the PFS futility Interim Analysis as 
the two analyses are expected to happen at 
about the same timeframe. 
To support delivering PFS analyses projections 
within a reasonable timeframe  
Section 11.2 Appendix 2: 
Clinical Laboratory Tests 
Table 25: Added option regarding testing 
for Total CO2 or CO2CP 
Updated BM biopsy/aspirate collection 
requirements 
To allow flexibility based on local country 
practices 
To ease testing burden for sites and to align with 
program language  
 

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Amendment 3: (21-Oct-2021) 
Overall Rationale for the Amendment:  
The protocol amendment has been introduced to increase the global enrollment cap 
(limit) for patients who have received 3 prior lines from 40% to 55%. Due to the 
increasing use of pomalidomide and anti-CD38 antibodies in 3rd and 4th lines of therapy 
in relapsed/refractory multiple myeloma, the closure of the cap (meeting the limit) for 
participants with 3 prior lines has resulted in the slowing of patient enrollment into the 
study. There will be no change in the 40% global enrollment cap for participants with 
prior anti-CD38 treatment, as data in anti-CD38-naive patients are required to meet 
global evidence needs. There are no changes to overall statistical assumptions for this 
study.  
The removal of the North-East Asia enrolment cap will also support delivering 
recruitment projections within a reasonable timeframe. 
The Inclusion Criteria (IC) 4b has also been updated to align with the International 
Myeloma Working Group (IMWG) definition of refractory Multiple Myeloma. 
Section # and Name 
Description of Change 
Brief Rationale 
Section 1.1 Synopsis 
Increase in global enrollment cap for 
patients who have received ≤3 prior 
lines from 40% to 55% 
 
Updated definition of refractory 
Multiple Myeloma 
 
Removal of enrollment cap for North-
East Asia countries 
To deliver recruitment projections within a 
reasonable timeframe 
 
 
 To align with the International Myeloma 
Working Group (IMWG) definition of 
refractory Multiple Myeloma 
 
To support delivering recruitment projections 
within a reasonable timeframe 
Section 1.2 Schema 
Added expanded definition of 
refractory multiple myeloma in 
schematic 
To align with the International Myeloma 
Working Group (IMWG) definition of 
refractory Multiple Myeloma 
Section 2 Schedule of 
Activities 
Updated HBV-DNA and HCV-RNA 
assessments to include central testing 
 
To ease testing burden for sites 
Section 5.1 Overall 
Design 
Increase in global enrollment cap for 
patients who have received ≤3 prior 
lines from 40% to 55% 
 
Updated definition of refractory 
Multiple Myeloma 
 
Removal of enrollment cap for North-
East Asia countries 
To deliver recruitment projections within a 
reasonable timeframe  
 
To align with the International Myeloma 
Working Group (IMWG) definition of 
refractory Multiple Myeloma 
 
To support delivering recruitment projections 
within a reasonable timeframe 
Section 6.1 Inclusion 
Criteria 
Updated definition of refractory 
Multiple Myeloma  
To align with the International Myeloma 
Working Group (IMWG) definition of 
refractory Multiple Myeloma 
Section 9.9 
Immunogenicity 
Remove statement that ADA samples 
will be disposed of three months after 
To align with sample retention for sBCMA 
and PK samples 

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Section # and Name 
Description of Change 
Brief Rationale 
Assessments 
final approved results are provided to 
the Clinical Study Team  
Section 10.2 Sample 
Size Determination 
Removal of enrollment cap for North-
East Asia countries 
To support delivering recruitment projections 
within a reasonable timeframe 
Section 10.4 Statistical 
Analyses 
Remove secondary endpoints for 
mITT 
To align with Statistical Analysis Plan 
 
Amendment 2: (20-Sep-2021) 
Overall Rationale for the Amendment: 
The protocol was amended to update the planned Progression-Free Survival (PFS) futility 
interim analysis (IA) to be based on the first 120 randomized participants. Due to the fast 
enrollment rate, enrollment was expected to be near complete by the time of the 
originally planned PFS futility IA, and a large proportion of study participants would 
have insufficient follow-up at the time of this IA. The PFS data based on all participants 
enrolled at the time of the IA would therefore be immature. To support an informed 
decision-making process, the non-binding PFS futility IA was planned to be based on the 
first 120 randomized participants, anticipated to occur when approximately 69 events 
(~35% information fraction) were observed. It was anticipated that participants at the 
time of this revised IA would have minimum follow-up of ~4.5 months and the data was 
considered to be mature.  
An additional Overall Survival (OS) interim analysis was introduced to allow for the 
comprehensive reporting of all available information to the Agencies at the time of the 
primary analysis. Long-term survival data would continue to be collected beyond this 
interim analysis. 
 
The enrollment cap for North-East Asia countries was increased from 15% to 20% to 
support recruitment expectations in this region and to enable more patients who meet the 
eligibility criteria to potentially benefit from study participation. 
 
Per the FDA guidance that allows participants with Hepatitis B, Hepatitis C, and Human 
Immunodeficiency Virus to be enrolled into clinical trials where they can be monitored 
appropriately [FDA Guidance Docket Number: FDA-2019-D-0363], eligibility criteria 
was updated accordingly. 
 
Additional changes were incorporated which align with program revisions and/or updates 
based on the latest Investigator’s Brochure [GSK2857916 IB, GSK Document Number 
2013M17518_09, 2021]. 
 
 
 
 
 
Section # and Name 
Description of Change 
Brief Rationale 
Throughout 
Administrative updates to add 
Editorial changes were made for accuracy, 

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Section # and Name 
Description of Change 
Brief Rationale 
clarification and/or remove 
discrepancies 
clarity, conformity, flow, and typographical 
error corrections 
Section 1.1 Synopsis 
Updated definition of End of Study 
 
Increase in North East Asia enrollment 
cap from 15% to 20% 
 
 
 
Update of data collection information 
after the end of study 
To account for change in language around OS 
follow up 
 
To support recruitment expectations in this 
region and to enable more patients who meet 
the eligibility criteria to potentially benefit from 
study participation 
 
Decrease burden on patients and sites 
Section 2 Schedule of 
Activities 
Table 1, Table 2, Table 3, Table 4: 
Added clarification around testing for 
BCMA expression  
 
Table 3: Added optional genetic 
sampling along with requirement of 
separate informed consent 
 
Table 3 and Table 4: Added the row on 
‘Dispense/return medication diary’ and 
‘Return medication diary’ respectively 
 
Table 6 & Table 7: Added assessments 
for Hepatitis C and Hepatitis B  
Added per country request 
 
 
To clarify that BM biopsy is the preferred way 
to collect genetic sampling at PD 
 
 
To remind sites to have participants fill out 
medication diary. 
 
 
To support the change in hepatitis B and C 
eligibility criteria and align with FDA guidance  
Section 3.4.3 
Pharmacokinetics and 
Pharmacodynamics in 
Humans 
Update background information of 
belantamab mafodotin PK data 
To be consistent with updated information in 
the investigator’s brochure. 
Section 3.5.1 Risk 
Assessment 
Table 8: Update in explanation of risks   
To align with IB update 
Section 5.1 Overall 
Design 
Increase in North East Asia enrollment 
cap from 15% to 20% 
 
 
 
Update of data collection information 
after the end of study 
To support recruitment expectations in this 
region and to enable more patients who meet 
the eligibility criteria to potentially benefit from 
study participation 
 
Decreased burden on patients and sites 
Section 5.4 End of Study 
Definition 
Updated definition to End of Study 
 
 
Update of data collection information 
after the end of study 
To account for change in language around OS 
follow up 
 
Decrease burden on patients and sites 
Section 6.2 Exclusion 
Criteria 
Updated Hepatitis B virus (HBV) and 
Hepatitis C Virus (HCV) eligibility 
criteria 
To support the change in hepatitis B and C 
eligibility criteria and align with FDA guidance 
New Section 7.5.3 Drug 
Interactions 
Updated drug interactions information 
To clarify drug interaction information  
Section 7.6.2 Dose 
Modifications 
Table 13: Updated footnotes to provide 
further clarifications on keratopathy 
grading criteria 
 
Addition of criteria to re-baseline BCVA 
if participant has cataract surgery 
To align with program-wide language 
 
 
 
To support accurate assessment of 
belantamab mafodotin-associated change in 
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Section # and Name 
Description of Change 
Brief Rationale 
Section 7.7 intervention 
after the End of Study 
Update of data collection information 
after the end of study  
Decreased burden on patients and sites 
Section 8.3 Participant 
Discontinuation/Withdraw
al from the Study 
Added the responsibilities of site 
personnel on collecting survival data 
from public sources 
Provide clarity on collecting survival data 
Section 9.1 Efficacy 
Assessments 
Extend the allowance of PET CT from 
21 days to 42 days after MRD 
negativity results are available 
Alignment with program-wide language 
Section 9.3.1 Time Period 
and Frequency for 
Collecting AE and SAE 
information 
Update of SAE collection information 
after the end of study  
Decreased burden on patients and sites 
Section 9.3.6 Pregnancy 
Addition of pregnancy data collection 
information 
To align with program language 
New Section 9.3.8 
Management of Hepatitis 
B+ Participants 
Addition of guidelines for management 
of Hepatitis B+ Participants and 
Hepatitis B reactivation  
To reflect the change in hepatitis B eligibility 
criteria 
Section 9.5.1 Blood 
Sample Collection for 
Pharmacokinetics 
Table 18 & Table 19: Clarification on 
PK and sBCMA collection schedule 
Clarity of assessment schedule for sites 
Section 10.2. Sample size 
determination 
Addition of 40% Information fraction 
 
 
 
The percentage of global enrollment 
cap on North East Asia Countries has 
been updated to 20% from 15% 
Decision to add OS interim analysis to allow 
for the comprehensive reporting at the time of 
the primary analysis 
 
To support recruitment expectations in this 
region and to enable more patients who meet 
the eligibility criteria to potentially benefit from 
study participation 
Section 10.5. Interim 
Analyses 
The non-binding interim PFS futility 
analysis is to be performed based on 
the first 120 randomized participants, 
and when ~69 (~35% information 
fraction) events are observed in these 
120 participants 
 
Addition of an OS interim analysis at 
40% IF 
 
 
OS follow-up wording updated to add  
OS interim analysis at the time of PFS 
final analysis 
 
Table 25 Stopping Boundaries for OS is 
updated 
To ensure data for PFS futility IA is sufficiently 
mature. 
 
 
 
 
 
Decision to add OS interim analysis to allow 
for the comprehensive reporting at the time of 
the primary analysis 
 
To allow for long-term survival data to be 
collected in the event of a significant outcome 
at 2nd OS IA. 
 
Addition of 40% IF to reflect additional OS IA 
Section 11.2 Appendix 2: 
Clinical Laboratory Tests 
Table 26 Update safety laboratory tests 
Addition of Hepatitis B DNA in line with 
eligibility and with pomalidomide label update 
Section 11.6 Appendix 6 
Liver Safety: Required 
Actions and Follow-up 
Assessments and Study 
Intervention Rechallenge 
Guidelines 
Addition of assessments for HBV and 
HCV patients 
 
Updated the assessment table to support the 
change in hepatitis B and C eligibility criteria  
New Section 11.14 
Appendix 14 Data 
management/Monitoring 
To provide guidance on remote 
monitoring 
Alignment with program-wide language 

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Section # and Name 
Description of Change 
Brief Rationale 
Section 11.15 Appendix 
15: Country Specific 
Requirements 
Japan: Addition of serology of HBsAb+ 
from exemption from Hepatitis B 
exclusion criteria 
China: Addition of serology of HBsAb+ 
from exemption from Hepatitis B 
exclusion criteria 
Added per country request 
 
 
Added per country request 
New Section 11.16 
Appendix 16 Protocol 
Amendment History 
Documentation of previous Protocol 
Amendment changes and rationale 
As per protocol template 
 
Amendment 1: (23-Oct-2020) 
Overall Rationale for the Amendment: 
The protocol has been amended based on regulatory agency comments. Additional 
changes were incorporated which align with program revisions and/or updates based on 
data from the analysis of the Phase II Study 205678 (DREAMM-2) evaluating the 
efficacy and safety of two doses of belantamab mafodotin monotherapy in patients with 
relapsed or refractory multiple myeloma who had 3 or more prior lines of treatment, were 
refractory to a proteasome inhibitor and an immunomodulatory agent and have failed an 
anti-CD38 antibody. 
Section # and Name 
Description of Change 
Brief Rationale 
Throughout 
Update of contraception use timeframe 
to 6 months for males and 4 months for 
females post-last dose of belantamab 
mafodotin 
Updated to align with FDA guidance 
“Oncology Pharmaceuticals Reproductive 
Toxicity and Testing recommendations” and 
considering the half-life of belantamab 
mafodotin 
Throughout 
Updated role of Medical Monitor to 
Medical Director 
Company change in the terminology for 
description of the lead GSK physician 
Throughout 
Added qualified eye care specialist to 
wording related to ophthalmologist/ 
optometrist and referred to Appendix 12 
listing the required qualifications  
To ensure consistency in qualification for 
those completing the ocular examinations and 
to further outline the necessary qualifications.  
Throughout 
Addition of DREAMM 2 primary 
analysis publication reference; 
clarification of data 
Updated reference due to publication of data; 
Clarification that supporting data was from 
primary analysis 
Throughout 
Amended GSK2857916 to belantamab 
mafodotin 
To refer to product by name versus compound 
number 
Throughout 
Updated reference to belantamab 
mafodotin investigator brochure, 
POMALYST PI and Imnovid SmPC 
To refer to the most recent versions 
Throughout 
 
 
 
 
 
 
Throughout 
Minor editorial and document formatting 
revisions 
To improve overall clarity and typographical 
corrections 
Throughout 
Renumbering of Tables, Figures and 
Footnotes  
As a result of changes within the document  
Title Page 
Added Study Logo 
For easier recognition 
Section 1.1 Synopsis 
Updated study rationale paragraph 
 
 
To align with current program level wording 
based on additional data from DREAMM-2/ 
205678 study and in alignment with 
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Section # and Name 
Description of Change 
Brief Rationale 
 
 
Added EORTC QLQ-MY20 to HRQOL 
endpoint  
 
 
 
 
Increased global enrollment cap for of 
participants with ≤3 prior lines and 
added global enrollment cap for of 
participants with prior anti-CD38 
treatment 
 
Revised study treatment completion 
statement 
 
Added sub header for End of Treatment 
and End of Study; adjusted OS analysis 
statement  
 
Revision of analyses language in IDMC 
section 
Investigator brochure update 
 
To align with the implementation of EORTC 
QLQ-MY20 assessment for participants 
enrolled under the protocol amendment 
 
 
 
To align with change in MM treatment 
paradigm 
 
 
 
 
Clarification  
 
 
Clarification  
 
 
 
To simplify the wording in the synopsis 
Section 1.2 Schema 
Renamed Figure 1 and Added PFS2 
 
Added Figure 2: Treatment and 
Assessment Schema 
Clarification  
 
A visual aid for readers of the protocol 
Section 2 Schedule of 
Activities 
Table 1, Table 2 & Table 3 Updated 
screening period from 21 to 28 days, 
including imaging  
 
Table 1, Table 2 & Table 3: Moved 
optional genetic consent from Table 2 
and Table 3 to Table 1 
 
Table 1, Table 2 & Table 3: clarified 
which assessment are not required to 
be repeated on C1D1 if performed 
within 72h prior to dosing and removed 
‘X’ for screening assessment from 
C1D1 column that do not need to be 
repeated. 
 
Table 1, Table 2, Table 3 & Table 4: 
Footnote numbering and placement 
updated throughout the tables. 
Abbreviations updated 
 
Table 1 and Table 2: replaced 
footnotes with abbreviated instruction 
where assessment is not done at every 
visit  
 
Table 1: Added collection of Prior anti-
myeloma therapy data 
 
Increase flexibility for completion of Screening 
activities.  
 
 
To better reflect flow of activities 
 
 
 
For simplification and to avoid unnecessary 
repeat of assessments 
 
 
 
 
 
 
Due to the addition and removal of footnotes 
and for simplification of footnotes 
 
 
 
For clarification (e.g. Q6W for urinalysis, MRD 
only for biomarker analysis) 
 
 
 
To clarify that this data is collected 
 
 
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Description of Change 
Brief Rationale 
Table 1: Clarification of ‘questionable 
cases’ in pregnancy testing footnote 
 
Table 1, Table 2, Table 3 & Table 4: 
Combined Urinalysis, with Spot Urine 
and updated information about albumin/ 
creatinine analysis 
 
Table 1, Table 2, Table 3 & Table 4: 
Removed Assessment of Troponin, 
BNP and Echocardiogram  
 
Table 1, Table 2, Table 3 & Table 4:  
Updated and clarified imaging 
requirements: Removed ‘whole body’ 
wording. Clarified when follow-up 
imaging is and is not required and 
added a timeframe where applicable. 
Follow-up requirements for 
extramedullary disease moved to 
Section 9.1. 
 
Table 1, Table 2 & Table 3: Bone 
Marrow sample requirements: Updated 
specimen for BCMA expression; added 
collection time requirements, added 
analytical methods used and clarified 
use of remaining sample for biomarker 
research 
 
Table 2 & Table 3: Addition of 
statement that all visits are based of 
timing from C1D1  
 
Table 2 & Table 3: Added cycle lengths 
to header 
 
Table 2 & Table 3: Removed ‘X’ for 
Physical exam at Q3W visits 
 
Table 2, Table 3 & Table 4: Update to 
AE language and requirement to collect 
AE/SAEs for 70 days post last dose. 
 
Table 1, Table 2, Table 3 & Table 4: 
Revisions to Ocular exam wording, 
requirements and frequency 
 
Table 2, Table 3 & Table 4: Updated 
MRD follow-up and reduced frequency 
after 2 years. 
Table 2, Table 3 & Table 4: Added 
timeframe for imaging after negative 
MRD 
 
Table 2, Table 3 & Table 4: Updated 
Clarification  
 
 
Revision of program wording for Urinalysis and 
assessment of urine protein.  
 
 
 
Based on cardiac data from earlier studies, 
cardiac risk was determined to be low and 
routine monitoring was removed 
 
Whole body scan is not a requirement for 
imaging, and not mandated by the protocol. 
Added follow-up guidance to minimize need 
for exposure. Other changes were made to 
clarify requirements and simplify text.  
 
 
 
 
 
Specimen updated based on assay 
requirements. Other updates were made for 
clarity and simplification   
 
 
 
 
 
 
Added clarity to ensure visits occur as 
scheduled post first dose 
 
 
Clarification  
 
 
Not needed for response assessment, only 
considered necessary if dosing 
 
Alignment with program level language.  
 
 
 
 
Updated based on review of earlier study data 
and in consultation with ocular experts 
 
 
In line with IMWG Multiple Myeloma guidance 
 
Clarification 
 
 
 

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Section # and Name 
Description of Change 
Brief Rationale 
requirements on M-protein testing 
 
Table 2, Table 3 & Table 4: EORTC-
QLQ-MY20 will be implemented for 
participants enrolled under protocol 
amendment 1. 
 
Table 2: Changed header of treatment 
prophylaxis to Supportive Care and 
simplified footnote 
 
Table 3, Removal of infusion wording 
for Arm 2 
 
Table 3, Added timeframe and 
specimen requirements for subsequent 
pregnancy testing 
 
Table 4: Adjustment of timing for EOT 
visit  
 
Table 4: Addition of wording to clarify 
end of study 
 
 
Table 4, Note 25: Inclusion of EORTC 
IL53 during OS follow-up, and removal 
of wording after progression for timing 
 
Table 5: 
 
In line with IMWG Multiple Myeloma guidance 
 
To allow a more comprehensive evaluation of 
belantamab mafodotin  
 
 
 
To align with main body of protocol and for 
simplification 
 
 
Arm 2 is an oral product, thus did not apply 
 
 
Clarification 
 
 
 
Alignment with program language for EOT.  
 
 
Language added to clarify collection of OS 
data if final OS analysis occurs at interim OS 
analysis 
 
Align with program language with revisions to 
PRO plans. 
 
 
 
Section 3.1 Study 
Rationale 
Condensed results section and 
referenced to Section 3.4  
To avoid duplication of text within document 
 
Section 3.3 Antibody-
Drug Conjugate 
Belantamab Mafodotin 
Replacement of section with current 
program language 
Clarification on mechanism of action 
Section 3.4 Human 
Experience with 
Belantamab mafodotin 
Section amended with updated data 
from DREAMM-2/205678 study and in 
alignment with Investigator brochure 
update.  
New and updated data available. Sub headers 
added for better navigation. 
Section 3.5.1. Risk 
Assessment 
Revisions to wording of risks for 
Keratopathy, IRR, thrombocytopenia, 
other hematological effects, 
nephrotoxicity, pulmonary, other 
laboratory abnormalities, 
immunosuppression, fertility and data 
acquisition  
 
Removal of the risks of potential for 
cardiotoxicity related to inflammatory 
response and hepatotoxicity 
To align with current program level wording 
based on additional data from DREAMM-2/ 
205678 study and in alignment with 
Investigator brochure update. 
 
 
 
 
Based on a comprehensive review of the data 
from studies BMA117159 and 205678, the 
risks are considered closed. 
Section 4 Objectives 
 
 
Removal of ECGs from exploratory 
endpoint 
 
 
Added EORTC QLQ-MY20 to HRQOL 
endpoint  
Based on available data, cardiac risk was 
determined to be low and routine monitoring 
was removed 
 
To align with the implementation of EORTC 
QLQ-MY20 assessment for participants 
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Section # and Name 
Description of Change 
Brief Rationale 
 
 
Revision of Endpoint to exploratory 
Objective of Exploring the relationship 
between biologic characteristics and 
response 
 
Addition of pharmacogenetics Objective 
and Endpoint 
 
enrolled under the protocol amendment 
 
To summarize all analysis on all biological 
material collected 
 
 
 
Was omitted from the exploratory endpoints in 
the original protocol 
 
 
Section 5.1 Overall 
Design 
Updated wording of prior lines 
 
 
 
Increased global enrollment cap for of 
participants with ≤3 prior lines and 
added global enrollment cap for of 
participants with prior anti-CD38 
treatment 
Align with wording for Inclusion Criteria 
 
 
To align with change in MM treatment 
paradigm 
 
Section 5.2 Scientific 
Rationale 
Removed duplicated wording on 
DREAMM-1 results and referenced 
Section 3.4.1 instead. 
To simplify and ensure alignment within 
document 
Section 5.3.1 Belantamab 
Mafodotin – Arm 1 
Removed duplicated wording on 
DREAMM-1 results and referenced 
Section 3.4.1 instead. 
To simplify and ensure alignment within 
document 
Section 5.4 End of Study 
Definition 
Revision to number of deaths required 
for end of study 
 
 
 
Addition of language to ‘End of Study’ 
definition 
To clarify that end of study is also reached if 
final OS analysis occurs at interim OS 
analysis, however, in this case, OS data will 
continue to be collected 
 
Language added to clarify how end of study is 
determined if final OS analysis occurs at 
interim OS analysis 
Section 6.1 Inclusion 
criteria 
Inclusion Criteria #4b, removal of 
IMWG wording 
 
 
 
 
 
Removal of LVEF entry criteria and 
associated footnote 
 
 
Deleted Inclusion Criteria #10 from 
section 
The reference to the International Myeloma 
Working Group (IMWG) guidance for definition 
of disease progression has been removed to 
allow flexibility to accommodate differences in 
global standards in determining disease 
progression prior to study entry.  
 
Based on cardiac data from available studies, 
cardiac risk was determined to be low and 
entry criteria was removed 
 
Avoid redundancy; Country specific criteria are 
stated in Appendix 14 
Section 6.2 Exclusion 
criteria 
Removal of QT interval exclusion 
criteria 
 
 
Addition of corneal related exclusion 
criteria 
Based on available data, cardiac risk was 
determined to be low and entry criteria was 
removed 
 
Update to eligibility criteria to align with 
program language  
Section 6.3 Lifestyle 
New sub-header 6.3.1. contact lenses; 
Sub-headers are for easier navigation; change 
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Section # and Name 
Description of Change 
Brief Rationale 
Considerations 
Revision to wording for contact lens 
usage; New sub-header 6.3.2. for 
Tobacco; New sub-header 6.3.3 for 
other lifestyle considerations 
in contact lens use is aligned with revised 
program language to allow re-start based on 
physician review 
Section 7.1 Study 
intervention(s) 
administered 
Added day dose every 21 days for 
belantamab mafodotin 
 
Add footnote for 20mg pomalidomide 
dose 
Clarification  
 
 
Align with other sections of the protocol and 
label 
Section 7.1.1. Supportive 
Care Guidelines for 
Belantamab Mafodotin – 
Arm 1 
Revision of language to corneal events 
and use of steroid eye drops  
 
Removed duplicated exam language 
and referenced Section 9.2.6.1 instead 
Revision of program corneal language 
 
 
Simplification  
Section 7.1.2: Supportive 
Care Guidelines for 
Pom/Dex – Arm 2 
Created subsection for Pom/Dex 
Supportive Care 
For added clarity and easier navigation via 
Table of content 
Section 7.3 Measures to 
Minimize Bias 
Added that dosing should occur on 
same randomization call where 
possible 
 
Amended caps on stratification factors  
Clarification  
 
 
 
In line with Section 5.1 
Section 7.5. Concomitant 
Therapy 
Addition of requirements for 
Concomitant Therapy recording after 
End of Study treatment 
Calrification 
Section 7.5.2. Prohibited 
Medication (s) 
Replacement of Section with reference 
to Arm 2 for allowed steroid use 
 
Addition of live or live attenuated 
vaccines 
Clarification  
 
 
Addition of wording due to language 
associated with dexamethasone 
Section 7.6.2.1 
Belantamab mafodotin – 
Arm 1 
Revision of introductory wording 
 
Table 9: Revision of Recommendations 
for Serum Creatinine, Urine Dipstick, 
Thrombocytopenia, Febrile 
neutropenia, Neutropenia, and 
Pneumonitis.  
 
Table 10: Addition of new footnote to 
clarify action for dose delay 
 
Table 11: Revision of Table header and 
replaced table with corneal toxicities  
 
New Table 12: Dose modification 
guidelines based on toxicities assessed 
with Table 10 
Update to program language 
 
Update to program language.  
 
 
 
 
 
 
Update to program language  
 
 
Update to program language  
 
 
 
 
Update to program language 
Section 7.7. Intervention 
after the End of the Study 
Update to post-study treatment options 
language 
Updated language to align with program-level 
post-study treatment policy 
Section 8.1 
Discontinuation of Study 
Intervention 
Revision of options for participants who 
permanently discontinue study 
treatment 
 
Addition of language to OS follow-ups 
Clarification of statement  
 
 
 
To clarify collection of OS data if final OS 
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Description of Change 
Brief Rationale 
Section 8.2.1. Liver 
Chemistry Stopping 
Criteria 
Updated Algorithms Figure 4 and 
Figure 5 and additional reference made 
to Appendix 7 
In line with GSK update to liver chemistry 
stopping criteria and creation of Appendix 7 
Previous Section 8.2.2. 
QTc Stopping Criteria 
Removal of Section  
Based on available data, cardiac risk was 
determined to be low and stopping criteria 
were removed 
Previous Section 8.2.4. 
Left Ventricular Ejection 
Fraction (LVEF) Stopping 
Criteria  
Removal of section  
Based on available data, cardiac risk was 
determined to be low and routine monitoring 
was removed 
Section 8.2.3. Corneal 
Event Stopping Criteria  
Revision of header and language 
Update to program language 
Section 9 Study 
Assessments and 
Procedures 
Revision of Language. Visit window 
updates: Removal of Echocardiogram 
window; addition of ocular exam 
window. Added that dosing should 
occur on same randomization call 
where possible. Separated instructions 
for pregnancy testing at screening and 
post screening. 
Based on available data, cardiac risk was 
determined to be low and routine monitoring 
was removed; ocular window expanded for 
flexibility. Other changes were made for 
clarification 
Section 9.1 Efficacy 
Assessments 
Bone Marrow sample: added biopsy for 
screening, and biopsy or aspirate for 
disease response. Clarified when 
PET/CT is recommended for MRD 
negativity 
 
Added which assessment and sample 
will be collected for what clinical 
response 
 
Addition of language to clarify 
timeframe for disease assessments; 
additional wording to clarify length of 
intervention 
 
Added requirements for extramedullary 
disease assessment 
Change in sample type; high assay failure due 
to hemodilution in bone marrow aspirate.  
 
 
 
 
Clarification  
 
 
 
Clarification 
 
 
 
 
Clarification 
Section 9.2.3 
Electrocardiograms 
Removal of reference to QT withdrawal 
criteria (Section 8.2.2) 
Section 8.2.2 removed 
Previous Section 9.2.4. 
Echocardiogram 
Removal of section 
Based on available data, cardiac risk was 
determined to be low and routine monitoring 
was removed 
Section 9.2.5 Clinical 
Safety Laboratory 
Assessments 
Revision of timing of laboratory tests 
post last dose 
Revision of End of Treatment visit and 
associated collection of laboratory results 
Section 9.2.6. Ocular 
Examinations and 
Procedures 
Revision of language 
Update to program language 
Section 9.2.6.1. 
Treatment Arm 1 – 
belantamab mafodotin 
Revision of language 
Update to program language 
Section 9.2.7 Pregnancy 
Tests 
Updated pregnancy test language and 
follow-up period in arm 1 
Clarification and update to program language 

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Description of Change 
Brief Rationale 
Section 9.2.8 
Pomalidomide 
REMS/Pregnancy 
prevention/Controlled 
distribution program  
Added counselling requirements 
In alignment with REMS 
Section 9.3.1. Time 
Period and Frequency for 
Collecting AE and SAE 
information 
Update of timing for final collection of 
AEs and SAEs 
 
Rearrangement of paragraph 
Update to program language 
 
 
To separate country specific requirements 
from study requirements 
Section 9.3.3. Follow-up 
of AEs and SAEs 
Revision of AE collection period for AEs 
Revision of language to ensure all AEs, not 
just those of clinical interest, are followed until 
resolution 
Section 9.3.5. Adverse 
Events of Special Interest  
Revision of wording from corneal 
epithelium to corneal events 
Revision of program corneal language 
Section 9.3.6. Pregnancy 
Removal of duplicated language for 
data collection post pregnancy 
For clarification as all details are captured in 
Appendix 4 
Previous Section 9.3.8. 
Disease Related Events 
and/or Disease Related 
Outcomes Not Qualifying 
as SAEs 
Removal of section  
Revision based on program decision  
Section 9.4. Treatment of 
Overdose 
Revision of timeframe for monitoring 
and addition of sBCMA sample for 
related PK sample 
Revision of language and addition of sBCMA 
sample for PK samples 
Section 9.5.1 Blood and 
Sample Collection for 
Pharmacokinetics 
Revised enhanced PK population 
 
 
States that all samples will be tested 
regardless of dosing 
 
Revised who will perform analysis 
 
 
To ensure 25% of evaluable sample will be 
available 
 
Clarification 
 
 
Clarification 
 
 
Section 9.8 Biomarkers 
Addition of potential sample use for 
assay development and/or diagnostics 
test 
 
Bone Marrow sample: replaced 
aspirate with biopsy for BCMA 
expression sample; clarified aspirate for 
other testing 
Alignment with GSK scope of biomarker 
research 
 
 
Sample specification updated based on the 
intended assay  
 
Section 9.9. 
Immunogenicity 
Assessments 
Provided definition of ADA and updated 
who will perform analysis 
Clarification 
Section 9.11 Patient 
related Outcomes 
Added language to allow interviewer-
administered format 
For added flexibility 
 
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Section # and Name 
Description of Change 
Brief Rationale 
 
The full EORTC-QLQ-MY20 will be 
implemented for participants enrolled 
under protocol amendment 1. 
 
To allow a more comprehensive evaluation of 
belantamab mafodotin. For participant enrolled 
under the original protocol assessment of 
EORTC IL52 will continue. 
Section 10.2. Sample 
Size Determination 
Revision of calculations and wording 
Removal of PFS Efficacy Interim Analysis 
adjusted the calculations and wording 
Section 10.3 Populations 
for Analysis. 
Added Table header to existing Table 
 
 
For completeness  
 
 
 
Section 10.4.1. Efficacy 
Analyses 
Subgroup analysis correct from 
‘gender’ to ‘sex’ 
 
Table 18: Primary Endpoint, removal of 
piecewise HR; additional analysis 
language added 
 
 
Table 18: Key Secondary removal of 
250 death observation; additional 
analysis language added 
 
Table 18: TTP analysis not to be 
conducted with same approach as PFS 
analysis  
 
Table 18: MRD analysis moved from 
Exploratory to Secondary 
 
 
Table 18: removed MRD from derived 
analysis 
 
 
 
In alignment with demographic data collected 
 
 
No longer applies. Provide additional 
information regarding analysis rules and 
populations 
 
 
Clarification that death events do not apply to 
analyses; Provide additional information 
regarding analysis rules and populations 
 
Stringency of analysis not needed as TTP is 
secondary endpoint 
 
 
Correction 
 
 
 
Correction 
 
 
 
 
Section 10.4.2. Safety 
Analyses 
Added header and numbered safety 
analysis table  
 
Table 19: Revision of AE collection 
period 
 
Table 19: Removal of ECG and ECHO 
wording 
Clarification  
 
 
 
Revision of program language 
 
 
Assessments no longer apply 
Section 10.4.4.3. 
Pharmacokinetic/ 
Pharmacodynamic 
Analyses 
Revision of wording from corneal 
epithelium to corneal events 
 
Moved paragraph of North East Asia 
PK analysis from Section 10.4.4.3 to 
Section 10.4.4.2 
Revision of program corneal language 
 
 
Correction 
Section 10.5. Interim 
Table 20: Revision of Table  
Internal decision to remove this interim 
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Section # and Name 
Description of Change 
Brief Rationale 
Analyses 
 
 
 
 
 
 
Table 20: Removal of PFS Efficacy 
information and Cumulative alpha 
spend  
 
Primary Endpoint wording adjusted to 
account for removal of PFS Efficacy 
analysis 
 
 
Key Secondary Endpoint: Addition of 
references to explain hierarchical 
testing; revision of stopping criteria 
during OS analyses; revision to Table 
21 and Table 22 
analysis following regulatory agency 
comments.  
 
Revision of table to account for removal of 
PFS Efficacy interim analysis 
 
 
Revision to account for removal of PFS 
Efficacy interim analysis 
 
 
 
Clarifications added based on regulatory 
agency feedback 
 
Section 10.5.1 IDMC 
Addition of safety review timings 
Clarification 
Section 11  
Moved Section of Supporting 
Documents in front of Reference 
Section 
GSK standard 
Section 11.1.7 Appendix 
1: Data Quality 
Assurance 
Updated Record retention section  
GSK update to record retention 
Section 11.2 Appendix 2: 
Clinical Laboratory Tests 
Updated pregnancy testing interval and 
clarified specimen 
 
Table 23: Revision of urinalysis 
wording; removal of Troponin and BNP 
and associated footnote  
 
Table 23 Updated Biomarker and 
optional testing sections 
Revision of program language 
 
 
Update based on safety recommendations for 
program 
 
 
Clarification which sample is used for 
biomarker research 
Section 11.3.4. Recording 
and Follow-up of AE and 
SAE 
Update of NCI-CTCAE version 
Correction of Version from 4.03 to 5.0 due to 
error in original protocol 
Section 11.4.2. Appendix 
4: Contraception 
guidance 
Added risk of fetal harm for belantamab 
mafodotin 
 
Table 24: Added that local requirement 
must be followed if stricter 
Clarification  
 
 
Clarification 
Section 11.4.3. Collection 
of Pregnancy Information 
Added that pregnant female partner 
follow-up occurs during pregnancy and 
after delivery 
 
For arm 1: updated follow-up period for 
pregnancy information of female 
partner 
 
For Arm 2, per requirements associated 
with Arm 2, follow-up of infant is to be 1 
year 
Clarification 
 
 
 
Revision of program language  
 
Addition of information per pomalidomide 
supplier requirements 
Section 11.6 Appendix 6 
Liver Safety: Required 
actions and Follow-up 
Assessments and Study 
For reference PK sample, a sBCMA 
sample to be collected and timeframe 
for collection updated and associated 
footnotes 
Revision of program language 
 
 
 

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Section # and Name 
Description of Change 
Brief Rationale 
intervention Rechallenge 
Guidelines 
 
Added headers for different criteria 
requiring different monitoring and 
follow-up; Added collection of GGT, 
GLDH and serum albumin to follow-up 
assessment; Added guidance on liver 
biopsy requirements 
 
GSK requirement 
Section 11.7, Appendix 7: 
Liver Safety Drug Restart 
or Rechallange 
Guidelines 
New Appendix 
Added to inform about the process after liver 
event as described in Appendix 6 occurred 
Section 11.12 Appendix 
12: Eye Care Specialist’s 
Qualifications and 
Requirements 
New Appendix to define the 
qualification and requirements -
ophthalmologists, optometrists and eye 
care specialists  
To ensure consistency in qualification for 
those completing the ocular examinations  
Section 11.13 Appendix 
13: Home Healthcare and 
Telemedicine Approaches 
New Appendix to allow Home 
Healthcare and Telemedicine 
Approaches 
To allow flexibility in study conduct 
Section 11.14 Appendix 
14: Country Specific 
Requirements 
Addition of statement applicable to 
France that only ophthalmologists are 
to be utilized 
 
Included country specific amendments 
issued for the original protocol and still 
applicable in the protocol amendment 1 
for Japan and China 
 
Addition of country specific exclusion 
criteria for Germany and France 
 
Addition of MRD sample requirements 
for China 
Added per regulatory agency’s request 
 
 
 
For completeness 
 
 
 
 
Added per regulatory agency’s request 
 
 
To ensure OHGRA approval is obtained prior 
to MRD sample collection 
 
Section 12 References 
Moved reference section to end of 
protocol 
 
Added new references used in the 
updated Sections and updated IB 
version and Year 
GSK standard 
 
 
 
 
For completeness 
 
CCI
CCI

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12. 
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