A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Phase: PHASE2
Conditions: Multiple Myeloma
Sponsor: Pfizer

PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 1 
 
Elranatamab 
Protocol C1071009 
Final Protocol Amendment 4, 20 Dec 2023 
 
 
 
 
 
MAGNETISMM-9 
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE A DOSING 
REGIMEN WITH TWO STEP-UP PRIMING DOSES AND LONGER DOSING 
INTERVALS OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN 
PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA 
 
 
Study Intervention Number: 
PF-06863135 
Study Intervention Name: 
Elranatamab 
US IND Number: 
133,940 
EudraCT Number: 
2021-001371-16 
ClinicalTrials.gov ID: 
NCT05014412 
Protocol Number: 
C1071009 
Phase: 
1 /2 
Sponsor Legal Address 
Pfizer Inc. 
66 Hudson Boulevard East 
New York, NY 10001 
Brief Title: A Study to Learn About the Study Medicine (Elranatamab) in Participants 
With Multiple Myeloma That Has Come Back After Responding to Treatment or Has 
Not Responded to Treatment 
 
 
 
This document and accompanying materials contain confidential information belonging to Pfizer. Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified. 

Eh-anatamab 
Protocol Cl071009 
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ro ·run-level u dates and eh-anatainab dosin 
 
Document History 
 
Document 
Version Date 
Amendment4 
20 Dec 2023 
Amendment3 
22Nov2022 
Amendment2 
10 June 2022 
Amendment 1 
09 Jun 2021 
Original orotocol 
28 March 2021 
 
This amendment inco1porates all revisions to date, including amendments made at the 
request of countiy health authorities and IRBs/ ECs and any protocol administl'ative 
clarification letter(s). 
Protocol Amendment Summary of Changes Table 
Amendment 4 (20 Dec 2023) 
Overall Rationale for the Amendment: 
The rima1 rationale for this amendment is to remove Pait 3 of the study 
 
 due to the evolving multiple myeloma ti·eatment 
landscape. As communicated to investigators via a letter dated 24 March 2023, the Sponsor's 
decision to no longer conduct Pait 3 of the study was not due to any safety issues or 
concerns. Some changes have been made to the infection prophylaxis guidance to align with 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
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Description of Change 
Brief Rationale 
Section # and Name 
Substantial Modification(s) 
Removed any mention of 
previously planned Study 
Pait 3 throughout the 
protocol, updated title page 
(Study title and brief title), 
study schematic, removed 
Pait 3 SoA, edited 
exclusion criterion #13 
related to 
removed 
figure 2 from Section 6, 
updated statistical section 
related to Pait 3. 
To reflect the Sponsor's 
decision to no longer 
conduct Study Pait 3 due to 
the evolving multiple 
myeloma treatment 
landscape. 
Title page (Study title and 
brief title), Section 1.1: 
Synopsis, Section 1.2: 
Schema; Section 1.3: SoAs, 
Section 2.1: Study Rationale, 
Section 2.2.1: Multiple 
Myeloma (Table 3), Section 
2.2.3.2: Clinical Overview 
(Sections 2.2.3.2.1 2.2.3.2.2 
and 2.2.3.2.3 
Benefit/Risk Assessment, 
Section 2.3.1: Risk 
Assessment, Section 2.3.2: 
Benefit Assessment, Section 
3: Objectives, Endpoints And 
Estimands, Section 4.1: 
Overall Design, Section 4.2: 
Scientific Rationale for Study 
Desi 
Section 4.3.3: 
 
5.2: Exclusion criteria 
(exclusion criterion #13), 
Section 6: Study 
intervention(s) and 
Concomitant Therapy, 
Section 6.1: Study 
futervention s) Administered, 
 (Figure 2), 
Section 6.3.1: Allocation to 
Study futeivention, 6.5.1.2: 
Dose Modifications for 
Ehanatamab-Related Toxicity 
and for Peripheral 
Neuro ath 
Section 6.7: Treatment of 
Overdose, Section 6.8.1: 

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Protocol Cl071009 
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Description of Change 
Brief Rationale 
Section # and Name 
Premedications Required for 
C  okine Release Syndrome, 
Section 8.6: 
B10mar ers, Section 8.6.8: 
B le for MRD (Pait 
2_, Section 9: 
Statistical Considerations 
(Sections 9.1, 9.2, 9.3, 9.4 
and 9.5 
- Pait 1: removed option to 
return to 76 mg QW dosing 
To remove the options to 
retmn to more frequent 
Section 1.1: Synopsis 
(Overall Design), Section 1.3: 
after staiting 76 mg Q2W 
from C7 onwai·ds and 
removed option to return to 
dosing (QW or Q2W) after 
staiting Q2W or Q4W 
dosing, as suppo1ted by 
SoA Pait 1, Section 4.1: 
Overall Design 
152 mg Q2W dosing after 
staiting 152 mg Q4W from 
C7 onwards (after RP2D 
mechanistic model 
simulations and expected 
reduction in disease burden. 
was detennined) 
- Pait 2A DL2, Pait 2B and 
Pait 2C: removed option to 
return to 152 mg Q2W 
dosing after staiting 152 
mg Q4W from C7 onwards 
 
 
 
 
 
 
 
 
 
 
 
- Added pre-dose SARS- 
CoV-2 testing (at CXDl) 
- For pa1ticipants with 
SARS-CoV-2 infection, 
study intervention should 
be delayed for at least 14 
days from the strut of 
symptoms or positive test 
result. 
To avoid dosing paiticipants 
while an infection is 
ongomg. 
Section 1.3: SoAs Pait 1 and 
Pait 2, Section 6.8.8: 
COVID-19, Section 10.2: 
Appendix 2- Clinical 
Laborato1y Assessments, 
Section 10.15: Appendix 15- 
Anti-infectious Prophylaxis 
and Monitoring 

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Description of Change 
Brief Rationale 
Section # and Name 
- Edited text to clarify 
administrntion route for 
immunoglobulins 
- Require (instead of 
recommend) the use of PJP 
prophylaxis and antiviral 
prophylaxis 
- Added one column 
''Required/recommended" 
in Appendix 15 
To clarify and align with 
program level infection 
guidance 
Section 6.8.7- Infection 
Prophylaxis, Section 10.15: 
Appendix 15- Anti-infectious 
Prophylaxis and Monitoring 
- Added that RP2D was 
selected after Pait 2A to be 
To info1m about the current 
study status at time of 
Section 1.1: Synopsis, 
Section 4.1: Overall Design, 
152 mg Q2W, that the 
rotocol amendment 4 and 
Section 4.3.4: Defmition of 
emollment is completed in 
RP2D for Pait 2B and Pait 1 
all coho1ts and that Part 2C 
FromC7 
- Updated the dose 
To align with program level 
Section 6.5.1.2- Dose 
modification rnles in case 
guidance and suppo1ted by 
 Modifications for 
of intenuption > 4 weeks 
 mechanistic model 
 Eh-anatamab-Related Toxicity 
(if on Q2W dosing) or >8 
simulations 
and for Peripheral 
weeks (if on Q4W dosing) 
Neuropathy 
or>12weeks (if on Q8W 
dosing) 
- Conected the guidance 
for QW and Q2Wre 
window± 3 da s 
m case 
eh-anatamab cannot be 
administered on the 
planned window (window 
± 6 days) 
- Clarified guidance 
regarding toxicity 
mana ement 
- Revised eh-anatamab 
- To align with updated 
Sections 1.3: SoAs Pait 1 and 
contraception requirements 
eh-anatamab PK data as 
 Pali 2, Section 4.2.3: Choice 
WOCBP and men : 
 described in last 
of Contrace tion/BaiTier 

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Protocol Cl071009 
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Description of Change 
Brief Rationale 
Section # and Name 
Clarification for 
investigators via a letter 
dated 01 Febmaiy 2023. 
eh-anatamab IB (WOCBP), 
to align with calculated 
safety mai·gin between 
Requirements, Section 5.3.1 
Contraception, Section 10.4: 
Appendix 4- Contraceptive 
- Added the sentence: "The 
investigator or designee 
will advise the paiiicipant 
to seek advice about the 
seminal transfer and 
estimated MABEL (men) 
and to align with latest 
protocol template 
and BaiTier Guidance 
(Sections 10.4.1, 10.4.2 and 
10.4.4). 
donation and 
c1yopreservation of ge1m 
- To align with program 
level guidance 
cells prior to the staii of 
study intervention, if 
a licable. " 
Non-substantial Modification(s) 
- Revised eh-anatamab 
clinical study smnmai·ies, 
refen-ing protocol users to 
the IB for the most cmTent 
info1mation 
- Added rationale for the 
risk of infections with 
eh-anatamab in RRMM 
aiiici ants 
To align with latest IB 
updates 
Section 2.2.3.2: Clinical 
Overview, Section 2.3.1: Risk 
Assessment 
Added that at the start of a 
cycle, pa1iicipant should 
have recovered from any 
To avoid dosing paiiicipants 
while an infection is 
ongomg 
Section 6.5.1.1: Redosing 
Criteria 
lung infection or other 
serious infection to 
baseline 
Sections 1.3: SoAs Pa1i 1 and 
Pali2 
Physical Exam, 
Nemologic Exam, Vital 
Signs ai·e to be perfo1med 
2 c des 
and PK sainples that 
samples should be 
coll 

Eh-anatamab 
Protocol Cl071009 
Final Protocol Amendment 4, 20 Dec 2023 
PFIZER CONFIDENTIAL 
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Description of Change 
Brief Rationale 
Section # and Name 
(only for pa1ticipants 
ah-eady dosed with 152 mg 
4 
Revised the guidance for 
To align with program level 
Section 6.5.1.2- Dose 
Grade 3 PN in case of 
guidance 
Modifications for 
initial occmTence and 
Ehanatamab-Related Toxicity 
recunent episode 
and for Peripheral 
Neuro ath  - Table 6 
 
 
 
 
 
 
 
Added more detailed 
descriptions for when 
sennn FLC should be used 
to assess disease response 
and about repeat sampling 
for confmnation of disease 
To better match descriptions 
in Section 10.10 (Appendix 
10) 
8.1.1. Laborato1y Assessment 
for Evaluation of Disease 
Response 
ro ·ess1on 
 
Added that only ADA 
positive samples will be 
tested for NAb 
Removed that the study 
team should be notified 
when treatment is restaited 
after SARS-CoV-2 
s 
toms have recovered 
Clarification of 
requirement for 
investigator adherence to 
European regulation 
536/2014 and European 
Medical Device Regulation 
2017/745. 
- Clarification that a 
paiticipant's legally 
authorized representative 
can sign a statement of 
info1med consent and can 
be rovided with a co 
of 
To add clarity on the NAb 
samples that will be 
anal zed 
To align with program level 
guidance 
 
 
 
To comply with cunent 
regulations 
 
 
 
 
 
To comply with cunent 
regulations 
Section 9.3.3.4. 
Immunogenicity Analyses 
 
Section 10.8.4. Study 
Intervention 
 
 
 
Section 10.1.1: Appendix l- 
Regulato1y and Ethical 
Considerations 
 
 
 
 
Section 10.1.3: Appendix l- 
Info1med Consent Process 
 

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Elranatamab 
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Description of Change 
Brief Rationale 
Section # and Name 
the ICD(s) only if allowed 
by local regulations. 
- Clarification that 
documents used to 
reconsent participants or 
their legally authorized 
representative must be 
IRB/EC-approved, as 
required per local 
regulations. 
Added information on 
security measures and 
associated SOPs for 
information technology 
systems used to collect, 
process, and store study- 
related data 
Added information on 
security measures and 
associated SOPs for 
information technology 
systems used to collect, 
process, and store study- 
related data 
Section 10.1.4: Appendix 1- 
Data Protection 
- Addition of CTIS and 
public websites to the 
locations where Pfizer 
discloses clinical study 
results. 
- Clarification that Pfizer 
posts CSR synopses and 
plain-language study 
results summaries on 
www.pfizer.com and that 
CSR synopses will have 
personally identifiable 
information anonymized 
- Clarification that Pfizer 
complies with applicable 
local laws/regulations to 
publish clinical documents 
included in marketing 
applications, with 
specification of the 
document types. 
- Clarification that CSRs 
provided to researchers as 
part of data sharing will 
have personally 
To comply with current 
regulations 
Section 10.1.6: Appendix 1- 
Dissemination of Clinical 
Study Data 

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Eh-anatamab 
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Description of Change 
Brief Rationale 
Section # and Name 
identifiable info1mation 
anon 
·zed. 
- Clarification that 
monitoring details are 
provided in the data 
management plan and 
monitoring plan 
maintained and utilized by 
the sponsor or designee. 
- Clarification that the 
investigator must provide 
direct access to source 
records and documents 
To comply with cunent 
regulations 
Section 10.1.7: Appendix 1- 
Data Quality Assurance 
- Updated the definition of 
the study sta1t date to be 
the date of the first 
paiticipant's first visit. 
- Updated some reasons at 
the sole discretion of the 
sponsor to close the study 
site or te1minate the study 
at an time 
To comply with cunent 
regulations 
Section 10.1.9: Appendix 1- 
Study and Site Stait and 
Closure 
Updated the publication 
policies for study 
investigators and for 
Pfizer. 
To comply with cunent 
regulations 
Section 10.1.10: Appendix I - 
Publication Policy 
Removed Tocilizumab 
from study intervention 
Since the use of tocilizumab 
for CRS induced by anti- 
cancer treatment was 
approved in Japan, it is no 
longer IMP and there is no 
need of safety reporting in 
Japan 
Section 10.14.1: Appendix 
14- Japan 
 
Minor administrative, 
editorial, typographical, or 
fo1matting changes. 
U dated list of 
Updated for grammatical 
Global 
conectness, consistency, 
and/or clarity. 

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Protocol C1071009 
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Description of Change 
Brief Rationale 
Section # and Name 
abbreviations. Added new 
references 

Elranatamab 
Protocol C1071009 
Final Protocol Amendment 4, 20 Dec 2023 
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TABLE OF CONTENTS 
LIST OF TABLES ................................................................................................................... 18 
LIST OF FIGURES .................................................................................................................. 19 
1. PROTOCOL SUMMARY ................................................................................................... 20 
1.1. Synopsis ................................................................................................................... 20 
1.2. Schema .................................................................................................................... 32 
1.3. Schedule of Activities .............................................................................................. 33 
1.3.1. Part 1 Schedule of Assessments .................................................................. 33 
1.3.2. Part 2 Schedule of Assessments .................................................................. 49 
2. INTRODUCTION ................................................................................................................ 66 
2.1. Study Rationale ........................................................................................................ 66 
2.2. Background .............................................................................................................. 66 
2.2.1. Multiple Myeloma ...................................................................................... 66 
2.2.2. BCMA and CD3 ......................................................................................... 67 
2.2.3. Elranatamab (PF-06863135) ....................................................................... 68 
2.2.3.1. Nonclinical Studies of Elranatamab .......................................... 68 
2.2.3.2. Clinical Overview ...................................................................... 68 
2.3. Benefit/Risk Assessment ......................................................................................... 69 
2.3.1. Risk Assessment ......................................................................................... 70 
2.3.2. Benefit Assessment ..................................................................................... 74 
2.3.3. Overall Benefit/Risk Conclusion ................................................................ 74 
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS ............................................................ 75 
4. STUDY DESIGN ................................................................................................................. 76 
4.1. Overall Design ......................................................................................................... 76 
4.2. Scientific Rationale for Study Design ..................................................................... 80 
CCI 
 
4.2.2. Diversity of Study Population ..................................................................... 81 
4.2.3. Choice of Contraception/Barrier Requirements .......................................... 82 
CCI 
 
4.3. Justification for Dose ............................................................................................... 82 
4.3.1. Justification for the 2 Step-up Priming Doses Regimen ............................. 82 

Elranatamab 
Protocol C1071009 
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4.3.2. Justification for Evaluation of Higher Elranatamab Doses ......................... 84 
4.3.3. Definition of DLT (Part 2A and Part 2C) ................................................... 84 
4.3.4. Definition of RP2D for Part 2B and Part 1 From C7 .................................. 86 
4.3.5. Dose Level in Part 2C ................................................................................. 86 
4.4. End of Study Definition ........................................................................................... 86 
5. STUDY POPULATION ...................................................................................................... 86 
5.1. Inclusion Criteria ..................................................................................................... 87 
5.2. Exclusion Criteria .................................................................................................... 88 
5.3. Lifestyle Considerations .......................................................................................... 90 
5.3.1. Contraception .............................................................................................. 90 
5.4. Screen Failures ........................................................................................................ 91 
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY .................................. 91 
6.1. Study Intervention(s) Administered ......................................................................... 91 
6.1.1. Elranatamab ................................................................................................ 93 
6.2. Preparation, Handling, Storage and Accountability ................................................ 94 
6.2.1. Preparation and Dispensing ........................................................................ 95 
6.3. Measures to Minimize Bias: Randomization and Blinding ..................................... 95 
6.3.1. Allocation to Study Intervention ................................................................. 95 
6.4. Study Intervention Compliance ............................................................................... 96 
6.5. Dose Modification ................................................................................................... 97 
6.5.1. Elranatamab ................................................................................................ 97 
6.5.1.1. Redosing Criteria ....................................................................... 97 
6.5.1.2. Dose Modifications for Elranatamab-Related Toxicity and 
for Peripheral Neuropathy .................................................................. 97 
6.5.1.3. Dose Reductions ...................................................................... 100 
6.6. Continued Access to Study Intervention After the End of the Study .................... 100 
6.7. Treatment of Overdose .......................................................................................... 100 
6.8. Concomitant Therapy ............................................................................................ 101 
6.8.1. Premedications Required for Cytokine Release Syndrome ...................... 101 
6.8.2. Permitted Concomitant Medications/Therapies ........................................ 101 
6.8.3. Prohibited During the Study ..................................................................... 102 
6.8.4. Supportive Care......................................................................................... 102 
6.8.5. Transfusion Support ................................................................................. 102 
6.8.6. Hematopoietic Growth Factors ................................................................ 103 

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6.8.7. Infection Prophylaxis ................................................................................103 
6.8.8. COVID-19 ................................................................................................ 103 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ......................................................................... 104 
7.1. Discontinuation of Study Intervention ...................................................................104 
7.1.1. Potential Cases of Acute Kidney Injury ....................................................105 
7.2. Participant Discontinuation/Withdrawal From the Study ......................................106 
7.2.1. Withdrawal of Consent ............................................................................ 106 
7.3. Lost to Follow-Up ................................................................................................ 107 
8. STUDY ASSESSMENTS AND PROCEDURES ............................................................ 107 
8.1. Efficacy Assessments ........................................................................................... 108 
8.1.1. Laboratory Assessment for Evaluation of Disease Response .................. 108 
8.1.2. Bone Marrow Sample Assessments for Evaluation of Disease Status..... 110 
8.1.3. Imaging Assessments (PET/CT, CT and/or MRI) ....................................110 
8.1.4. Disease Characteristics and Treatment History ....................................... 111 
CCI 
 
8.2. Safety Assessments ............................................................................................... 113 
8.2.1. Participant Demographics and Other Baseline Characteristics ................ 113 
8.2.2. Physical Examinations ............................................................................. 113 
8.2.3. Vital Signs ................................................................................................ 114 
8.2.4. Electrocardiograms ................................................................................... 114 
8.2.5. Echocardiograms/Multigated Acquisition Scans ......................................115 
8.2.6. Clinical Safety Laboratory Assessments .................................................. 115 
8.2.7. Pregnancy Testing .....................................................................................116 
8.2.8. ECOG Performance Status....................................................................... 116 
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting ................116 
8.3.1. Time Period and Frequency for Collecting AE and SAE Information .....117 
8.3.1.1. Reporting SAEs to Pfizer Safety ............................................ 118 
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF ................ 118 
8.3.2. Method of Detecting AEs and SAEs ........................................................ 118 
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8.3.3. Follow-Up of AEs and SAEs .................................................................... 118 
8.3.4. Regulato1y Repo1ting Requirements for SAEs ......................................... 119 

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8.3.5. Enviromnental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure ................................................... 119 
8.3.5.1. Exposure During Pregnancy .................................................... 119 
8.3.5.2. Exposure During Breastfeeding ............................................... 121 
8.3.5.3. Occupational Exposure ............................................................ 121 
8.3.6. Cardiovascular and Death Events ............................................................. 122 
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs ............................................................................ 122 
8.3.8. Adverse Events of Special futerest ............................................................ 122 
8.3.8.1. Cytokine release Syndrome ..................................................... 122 
8.3.8.2. Immune  Effector  Cell-Associated  Neurotoxicity 
Syndrome ......................................................................................... 122 
8.3.8.3. Peripheral Neuropathy ............................................................. 123 
8.3.8.4. Lack of Efficacy ...................................................................... 123 
8.3.9. Medical Device Deficiencies .................................................................... 123 
8.3.10. Medication E1Tors .................................................................................. 123 
8.4. Pharmacokinetics ................................................................................................. 124 
 

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CCI 
 
8.7. Immunogenicity Assessments ............................................................................... 129 
8.8. Health Economics .................................................................................................. 129 
9. STATISTICAL CONSIDERATIONS ............................................................................... 129 
9.1. Statistical Hypotheses ............................................................................................ 130 
9.1.1. Estimands .................................................................................................. 130 
9.1.1.1. Primary Estimand .................................................................... 130 
9.1.1.2. Secondary Estimand ................................................................ 130 
9.2. Analysis Sets .......................................................................................................... 131 
9.3. Statistical Analyses ................................................................................................ 131 
9.3.1. General Considerations ............................................................................. 132 
9.3.2. Primary Endpoint/Estimand/Analysis ....................................................... 132 
9.3.3. Secondary Endpoints/Estimands/Analyses ................................................ 132 
9.3.3.1. Secondary Safety Endpoint ..................................................... 132 
9.3.3.2. Secondary Efficacy Endpoints ................................................. 133 
9.3.3.3. Pharmacokinetic Analyses ....................................................... 135 
9.3.3.4. Immunogenicity Analyses ....................................................... 135 
9.3.4. Tertiary/Exploratory Endpoints ................................................................ 136 
9.3.5. Other Safety Analyses ............................................................................... 136 
9.3.5.1. Electrocardiogram Analyses .................................................... 136 
9.3.5.2. Adverse Events ........................................................................ 137 
9.3.5.3. Laboratory Test Abnormalities ................................................ 137 
CCI 
 
9.4. Interim Analyses .................................................................................................... 137 
9.4.1. Interim Safety Assessments ...................................................................... 137 
9.4.2. Interim Analysis for Futility ..................................................................... 141 
9.5. Sample Size Determination ................................................................................... 141 
9.5.1. Primary Endpoint ...................................................................................... 142 
9.5.2. Part 2A and Part 2C .................................................................................. 143 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS......................................................................................................... 146 
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations .............. 146 

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10.1.1. Regulatory and Ethical Considerations .................................................. 146 
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP .......................................................................146 
10.1.2. Financial Disclosure ............................................................................... 147 
10.1.3. Informed Consent Process ..................................................................... 147 
10.1.4. Data Protection ....................................................................................... 148 
10.1.5. Committees Structure ............................................................................. 148 
10.1.5.1. Data Monitoring Committee ................................................. 148 
10.1.6. Dissemination of Clinical Study Data .................................................... 149 
10.1.7. Data Quality Assurance ......................................................................... 150 
10.1.8. Source Documents ..................................................................................151 
10.1.9. Study and Site Start and Closure ............................................................ 151 
10.1.10. Publication Policy .................................................................................152 
10.1.11. Sponsor’s Qualified Medical Personnel ............................................... 153 
10.2. Appendix 2: Clinical Laboratory Assessments ................................................... 154 
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting ................................................................... 155 
10.3.1. Definition of AE .................................................................................... 155 
10.3.2. Definition of an SAE .............................................................................. 156 
10.3.3. Recording/Reporting and FollowUp of AEs and/or SAEs During 
the Active Collection Period ......................................................................... 158 
10.3.4. Reporting of SAEs ................................................................................. 161 
10.4. Appendix 4: Contraceptive and Barrier Guidance ...............................................163 
10.4.1. Male Participant Reproductive Inclusion Criteria .................................. 163 
10.4.2. Female Participant Reproductive Inclusion Criteria .............................. 163 
10.4.3. Woman of Childbearing and Non-Childbearing Potential ......................163 
10.4.4. Contraception Methods .......................................................................... 164 
CCI 
 
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments ..... 167 
10.7. Appendix 7: ECG Findings of Potential Clinical Concern ................................. 169 
10.8. Appendix 8: Alternative Measures During Public Emergencies .........................171 
10.8.1. Eligibility ............................................................................................... 171 

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10.8.2. Telehealth Visits .................................................................................... 171 
10.8.3. Alternative Facilities for Safety Assessments .........................................172 
10.8.3.1. Laboratory Testing ............................................................... 172 
10.8.3.2. Electrocardiograms ............................................................... 172 
10.8.4. Study Intervention .................................................................................. 172 
10.8.5. Adverse Events and Serious Adverse Events ........................................ 173 
10.9. Appendix 9: Subcutaneous Injection Site Locations ...........................................174 
10.10. Appendix 10: IMWG Response Criteria for Multiple Myeloma .......................175 
10.11. Appendix 11: Prior Lines of Therapy ................................................................179 
10.12. Appendix 12: CRS and ICANS Grading, Mitigation, and Management ...........181 
10.12.1. Cytokine release syndrome ...................................................................181 
10.12.1.1. CRS management guidelines by ASTCT Severity 
Grading[35,36] ................................................................................ 182 
10.12.2. Immune effector cell-associated neurotoxicity syndrome (ICANS) .....184 
10.12.2.1. ICANS Management Guidelines Per ASTCT[35,36] ..........185 
10.13. Appendix 13: Concomitant Medications That May Result in DDI ...................189 
10.14. Appendix 14 : Country specific requirements ...................................................190 
10.14.1. Japan .................................................................................................... 190 
10.14.2. United States ........................................................................................ 191 
10.15. Appendix 15: Anti-infectious Prophylaxis and Monitoring ..............................192 
10.16. Appendix 16: Protocol Amendment History .....................................................195 
10.17. Appendix 17: Abbreviations ..............................................................................219 
11. REFERENCES ................................................................................................................ 227 

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LIST OF TABLES 
Table 1. 
Schedule of Assessments: Part 1 .............................................................. 33 
Table 2. 
Study Schedule of Assessments: Part 2 ................................................... 49 
Table 3. 
Efficacy Results for Available Therapies for Patients With 
Relapsed/ Refractory Multiple Myeloma Who Have Received at 
Least 2 Prior Therapies ............................................................................ 67 
Table 4. 
Relevant Population Metrics – US ........................................................... 81 
Table 5. 
Hematological and Non-hematological Dose-limiting Toxicities ........... 85 
Table 6. 
Dose Modifications for Elranatamab-Related Toxicity and for 
Peripheral Sensory or Motor Neuropathy .................................................98 
Table 7. 
Staging Systems for Multiple Myeloma .................................................111 
Table 8. 
Eastern Cooperative Oncology Group (ECOG) Performance Status 
Scale ....................................................................................................... 116 
Table 9. 
Minimum Number of Participants With Identified Events That 
Would Prompt Temporary Enrollment Hold (CRS, ICANS, Non- 
hematologic treatment-related AEs) ...................................................... 138 
Table 10. 
Minimum Number of Participants With Identified Treatment- 
Related Events That Would Prompt Temporary Enrollment Hold 
(GBS/GB-like AEs, Peripheral Neuropathy/IR Neurologic AEs) ..........140 
Table 11. 
Futility Boundary (Number of Participants with Grade ≥2 CRS 
Events) at the Interim Analysis .............................................................. 141 
Table 12. 
Operating Characteristics of Bayesian 2-Stage Dual-Criterion 
Design for Grade ≥2 CRS rate ............................................................... 143 
Table 13. 
Data Scenarios, Next Dose Recommendation, and the Interval 
Probability of Target Toxicity and Overdosing at Next Dose ................144 
Table 14. 
Protocol Required Safety Laboratory Assessments (locally 
performed) .............................................................................................. 154 
Table 15. 
IMWG MRD Criteria ............................................................................. 175 
Table 16. 
Modified IMWG Response Criteria ....................................................... 176 
Table 17. 
ASTCT CRS Grading ............................................................................ 182 
Table 18. 
Immune Effector Cell-Associated Encephalopathy (ICE) Score ............184 
Table 19. 
ASTCT ICANS Grading ........................................................................ 185 

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LIST OF FIGURES 
Figure 1. 
Logistic Regression Analysis of Elranatamab Concentration at 24 
hours Versus Probability of all Grade and Grade 2 CRS .......................... 83 

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1. PROTOCOL SUMMARY 
1.1. Synopsis 
A Phase 1/2, open-label, multicenter study to evaluate a dosing regimen with 2 step-up 
priming doses and longer dosing intervals of elranatamab (PF-06863135) monotherapy in 
paiticipants with RRMM. 
Brief Title: A Study to Learn About the Study Medicine (Elranatamab) in Paiticipants With 
Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not 
Responded to Treatment. 
Rationale 
The pmpose of the study (Pait 1 and Pait 2) is to evaluate the rate of Grade ::::: 2 CRS using a 
priming regimen that involves a premedication cocktail and 2 step-up priming doses to be 
administered within the first week of elranatamab ti·eatment. The study will also evaluate the 
safety, tolerability, PK, phaimacodynamics, and preliminaiy anti-myeloma activity of 
elranatamab full doses 76 mg and >76 mg with different dosing intervals. 
 
Objectives, Endpoints, and Estimands 
 
Objectives 
Endpoints 
Estimands 
Prima1-y 
Pa1·t 1 and Pa1·t 2 
• To assess the rate of 
Grade c:::2 CRS when 
eh-anatamab is 
administered with a 
dosing regimen of 2 step- 
up priming doses and 
premedication in 
participants with RRMM. 
• Grade c:::2 CRS rate dming 
Cl. 
• The prima1y estimand is rate of Grade c:::2 
CRS dming Cl as assessed by ASTCT 
criteria. It will be estimated based on all 
enrolled RRMM participants who 
received at least 1 dose of study 
intervention regardless of duration on the 
study treatment. 
Secondarv 
Pa1·t 1 and Pa1·t 2 
• To assess the safety and 
tolerability of eh-anatamab 
at doses >76 mg with a 
longer dosing interval (> 
1 week) in order to 
identify the RP2D. (Pa11 
2A and 2C) 
•  Incidence ofDLTs during 
DLT observation period. 
• The secondruy estimand is DLT rate 
estimated based on data from DLT- 
evaluable pruticipants during the DLT 
observation period 
• To evaluate the overall 
safety profile of 
eh-anatamab with 2 step- 
up priming doses and 
altemative dosing 
• Adverse Events as 
characterized by type, 
frequency, severity as graded 
by NCI CTCAE version 5.0, 
timing, seriousness, and 
relationship to eh-anatamab. 
• Not Applicable 

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Objectives 
Endpoints 
Estimands 
regimens in pa1ticipants 
withRRMM 
The severity of CRS and 
ICANS will be assessed 
according to ASTCT criteria; 
• Laborato1y abnonnalities as 
characterized by type, 
frequency, severity (as 
graded by NCI CTCAE 
version 5.0), and timing. 
• To evaluate the anti- 
myeloma activity of 
eh-anatamab with 
•  ORR and CRR, per IMWG 
response criteria as 
determined by investigator; 
• Not Applicable 
alternative dosing 
regimens in participants 
withRRMM 
• Time to event endpoints: 
TIR, DOR, DOCR and PFS 
per IMWG response criteria 
as detennined by 
investigator, and OS; 
• MRD (assessed by central 
lab) negativity rate per 
IMWG sequencing criteria. 
• To evaluate the PK of 
• Pre- and postdose 
• Not Applicable 
eh-anatamab 
concentrations of 
eh-anatamab. 
• To evaluate 
• Incidence and titers of ADA 
• Not Applicable 
immunogenicity of 
and NAb against 
eh-anatamab 
eh-anatamab. 
·- 
I 
·- 

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Final Protocol Amendment 4, 20 Dec 2023 
 
Objectives 
Endpoints 
- 
Estimands 
I' 
Overall Design 
Study C1071009 is a prospective, open-label, multicenter, non-randomized Phase 1/2 study 
aimed to evaluate the safety (in paiticular the rate of Grade::::2 CRS) of a priming dose 
regimen of elranatamab that involves premedication and 2 step-up p1iming doses 
administered within the first week of treatment (Pait 1 and Pait 2). Study C1071009 will 
include RRMM paiticipants who are refracto1y to at least 1 PI, 1 IMiD, and 1 anti-CD38 
mAb. 
Part 1 and Part 2: the following dosing regimen will be evaluated in the first cycle (Cl) of 
elranatamab treatment: 
• 
 C1D1: Premedication + elranatainab 4 mg (hospitalization for at least 2 days, 
see Section 2.3.1) 
• 
 C1D4: Premedication + elranatainab 20 mg (hospitalization for at least 1 day, 
see Section 2.3.1) 
 
• 
C1D8: Premedication + elranatainab 76 mg 
 
• 
C1D15 and C1D22: elranatamab 76 mg QW 
The first 2 doses of elranatamab on ClDl and C1D4 will serve as the step-up priming doses 
and will be administered on an inpatient basis to monitor paiticipants for CRS/ICANS. The 
dose of elranatamab should be increased to 20 and 76 mg on C1D4 and C1D8, respectively, 
as long as the paiticipant meets redosing criteria (Section 6.5.1). 
All paiticipants emolled in Pait 1 and Pait 2 described below will contribute to the primaiy 
objective of the study, ie, assessing the rate of Grade ::::2 CRS dming Cl, asthe same dosing 
regimen is administered to all treatment groups dming the first cycle. 
In addition, the study will evaluate the overall safety, tolerability, PK, phannacodynainics, 
and preliminaiy anti-myeloma activity of a regimen of elranatamab full dose of 76 mg QW 
for 6 cycles followed by Q2W or> 76 mg Q4W (Pait 1) and alternative regimens of 
elranatamab at dose levels >76 mg sta1ting from C2 with different dosing intervals (QW, 
Q2W, Q4W) (Pait 2). 

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The following dosing regimens will be assessed: 
 
• 
Part 1: Premedication, 2 step-up priming doses, and full dose 76 mg QW for 6 cycles 
followed by Q2W and/or RP2D (116 mg or 152 mg) Q4W as determined from Part 
2A 
Pait 1 aims to evaluate the overall safety, tolerability, PK, phannacodynamics, and 
preliminaiy anti-myeloma activity of the following regimen: 
C2 to C6: ehanatainab 76 mg QW 
C7 onwards: ehanatamab 76 mg Q2W (for participants with IMWG response of PR or 
better persisting for 2 months on QW) 
C7 onwards once the RP2D is identified in Part 2A: ehanatainab RP2D (116 mg or 
152 mg) Q4W (for paiticipants with IMWG response of PR or better persisting for 
2 months on QW or Q2W). An optional day of hospitalization may be considered for 
the first RP2D dosing (116 mg or 152 mg) Q4W depending on CRS profile observed 
in Pait 2A and Pait 2B. 
 
• 
Part 2: Premedication, 2 step-up priming doses, and full dose >76 mg (ie, 116 and 
152 mg) at different dosing intervals 
Pait 2 aims to evaluate the safety and efficacy of a regimen that includes premedication 
Pait 2A dose detennination and Pait 2C tolerability evaluation will be based on a BLRM 
approach. The decision to strut emolling paiticipants in a new coho1t (Pait 2A Dose level 
2, Pait 2B or Pait 2C) will be a joint decision to be detennined by the investigators and 
the sponsor in dose level review meetings. 

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Part 2A (Dose Detennination) will evaluate full ehanatamab doses >76 mg staiiing from 
C2 with a longer dosing interval (>1 week) to determine the potential RP2D to be 
finiher evaluated in Pa.ii 2B. Approximately 8 pai·ticipants will be enrolled at each 
dose level in Pa.ii 2A. 
• 
Dose level 1 will assess the following regimen: 
C2 to C6: elranatainab 116 mg Q2W. DLT observation period is C2 or 28 days 
staiiing from the first dose of 116 mg. Hospitalization on C2D1 or on the day 
of the first dose of 116 mg for at least 1 day is required, see Section 2.3.1. 
Ehanatamab 116 mg represents an ~ 50% increase in elranatamab dose versus 
76mg. 
C7 onwards: ehanatamab 116 mg Q4W (for paiiicipants with IMWG response of 
PR or better persisting for 2 months on Q2W). 
• 
If Dose level 1 is tolerable, Dose level 2 will be initiated to assess the 
following regimen: 
C2 to C6: ehanatamab 152 mg Q2W. DLT observation period is C2 or 28 days 
staiiing from the first dose of 152 mg. Hospitalization on C2D1 or on the day 
of the first dose of 152 mg for at least 1 day is required, see Section 2.3.1. 
Ehanatamab 152 mg represents an ~ 30% increase in elranatamab dose versus 
116 mg and will be the MAD in this study. 
C7 onwards: ehanatamab 152 mg Q4W (for pa1iicipants with IMWG response of 
PR or better persisting for 2 months on Q2W). 
 
The potential RP2D identified in Pa.ii 2A Dose level 1 or Dose level 2 will be fmiher 
evaluated and confnmed in Pali 2B. 
Part 2B (Dose Expansion) will begin once the potential RP2D from Pa.ii 2A Dose level 1 
or Dose level 2 is selected. Approximately 22 paiiicipants will be enrolled to confnm 
the safety and efficacy of the selected dosing regimen to have at least 15 paiiicipants 
treated for 2 cycles. Approximately a total of 30 pa1iicipants will be enrolled and 
treated at the potential RP2D, 8 from Pa1i 2A and 22 from Pa.ii 2B. 
 
 

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fu Paiis 2B and 2C, hospitalization on C2Dl or on the day of the first dose of 116 mg or 
152 mg may not be required depending on CRS profile observed in Pait 2A (See Section 
2.3.1). This will be a joint decision to be detennined by the investigators and the sponsor 
before opening enrolhnent to Pait 2B and Pait 2C. 
fu Pait 2 (A, B, and C), the ehanatamab dose may be escalated to 116 or 152 mg only in 
paiiicipants who have received at least 2 doses at 76 mg. 
Pait 2 enrollment will staii after approximately 30 participants have been enrolled in Pa.ii 1. 
The decision to proceed with Pa.ii 2 of the study will be a joint agreement between the 
sponsor and the investigators based on the review of the available data, including CRS 
incidence and severity. 
If neither Dose level 1 nor Dose level 2 in Pa.ii 2A proves to be tolerable, Pa1i 2C and 
Pa.ii 2B will not start and Pa.ii 1 will enroll approximately 68 participants for a total of 
76 participants in the study. 
At time of protocol amendment 4, Pait 1 and Pa.ii 2 (Pait 2A and Pa.ii 2B) were ongoing, 
and the enrollment is completed in all coho1is. Pait 2C will not be explored. The 152 mg 
Q2W dose was selected as the RP2D from Pa1i 2A, with a switch to 152 mg Q4W staiiing in 
C cle 7 for  aiiici ants with an IMWG res onse of PR or better  ersistin  for 
2 months). 
 
 
 
 
Number of Participants 
Part 1 and Part 2: 
Approximately 76 participants will be enrolled and treated across the study including: 
30 participants in Pa.ii 1, 16 participants in Pa.ii 2A (n = 8 for each dose level), 22 pa1iicipants 
in Pa.ii 2B and 8 participants in Pa.ii 2C. 

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Note: “Enrolled” means a participant’s, or their legally authorized representative’s, 
agreement to participate in a clinical study following completion of the informed consent 
process and assignment to study treatment. 
Study Population and Specific Inclusion/Exclusion Criteria 
Inclusion and exclusion criteria are listed below: 
Inclusion Criteria 
Participants must meet the following inclusion criteria to be eligible for enrollment into the 
study: 
1. Participants age ≥18 years (or the minimum country specific age of consent if >18). 
A female participant is eligible to participate if she is not pregnant or breastfeeding. 
Refer to Appendix 4 for all reproductive criteria for male (Section 10.4.1) and female 
(Section 10.4.2) participants. 
2. Participants who are willing and able to comply with all scheduled visits, treatment 
plan, laboratory tests, lifestyle considerations, and other study procedures. 
3. Prior diagnosis of MM as defined according to IMWG criteria.[1] 
4. Measurable disease based on IMWG criteria as defined by at least 1 of the following: 
a. Serum M-protein >0.5 g/dL by SPEP; 
b. Urinary M-protein excretion >200 mg/24 hours by UPEP; 
c. Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum 
immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65). 
5. Refractory to at least 1 IMiD. 
6. Refractory to at least 1 PI. 
7. Refractory to at least 1 anti-CD38 antibody. 
8. Relapsed or refractory to last anti-MM regimen. 
Note: Refractory is defined as having disease progression while on therapy or 
within 60 days of last dose in any line, or no response to therapy 
9. ECOG performance status ≤1. 
10. LVEF ≥40% as determined by a MUGA scan or ECHO. 

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11. Adequate hepatic function characterized by the following: 
a. Total bilirubin ≤2 x ULN (≤3 x ULN if documented Gilbert’s syndrome); 
b. AST ≤2.5 x ULN; and 
c. ALT ≤2.5 x ULN 
12. Adequate renal function defined according to local institutional standard method: 
eGFR ≥ 30 mL/min/1.73 m2 using CKD-EPI 2021 equation[2] or estimated 
creatinine clearance ≥ 30 mL/min using Cockcroft Gault formula. If both formulae 
are calculated, the higher of the 2 values may be used. A 24-hour urine collection for 
creatinine clearance may also be used in equivocal cases where amyloidosis is 
suspected. 
13. Adequate BM function characterized by the following: 
a. ANC ≥1.0 × 109/L (use of G-CSF is permitted if completed at least 7 days 
prior to planned start of dosing); 
b. Platelets ≥25 × 109/L (transfusion support is permitted if completed at least 
7 days prior to planned start of dosing); and 
c. Hemoglobin ≥8 g/dL (transfusion support is permitted if completed at least 
14 days prior to planned start of dosing). 
14. Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L). 
15. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1. 
16. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and in 
this protocol. 
Exclusion Criteria 
Participants with any of the following characteristics/conditions will be excluded: 
1. 
Smoldering MM 
2. 
Active plasma cell leukemia 
3. 
POEMS syndrome 
4. 
Amyloidosis 
5. 
Waldenström’s macroglobulinemia 

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6. 
Known active CNS involvement or clinical signs of myelomatous meningeal 
involvement 
7. 
Stem cell transplant within 12 weeks prior to enrollment or active GVHD 
8. 
Impaired cardiovascular function or clinically significant cardiovascular diseases, 
defined as any of the following within 6 months prior to enrollment: 
a. Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, 
coronary artery bypass graft, coronary angioplasty or stenting, symptomatic 
pericardial effusion); 
b. Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or 
uncontrolled paroxysmal supraventricular tachycardia); 
c. Thromboembolic or cerebrovascular events (eg, transient ischemic attack, 
cerebrovascular accident, deep vein thrombosis [unless associated with a central 
venous access complication] or pulmonary embolism); 
d. Prolonged QT syndrome (or QTcF >470 msec at screening) 
9. 
Ongoing Grade ≥ 2 peripheral sensory or motor neuropathy 
10. History of any grade peripheral sensory or motor neuropathy with prior BCMA-directed 
therapy 
11. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor 
polyneuropathy 
12. Active HBV, HCV, COVID-19/SARS-CoV-2, HIV or AIDS-related illness, or any 
active, uncontrolled bacterial, fungal, or viral infection. Active infections must be 
resolved at least 14 days prior to enrollment. 
COVID-19/SARS-CoV-2: While SARS-CoV-2 testing is not mandated for entry into this 
study, testing should follow local clinical practice standards. If a participant has a 
positive test result for SARS-CoV-2 infection within 14 days prior to enrollment, is 
known to have asymptomatic infection or is suspected of having SARS-CoV-2, the 
participant is excluded. 
HBV: 
• This criterion excludes participants with a positive HBsAg (ie, either acute or 
chronic active hepatitis). 
• However, participants with HBV antibody positivity indicating immunity, 
either due to vaccination or prior natural infection, are eligible. 

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• 
Paiiicipants with positive anti-HBcAb but negative HBsAg and negative anti- 
HBsAb profile ai·e eligible if HBV DNA is not detected. 
13. Known or suspected hypersensitivity to the study intervention, or any of its excipients 
14. Any other active malignancy within 3 yeai·s prior to enrolhnent, except for adequately 
treated basal cell or squamous cell skin cancer, carcinoma in situ or Stage 0/1 
malignancy with minimal risk of recmrence per investigator 
15. Other surgical (including major surge1y within 14 days prior to enrollment), medical or 
psychiatric conditions including recent (within the past year) or active suicidal 
ideation/behavior or laborato1y abno1mality that may increase the risk of study 
paiiicipation or, in the investigator's judgment, make the pa1iicipant inappropriate for 
the study 
16. Previous treatment with anti-BCMA bispecific antibody or CAR-T cell therapy 
17. Live attenuated vaccine within 4 weeks of the first dose of study inte1vention. 
18.  Previous administration with an investigational dmg or vaccine within 30 days (or as 
dete1mined by the local requirement) or 5 half-lives preceding the first dose of study 
inte1vention used in this study (whichever is longer). 
19.  A paiiicipant may be eligible even if they are in the follow-up phase of an investigational 
study as long as they meet the criteria for time elapsed from previous administration of 
investigational product. Cases must be discussed with sponsor's medical monitor to judge 
eligibility. 
20. fuvestigator site staff directly involved in the conduct of the study and their family 
members, site staff othe1wise supe1vised by the investigator, and sponsor and sponsor 
delegate employees directly involved in the conduct of the study and their fainily 
members 
Intervention Groups and Duration 
 
Arm title 
Description 
Pait 1 
Participants will receive eh-anatamab 4 mg on ClDl and 20 mg on ClD4 (2 
priming doses) and then 76 mg QW for 6 cycles. 
Thereafter, pa1ticipants with PR or better response persisting for c:::2 months on QW 

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Pa1t2A 
Participants will receive eh-anatamab 4 mg on ClDl and 20 mg on ClD4 
(2 priming doses) and then 76 mg QW for 1 cycle. 
Thereafter, paiticipant.s will receive: 
- Dose level 1: I16 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards 
(paiticipants with PR or better response persisting for:?:2 months on Q2W). 
- Dose level 2: 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards 
Pa1ticipants will receive eh-anatamab 4 mg on ClDI and 20 mg on CID4 (2 
priming doses) and then 76 mg QW for I cycle. 
Thereafter, paiticipants will receive 116 or 152 mg Q2W for C2 to 6and116 mg or 
152 mg Q4W from C7 and onwards 
artici ants with PR or better res onse 
Pa1t2B 
. for :?:2 months on  2 
 
Each pa1ticipant should receive study intervention until confmned disease progression, 
unacceptable toxicity, withdrawal of consent, or study tennination. 
The study will be completed when all paiticipants have been followed for OS for at least 
2 years from the date of enrollment. 
Data Monitoring Committee or Other Independent Oversight Committee: No. 
Statistical Methods 
A Bayesian dual-criterion design[3] will be used to estimate the primaiy endpoint of the tme 
Grade 2 CRS rate during Cycle 1 in Pait 1 and Pait 2.. With this design, the following 
criteria ai·e defined: 
Part 1 and Part 2 
• 
 Bayesian statistical significance: Substantial evidence that the hue Grade 2 CRS rate 
exceeds a pre-specified value. For this study, Bayesian statistical significance will be 
achieved if the posterior probability of the hue Grade 2 CRS rate exceeding 35% is 
<10%; 

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• Clinical relevance: The maximum number Grade ≥2 CRS events threshold that could 
justify further clinical development. For this study, it is defined as the median of the 
posterior distribution of the true Grade ≥2 CRS rate is ≤ 27%. 
The analysis will use a Beta-binomial model (binomial sampling for number of Grade ≥2 
CRS events and a beta prior distribution). A minimally informative beta prior distribution of 
the true Grade ≥2 CRS rate will be used. It is assumed a priori that the true mean Grade ≥2 
CRS rate is 35%, so the prior distribution will be Beta (0.7, 1.3). Using this prior and based 
on the dual criteria defined above, approximately 76 participants will be enrolled and treated 
in Part 1 and Part 2 and a maximum of 20 participants with Grade ≥2 CRS events is allowed 
to meet the dual criteria in 76 participants. If exactly 20 participants in 76 participants 
experience Grade ≥2 CRS events, the observed Grade ≥2 CRS rate is 26.3% with median 
26.3% and 90% credible interval of (18.7%, 35.0%) based on the posterior distribution. 
The primary analysis will be conducted once all participants have completed C1 of study 
intervention or have otherwise discontinued the study intervention. 
An interim analysis for non-binding futility will be conducted on the 30 participants enrolled 
and treated in Part 1 of the study. 

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Part 2A Dose Deten11ination (n = 16) 
Elranatamab rnonotherapy SC 2 step-up priming doses (4/20 mg) + 
 
Escalate if 
tolerable  
RP2D 
 
 
identified 
from Pait 2A 
Part 2B 
Dose Expansion 
 
Dose Level2 
152 mgQ2W 
Dose Level 1 
116 mgQ2W 
Part 1 (n = 30) 
 
Elranatamab monotherapy SC 2 step-up priming closes (4120 mg) - 
foll close 76 mg QW 
 
1.2. Schema 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Based on tolerability ofDLl 
and DL2, Part 2C may open 
 
 
 
QW:Once weekly 
Q2W: Once every 2 weeks 
SC: Subcutaneous 
RP2D: Recommended Phase 2 Dose 
All participants will be followed for OS for at least 2 years from the date of enrollment 
 
Note: Premedications are administered on ClDl, ClD4, and ClD8 (refer to Section 6.8.1). The decision to proceed with Prut 2 of the study will be a joint 
agreement between the sponsor and the investigators based on the review of the available data, including CRS incidence and severity. If neither Dose level 1 or 
Dose level 2 in Pait 2A proves to be tolerable, Part 2B and Pait 2C will not stait and Part 1 will enroll approximately 68 pruticipants. In total, this study will 
enroll approximately 76 paiticipants. 

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1.3. Schedule of Activities 
The SoA tables provide an overview of the protocol visits and procedures. Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section of the protocol for detailed info1mation on each assessment required for compliance with the protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA tables, in order to conduct evaluations or 
assessments required to protect the well-being of the paiiicipant. 
1.3.1. Part 1 Schedule of Assessments 
Table 1. 
Schedule of Assessments: Part 1 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day4 Day8 
Day15 Day22 
Cycles 
2-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Q12W 
Visit Window 
Day-28 
to Day-1 
- 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
±14D 
Info1med consent 
X 
See Section 10.1.3. 
Eligibility criteria 
X 
See Section 5.1 and Section 5.2. 
Register with IRT 
X 
See Section 6.3.1. 
Elll'ollment in IRT 
X 
See Section 6.3.1 
Demography/ 
medical history 
X 
See Section 8.2.1. 
Disease 
characteristics/ 
treatment history 
X 
See Section 8.2.1. 
Clinical Procedures/Assessments - Note: Dmin2 the ti·eatment pe1iod, all assessments must be done within 72 hom·s p1ior to dosin2, except fo1·disease assessments 
which are to be done every 28 days from ClDl 
Physical exam 
X 
X 
X 
X 
x• 
X 
X ----

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Treatment Period 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Cycle 1 
(each 28 Day Cycle) 
Visit Window 
Neurologic exam 
I E score 
Height/weight 
Day-28 
to Day-1 
X 
X 
Day 1 
X 
Day 4  Day 8 
Day 15 
-1/+3 
-1/+3 
±3D 
D 
 D 
X 
X 
X 
Day 22 
±3D 
X 
Cycles 
Cycle 7 
2-6 
Onwards 
Dayl 
Dayl 
±3D 
±3D 
X 
x• 
14 Dpost- 
final dose 
X 
28 to 35 
days post- 
final dose 
X 
Q12W 
±14D 
Starting C2D1, neurological exam 
to be performed weekly (on D1, 
D8, D15 and D22) for cycles 2-3, 
then eve1y other week (on D1 and 
D15) for cycles 4-6, then every 28 
days (on D1) from cycle 7 
onwards. 

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
14 Dpost- 
final dose 
X 
FU Visit 
28 to 35 
days post- 
final dose 
X 
LTFU 
Notes/Protocol Section 
Pre-dose vital signs collected on 
ClDl, C1D4, C1D8, C1D15, and 
C1D22 should be repo,ted in the 
CRF. 
Vital signs monitored at least 
eveiy 4 hours (±30 minutes) 
during the first 48 hrs aftei·first 
(ClDl) and during 24 hrs after 
second dose of study intervention 
(C1D4) should be repoited in the 
CRF. If performed, abnormal vital 
signs associated with AEs (eg 
CRS or an infection) should be 
reported in the CRF 
Dayl 
Day 4 Day 8 
Day 15 
Day 22 
Cycles 
2-6 
Dayl 
Cycle 7 
Onwards 
Dayl 
Q12W 
±14D 
Visit Window 
Vital signs 
(temperature, HR, BP, 
and02 saturation) 
Day-28 
to Day-1 
X 
X 
-1/+3 
D 
X 
-1/+3 
D 
X 
±3D 
X 
±3D 
X 
±3D 
X 
±3D 
x• 
ECOGPS 
X 
CMVtesting 
(quantitative PCR) 
X 
X(See 
Notes) 
To be done prior to administration 
of study intervention (at screening 
or prior to first dose) and then 
either monthly or eve,y 1 to 3 
cycles depending on risk factors 
and baseline CMV viral load as 
clinically indicated. See 
Section 6.8.7 and Appendix 15. 

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day 4 
Day 8 
Day 15 Day 22 
Cycles 
Cycle 7 
2-6 
Onwards 
Day 1 
Day 1 
Q12W 
Visit Window 
Day-28 
to Day-1 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
± 14D 
For participants already enrnlled 
and treated under Pait 1, a CMV 
testing should be pe,fonued as a 
baseline reference for CMV status 
at the next scheduled dosing visit 
and repeated either monthly or 
every 1 to 3 cycles depending on 
risk factors and baseline CMV 
viral load as clinically indicated. 
SARS-CoV-2 test 
X 
• 
tarting with protocol amendment 
, PCR or antigen test required 
redose on Day 1 (CXDl ), upon 
uspected exposm·e to SARS-CoV- 
and at signs or symptoms of 
OVID-19 infection (see 
ppendix 2 and Appendix 15). 
or pa,ticipants with SARS-CoV-2
fection, study intervention should
e delayed for at least 14 days fron
e sta,t of symptoms or positive 
est result. 

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day 4 
Day 8 
Day 15 
Day 22 
Cycles 
2-6 
Dayl 
Cycle 7 
Onwards 
Dayl 
Q12W 
Visit Window 
Day-28 
to Day-1 
X 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
X 
(Cycle2 
and4) 
±3D 
14 Dpost- 
final dose 
X 
28 to 35 
days post- 
final dose 
± 14D 
Single assessment at screening. 
Triplicate at all other time points. 
Predose ECG for all specified 
visits. Perform ECG prior to 
elrnnatamab administration (and 
premedication) and PK sample 
collection (if scheduled). ECG 
assessments should be skipped if 
CRS symptoms are ongoing. 
Additional ECGs should be 
performed as clinically indicated. 
See Section 8.2.4. 
Triplicate 
X 
12-LeadECG 
(Singlet) 
EC 
See Section . . . 
Premedication for 
CRS 
X 
X 
X 
Must be administered 
approximately 60 minutes 
(±15 min) prior to elranatamab 
dose. See Section 6.8.1. 
Ekanatamab 
administration 
X 
X 
X 
X 
X 
X 
(QW) 
X 
(Q2W or 
-· 
If participant has received QW 
dosing for at least 6 cycles and has 
achieved a PR or better persisting 
for :C::2 months the dose interval 
will be changed from QW to Q2W 
or Q4W when the RP2D is 
identified in Pait 2A 

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day4 Day8 
Day15 
Day22 
Cycles 
2-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Q12W 
Visit Window 
Day-28 
to Day-1 
- 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
±14D 
Participant 
hospitalization 
X 
X 
(X) 
v
!Hospitalization requit·ed for at least 
12 days on ClDl and 1 day 
overnight) for C1D4. 
!Hospitalization from ClDl to 
IDS may be considered. Optional 
1t1ospitalization may be considered 
hen escalating to the RP2D (116 
mg or 152 mg) Q4W depending on 
k:RS profile observed in Pait 2A 
and Pait 2B. See Section 2.3.1. and 
4.1 
AE monitoring 
Assess Continuously 
See Section 8.3 
Concomitant therapy 
Assess Continuously 
See Section 6.8. 
Subsequent anticancer 
therapies/date of 
progression 
Assess continuously 
See Section 7.1. 
Survival status 
X 
X 
Collected by telephone eve1y 
12 weeks until death, or at least 
2 years from the date of 
enrollment, whichever comes first. 

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day4 
Day8 
Day15 
Day22 
Cycles 
2-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Q12W 
Visit Window 
Day-28 
to Day-1 
- 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
±14D 
Disease response 
assessment (per 
IMWG criteria) 
X 
X 
X 
X* 
X* 
To be conducted on a 28-day 
(±1 wk) interval whether dose 
given or not (ie, the 28-day 
interval (±1 wk) from ClDl 
should be maintained regardless of 
dose delays/intem1ptions). 
See Section 8.1. 
*For pa1ticipants who discontinue 
study intervention without PD: 
perform at EOT visit, then at least 
Q4W (±1 wk) until PD, 
withdrawal of consent, participant 
lost to follow-up, death or defined 
end of study. 
For additional details on IMWG 
response criteria, see 
Appendix 10. 

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day4 
Day8 
Day15 
Day22 
Cycles 
2-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Q12W 
Visit Window 
Day-28 
to Day-1 
- 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
±14D 
SPEP, SIPE, serum 
FLC 
X 
X 
X 
X 
X 
X* 
X* 
Screening and CIDI (if not done 
within 72 hours prior to dosing). 
To be conducted on a 28-day 
(±I wk) interval whether dose 
given or not (ie, the 28-day 
interval (±I wk) from CIDI 
should be maintained regardless of 
dose delays/intem1ptions). 
*For pa1ticipants who discontinue 
study intervention without PD: 
perform at EOT visit, then at least 
Q4W (±I wk) until PD, 
withdrawal of consent, participant 
lost to follow-up, death or defined 
end of study. 
Except for sCR, semm FLC 
analysis is required when both 
serum and urine M-component 
levels are deemed non measm·able 
or uninterpretable (including at 
suspected CR). 
See Section 8.1.1. 

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Page41 
 
 
 
Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day4 
Day8 
Day15 
Day22 
Cycles 
2-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Q12W 
Visit Window 
Day-28 
to Day-1 
- 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
±14D 
UPEP, UIFE (24-hour 
urine collection 
required) 
X 
X 
X 
X 
X 
X* 
X* 
Screening and CIDI (if not done 
within 72 hours prior to dosing). 
To be conducted on a 28-day 
(±I wk) interval whether dose 
given or not (ie, the 28-day 
interval (±I wk) from CIDI 
should be maintained regardless of 
dose delays/intem1ptions). See 
Section 8.1. 
*For participants who discontinue 
study intervention without PD: 
perform at EOT visit, then at least 
Q4W (±I wk) until PD, 
withdrawal of consent, participant 
lost to follow-up, death or defined 
end of study. 
If an evaluable 24-hour urine 
collection is missed, another 
attempt for collection should be 
scheduled within 7 days of the 
missed assessment. 
See Section 8.1.1. 

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day4 
Day8 
Day15 
Day22 
Cycles 
2-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Q12W 
Visit Window 
Day-28 
to Day-1 
- 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
±14D 
Senuu quantitative 
immunoglobulins 
(IgG, IgM, IgA, IgD, 
IgE) 
X 
X 
X 
X 
X 
X* 
X* 
Screening and CIDI (if not done 
within 72 hours prior to dosing). 
For all participants, to be collected 
on a 28-day (±I wk) interval 
whether dose given or not (ie, the 
28-day interval [±I wk] from 
CIDI should be maintained 
regardless of dose 
delays/intem1ptions). IgD or IgE 
only required if the heavy chain 
component of the disease is 
known to be D or E. 
See Section 8.1.1. 
*For pa1ticipants who discontinue 
study intervention without PD: 
perform at EOT, then at least 
Q4W (±I wk) until PD, 
withdrawal of consent, participant 
lost to follow-up, death, or defined 
end of study. For additional 
details, see Appendix I0 

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Page43 
 
 
 
Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day4 
Day8 
Day15 
Day22 
Cycles 
2-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Q12W 
Visit Window 
Day-28 
to Day-1 
- 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
±14D 
Imaging 
(PET/CT, CT or MRI) 
X 
Time points for disease assessments described in notes 
At screening, as clinically 
indicated if EMD is suspected, and 
annually. 
For participants with measurable 
EMD (paramedulla1y disease or 
plasmacytomas associated with 
bone are not considered EMD) at 
screening, every 12 wks (±1 wk) 
and at suspected CR/sCR. 
Paiticipants with non-meastu·able 
EMD must be assessed at 
suspected CR/sCR. Once all 
EMD has resolved/disappeared, 
imaging can be conducted 
annually (or eai·lier if clinically 
indicated) and at suspected PD. 
For pa1ticipants w'ith only skin 
involvement, skin lesions should 
be measured with a mler eve1y 4 
wks (+ 1 wk). Pe1fo1m until PD, 
withdrawal of consent, patticipant 
lost to follow-up, death, or defined 
end of study. 
See Section 8.1.3. 

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Treatment Period 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Cycle 1 
(each 28 Day Cycle) 
 
 
 
 
 
Visit Window 
 
 
 
Day-28 
to Day-1 
I 
 
 
 
 
 
 
 
I 
I 
Day 1 
Day 4 
 
 
-1/+3 
D 
Day 8 
 
 
-1/+3 
D 
Day 15 
 
 
±3D 
Day 22 
 
 
±3D 
Cycles 
Cycle 7 
2-6 
Onwards 
Day 1 
Day 1 
±3D 
±3D 
14 Dpost- 
final dose 
 
 
 
28 to 35 
days post- 
final dose 
Q12W 
 
 
± 14D 

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Page45 
 
 
 
Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day4 
Day8 
Day15 
Day22 
Cycles 
2-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Q12W 
Visit Window 
Day-28 
to Day-1 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
±14D 
Contraception check 
X 
X 
X 
X 
X 
X 
Only required in WOCBP . 
Through 5 months post last dose 
of study intervention. See Section 
5.3.1. 
Pregnancy test 
X 
X 
X 
X 
X 
X 
Only required in WOCBP. Also to 
be done whenever I menstmal 
cycle is missed dming the active 
treatment period (or when 
potential pregnancy is otheiwise 
suspected). Senun required at 
screening. See Section 8.2.7. 
Hematology/chemistry 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
See Section 10.2. For CI D4, 
hematology only. 
PT/INR 
X 
See Section 10.2. 
Hepatitis B and C 
testing 
X 
Hepatitis B and C testing results 
will not be collected in the eCRF. 
See Section 10.2. 

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Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Treatment Period 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Cycle 1 
(each 28 Day Cycle) 
 
 
 
 
Visit Window 
 
 
 
Day-28 
to Day-1 
Day 1 
Day 4 
 
 
-1/+3 
D 
Day 8 
 
 
-1/+3 
D 
Day 15 
 
 
±3D 
Day 22 
 
 
±3D 
Cycles 
Cycle 7 
2-6 
Onwards 
Day 1 
Day 1 
±3D 
±3D 
Q12W 
 
 14 Dpost-  28 to 35 
±14D 
final dose days post- 
final dose 
I 
I 
I 
I 
I 
 
 
 
 
I 
I 
I 
I 
I 
I 

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Page47 
 
 
 
Table 1. 
Schedule of Assessments: Part 1 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
 
 
 
Visit Window 
Day 1  Day 4  Day 8 
 
 
Day-28 
-1/+3 
-1/+3 
to Day-1 
D 
D 
I 
I 
Day 15 
 
 
±3D 
 
I 
Day 22 
 
 
±3D 
Cycles 
2-6 
Dayl 
±3D 
+ 
Cycle 7 
Onwards 
Dayl 
±3D 
 
 
 
14 Dpost- 
final dose 
 
 
 
28 to 35 
days post- 
final dose 
Q12W 
 
 
± 14D 
I 
I 
I 
I 
I 
 
I 
 
 
I 
I 

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Page48 
 
 
 
Table 1. 
Schedule of Assessments: Part 1 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day Cycle) 
EOTVisit 
FU Visit 
LTFU 
Notes/Protocol Section 
Dayl 
Day 4 
Day 8 
Day 15 Day 22 
Cycles 
Cycle 7 
2-6 
Onwards 
Day 1 
Day 1 
Q12W 
Visit Window 
Day-28 
to Day-1 
-1/+3 
D 
-1/+3 
D 
±3D 
±3D 
±3D 
±3D 
14 Dpost- 
final dose 
28 to 35 
days post- 
final dose 
± 14D 
Phannacokinetics and Immunogenicity Assessments 
Blood sample for PK 
X 
X 
X 
X 
(C2, 4, 6) 
x• 
(ClO, 16, 
etc.) 
X 
Predose, 24, and 48 hrs postdose 
on ClDl. Predose and 24 hon 
C1D4. Collect predose on C1D8, 
and Day 1 of C2, 4, 6, then at D1 
of eveiy sixth cycle starting from 
ClO(ie, ClODl, C16D1, etc.). 
If CRS is suspected, additional PK 
samples should be collected if not 
ah-eady scheduled. 
Blood sample for 
ADAs and Nabs 
X 
X 
(C2, 4, 6) 
X 
(ClO, 16, 
etc.) 
X 
Predose on ClDl, C2D1, C4D1, 
C6D1, and eve,y sixth cycle 
sta,ting ClO(ie, ClODl, C16D1, 
etc). If AE possibly related to 
ADA occurs, additional samples 
for ADA and PK should be 
collected if not scheduled. See 
Section 8.7. 

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1.3.2. Part 2 Schedule of Assessments 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day4 Day8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3D ±3D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
±14D 
Info1med consent 
X 
See Section 10.1.3. 
Eligibility criteria 
X 
See Section 5.1 and Section 5.2. 
Register with IRT 
X 
See Section 6.3.1. 
Enrollment in IRT 
X 
See Section 6.3.1. 
Demography/ 
medical history 
X 
See Section 8.2.1. 
Disease 
characteristics/ 
treatment history 
X 
See Section 8.2.1. 
Clinical Procedures/Assessments - Note: Dmin2 theh·eatment pe1iod, all assessments must be done within 72 hom·s p1ior to dosin2, except for disease assessments which 
are to be done eve1-y28 days from ClDl 
Physical 
exam 
X 
X 
X 
X 
X 
X* 
X 
X 
Starting C2Dl up to end ofC6, 
neurological exam to be perfonued 
biweekly (on D1, D15), then eve1y 28 days 
. 
Neurologic exam 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
X 
X 
I E score 

Eh-anatamab 
Protocol Cl071009 
Final Protocol Amendment 4, 20 Dec 2023 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 50 
 
 
 
 
 
 
 
 
 
Visit Window 
Day-28 
 
 
 
-1/+3 
 
-1/+3 
 
 
 
 
Onwards 
 
 
 
 
 
 
 
 
 
 
post- 
 days 
fmal 
post-final 
dose 
  dose 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Treatment Period 
EOT 
FU Visit LTFU 
Notes/Protocol Section 
Cycle 1 
(each 28 Day cycle) 
Visit 
  
 
 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 51 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day 4 Day 8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3 D ±3 D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
± 14D 
Vital signs 
(temperature, HR, 
BP and 02 
saturation) 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
X 
X 
Pre-dose vital signs collected on ClDl, 
C1D4, ClDS, ClD15, and C1D22 and 
C2Dl should be repo1ted in the CRF. 
Vital signs Monitored at least eveiy 4 hrs 
(± 30 min) during the first 48 hrs after first 
dose (ClDl), dtuing 24 hrs after second 
dose of study intervention (C1D4), and 
dming 24 hrs after study intervention 
administration on C2Dl should be repo1ted 
in the CRF (the latter may not be required 
for Pait 2B and Part 2C depending on 
whether CRS is observed after C2D1 dose 
in Pa1t2A). 
If pe1fo1med, abnonual vital signs 
associated with AEs (eg, CRS or an 
infection should be r . 01ted in the CRF. 
 
ECOGPS 
X 

Eh-anatamab 
Protocol Cl071009 
Final Protocol Amendment 4, 20 Dec 2023 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 52 
 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day 4 Day 8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3 D ±3 D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
± 14D 
CMVtesting 
(quantitative PCR) 
X 
X(See 
Notes) 
Local laborato,y. 
To be done prior to administration of first 
study intervention (at screening or prior to 
first dose) and then either monthly or eveiy 
I to 3 cycles depending on risk factors and 
baseline CMV viral load as clinically 
indicated. See Section 6.8.7 and 
Appendix 15. 
For pa,ticipants akeady enrolled and 
treated under Part 2, a CMV testing should 
be pe1fo1med as a baseline reference for 
CMV status at the next scheduled visit and 
repeated eveiy I to 3 cycles depC11ding on 
risk factors and baseline CMV viral load 
SARS-CoV-2 test 
X 
X 
X* 
Starting with protocol amendmC11t 4, PCR 
or antigen test required predose on Day I 
(CXDI), upon suspected exposure to 
SARS-CoV-2 and at signs or symptoms of 
COVID-19 infection (see AppC11dix 2 and 
Appendix 15). 
or pa,ticipants with SARS-CoV-2 
• fection, study intervention should be 
elayed for at least 14 days from the start of 
ptoms or positive test result. 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 53 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day4 Day8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3D ±3D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
±14D 
Triplicate 
X 
X 
X 
X 
X 
Single assessment at screening. 
12-LeadECG 
(Singlet) 
(Predose 
(C4 and 
Triplicate at all other time points. 
and 24 hr 
C6) 
Predose ECG for all specified visits. 
postdose) 
Perform ECG prior to elranatamab 
administration (and premedication) and PK 
sample collection (if scheduled). 
Additional 24 hr postdose time point at 
C2D1 should be collected. 
ECG assessments should be skipped if 
CRS symptoms are ongoing. Additional 
ECGs should be pe1fo1med as clinically 
indicated. 
See Section 8.2.4. 
ECHO/MUGA 
X 
See Section 8.2.5. 
Premedication for 
CRS 
X 
X 
X 
Must be administered approximately 
60 min (±15 min) prior to elranatamab 
dose. See Section 6.8.1. 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 54 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Treatment Period 
EOT 
FU Visit LTFU 
Notes/Protocol Section 
Cycle 1 
(each 28 Day cycle) 
Visit 
  
 
 
Day 1 Day 4 Day 8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3 D ±3 D 
± 3 D 
±3D 
±3D 
14D 
28 to35 ±14D 
post- 
 days 
fmal 
post-final 
dose 
  dose 
Eh-anatamab 
administration 
X 
X 
X 
X 
X 
X 
(Q2W) 
X 
(Q2W) 
X 
iif 
 
or 
 
 
 
 
 
Participant 
hospitalization 
 
 
 
 
 
 
 
DLT evaluation 
(Part 2A and 2C 
only) 
AE  o 'to. g 
Concomitant 
therapy 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
 
 
sess Co t' uously 
Assess Contmuously 
Hospitalization requit·ed for at least 2 days 
on ClDl and 1 day (ovemight) on C1D4. 
Hospitalization from ClDI to ClDS may 
be considered. Hospitalization required for 
at least I day on C2D1 for Patt 2A. 
Hospitalization on C2D1 may not be 
required for Part 2B and Pait 2C dependmg 
on CRS profile observedm Patt 2A. See 
Section 2.3.1and 4.1. 
See Section 4.3.3. 
 
 
See Sect'o 8.. 
See Section 6.8. 

Eh-anatamab 
Protocol Cl071009 
Final Protocol Amendment 4, 20 Dec 2023 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 55 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day4 Day8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3D ±3D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
±14D 
Subsequent 
anticancer 
therapies/date of 
progression 
Assess continuously 
See Section 7.1. 
Survival status 
X 
X 
Collected by telephone eve,y 12 weeks 
until death, or at least 2 years from the date 
of enrolhnent, whichever comes first. See 
Section 7.I. 
Disease response 
assessment (per 
IMWG criteria) 
X 
X 
X 
X 
X* 
X* 
To be conducted on a 28-day (±I wk) 
interval whether dose given or not (ie, the 
28-day interval (±I wk) from CIDI should 
be maintained regardless of dose 
delays/intem1ptions). 
See Section 8.1. 
*For pa,ticipants who discontinue study 
intervention without PD: pe1fo1m at EOT 
visit, then at least Q4W (±I wk) until PD, 
withdrawal of consent, pa,ticipant is lost to 
follow-up, death, or defined end of study. 
See Appendix I 0. 

Eh-anatamab 
Protocol Cl071009 
Final Protocol Amendment 4, 20 Dec 2023 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 56 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day4 Day8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3D ±3D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
±14D 
SPEP, SIFE, serum 
FLC 
X 
X 
X 
X 
X 
X 
X* 
X* 
Screening and CIDI (if not done within 72 
hours prior to dosing). 
To be conducted on a 28-day (±I wk) 
interval whether dose given or not (ie, the 
28-day interval (±I wk) from CIDI should 
be maintained regardless of dose 
delays/intem1ptions). 
*For pa1ticipants who discontinue study 
intervention without PD: pe1fo1m at EOT 
visit, then at least Q4W (±I wk) until PD, 
withdrawal of consent, pa1ticipant lost to 
follow-up, death. or defined end of study. 
Except for sCR, semm FLC analysis is 
required when both semm and tu-ine M- 
component levels are deemed non 
measm·able or uninte1pretable(including at 
suspected CR). 
See Section 8.1.1. 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 57 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day4 Day8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3D ±3D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
±14D 
UPEP, UIFE (24- 
hotu·urine 
collection 
required) 
X 
X 
X 
X 
X 
X 
X* 
X* 
Screening and CIDI (if not done within 72 
hours prior to dosing). 
To be conducted on a 28-day (±I wk) 
interval whether dose given or not (ie, the 
28-day interval (±I wk) from CIDI should 
be maintained regardless of dose 
delays/intem1ptions). 
"'For pa1ticipants who discontinue study 
intervention without PD: pe1fo1m at EOT 
visit, then at least Q4W (±I wk) until PD, 
withdrawal of consent, pa1ticipant lost to 
follow-up, death, or defined end of study. 
If an evaluable 24-hotu·urine collection is 
missed, another attempt for collection 
should be scheduled within 7 days of the 
missed assessment. 
See Section 8.1.1. 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 58 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day4 Day8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3D ±3D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
±14D 
Senuu quantitative 
immunoglobulins 
(IgG, IgM, IgA, 
IgD, IgE) 
X 
X 
X 
X 
X 
X 
X* 
X* 
For all participants, to be collected on a 28- 
day (±1 wk) interval whether dose given or 
not (ie, the 28-day interval [±I wk] from 
CIDI should be maintained regardless of 
dose delays/intem1ptions) . IgD or IgE only 
required if the heavy chain component of 
the disease is known to be DorE. 
See Section 8.1.1 
"'For pa1ticipants who discontinue study 
intervention without PD: pe1fo1m at EOT, 
then at least Q4W (±I wk) until PD, 
withdrawal of consent, pa1ticipant lost to 
follow-up, death, or defmed end of study. 
See Appendix 10. 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 59 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day4 Day8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3D ±3D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
±14D 
Imaging 
(PET/CT, CT or 
MRI) 
X 
Time points for disease assessments described in notes 
At screening, as clinically indicated if 
EMD is suspected and annually. 
For pa1ticipants with measurable EMD 
(paramedullarydisease or plasmacytomas 
associated with bone are not considered 
EMD) at screening, every 12 wks (± 1 wk) 
and at suspected CR/sCR. Pa1ticipants w-ith 
non-measurable EMD must be assessed at 
suspected CR/sCR. Once all EMD has 
resolved/disappeared, intaging can be 
conducted annually (or earlier if clinically 
indicated) and at suspected PD. For 
participants with only skin involvement, 
skin lesions should be measured with a 
mler every 4 wks (+ 1 wk). Pe1form until 
PD, withdrawal of consent, participant lost 
to follow-up, death, or defined end of 
study. See Section 8.1.3. 

Eh-anatamab 
Protocol Cl071009 
Final Protocol Amendment 4, 20 Dec 2023 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 60 
 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Treatment Period 
EOT 
FU Visit LTFU 
Notes/Protocol Section 
Cycle 1 
(each 28 Day cycle) 
Visit 
 
Day 1 Day 4 Day 8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3 D ±3 D 
± 3 D 
±3D 
±3D 
14D 
post- 
fmal 
28 to35 
days 
post-final 
±14D 
dose 
dose 
 
I 
 
 
 
 
 
I 
 
I 
 
 
 
 
Contraception 
check 
X 
X 
X 
X 
X 
X 
X 
Only requit·ed in WOCBP. Through 5 
months post last dose of study intervention. 
See Section 5.3.1. 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 61 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
FU Visit  LTFU 
Visit 
 
Ql2W 
Notes/Protocol Section 
Day 1 Day 4 Day 8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Visit Window 
Day-28 
-1/+3 
-1/+3 
±3 D ±3 D 
± 3 D 
±3D 
±3D 
14D 
28 to35 ±14D 
post- 
 days 
fmal 
post-final 
dose 
dose 
to 
D 
D 
Day-1 
Pregnancy test 
X 
X 
X 
X 
X 
X 
X 
Only requit·ed in WOCBP. Also to be done 
whenever 1 menstrual cycle is missed 
during the active treatment period (or when 
potential pregnancy is otherwise 
suspected). Serum requit·ed at screening. 
See Section 8.2.7. 
Hematology/ 
chemistiy 
PT/INR 
Hepatitis B and C 
testing 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
See Section 10.2. For Cl D4, hematology 
only. 
See Section 10.2. 
Hepatitis B and C testing results will not be 
collected in the eCRF. 
See Section 10.2. 

Eh-anatamab 
Protocol Cl071009 
Final Protocol Amendment 4, 20 Dec 2023 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 62 
 
 
Notes/Protocol Section 
 
 
 
 
 
 
 
 
 
 
 
 
I 
fmal 
post-final 
dose 
 
dose 
I 
I 
I 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
FU Visit LTFU 
Visit 
 
Day 1 Day 4 Day 8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
-1/+3 
D 
-1/+3 
D 
±3D ±3D 
±3D 
±3D 
±3D 
14D 
post- 
28 to35  ±14D 
days 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 63 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
  
 Ql2W 
Day 1 Day 4 Day 8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Visit Window 
Day-28 
-1/+3 
-1/+3 ±3D ±3D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
I 
28to35 
days 
post-final 
dose 
±14D 
to 
D 
D 
Day-1 
I 
I 
I 
I 
I 
I 
I 
I 
1111 
- 
I 
I 
I 
I I 

Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 64 
 
 
 
 
 
 
 
 
 
 
 
-1/+3 
 
-1/+3 
 
 
 
 
Onwards 
 
 
 
Visit Window 
 
post- 
 
 
days 
post-final 
dose 
I 
I 
I 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Treatment Period 
EOT 
FU Visit LTFU 
Notes/Protocol Section 
Cycle 1 
(each 28 Day cycle) 
Visit 
  
 
 

Elranatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 65 
 
 
 
Table 2. 
Study Schedule of Assessments: Part 2 
 
Visit Identifier 
Screening 
Treatment Period 
Cycle 1 
Treatment Period 
(each 28 Day cycle) 
EOT 
Visit 
FU Visit LTFU 
Notes/Protocol Section 
Day 1 Day 4 Day 8 Day 
15 
Day 
22 
Cycle2 
Dayl 
Cycles 3-6 
Dayl 
Cycle7 
Onwards 
Dayl 
Ql2W 
Visit Window 
Day-28 
to 
Day-1 
-1/+3 
D 
-1/+3 
D 
±3 D ±3 D 
±3D 
±3D 
±3D 
14D 
post- 
fmal 
dose 
28 to35 
days 
post-final 
dose 
± 14D 
Phannacokinetics and Immunogenicity Assessments 
Blood sample for 
PK 
X 
X 
X 
X 
X 
(C4 and 
C6) 
X* 
(C8, 10, 
13, etc.) 
X 
Predose, 24 and 48 hrs postdose on Cl DI. 
Predose and 24 hon C1D4 and C2Dl. If 
no hospitalization required on C2Dl for 
Part 2B and Pait 2C, the 24 h postdose w-ill 
not be required. 
Collect predose on C1D8 and on DI ofC2, 
4, 6, 8, then at Day 1 of eve1y third cycle 
starting ClO (ie, ClODl, Cl3Dl, etc). 
In the event of suspected CRS, unexpected 
or serious AE, or AE leading to 
discontinuation of study intervention, 
additional PK samples should be collected 
if not already scheduled. 
Blood sample for 
ADAs and NAbs 
X 
X 
X 
(C4 and 
C6) 
ClO, 16, 
etc 
X 
Predose on ClDl, C2Dl, C4Dl, C6Dl and 
every sixth cycle sta1ting ClO(ie, ClODl, 
C16Dl, etc). If AE possibly related to 
ADA occurs, additional samples for ADA 
and PK should be collected if not 
scheduled. 
See Section 8.7. 

Elranatamab 
Protocol C1071009 
Final Protocol Amendment 4, 20 Dec 2023 
PFIZER CONFIDENTIAL 
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021) 
Page 66 
 
 
2. INTRODUCTION 
Elranatamab (PF-06863135), a heterodimeric humanized full-length bispecific IgG2 kappa 
antibody that targets both BCMA on MM cells and CD3 on T-cells (BCMA x CD3 bispecific 
antibody), is currently being developed for the treatment of participants with MM. 
2.1. Study Rationale 
The purpose of the study Part 1 and Part 2 is to evaluate the rate of Grade ≥ 2 CRS using a 
priming regimen that involves a premedication cocktail and 2 step-up priming doses to be 
administered within the first week of elranatamab treatment. The study will also evaluate the 
safety, tolerability, PK, pharmacodynamics, and preliminary anti-myeloma activity of 
elranatamab full doses 76 mg and > 76 mg with different dosing intervals.. 
2.2. Background 
2.2.1. Multiple Myeloma 
MM is a hematological B-cell malignancy characterized by dysregulated proliferation of BM 
plasma cells. Globally, there are approximately 176,000 new cases and 117,000 deaths per 
year attributed to MM.[4] The American Cancer Society estimates that for the US in 2021, 
approximately 34,920 new MM cases will be diagnosed and approximately 12,410 
MM-related deaths will occur.[5] 
Despite recent advances in treatment, MM remains an incurable disease and almost all 
patients, even those who initially respond to treatment, are expected to relapse. Even for 
patients who receive ASCT, the median time to relapse is only 17.2 months.[6] Similarly, for 
patients who are treated with novel PI-based or IMiD-based combination regimens as 
frontline treatment, the median time to relapse is 16.4 months.[7] 
Moreover, MM patients typically cycle through many lines of treatment, having become 
relapsed/refractory to various therapeutic approaches. Trials that have treated patients with 
BCMA-directed therapy in the RRMM population have included heavily pretreated patients; 
for example, 57% of patients studied by Trudel et al had received ≥5 lines of therapy[8] and 
other trials have included populations receiving a median of 6 (range 3-18) prior therapies[9] 
and a median of 5 (range 3 to 18) prior therapies.[10] 
Outcomes in the RRMM population are quite poor; for example, patients with RRMM who 
respond poorly to PI-based or IMiD-based regimens show a median OS of 13 months (95% 
CI: 11, 15).[11] Newer and more effective therapies have substantially increased patient 
benefit; however, in this real-world setting (N=3449), the most recent 4-year survival is only 
75%.[12] Results from 2 trials in patient populations similar to the current protocol are 
summarized in Table 3. The lack of effective and durable therapeutic options highlights the 
unmet medical need in the RRMM patient population. 

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Table 3. 
Efficacy Results for Available Therapies for Patients With Relapsed/ 
Refractory Multiple Myeloma Who Have Received at Least 2 Prior 
Therapies 
 
Available 
Therapy 
Prior 
Therapy for 
Eligibility 
Median 
Number of 
Prior 
Therapies 
ORR 
% (n/N) 
mDOR 
(months) 
Reference 
Selinexor + 
dexamethasone 
IMiD, PI, 
anti-CD38 
mAb 
8 
25.3% (21/83) 
3.8 
XPOVIO® 
USPI 
Belantamab 
mafodotin 
(belamaf)a 
IMiD, PI, 
anti-CD38 
mAb 
7 
32% 
(31/97) 
11.0 months 
(95% CI, 4.2 
months to not 
reached), 
BLENREP 
USPI 
Idecabtagene 
vicleucelb 
IMiD, PI, 
anti-CD38 
mAb 
6 (3-6) 
72% 
(72/100)b 
11.0 
ABECMA® 
USPI 
Melphalan 
flufenamide + 
dexamethasonec 
IMiD, PI, 
anti-CD38 
mAb 
6 
23.7% (23/97) 
4.2 
PEPAXTO® 
USPI 
Carfilzomib 
IMiD, PI 
5 
23% (61/266) 
7.8 
KYPROLIS® 
USPI 
Kd (carfilzomib + 
dexamethasone) 
IMiD, PI 
1-3 
76.9% 
(357/464) 
21.3 
KYPROLIS® 
USPI 
(ENDEAVOR 
study) 
Daratumumab 
IMiD, PI 
5 
29.2% 
(31/106) 
7.4 
DARZALEX® 
USPI 
Pomalidomide + 
dexamethasone 
IMiD, PI 
5 
29.2% 
(33/113) 
7.4 
POMALYST® 
USPI 
Ciltacabtagene 
autoleucel 
IMiD, PI, 
anti-CD38 
mAb 
6 
97.9% (95/97) 
21.8 (21.8, NE) 
CARVYKTI 
USPI 
a. 
Blenrep® was withdrawn from the US market on 22 Nov 2022, based on the outcome of the 
DREAMM-3 phase III confirmatory trial[13]. 
b. ORR for the evaluable population; ORR for the mITT (N=135) was 64%. 
c. 
Pepaxto® was withdrawn from the US market on 22 October 2021 due to an overall survival data (ie, 
lack of efficacy) in the ITT population of the Phase 3 OCEAN study [14]. 
[15-22] 
 
2.2.2. BCMA and CD3 
BCMA is a transmembrane glycoprotein belonging to the TNFr SF 17 superfamily. BCMA is 
normally expressed exclusively in lymphocytes of the B-cell lineage, including plasmablasts 
and differentiated plasma cells, where it is involved in the regulation of B-cell maturation. 
BCMA is widely expressed on malignant plasma cells collected from patients with MM 
whereas BCMA is detected in a very small proportion of normal BM mononuclear cells from 
healthy volunteers.[23] Cleavage of cell surface BCMA by γ-secretase releases sBCMA[24] 
which can act as a decoy for BCMA-directed antibodies. Inhibition of γ-secretase can reduce 
levels of sBCMA and increase activity of BCMA-directed therapies.[25] sBCMA levels in 

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serum are elevated in patients with MM and correlate with the proportion of MM cells in the 
BM microenvironment. sBCMA levels are independent of renal function, which permits its 
use as a biomarker in patients with renal insufficiency, and BCMA is detectable in the serum 
of patients with non-secretory disease.[26] Moreover, patients in 2 studies with high baseline 
levels of sBCMA appeared to have poorer clinical outcomes.[23,26] 
T-cells are potent immune cells capable of mediating adaptive immunity through the 
expression of antigen receptor complexes (TCR), which comprise an antigen-specific 
alpha-beta heterodimer and a transmembrane CD3 protein and mediate receptor signaling 
and T-cell activation.[27] TCRs recognize specific protein fragments (ie, peptides) presented 
by MHC proteins on APCs, virally infected cells, and tumor cells. Triggering of CD3 
signaling in a CD8+ T-cell synapsed with another cell presenting a target antigen can cause 
the T-cell to release perforin and granzyme B, resulting in cancer cell lysis and death. Cancer 
cells can avoid T-cell recognition and destruction by down-modulating peptide/MHC 
presentation. One way to remove dependence on peptide/MHC presentation is through direct 
bridging of a cell-surface antigen on a target cell with the extracellular CD3 on T-cells, 
leading to T-cell signaling equivalent to that generated by MHC/TCR-based engagement. 
2.2.3. Elranatamab (PF-06863135) 
Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa mAb derived 
from 2 mAbs, the anti-BCMA mAb (PF-06863058) and the anti-CD3 mAb (PF-06863059).. 
Targeted T-cell-mediated cytotoxicity follows the binding of 1 epitope of elranatamab to 
CD3-expressing T-cells and a second epitope to BCMA-expressing MM cells. 
2.2.3.1. Nonclinical Studies of Elranatamab 
In vitro, elranatamab has been shown to induce cytokine release by human T-cells and to 
redirect patient T-cells to lyse tumor cells from MM patients in a concentration-dependent 
manner. Elranatamab also showed robust anti-tumor activity in vivo following a single dose 
in 3 different orthotopic human MM models established in immunodeficient mice engrafted 
with human T-cells, and greater potency was correlated with higher BCMA expression 
levels. In another orthotopic tumor model with low BCMA expression levels, a second 
dosing of elranatamab was found to delay tumor progression. As part of a secondary 
pharmacology assessment, elranatamab induced cytokine release in human whole blood, 
which was expected due to the presence of BCMA-expressing target cells, confirming the 
mechanism of action. Finally, two 1-month GLP toxicology studies in cynomolgus monkeys 
showed mechanism-based effects, including increased T-cell activation, increased cytokines 
and microscopic findings in the secondary lymphoid tissues. Decreases in circulating 
lymphocytes and serum globulins were also noted. 
2.2.3.2. Clinical Overview 
Elranatamab is being evaluated for the treatment of adult patients with RRMM or NDMM in 
11 ongoing studies. For detailed information on these studies, refer to the IB (January 2023). 

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The safety, efficacy, and PK of elranatamab as a single agent were initially evaluated in a 
Phase 1 study (C1071001) as monotherapy (IV and SC) or in combination with lenalidomide 
or pomalidomide. This study is ongoing, and enrollment is complete. Results from the study 
were recently published by Bahlis et al, 2023 [28]. 
Enrollment in the Phase 2 study C1071003 completed in January 2022 with a total of 187 
participants enrolled and treated. Study results on the safety, efficacy, clinical pharmacology 
and immunogenicity of elranatamab are provided in the IB and were recently published by 
Lesokhin et al, 2023 [29]. 
2.3. Benefit/Risk Assessment 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of elranatamab may be found in the IB, which is the SRSD for this study. 

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2.3.1. Risk Assessment 
 
Potential Risk 
of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
Study Intervention: Elranatamab monotherapy 
CRS 
A known toxicity of 
Patticipants will be hospitalized for at least 2 days after the CIDl dose and at least 1 day after the ClD4 
dose for safety surveillance (Patt I, Part 2). Hospitalization from Cl DI to CID5 may be considered. Since 
CRS events occmTed after the first (predominantly within the first 2 days) and second dose of 
eh-anatamab, the planned 2-day hospitalization after the first dose allows for the detection of initial CRS 
signs and symptoms and enables timely management of these events according to the ASTCT 
management guidelines. The I-day hospitalization on CID4 is considered adequate given the anticipated 
lower incidence and grade CRS after the second step-up dose of 20 mg. 
For Patt 2A, participants will be hospitalized for at least 1 day also on C2Dl. For Part 2B and Patt 2C, 
hospitalization on C2Dl may not be required depending on CRS profile observed in Part 2A. For 
patticipants enrolled in Part 1 who would switch to the RP2D Q4W, optional hospitalizationmay be 
considered on the day of RP2D administration depending on CRS profile observed in Patt 2A and Patt 2B. 
The 2 step-up priming doses schema is expected to mitigate the rate and severity of CRS, which is mainly 
expected after the first 1 to 2 doses. 
To fwther mitigate the CRS risk, premedications will be administered prior to the first 3 doses on ClD I, 
CID4 and CID8 (see Section 6.8.I). No premedications will be administered on C2Dl for Part 2 as the 
risk of CRS after repeated eh-anatamab administration, even with a higher eh-anatatnab dose, is considered 
low. 
Guidance for monitoring, grading, and management of CRS per ASTCT criteria and guidelines is included 
in Appendix 12. 
Dose modification/discontinuation in the setting of Grade c:::2 AEs (including CRS) is described in 
Section 6.5. 
This study will include only participants who are likely to tolerate potential events of CRS by excluding 
patticipants who at·e particularly susceptible to complications of CRS, including those with impaired 
cardiac function or clinically significant CV disease (see Section 5.1 and Section 5.2). 
Criteria for temporary study hold based on Grade c:::3 CRS events are described in Section 9.4.1. 
therapeutics that function by 
activation of immune 
effector cells. 
Circulating cytokines are 
elevated after IV or SC 
administration of 
elranatamab. CRS signs and 
symptoms are expected 
mainly after the first and 
second dose and 
occasionally after the third 
or later doses of 
elranatamab. 
In the present study, 
elranatamab dose will be 
increased to> 76 mg starting 
from Cycle 2 either with 
longer dosing intervals in 
Patt 2A DLI, Patt 2A DL2, 
and Patt2B 
For Part 2, the planned 
regimen would result in up 
to 2-fold higher Cmax on 
Cycle 2 Day 1 (152 mg 
Q2W) compat·ed to 76 mg 
QW. Higher Cma.x during the 
first 24 hours of the first 

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Potential Risk 
of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
dose of elranatamab was 
associated with a higher risk 
of CRS 
(See Section 4.3). Despite 
the predicted higher Cmax for 
C2D1 in Part 2, the risk of 
CRS events on C2D1 (ie, 
after 2 step-up priming 
doses, and 3 full doses of 76 
mg in Cycle 1) is considered 
low. 
For further information, refer 
to the IB. 
ICANS 
A known toxicity of 
therapeutics that function by 
activation of immune 
effector cells. 
Data from ongoing studies 
suggest ICANS is infrequent 
and most often Grade ≤2. 
For further information, refer 
to the IB. 
Participants will be hospitalized for at least 2 days after the C1D1 dose and at least 1 day after the C1D4 
dose for safety surveillance. Hospitalization from C1D1 to C1D5 may be considered. For Part 2A, 
participants will be hospitalized for at least 1 day also on C2D1. For Part 2B and Part 2C, hospitalization 
on C2D1 may not be required depending on CRS profile observed in Part 2A. For participants enrolled in 
Part 1 who would switch to the RP2D Q4W, optional hospitalization may be considered on the day of 
RP2D administration depending on CRS profile observed in Part 2A and Part 2B. 
The 2 step-up priming doses schema may mitigate the rate and severity of ICANS, which is mainly 
expected after the initial dose. 
Regular neurologic examinations will be performed by the investigator (or designee) (Section 8.2.2). 
Guidance for monitoring, grading, and management of ICANS per ASTCT criteria and guidelines is 
included in Appendix 12. 
Dose modification/discontinuation in the setting of Grade ≥2 AEs (including ICANS) is described in 
Section 6.5.1.2. 
Additional management for Grade ≥3 ICANS events is described in Section 10.12.2 
Criteria for temporary study hold based on Grade ≥3 ICANS events are described in Section 9.4.1. 

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Potential Risk 
of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
Peripheral 
neuropathy 
including GBS 
Peripheral neuropathy is a 
complication of multiple 
myeloma and its treatment. 
This study excludes participants who may be particularly susceptible to new or worsening peripheral 
neuropathy, including those with POEMS syndrome, history of GBS or GBS variants, ongoing Grade ≥2 
peripheral neuropathy and history of prior neuropathy with BCMA-directed drugs (see Section 5.2). 
In the Phase 1 study 
(C1071001) and Phase 2 
study (C1071003, cohort A), 
Grade 3 peripheral 
neuropathy has been 
observed with elranatamab. 
Regular neurologic examinations will be performed by the investigator (or designee) to monitor for 
emerging signs and symptoms of new or worsening peripheral neuropathy. 
The administration of drugs known to cause peripheral neuropathy should be carefully considered, and if 
possible, avoided by the investigator; effective treatment and prophylaxis for infections should be 
prioritized (Section 6.8). 
Participants should be closely monitored for signs and symptoms of neuropathy following infections or 
following the administration of any vaccine (Section 8.3.8). 
Dose modification/discontinuation for peripheral neuropathy is described in Section 6.5. 
Work-up recommendations for new or worsening peripheral neuropathy (Grade ≥2) is described in 
Section 8.3.8. 
Additional management for peripheral neuropathy is described in Section 9.4.1. 
Infections 
Infections are common in 
patients with RRMM due 
to underlying 
immunosuppression. As 
elranatamab causes plasma 
cell depletion, and likely 
contributes to worsening 
hypogammaglobulinemia 
and neutropenia, 
elranatamab treatment 
increases the risk of 
infections. 
See Section 6.8.8 and Appendix 15 for infection prophylaxis. 
Monitor participants, especially those with neutropenia, for signs of infection. See Section 6.5.1 for dose 
modifications for elranatamab. 
For further information refer 
to the IB. 
( 

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Potential Risk 
of Clinical 
Significance 
Summary of 
Data/Rationale for Risk 
Mitigation Strategy 
Disease 
The elranatamab dose will 
Understanding the association between Ctrough and other exposure metrics on efficacy is evolving. While a 
progression 
be increased from Cycle 2 
dose > 76 mg with longer dosing intervals starting from Cycle 2 may be associated with a lower Ctrough, the 
due to lower 
while increasing the dosing 
risk of increased disease burden is considered low given the similar overall dose intensity (eg, 76 mg QW 
Ctrough in Part 
interval from QW to Q2W. 
versus 152 mg Q2W) and the potential for better saturation of the sBCMA across the dosing interval with 
2A/Part 
Based on predictions from 
doses > 76 mg even with longer dosing intervals. 
2B/Part 1 from 
preliminary population PK 
C7 
analyses, switching the 
elranatamab dose to 152 mg 
Q2W starting from Cycle 2 
are predicted to result in an 
average Ctrough ~ 14 and 
~10% lower compared to 76 
mg QW for free and total 
elranatamab, respectively. 

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2.3.2. Benefit Assessment 
There are few viable treatment options for RRMM, especially for those patients who are 
refracto1y to Pls, IMiDs and anti-CD38 mAbs (see Section 2.2.1). Based on data from the 
ongoing Phase 1 study (C1071001) and Phase 2 study (C1071003), elranatamab 
monotherapy has the potential to provide clinical benefit to participants with RRMM (see 
IB). 
The 2 step-up priming doses approach and premedication schema proposed in this study are 
expected to fmiher reduce the rate and severity of CRS (see Section 6.1). 
The dosing regimen of 76 mg QW SC, as implemented in Pait 1 for the first 6 cycles and Pali 
2 dming Cycle 1, is expected to result in clinical benefit and provide coverage for the 
majority of triple-class RRMM patients with a manageable safety profile. 
In Pait 2, the administration of elranatamab doses> 76 mg with longer dosing intervals, eg, 
152 
4W will mai 
• 
• 
• • 
 
 
e p anne regunens m Pait 2 
B or C an m Pait 1 a er 6 eye es cou 
ui er 
saturate the sBCMA sink across the dosing interval especially in patients with relatively high 
sBCMA levels. Better satmation of sBCMA would result in higher unbound elranatamab 
exposme which is anticipated to derive, maintain and/or fiuther deepen clinical responses. In 
addition, less frequent dosing can increase patient convenience and improve compliance. 
2.3.3. Overall Benefit/Risk Conclusion 
Considering the measmes taken to miniinize risk to study paiticipants, the potential risks 
identified in association with elranatamab are justified by the anticipated benefits that may be 
afforded to paiticipants with RRMM. 
 
More details on the safety, efficacy, clinical phaimacological and immunogenicity of 
elranatamab are provided in the IB. 

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3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS 
 
Objectives 
Endpoints 
Estimands 
Prima1-y 
Pa1·t 1 and Pa1·t 2 
•  To assess the rate of Grade 
2 CRS when eh-anatamab is 
administered with a dosing 
regimen of2 step-up priming 
doses and premedication in 
pa1ticipants with RRMM 
• Grade2 CRS rate during Cl. 
• The primary estimand is rate of 
Grade2 CRS during Cl as 
assessed by ASTCT criteria. It will 
be estimated based on all enrolled 
RRMM pa1ticipants who received 
at least 1 dose of study intervention
regardless of duration on the study 
treatment. 
Seconda1-y 
Part 1 and Part 2 
• To assess the safety and 
tolerability of eh-anatamab at 
doses >76 mg with a longer 
dosing interval(> 1 week) in 
order to identify the RP2D 
(Part 2A and 2C) 
• Incidence ofDLTs during DLT 
observation period. 
• The secondruy estimand is DLT 
rate estimated based on data from 
DLT-evaluable pruticipants during 
the DLT observation period 
• To evaluate the overall safety 
profile of eh-anatamab with 2 
step-up priming doses and 
alternative dosing regimens 
in participants with RRMM 
• Adverse Events as chru·acterized 
by type, frequency, severity as 
graded by NCI CTCAE version 
5.0, timing, seriousness, and 
relationship to elranatrunab. The 
severity of CRS and ICANS will 
be assessed according to ASTCT 
criteria; 
•  Laborato1y abnormalities as 
characterized by type, frequency, 
severity (as graded by NCI 
CTCAE version 5.0), and timing. 
• Not Applicable 
• To evaluate the anti- 
myeloma activity of 
eh-anatamab with alternative 
dosing regimens in 
pa1ticipants with RRMM 
• ORR and CRR, per IMWG 
response criteria as determined by 
investigator; 
• Time to event endpoints: TTR, 
DOR, DOCR and PFS per IMWG 
response criteria as detennined by 
investigator, and OS; 
• MRD (assessed by central lab) 
negativity rate per IMWG 
sequencing criteria. 
• Not Applicable 

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4. STUDY DESIGN 
4.1. Overall Design 
Study C1071009 is a prospective, open-label, multicenter, non-randomized Phase 1/2 study 
aimed to evaluate the safety (in paiticular the rate of Grade::::2 CRS) of a priming dose 
regimen of eh-anatamab that involves premedication and 2 step-up p1irning doses to be 
administered within the first week of treatment (Pait 1 and Pait 2). Study C1071009 will 
include RRMM paiticipants who are refracto1y to at least 1 PI, 1 IMiD, and 1 anti-CD38 
mAb. 
All participants emolled in Pait 1 and Pait 2 will contribute to the primaiy objective of the 
study, ie, assessing the rate of Grade ::::2 CRS during Cl, asthe same dosing regimen is 
administered to all treatment groups during the first cycle. 
To evaluate immunogenicity 
• 
 Incidence and titers of ADA and 
of eh-anatamab 
 
NAb against eh-anatamab. 
I 
·- 
·- 
·- 
Not Applicable 
• Not Applicable 
 Pre- and postdose concentrations 
of eh-anatamab. 
To evaluate the PK of 
eh-anatamab 
 
 
 

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Overall, at time of protocol amendment 4, Pait 1 and Pait 2 (Pait 2A and Pait 2B) were 
ongoing, and the enrollment is completed in all coho1ts. Pait 2C will not be explored. The 
RP2D was detennined from Pait 2A and is described below. 
Twelve pa1ticipants were enrolled and treated in Pait 2A DLI (116 mg Q2W from C2Dl) 
and 7 were DLT evaluable. There was one DLT event. Eleven paiticipants were enrolled and 
treated in Pait 2A DL2 (152 mg Q2W from C2D 1) and 7 were DLT evaluable. There was 
one DLT event. During the dose level review meeting (DLRM), the 152 mg Q2W dose was 
selected as the RP2D with a switch to 152 mg Q4W sta1ting in Cycle 7 (for paiticipants with 
an IMWG response of PR or better persisting for 2 months). In addition, participants in 
Pait 1 dosed with 76 mg Q2W, with an IMWG response of PR or better persisting 
for 
2 months were also pennitted to switch to 152 mg Q4W. RP2D is cmTently investigated 
in Pait 2B with a dosing of 152 mg Q2W or 152 mg Q4W (depending on IMWG response). 
 
All study pa1ts ai·e detailed below. 
 
Part 1 and Part 2: 
The following dosing regimen will be evaluated in the first cycle (Cl) of elranatamab 
treatment: 
• 
C1D1: Premedication + elranatainab 4 mg (hospitalization for at least 2 days, see 
Section 2.3.1) 
• 
C1D4: Premedication + elranatainab 20 mg (hospitalization for at least 1 day, see 
Section 2.3.1) 
• 
C1D8: Premedication + elranatainab 76 mg 
 
• 
C1D15 and C1D22: elranatainab 76 mg QW 
The first 2 doses of elranatamab on ClDl and C1D4 will serve as the step-up priming doses 
and will be administered on an inpatient basis to monitor paiticipants for CRS/ICANS. The 
dose of elranatamab should be increased to 20 and 76 mg on C1D4 and C1D8, respectively, 
as long as the paiticipant meets redosing criteria (Section 6.5.1). 
In addition, the study will evaluate the overall safety, tolerability, PK, phaimacodynainics, 
and preliminaiy anti-myeloma activity of a regimen of elranatainab full dose of 76 mg QW 
for 6 cycles followed by Q2W or> 76 mg Q4W (Pait 1) and alternative regimens of 

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ehanatamab at dose levels >76 mg staiting from C2 with different dosing intervals (QW, 
Q2W, Q4W) (Pait 2). 
The following dosing regimens will be assessed: Part 1: Premedication, 2 step-up priming 
doses, and full dose 76 mg QW for 6 cycles followed by Q2W and/or RP2D (116 mg or 
152 mg) Q4W as determined from Part 2A. 
Pait 1 aims to evaluate the overall safety, tolerability, PK, phannacodynamics, and 
preliminaiy anti-myeloma activity of the following regimen: 
• 
C2 to C6: ehanatainab 76 mg QW 
 
• 
C7 onwards: ehanatamab 76 mg Q2W (for participants with IMWG response of 
PR or better persisting for 2 months on QW) 
• 
C7 onwards once the RP2D is identified in Part 2A: ehanatainab RP2D (116 
mg or 152 mg) Q4W (for paiticipants with IMWG response of PR or better 
persisting for  2 months on QW or Q2W). An optional day of hospitalization 
may be considered for the first RP2D dosing (116 mg or 152 mg) Q4W depending 
on CRS profile observed in Pait 2A and Pait 2B. 
• 
 
 
Part 2: Premedication, 2 step-up priming doses, and full dose> 76 mg (ie 116 and 152 
mg) at different dosing intervals 
Pait 2 aims to evaluate the safety and efficacy of a regimen that includes premedication and a 
dosing regimen of2 step-up priming doses (Week 1) followed by full dose >76 mg with 
different dosing intervals staiting from C2. 
Pait 2 includes a dose detennination rut Pait 2A Dose level 1 and Dose level 2), a dose 
expansion pait (Pait 2B), 
Pait 2A dose 
detennination and Pait 2C tolerability evaluation will be based on a BLRM approach. 
The decision to strut enrolling paiticipants in a new cohoit (Pait 2A Dose level 2, Pait 2B or 
Pait 2C) will be a joint decision to be detennined by the investigators and the sponsor in dose 
level review meetings. 
Part 2A will evaluate full ehanatainab doses >76 mg staiting from C2 with a longer 
dosing interval (> 1 week) to determine the potential RP2D to be further evaluated in 
Pait 2B. Approximately 8 paiticipants will be enrolled at each dose level in Pait 2A. 

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Dose level 1 will assess the following regimen: 
 
• 
C2 to C6: elranatamab 116 mg Q2W. DLT observation period is C2 or 28 
days staiting from the first dose of 116 mg. Hospitalization on C2 DI or 
on the day of the first dose of 116 mg for at least 1 day is required, see 
Section 2.3.1. Ehanatamab 116 mg represents an ~ 50% increase in 
ehanatamab dose versus 76 mg. 
• 
C7 onwards: eh-anatamab 116 mg Q4W (for paiticipants with IMWG 
response of PR or better persisting for 2 months on Q2W). 
If Dose level 1 is tolerable, Dose level 2 will be initiated to assess the following 
regnnen: 
• 
C2 to C6: ehanatainab 152 mg Q2W. DLT observation period is C2 or 28 
days staiting from the first dose of 152 mg. Hospitalization on C2 DI or 
on the day of the first dose of 152 mg for at least 1 day is required, see 
Section 2.3.1. Ehanatamab 152 mg represents an ~ 30% increase in 
ehanatamab dose versus 116 mg and will be the MAD in this study. 
 
• 
C7 onwards: ehanatamab 152 mg Q4W (for participants with IMWG 
response of PR or better persisting for 2 months on Q2W). 
• 
 
 
The potential RP2D identified in Pait 2A Dose level 1 or Dose level 2 will be further 
evaluated and confomed in Pait 2B (dose expansion). 
Part 2B will begin once the potential RP2D from Pait 2A Dose level 1 or Dose level 2 is 
selected. Approximately 22 pa1ticipants will be enrolled to confnm the safety and 
efficacy of the selected dosing regimen to have at least 15 pa1ticipants ti·eated for 2 
cycles. Approximately a total of 30 paiticipants will be enrolled and ti·eated at the 
potential RP2D, 8 from Pait 2A and 22 from Pait 2B . 
• 
 
 
I 

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I 
 
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ill Paits 2B and 2C, hospitalization on C2Dl or on the day of the first dose of 116 mg or 152 
mg may not be required depending on CRS profile observed in Pait 2A (See Section 2.3.1). 
This will be a joint decision to be detennined by the investigators and the sponsor before 
opening enrollment to Pait 2B and Pait 2C. 
ill Pait 2 (A, B, and C), the elranatamab dose may be increased to 116 or 152 mg only in 
paiticipants who have received at least 2 doses at 76 mg. 
Pait 2 enrollment will stait after approximately 30 participants have been enrolled in Pait 1. 
The decision to proceed with Pait 2 of the study will be a joint agreement between the 
sponsor and the investigators based on the review of the available data, including CRS 
incidence and severity. 
If neither Dose level 1 or Dose level 2 in Pait 2A proves to be tolerable, Part 2C and Pait 2B 
will not strut and Pait 1 will enroll approximately 68 paiticipants. 
4.2. Scientific Rationale for Study Design 
Elranatamab has the potential to provide clinical benefit to paiticipants with RRMM 
(Section 2.2.3.2). The totality of efficacy, safety, PK, phannacodynainics data, and exposme- 
response analyses from Study C1071001 suppo1ted the RP2D of 76 mg, fixed dose 
equivalent of 1000 µg/kg, QW administered as a SC injection with a priming dose of 44 mg, 
fixed dose equivalent of 600 µg/kg, for the first dose. The RP2D is expected to result in 
clinical benefit for the majority of triple-class RRMM patients, including those with 
relatively high levels of baseline sBCMA, which Inight have an impact on unbound 
elranatamab diug exposme in the circulation and hence Inight impact the probability of 
achieving responses.[27] Impo1tantly, the RP2D demonstrated a manageable safety profile. 
ill Study C1071001, elranatamab has shown a manageable safety profile mainly 
characterized by Grade 1 or 2 CRS (refer to the IB). To fmther reduce the rate of CRS and in 
paiticulai·the rate of Grade 2 and higher CRS, the cunent study will evaluate a regimen that 
involves a premedication cocktail and 2 step-up priming doses to be administered within the 
first week of elranatamab treatment. 
ill ongoing elranatainab clinical studies, paiticipants who received at least 6 cycles and have 
achieved response of PR or better with responses pe • • 
• 
gQ2W. 
Pait 1 a 
 
 

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ehanatamab full dose of 76 mg QW for 6 cycles followed by Q2W. However, the cmTent 
study will also evaluate the overall safety, tolerability, PK, phru.macodynamics, and 
preliminru.y anti-myeloma a f 
ehanatamab full doses> 76 mg with alternative dosing 
intervals (QW, Q2W, Q4W,-(refer toSection 4.3.2). Pru.t 2 includes a dose 
dete1mination pru.t (Pait 2A Dose level 1, 116 mg, and Dose level 2, 152 mg, which represent 
~ 50% and 30% increases from 76 m and 116 m 
res ectively), a dose expansion pru.t (Pait 
2B), 
 
 
 
 
4.2.2. Diversity of Study Population 
Reasonable attempts will be made to emoll pru.ticipants in the US with the distribution of 
characteristics shown below (Table 4) to ensme the study population is representative of the 
patient population that will use ehanatamab in clinical practice. 
 
Table 4. 
Relevant Population Metrics - US 
 
Race 
Prevalence Rate (%) 
Black/African American 
19 
American Indian or Alaska Native 
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Table 4. 
Relevant Population Metrics - US 
 
Race 
Prevalence Rate (%) 
Asian 
6 
Native Hawaiian or other Pacific Islander 
Not available 
White 
72 
Ethnicitv 
Hispanic or Latino(a) or of Spanish Origin 
12 
Not Hispanic or Latino(a) or of Spanish Origin 
88 
Sex 
Male 
56 
Female 
44 
Ae:e (years) 
18-39 
I 
40-64 
36 
>65 
63 
 
 
4.2.3. Choice of Contraception/Barrier Requirements 
Studies to evaluate the developmental toxicity of eh-anatamab have not been 
conducted. Therefore, the use of a highly effective method of contraception is required for 
WOCBP (see Appendix 4). There are no contrnception requirements for male pa.iiicipants 
who receive eh-anatamab, as the calculated safety ma.i·gin i1s 00-fold between the estimated 
maternal exposure due to seminal transfer and the estimated MABEL used as conservative 
estimate of exposure that may result in serious manifestations of developmental toxicity. 
 
4.3. Justification for Dose 
4.3.1. Justification for the 2 Step-up Priming Doses Regimen 
fu the SC coho1is from Study C1071001, only 2 out of 50 pa.iiicipants experienced CRS after 
the second dose and no CRS events were observed after the third or later doses. The rate of 
Grade 1 and 2 CRS events in paiiicipants receiving dose levels 
600 µg/kg (which is the 
body weight dosing equivalent of 44 mg) is 62.5% and 37.5%, respectively, according to 
ASTCT grading. The maximum severity of CRS was consistently observed after the first 
dose including pa1iicipants in the priming coho1is who received a higher dose on C1D8 
indicating that CRS is associated mostly with the initial exposure (ie, the first dose). A 
logistic regression analysis that included data from both IV (n =23) and SC coho1is (n = 43) 
from Study C1071001 shows an association between eh-anatamab Cmax within 24 hours post 
first dose (Cmax-24h) and probability of CRS of All Grade and Grade 2 and higher (according 
to ASTCT criteria, Figure 1) 
Priming dose approaches a.i·e commonly applied for T cell engager bispecific modalities to 
initially sensitize the immune system at lower doses to reduce rate and grade of CRS.[31-34] 

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Across the elranatamab program, multiple priming dose regimens are being investigated to 
determine optimal dosing strategies for the mitigation of CRS events early in elranatamab 
treatment. The Phase 2 Study C1071003 and Phase 3 Study C1071005 have implemented a 
priming dosing regimen that includes premedications as well as 2 step-up priming doses of 
12 mg on C1D1 and 32 mg on C1D4 to reduce the rates of CRS observed with doses ≥ 600 
µg/kg (body weight dosing equivalent of 44 mg) administered early in the treatment regimen. 
The current study will evaluate a priming dosing regimen that includes premedications as 
well as 2 step-up priming doses of 4 mg on C1D1 and 20 mg on C1D4 before increasing 
elranatamab dose to 76 mg on C1D8. The logistic regression analysis indicates that the 
predicted probability of Grade 2 or higher CRS after a starting dose of 4 mg on Cycle 1 Day 
1 is 6% (95% CI: 1% to 26%) compared to a predicted probability of 34% (95% CI: 22% to 
49%) associated with a regimen that uses a single priming dose of 44 mg on C1 D1 before 
increasing to full elranatamab dose of 76 mg on C1 D8, which is the RP2D implemented in 
the ongoing dose expansion cohort in Study C1071001. The model predicted rates of All 
Grade CRS at a starting dose of 4 mg and 44 mg initial priming doses are 7% (95% CI: 1%% 
to 41%%) and 97% (95% CI: 86% to 99%). Overall, the analysis predicts that a 4 mg initial 
priming dose will significantly reduce the rate of All Grade and Grade 2 and higher CRS 
associated with elranatamab treatment compared to a regimen using an initial single priming 
dose of 44 mg on C1D1. 
Figure 1. Logistic Regression Analysis of Elranatamab Concentration at 24 hours 
Versus Probability of all Grade and Grade 2 CRS 
 

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4.3.2. Justification for Evaluation of Higher Elranatamab Doses 
An MTD was not achieved in C1071001, and the safety and efficacy for doses greater than 
76 mg has not been established. Increasing the dose of elranatamab may allow for a longer 
dosing interval and a lower frequency of administration while maintaining the overall 
exposure (ie, AUC) of total eh-anatamab between 152 mg Q2W similar to 76 mg QW. 
Based on the results of the quantitative systems phru.macology simulations, higher 
eh-anatamab doses with longer dosing intervals (ie, Q2W, Q4W and- 
are expected to be 
adequate to maintain the response given the reduced disease burden in these paiiicipants. The 
higher eh-anatamab dose levels explored in Pru.i 2A/Pru.i 2B, specifically Pru.i 2A Dose level 2 
of 152 mg Q2W/Q4W which is the tai·get dose level for Pa1i 2A/2B, provide a similru.·overall 
dose intensity (AUC) to 76 mg QW/Q2W. Dose level 1 (116 mg) represents~ 50% increases 
The dosing regimens to be evaluated in Pait 2AIB, Pru.i 2C and Pait 1 after 6 cycles and after 
12 cycles are expected to finiher saturate the sBCMA sink and result in higher unbound 
eh-anatamab exposure across the dosing interval. Therefore, these regimens could derive, 
maintain and/or finiher deepen clinical responses. In addition, less frequent dosing might 
provide additional patient convenience and improve compliance. 
 
4.3.3. Definition of DLT (Part 2A and Part 2C) 
Severity of AEs will be graded according to NCI CTCAE version 5.0. The severity of CRS 
and ICANS will be assessed according to the modified grading described by ASTCT. The 
DLT observation period will be 28 days staiting from the first 116 or 152 mg dose. 
A pru.iicipant is classified as DLT-evaluable if they meet either criterion: 
 
• 
Experiences a DLT during the DLT observation period, 
 
• 
In the absence of a DLT, receives the planned number of doses at the planned dose 
level of the study inte1vention and receives scheduled safety assessments during the 
DLT obse1vation period. 
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For the purpose of RP2D determination, additional late toxicities in the context of all safety 
data available will also be considered. Safety information from any participants that do not 
meet DLT-evaluable criteria could still be considered for overall dose determination 
decisions. 
As described in Table 5, any of the following AEs observed within the DLT observation 
period and considered related to study intervention will be classified as DLTs. Participants 
experiencing a DLT may resume dosing only if adequate recovery is achieved within the 
allowed time window and if permitted for the specific toxicity (see Sections 6.5.1 and 
6.5.1.2). 
 
Table 5. 
Hematological and Non-hematological Dose-limiting Toxicities 
 
Hematological 
• 
Grade 4 neutropenia lasting >5 days. 
• 
Febrile neutropenia (defined as an ANC <1000/mm3 with a single temperature of >38.3°C [101°F], 
or a sustained temperature of ≥38°C [100.4°F] for more than 1 hour). If fever is determined to be a 
symptom of CRS confirmed by clinical course and cytokine levels, and resolves in a manner 
consistent with CRS, this would no longer be considered a DLT, and the participant may resume 
treatment. 
• 
Grade ≥3 neutropenia with infection. 
• 
Grade 4 thrombocytopenia: 
o 
For participants with baseline platelets ≥50,000/mm3, any platelet count <25,000/mm3 is a 
DLT 
o 
For participants with baseline platelets ≥25,000/mm3 and <50,000/mm3, any platelet count 
< 10,000/mm3 is a DLT, while platelet counts < 25,000 and ≥10,000 are a DLT only if 
associated with Grade ≥2 bleeding or requiring platelet transfusion. 
• 
Grade 3 thrombocytopenia with Grade ≥2 bleeding. 
Non-hematological 
• 
Grade ≥4 AEs. 
• 
Grade 3 CRS, except those CRS events that have i) not been maximally treated (ie, lack of 
administration of standard of care treatment per the institution’s, investigator’s, or treating 
physician’s guidelines for the management of CRS) or ii) improved to Grade ≤1 within 48 hours. 
• 
Grade 3 AEs, with the exception of: 
o 
AEs attributed to a CRS event (ie, Grade 3 transaminitis) 
o 
Grade 3 nausea, vomiting and diarrhea that improve to Grade ≤ 2 within 72 hours after 
maximal medical management has been initiated 
o 
Grade 3 fatigue lasting <1 week 
o 
Grade 3 AEs that recover to baseline or Grade 1 within 5 days 
• 
Confirmed DILI meeting Hy’s law criteria (See Appendix 6) 

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Table 5. 
Hematological and Non-hematological Dose-limiting Toxicities 
 
• 
Grade 3-4 laboratory abnonnalities with the exception of: 
0 
 Grade 3-4 laboratory abnonnalities that are not associated with clinical sequelae and 
improve to Grade 2 with appropriate management or supplementation within 72 hours of 
their onset. 
•  Other clinically important or persistent AEs (eg, AEs responsible for significant dose delay or dose 
reduction) may also be considered a DLT following review by the investigators and the sponsor. 
DLTs need to represent a clinically significant shift from baseline. 
• 
Grade 3 ISR• 
a. Allergic reaction or anaphylaxis will not be considered a DLT. 
 
4.3.4. Definition of RP2D for Part 2B and Part 1 From C7 
The RP2D for eh-anatamab to be fmther evaluated in Pait 2B and Pait 1 after 6 cycles is the 
dose chosen based on Part 2A (Dose level 1 and Dose level 2). Dose level 2, 152 mg, is the 
MAD. The RP2D decision will be determined based on the totality of available data from 
Pait 2A and will include safety, efficacy, PK, and pha1macodynamics data. This will be a 
joint decision to be detennined by the investigators and the sponsor in dose level review 
meetings. Refer to Section 4.1 for more infonnation on the cmTent RP2D fmther investigated 
in Pait 2A DL2, Pait 2B and Pait 1. 
 
4.4. End of Study Definition 
The study will be completed when all paiticipants have been followed for OS for at least 
2 years from the date of enrollment. 
5. STUDY POPULATION 
This study can fulfill its objectives only if appropriate paiticipants ai·e enrolled. The 
following eligibility criteria ai·e designed to select pa1ticipants for whom pa1ticipation in the 
study is considered appropriate. All relevant medical and nonmedical conditions should be 
taken into consideration when deciding whether a paiticulai·paiticipant is suitable for this 
protocol. 
Prospective approval of protocol deviations to recmitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not pe1mitted. 

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5.1. Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Age and Sex: Participants age ≥18 years (or the minimum country specific age of 
consent if >18). 
- A female participant is eligible to participate if she is not pregnant or 
breastfeeding. Refer to Appendix 4 for all reproductive criteria for male 
(Section 10.4.1) and female (Section 10.4.2) participants. 
• 
Type of Participant and Disease Characteristics: 
2. Participants who are willing and able to comply with all scheduled visits, 
treatment plan, laboratory tests, lifestyle considerations, and other study 
procedures. 
3. Prior diagnosis of MM as defined according to IMWG criteria.[1] 
4. Measurable disease based on IMWG criteria as defined by at least 1 of the 
following: 
a. Serum M-protein >0.5 g/dL by SPEP; 
b. Urinary M-protein excretion >200 mg/24 hours by UPEP; 
c. Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum 
immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65). 
5. Refractory to at least 1 IMiD. 
6. Refractory to at least 1 PI. 
7. Refractory to at least 1 anti-CD38 antibody. 
8. Relapsed or refractory to last anti-MM regimen. 
Note: Refractory is defined as having disease progression while on therapy or within 
60 days of last dose in any line, or no response to therapy. 
9. ECOG performance status ≤1. 
10. LVEF ≥40% as determined by a MUGA scan or ECHO. 
11. Adequate hepatic function characterized by the following: 
a. Total bilirubin ≤2 x ULN (≤3 x ULN if documented Gilbert’s syndrome); 

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b. AST ≤2.5 x ULN; and 
c. ALT ≤2.5 x ULN 
12. Adequate renal function defined according to local institutional standard method: 
eGFR ≥ 30 mL/min/1.73 m2 using CKD-EPI 2021 equation [2] or estimated 
creatinine clearance ≥ 30 mL/min using Cockcroft Gault formula. If both 
formulae are calculated, the higher of the 2 values may be used. A 24-hour urine 
collection for creatinine clearance may also be used in equivocal cases where 
amyloidosis is suspected. 
13. Adequate BM function characterized by the following: 
a. ANC ≥1.0 × 109/L (use of G-CSF is permitted if completed at least 7 days prior 
to planned start of dosing); 
b. Platelets ≥25 × 109/L (transfusion support is permitted if completed at least 
7 days prior to planned start of dosing); and 
c. Hemoglobin ≥8 g/dL (transfusion support is permitted if completed at least 
14 days prior to planned start of dosing). 
14. Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L). 
15. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 
≤1. 
Informed Consent: 
16. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and 
in this protocol. 
5.2. Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
Medical Conditions: 
1. Smoldering MM. 
2. Active plasma cell leukemia. 
3. POEMS syndrome. 
4. Amyloidosis. 

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5. Waldenström’s macroglobulinemia 
6. Known active CNS involvement or clinical signs of myelomatous meningeal 
involvement 
7. Stem cell transplant within 12 weeks prior to enrollment or active GVHD. 
8. Impaired cardiovascular function or clinically significant cardiovascular diseases, 
defined as any of the following within 6 months prior to enrollment: 
a. Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, 
coronary artery bypass graft, coronary angioplasty or stenting, symptomatic 
pericardial effusion); 
b. Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or 
uncontrolled paroxysmal supraventricular tachycardia); 
c. Thromboembolic or cerebrovascular events (eg, transient ischemic attack, 
cerebrovascular accident, deep vein thrombosis [unless associated with a central 
venous access complication] or pulmonary embolism); 
d. Prolonged QT syndrome (or QTcF >470 msec at screening). 
9. Ongoing Grade ≥2 peripheral sensory or motor neuropathy. 
10. History of any grade peripheral sensory or motor neuropathy with prior BCMA- 
directed therapy. 
11. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor 
polyneuropathy. 
12. Active HBV, HCV, COVID-19/SARS-CoV-2, HIV, or AIDS-related illness, or any 
active, uncontrolled bacterial, fungal, or viral infection. Active infections must be 
resolved at least 14 days prior to enrollment. 
COVID-19/SARS-CoV-2: While SARS-CoV-2 testing is not mandated for entry into 
this study, testing should follow local clinical practice standards. If a participant has 
a positive test result for SARS-CoV-2 infection within 14 days prior to enrollment, is 
known to have asymptomatic infection or is suspected of having SARS-CoV-2, they 
are excluded. 
HBV: 
• This criterion excludes participants with a positive HBsAg (ie, either acute 
or chronic active hepatitis). 

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• However, participants with HBV antibody positivity indicating immunity, 
either due to vaccination or prior natural infection, are eligible. 
• Patients with positive anti-HBcAb but negative HBsAg and negative anti- 
HBsAb profile are eligible if HBV DNA is not detected. 
13. Known or suspected hypersensitivity to the study intervention or any of its excipients. 
14. Any other active malignancy within 3 years prior to enrollment, except for adequately 
treated basal cell or squamous cell skin cancer, carcinoma in situ or Stage 0/1 
malignancy with minimal risk of recurrence per investigator. 
15. Other surgical (including major surgery within 14 days prior to enrollment), medical 
or psychiatric conditions including recent (within the past year) or active suicidal 
ideation/behavior or laboratory abnormality that may increase the risk of study 
participation or, in the investigator’s judgment, make the participant inappropriate for 
the study. 
Prior/Concomitant Therapy: 
16. Previous treatment with anti-BCMA bispecific antibody or CAR-T cell therapy. 
17. Live attenuated vaccine within 4 weeks of the first dose of study intervention. 
Prior/Concurrent Clinical Study Experience: 
18. Previous administration with an investigational drug or vaccine within 30 days (or as 
determined by the local requirement) or 5 half-lives preceding the first dose of study 
intervention used in this study (whichever is longer). 
19. A participant may be eligible even if they are in the follow-up phase of an 
investigational study as long as they meet the criteria for time elapsed from previous 
administration of investigational product. Cases must be discussed with sponsor’s 
medical monitor to judge eligibility. 
Other Exclusions: 
20. Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and sponsor 
delegate employees directly involved in the conduct of the study and their family 
members. 
5.3. Lifestyle Considerations 
5.3.1. Contraception 
The investigator or their designee, in consultation with the participant, will confirm that the 
participant is using an appropriate method of contraception for the individual participant 

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from the permitted list of contraception methods (see Appendix 4) and will confirm that the 
participant has been instructed in its consistent and correct use. The investigator or designee 
will advise the participant to seek advice about the donation and cryopreservation of germ 
cells prior to the start of study intervention, if applicable. 
At time points indicated in the SoA (including long term follow-up visit/contacts covering 
the required contraception period [through 5 months post last dose of study intervention for 
WOCBP [Appendix 4]]), the investigator or designee will inform the participant of the need 
to use highly effective contraception consistently and correctly and document the 
conversation and the participant’s affirmation in the participant’s chart. Participants need to 
affirm their consistent and correct use of at least 1 of the selected methods of contraception, 
considering that their risk for pregnancy may have changed since the last visit. Contraception 
check is only required for WOCBP. 
In addition, the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued and document the requirement to use an 
alternate protocol-specified method, including if the participant will no longer use abstinence 
as the selected contraception method, or if pregnancy is known or suspected in the 
participant. If a participant is confirmed to be pregnant, study intervention should be 
discontinued. 
5.4. Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently enrolled in the study. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants to meet the CONSORT 
publishing requirements and to respond to queries from regulatory authorities. Minimal 
information includes demography, screen failure details, eligibility criteria, and any SAE. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened. Rescreened participants should be assigned a new participant number as for the 
initial screening. 
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY 
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, medical device(s), or study procedure(s) intended to be administered to a study 
participant according to the study protocol. 
For the purposes of this protocol, study intervention refers to elranatamab. 
6.1. Study Intervention(s) Administered 

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Intervention Name 
Diluent 
Eh-anatamab 
Part 1, Part 2A, Pa1·t 2B, and 
Part 2C (group of pa11icipants 
receiving a specific treatment or 
no treatment) 
Pait 1 and Part 2 
All enrolled 
Tvoe 
Diluent 
Biologic: BITE 
Dose Formulation 
Solution for SC injection 
Solution for SC injection 
Unit Dose Strength(s) 
Diluent solution for Injection in a 
6 mLvial 
40 mg/mL with an extractable 
volume of 1.9 mL (76 mg per 
vial) 
Dosa2e Level(s) 
Suooorts 4 mg Dosage Level 
See table below 
Route of Administration 
SC 
SC 
Use 
Exoerimental 
Exoerimental 
IMPorNIMP 
NIMP 
IMP 
Sourcing 
Provided centrally by the sponsor 
Provided centrally by the sponsor. 
Packaging and Labeling 
Study intervention will be 
provided in a cation containing I 
vial. Each vial and ca1ton will be 
open labeled as required per 
countiy reauirement. 
Study intervention will be 
provided in a carton containing I 
vial. Each vial and cation will be 
open labeled as required per 
countiy requirement. 
Current/Former Name(s) or 
Alias(es) 
Diluent 
Eh-anatamab!PF-06863135 
 
 
Arm title 
Arm Type 
Description 
Associated Intervention 
Labels 
Pait 1 
Experimental 
Participants will receive eh-anatamab 4 mg on 
ClDI and 20 mg on ClD4 (2 priming doses) and 
then 76 mg QW for 6 cycles. 
Thereafter, pa1ticipants with PR or better response 
persisting for c:::2 months on QW will receive 76 
mg Q2W and/or 116 m. or 152 m.  4W from C7 
and onwat·ds. 
76 mg Full Dose 

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Arm title 
Arm Type 
Description 
Associated Intervention 
Labels 
Pa1t2A 
Experimental 
Participants will receive eh-anatamab 4 mg on 
ClDI and 20 mg on ClD4 (2 priming doses) and 
then 76 mg QW for I cycle. 
Thereafter, pa1ticipants will receive: 
- Dose level 1: 116 mg Q2W for C2 to C6. From 
C7 onwards, pruticipants with PR or better 
response for at least 2 cycles will receive I I6 mg 
Q4W. 
- Dose level 2: 152 mg Q2W for C2 to C6. From 
C7 onwards, pruticipants with PR or better 
>76 mg Full Dose 
Longer Dosing Interval 
(Dose detennination) 
. for :C:: 2 months will receive 
Pa1t2B 
Experimental 
Participants will receive eh-anatamab 4 mg on 
> 76 mg Full Dose 
ClDl and 20 mg on ClD4 (2 priming doses) and 
 Longer Dosing Interval 
then 76 mg QW for 1 cycle. 
(Dose expansion) 
Thereafter, pruticipants will receive 116 or 152 mg 
Q2W for C2 to C6. From C7 onwards, pa1ticipants 
with PR or better response persisting for :C:: 2 
months will receive 116 m or 152 m0 4W. 
Pa1t2C 
Experimental 
See Section 6.8 for required premedications for CRS. 
6.1.1. Elranatamab 
Qualified and trained investigator site personnel will administer eh-anatamab to pa1iicipants 
by SC injection. Ideally, each injection may be up to 2 mL in volume; however, if the 
maximum volume allowed per institution's policy is lower than 2 mL, the number of 
injections may be increased to accommodate this difference in volume and ensure the con-ect 
dose is delivered. If more than one injection is needed, these injections should be 

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administered within 2-3 minutes from each other. See Appendix 9 for details on 
administration of multiple injections to the abdomen. Elranatamab should be administered to 
the abdomen, with preference given to the lower quadrants when possible. 
A minimum of 2 days should be maintained between the 2 step-up priming doses (C1D1 and 
C1D4), a minimum of 3 days should be maintained between C1D4 and the first full dose 
(C1D8); a minimum of 6 days should be maintained between doses thereafter. 
The windows for the different administration schedules are -1/+3 days for C1D4, C1D8 and 
then ± 3 days for QW and Q2W and ± 6 days for Q4W or CCI  Study staff should refer to 
the IP Manual for specific instructions on the handling, preparation and administration 
volumes of study intervention. 
Dose modifications may occur according to the guidelines described in Section 6.5. 
If the dose interval is changed, cycles will remain the same length (ie, 28-day cycles). 
Each participant should receive study intervention until confirmed disease progression, 
unacceptable toxicity, withdrawal of consent, or study termination. 
6.2. Preparation, Handling, Storage and Accountability 
1. The investigator or designee must confirm appropriate temperature conditions have 
been maintained during transit for all study interventions received and any 
discrepancies are reported and resolved before use of the study intervention. 
2. 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 recording) area in accordance with the labeled storage 
conditions with access limited to the investigator and authorized site staff. At a 
minimum, daily minimum and maximum temperatures for all site storage locations 
must be documented and available upon request. Data for nonworking days must 
indicate the minimum and maximum temperatures since previously documented for 
all site storage locations upon return to business. 
3. Any excursions from the study intervention label storage conditions should be 
reported to Pfizer upon discovery along with any actions taken. The site should 
actively pursue options for returning the study intervention to the storage conditions 
described in the labeling, as soon as possible. Once an excursion is identified, the 
study intervention must be quarantined and not used until Pfizer provides permission 
to use the study intervention. Specific details regarding the definition of an excursion 
and information the site should report for each excursion will be provided to the site 
in the IP manual. 
4. Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the label. 

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5. Study interventions should be stored in their original containers. 
6. See the IP manual for storage conditions of the study intervention. 
7. The investigator, institution, or the head of the medical institution (where applicable) 
is responsible for study intervention accountability, reconciliation, and record 
maintenance (ie, receipt, reconciliation, and final disposition records), such as the 
IPAL or sponsor-approved equivalent. All study interventions will be accounted for 
using a study intervention accountability form/record. 
8. Further guidance and information for the final disposition of unused study 
interventions are provided in the IP manual. All destruction must be adequately 
documented. If destruction is authorized to take place at the investigator site, the 
investigator must ensure that the materials are destroyed in compliance with 
applicable environmental regulations, institutional policy, and any special instructions 
provided by Pfizer. 
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IP manual. 
6.2.1. Preparation and Dispensing 
See the IP manual for instructions on how to prepare the study intervention for 
administration. Study intervention should be prepared and dispensed by an appropriately 
qualified and experienced member of the study staff (eg, physician, nurse, physician’s 
assistant, nurse practitioner, pharmacy assistant/technician, or pharmacist) as allowed by 
local, state, and institutional guidance. A second staff member will verify the dispensing. 
Only qualified personnel who are familiar with procedures that minimize undue exposure to 
themselves and to the environment should undertake the preparation, handling, and safe 
disposal of biotherapy agents. 
6.3. Measures to Minimize Bias: Randomization and Blinding 
6.3.1. Allocation to Study Intervention 
This is an open-label study. No randomization or blinding mechanisms will be used; 
however, the specific study intervention dispensed to the participant will be assigned using 
an IRT. 
The site personnel (study coordinator or specified designee) will be required to enter or select 
information including but not limited to the user’s ID and password, the protocol number, 
and the participant number. The site personnel will then be provided with a treatment 
assignment, and DU or container number when study intervention is being supplied via the 
IRT system. The IRT system will provide a confirmation report containing the participant 
number, and DU or container number assigned. The confirmation report must be stored in the 
site’s files. 

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The study will start with enrolling 30 participants in Part 1. Part 2 enrollment will start based 
on a joint agreement between the sponsor and the investigators after the review of the 
available data, including CRS incidence and severity. 
Allocation to dose level will be decided by the sponsor based on the participant’s eligibility 
and availability of open slots. Study intervention and allocation of participants will be 
assigned using IRT. The investigator’s knowledge of the treatment should not influence the 
decision to enroll a particular participant or affect the order in which participants are 
enrolled. 
Following full assessment and determination that the participant meets all eligibility criteria, 
the investigator or designee will enroll the participant. 
For Part 2A and Part 2C, no participant shall sign the informed consent document until the 
investigator or designee has received the confirmation of the participant’s screening in 
writing from the sponsor or delegate. 
Study intervention will be dispensed at the study visits summarized in the SoA. The 
study-specific IRT reference manual and IP manual will provide the contact information and 
further details on the use of the IRT system. 
6.4. Study Intervention Compliance 
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 recorded in the CRF. 
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. 
The site will complete the required dosage Preparation Record located in the IP manual. The 
use of the Preparation Record is preferred, but it does not preclude the use of an existing 
appropriate clinical site documentation system. The existing clinical site's documentation 
system should capture all pertinent/required information on the preparation and 
administration of the dose. This may be used in place of the Preparation Record after 
approval from the sponsor and/or designee. 
Compliance with study intervention will be documented in the source documents and CRF. 
Study intervention start dates, reasons for delays, dose reductions, and/or missed doses will 
be recorded in the CRF. Deviation(s) from the prescribed dosage regimen will be recorded in 
the CRF. 
A record of study intervention dispensed and administered to each participant must be 
maintained. 

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6.5. Dose Modification 
Every effort should be made to administer study intervention on the planned dose and 
schedule. 
The recommended dose modification guidelines for participants who have active confirmed 
(positive by regulatory authority-approved test) or presumed (test pending/clinical suspicion) 
SARS-CoV-2 infection can be found in Appendix 8. 
In the event of significant toxicity, dosing may be modified in any cycle as described in 
Table 6. All dose modifications should be based on the worst preceding toxicity and must be 
recorded on the CRF. 
6.5.1. Elranatamab 
6.5.1.1. Redosing Criteria 
During a Cycle: Re-treatment following interruption for treatment-related toxicity and for 
peripheral neuropathy (any causality) within a cycle should follow the dose modification 
tables and guidance below. 
At the Start of a Cycle: Dosing at the start of any new cycle should not occur until all of the 
following parameters have been met: 
• ANC ≥1.0 × 109/L 
• Platelets count ≥25 × 109/L 
• Recovery of treatment-related non-hematologic toxicities to baseline or Grade ≤1 
severity 
• For any dosing day (at start of a cycle or during a cycle), no ongoing CRS or ICANS 
of any grade 
• Recovery of treatment-emergent peripheral neuropathy to Grade ≤ 1 severity 
• Recovery of any lung infection or other serious infection to baseline 
6.5.1.2. Dose Modifications for Elranatamab-Related Toxicity and for Peripheral 
Neuropathy 
The dose modifications for elranatamab-related toxicities and for peripheral neuropathy (any 
causality) are presented in Table 6. All dose modifications should be based on the worst 
preceding toxicity and must be recorded on the CRF. 

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Table 6. 
Dose Modifications for Elranatamab-Related Toxicity and for Peripheral 
Sensory or Motor Neuropathy 
 
Toxicity 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Non-hematologic 
(excluding 
peripheral 
neuropathy – see 
below) 
Continue 
treatment.a 
Continue treatment. 
Alternatively, per 
investigator discretion, 
withhold treatment until 
toxicity is Grade ≤1, 
then resume.a 
Withhold treatment 
until toxicity is 
Grade ≤1 or has 
returned to baseline, 
then resume 
treatment.a,b 
Permanently 
discontinue.a,b 
Hematologicc,d 
Continue 
treatment. 
Continue treatment. 
Withhold treatment 
until toxicity is 
Grade ≤2 or has 
returned to baseline, 
then resume treatment.d 
Withhold treatment 
until toxicity is 
Grade ≤2 or returns 
to baseline.d 
Peripheral 
sensory or motor 
neuropathy (any 
causality) 
See 
Section 8.3.8 for 
recommended 
work-up. 
Continue 
treatment. 
Continue to 
monitor the 
participant for 
signs of 
worsening 
neuropathy e 
For new or worsening 
Grade 2 peripheral 
neuropathy withhold 
treatment until 
resolution to Grade ≤1, 
then resume treatment. 
Continue to monitor the 
participant for signs of 
worsening neuropathy.e 
First occurrence: 
withhold treatment until 
neurologic toxicity 
symptoms improve to 
Grade ≤1. 
Recurrent: permanently 
discontinue 
elranatamab. 
Permanently 
discontinue 
elranatamab 
If Grade ≥2 neuropathy 
reoccurs, permanently 
discontinue 
elranatamab. 
a Both elranatamab priming doses must be administered before the full elranatamab dose. If C1D4 dose 
cannot be administered on the planned date, elranatamab treatment may restart at the planned 20 mg C1D4 
dose upon meeting the re-treatment criteria. If the 20 mg dose is tolerable, elranatamab should then be 
increased to the full 76 mg dose 1 week later. If after C1D4, a participant experiences a treatment-related 
adverse event that leads to a dose interruption or delay (ie, dose held on C1D8), elranatamab treatment may 
restart at the same dose (20 mg) upon meeting the re-treatment criteria (Section 6.5.1). If the 20 mg dose was 
tolerable, the elranatamab dose should be increased to 76 mg. In case of ongoing CRS or ICANS of any 
grade on any dosing day, dosing will be held until CRS or ICANS resolution. 
b Grade 3 or 4 nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy to 
require dose modification or permanent discontinuation. 
c Excludes lymphopenia which is expected based on the elranatamab mechanism of action. 
d For thrombocytopenia: dosing can continue if platelets ≥25 × 109/L. 
e Consider additional diagnostic work-up (see Section 8.3.8). 
Note: Cycles will not be extended to allow make-up for missed doses. 
 
 
Doses may be held as needed until toxicity resolution. Appropriate follow-up assessments 
should be done until adequate recovery occurs as assessed by the investigator. 

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Missed doses will not be made up and cycles will not be extended to allow for missed doses. 
C1D1 will be based on Day 1 of elranatamab dosing. After C1D1, 
• for QW regimen, if elranatamab cannot be administered on the planned day 
including the protocol defined window (±3 days), it should be skipped until the 
next planned dose (ie, if Day 15 cannot be administered within ±3 days of 
planned dose, the dose should be skipped until Day 22). 
• for Q2W regimen, if elranatamab cannot be administered on the planned day 
including the protocol defined window (± 3 days), it should be skipped until the 
next planned dose (ie, if Day 15 cannot be administered within ± 3 days of 
planned dose, the dose should be skipped until Day 1 of the next cycle). 
• For Q4W CCI 
, if elranatamab cannot be administered on the 
planned day including the protocol defined window (± 6 days), it should be 
skipped until Day 1 of the next cycle. 
Participants must receive both elranatamab priming doses before receiving the elranatamab 
76 mg dose. If C1D4 cannot be administered within the protocol defined window, 
elranatamab treatment may restart at the planned C1D4 dose upon meeting the re-treatment 
criteria. Upon re-treatment, if the C1D4 dose was tolerable, the elranatamab dose should be 
increased to the 76 mg dose 1 week later, after which QW dosing with the 76 mg dose should 
continue. If elranatamab treatment is interrupted for >2 weeks within the first cycle between 
the 20 mg priming dose and the first full dose (76 mg), the participant should be retreated 
with 20 mg elranatamab. If well-tolerated, the elranatamab dose can be escalated to 76 mg 1 
week later. 
For Part 2, participants should receive 2 doses of 76 mg before further dose escalation. After 
dose escalation, if the 116 mg or 152 mg dose is not tolerated due to elranatamab-related 
grade 3 and higher toxicity, after consultation with the Sponsor, the participant may return to 
the 76 mg QW dosing regimen for 6 cycles followed by Q2W if PR or better is persisting for 
≥ 2 months on QW. 
For Part 1, if the RP2D (116 mg or 152 mg dose) Q4W is not tolerated after C7 and beyond 
due to elranatamab-related Grade 3 and higher toxicity, after consultation with the Sponsor, 
the participant may return to the 76 mg dose Q2W. Less frequent dosing may be required to 
manage adverse events. 
If re-treatment criteria are not met within 4 weeks (8 weeks if participants are on Q4W or 
PPD
 
of treatment interruption/delay, study intervention 
should be permanently discontinued, unless the benefit/risk assessment per the investigator 
suggests otherwise, in agreement with the sponsor. In the event of a treatment 
interruption/delay lasting >4 weeks (>8 weeks if on Q4W CCI 
 for 
reasons other than treatment-related toxicity (eg, elective surgery), treatment resumption will 
be decided in consultation with the sponsor. 

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6.5.1.3. Dose Reductions 
Dose reduction of elranatamab below 76 mg is not permitted; dose delay is the primary 
method for managing elranatamab-related toxicities. Appropriate follow-up assessments 
should be done until adequate recovery occurs as assessed by the Investigator. 
6.6. Continued Access to Study Intervention After the End of the Study 
No study intervention will be provided to study participants at the end of the study. 
Availability of study treatment following closure of the study through expanded 
access/compassionate/continued use mechanism if the investigator and participant desire to 
continue treatment and if there is documented continued benefit from study treatment for the 
participant would be at the discretion of the sponsor and subject to study treatment 
availability and compliance with local laws and regulations. 
6.7. Treatment of Overdose 
Elranatamab: For this study, if a participant receives a dose ≥10% higher than the planned 
dose of elranatamab, it will be considered an overdose. 
The sponsor does not recommend specific treatment for an overdose. 
In the event of an overdose, the treating physician should: 
1. Contact the medical monitor within 24 hours. 
2. Closely monitor the participant for any AEs/SAEs and laboratory abnormalities for at 
least 90 days after the overdose of elranatamab. 
3. Document the quantity of the excess dose as well as the duration of the overdose in the 
CRF. 
4. Overdose is reportable to Pfizer Safety only when associated with an SAE. 
5. Obtain a blood sample for PK analysis within 28 days from the date of the last dose of 
study intervention if requested by the medical monitor (determined on a case-by-case 
basis). 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant. 

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6.8. Concomitant Therapy 
6.8.1. Premedications Required for Cytokine Release Syndrome 
Part 1 and Part 2 
For both the 2 step-up priming doses (4 and 20 mg) and first full dose (76 mg), administer 
these medications approximately 60 min (± 15 min) prior to elranatamab dose: 
• acetaminophen 650 mg (or paracetamol 500 mg)* 
• diphenhydramine 25 mg (or equivalent)*, oral or IV 
• dexamethasone 20 mg (or equivalent), oral or IV 
*Different but comparable doses due to local strength variations per local prescribing 
information are permissible. 
Similar premedications for doses at other time points including the first 116 mg and 152 mg 
doses may be given according to the investigator’s discretion. 
See Appendix 10 for management of CRS and ICANS.[35,36] 
6.8.2. Permitted Concomitant Medications/Therapies 
All concomitant treatments, blood products, as well as nondrug interventions received by 
participants from screening until the end of treatment visit will be recorded on the CRF. 
Concomitant treatment considered necessary for the participant’s well-being may be given at 
discretion of the treating physician. 
Hormonal contraceptives that meet the requirements of this study are allowed to be used in 
participants who are WOCBP (see Appendix 4). Please note for participants who receive oral 
contraceptives that are metabolized by CYP enzymes cytokines released during elranatamab 
treatment may cause drug-drug interaction with hormonal oral contraceptives at both PK and 
PD levels, and may accentuate the side effects associated with oral contraceptives. 
See Appendix 12 for management of CRS and ICANS. 
Elranatamab has been demonstrated to transiently increase cytokine levels (eg, IL-6) in vivo 
in monkeys and humans (also demonstrated via in vitro assays) which is expected with 
CD3-targeted BsAbs. 
Cytokines have been shown to result in modest and temporary inhibition of major CYP 
enzymes (eg, CYP3A4 and CYP2C9). Therefore, treatment with elranatamab can result in 
modest and temporal increase in the exposure of concomitant medications that are substrates 
for these enzymes. Caution should be used upon concomitant use of sensitive substrates of 
CYP enzymes with narrow therapeutic index (eg, CYP3A4: alfentanil, cyclosporine, 

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dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus; 
CYP2C9: phenytoin, warfarin) especially during the initial treatment cycle. If the use of 
warfarin is clinically necessary, caution and additional INR monitoring is recommended 
during the initial treatment cycle. 
The administration of drugs known to cause peripheral neuropathy should be carefully 
considered, and if possible, avoided by the investigator. Effective treatment and prophylaxis 
for infections should be prioritized. 
Caution is advised on theoretical grounds for any surgical procedures during the study. The 
appropriate interval of time between surgery and study intervention required to minimize the 
risk of impaired wound healing and bleeding has not been determined. Postoperatively, the 
decision to reinitiate study intervention should be based on a clinical assessment of 
satisfactory wound healing and other aspects of surgical recovery. 
Palliative radiotherapy to specific sites of disease in the event of increased localized pain will 
be permitted if considered medically necessary by the treating physician. Progressive disease 
should be ruled out. The appropriate interval of time between radiotherapy and study 
intervention has not been determined. 
6.8.3. Prohibited During the Study 
No additional anticancer therapy will be permitted while participants are receiving study 
intervention. 
Chronic systemic corticosteroid use for palliative or supportive purposes is not permitted; 
however, steroid replacement for adrenal insufficiency at doses equivalent to ≤10 mg 
prednisone daily is acceptable. Acute emergency administration, topical applications, inhaled 
sprays, eye drops, or local injections of corticosteroids are allowed. 
Administration of live attenuated vaccines is prohibited during study treatment, and for 90 
days after the last dose of study treatment. Annual inactivated influenza vaccines are 
allowed. 
6.8.4. Supportive Care 
Palliative and supportive care for disease related symptoms may be administered at the 
investigator’s discretion and according to the specific supportive care product Prescribing 
Information or the current ASCO guidelines. 
Allopurinol/rasburicase may be administered as needed for tumor lysis prophylaxis or 
treatment. 
6.8.5. Transfusion Support 
During study intervention, primary prophylactic use of transfusion support for anemia and/or 
thrombocytopenia is allowed, as indicated by the current ASCO and AABB 
guidelines.[37,38] 

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6.8.6. Hematopoietic Growth Factors 
Prophylactic use of G-CSF is restricted within 7 days of first elranatamab dose by eligibility. 
During study intervention, primary prophylactic use of G-CSF is not permitted during Cycle 
1 and 2 of Part 2A and Part 2C, but they may be used to treat treatment emergent neutropenia 
as indicated by the current American Society of Clinical Oncology guidelines.[39] 
Use of erythropoietin growth factors is allowed as needed to treat anemia. 
6.8.7. Infection Prophylaxis 
The administration of bacterial, fungal and/or viral prophylaxis in accordance with NCCN, 
ESMO, IMWG and/or local institutional guidelines in participants at increased risk of 
infection is strongly encouraged. Refer to Appendix 15 for anti-infectious prophylaxis and 
monitoring recommendation. 
Monitor immunoglobulin levels for the occurrence of hypogammaglobulinemia/immune- 
paresis. Administration of immunoglobulin for IgG level <400 mg/dL (excluding the M- 
spike in participants with IgG myeloma) is strongly recommended. In participants with IgG 
myeloma, evaluation of uninvolved immunoglobulins (IgA and IgM) can also be used to 
determine immune paresis and the need for immunoglobulin replacement. Participants are 
required to receive a prophylaxis against HSV/VZV and PJP infections during the course of 
the study (See Appendix 15). 
6.8.8. COVID-19 
All COVID-19 vaccines are permitted. COVID-19 vaccines received prior to study 
enrollment and during study participation should be collected in the CRF. The timing of 
vaccine administration relative to study intervention is at the discretion of the investigator 
although, if possible, it is best to avoid vaccine administration within 48 hours before or after 
the first and second doses of study intervention and to avoid the DLT observation period, if 
applicable. Discussions between the investigator and the sponsor regarding individual cases 
may occur if further clarification is required. 
Participants with MM are at increased risk of severe disease and complications from 
COVID-19 infections.[40] Participants should be regularly educated on the continuing risk 
and symptoms of COVID-19 infection, best practices to reduce the risk of infection including 
mask usage, and the importance of regular testing including at home. 
Participants are to be tested by PCR or antigen test for SARS-CoV-2 exposure before any 
elranatamab dosing (at any cycle) and upon suspected signs or symptoms of COVID-19 
infection (eg, new or worsening fever, cough, sore throat, shortness of breath or fatigue). 
Frequent reflex testing is encouraged. A positive SARS-CoV-2 test result should be 
immediately reported to the study investigator and documented. 
Participants who develop COVID-19 infection while on study should be treated in 
accordance with their treating healthcare provider’s usual standard of care, local and/or 
regional guidelines, considering all treatments available to study participants, including 

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PAXLOVIDTM and remdesivir. In accordance with standard of care practice, it is expected 
that initiation of treatment will start as soon as possible and ideally within 24 hours following 
a positive SARS-CoV-2 test. 
For participants with SARS-CoV-2 infection, study intervention should be delayed for at 
least 14 days. 
Recommendations from the American Society of Hematology and American Society for 
Transplantation and Cellular Therapy (ASH-ASTCT COVID-19 Vaccination for 
Hematopoietic Cell Transplant and CAR T Cell Recipients: Frequently Asked Questions), 
the European Society for Blood and Marrow Transplantation (Coronavirus Disease COVID- 
19: EBMT Recommendations), and Management of patients with multiple myeloma and 
COVID-19 in the post pandemic era: A consensus paper from the European Myeloma 
Network (EMN) should be followed [41-43]. 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1. Discontinuation of Study Intervention 
It may be necessary for a participant to permanently discontinue study intervention. Reasons 
for permanent discontinuation of study intervention may include the following: 
• Objective disease progression; 
• Global deterioration of health status requiring discontinuation; 
• Unacceptable toxicity; 
• Pregnancy; 
• Significant protocol violation; 
• Lost to follow-up; 
• Participant refused further treatment; 
• Study terminated by sponsor; 
• Death. 
Note that discontinuation of study intervention does not represent withdrawal from the study. 
If study intervention is permanently discontinued, the participant will remain in the study to 
be evaluated for safety, disease assessments, subsequent anticancer therapies, and survival. 
See the SoA for data to be collected at the time of discontinuation of study intervention and 
follow-up for any further evaluations that need to be completed. 

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In the event of discontinuation of study intervention, it must be documented on the 
appropriate CRF/in the medical records whether the participant is discontinuing further 
receipt of study intervention or also from study procedures, posttreatment study follow-up, 
and/or future collection of additional information. 
Follow-Up Visit: 
At least 28 calendar days, and no more than 35 calendar days after discontinuation of study 
intervention, participants will return to undergo review of concomitant treatments, 
contraception check, vital signs, and assessment for resolution of any treatment related AEs 
(see SoA for all activities). 
Participants continuing to experience AEs at this point following discontinuation of treatment 
will continue to be followed at least every 4 weeks until resolution or determination, in the 
clinical judgment of the investigator, that no further improvement is expected (see also 
Section 8.3.1 for AE reporting period). If the unresolved AE is considered by the investigator 
as possibly related to or associated with ADA formation, the participant will be asked to 
return for drug concentration and ADA blood sampling at up to 3-month intervals, until the 
last follow-up of the AE. 
Survival Long Term Follow-Up: 
If the participant has not discontinued from study procedures, post-treatment study 
follow-up, and/or future collection of additional information, long term follow-up will 
continue as outlined in the SoA until the end of study (Section 4.4). 
Follow-up will be conducted every 3 months from the last dose of study intervention to 
confirm survival status and collect information including any new anti-cancer therapies 
initiated, AEs and contraception check (see SoA, active AE reporting period as defined in 
Section 8.3.1 and contraception check period in Section 5.3.1); the follow-up may be 
conducted via telephone. Date of disease progression recorded in the source notes will be 
collected. Public records may be used to find current contact information and/or to document 
date of death if permitted by local law. 
NOTE: for participants who discontinue study intervention without disease progression, 
disease response assessments should continue at least Q4W (±1 wk) until disease 
progression, withdrawal of consent, participant lost to follow up, death or defined end of 
study. 
7.1.1. Potential Cases of Acute Kidney Injury 
Abnormal values in SCr concurrent with presence or absence of increase in urea that meet 
the criteria below, in the absence of other causes of kidney injury, are considered potential 
cases of acute kidney injury. 
An increase of ≥0.3 mg/dL (or ≥26.5 µmol/L) in SCr level relative to the participant’s own 
baseline measurement should trigger confirmatory assessment of SCr as soon as practically 

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feasible, preferably within 48 hours from awareness. Confirmation that SCr relative to the 
participant’s own baseline measurement is ≥0.3 mg/dL (or ≥26.5 µmol/L) should trigger 
immediate, supportive measures taken to correct apparent acute kidney injury and clinical 
evaluation—including detailed history, physical assessment, laboratory tests. All cases 
confirmed on repeat testing as meeting the laboratory criteria for acute kidney injury (>50% 
decrease in eGFR compared to participant’s baseline eGFR), with no other cause(s) of 
laboratory abnormalities identified, should be considered potential cases of drug-induced 
kidney injury irrespective of availability of all the results of the investigations performed to 
determine etiology of the abnormal SCr. 
7.2. Participant Discontinuation/Withdrawal From the Study 
A participant may withdraw from the study at any time at their own request. Reasons for 
discontinuation from the study may include: 
• Refused further study procedures; 
• Lost to follow-up; 
• Death; 
• Study terminated by sponsor. 
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly. 
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations should be performed and no 
additional data should be collected. The sponsor may retain and continue to use any data 
collected before such withdrawal of consent. 
7.2.1. Withdrawal of Consent 
Participants who request to discontinue receipt of study intervention will remain in the study 
and must continue to be followed for protocol specified follow-up procedures. The only 
exception to this is when a participant specifically withdraws consent for any further contact 
with him or her or persons previously authorized by the participant to provide this 
information. Participants should notify the investigator in writing of the decision to withdraw 
consent from future follow-up, whenever possible. The withdrawal of consent should be 
explained in detail in the medical records by the investigator, as to whether the withdrawal is 
only from further receipt of study intervention or also from study procedures and/or 
posttreatment study follow-up, and entered on the appropriate CRF page. In the event that 
vital status (whether the participant is alive or dead) is being measured, publicly available 
information should be used to determine vital status only as appropriately directed in 
accordance with local law. 

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7.3. Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible. Counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether 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. 
8. STUDY ASSESSMENTS AND PROCEDURES 
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures. 
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed. 
Safety issues should be discussed with the sponsor immediately upon occurrence or 
awareness to determine whether 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 (eg, blood 
count) and obtained before signing of the ICD may be utilized for screening or baseline 
purposes provided the procedures met the protocol-specified criteria and were performed 
within the time frame defined in the SoA. 

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Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to perform 
the test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner. 
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study. 
8.1. Efficacy Assessments 
All disease responses will be assessed according to IMWG response criteria (Appendix 10) 
and entered on the CRF. All response categories (except stable disease) require 2 consecutive 
assessments (confirmation). 
Disease assessments are to be conducted per SoA 28-day (±1 wk) interval whether dose 
given or not (ie, the 28-day interval [±1 wk] from C1D1 should be maintained regardless of 
dose delays/interruptions). 
Disease assessments should continue until confirmed PD, withdrawal of consent, lost to 
follow-up, death, or defined end of study (whichever occurs first). 
8.1.1. Laboratory Assessment for Evaluation of Disease Response 
The following laboratory assessments will be performed locally for evaluation of disease 
response according to IMWG criteria. Assessments are to be conducted at the time points 
specified in the SoA. Assessments will include: 
• SPEP for the measurement of all serum M proteins. 
• Serum quantitative immunoglobulins (IgG, IgM, IgA, IgD, IgE) assessment is 
required for all participants at the time points specified in the SoA. In cases where 
SPEP is found to be unreliable (eg, IgA, IgD myeloma) for M-protein assessment, 
quantitative immunoglobulin measurements can be used for disease assessment. If 
used, quantitative immunoglobulin assessment must be used exclusively for a 
participant (ie, quantitative immunoglobulin and SPEP cannot be used 
interchangeably for disease assessment of the same participant). IgD or IgE are only 
required if the heavy chain component of the disease is known to be D or E. 
• SIFE for definitive identification of specific M proteins (including IgG, IgA, IgM, 
and kappa and lambda light chains). SIFE will be required at baseline, when SPEP 
shows no measurable protein, at suspected CR/sCR and at suspected PD (clinical or 
biochemical). 

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• 24-hour UPEP for the measurement of urine M proteins. If any scheduled 24-hour 
UPEP is missed or is non-evaluable, a second attempt for collection of an evaluable 
specimen should be scheduled within 7 days of the missed assessment. For 
participants without measurable disease in the urine at baseline, UPEP is only 
required at suspected VGPR or CR/sCR, and at suspected PD (clinical or 
biochemical). 
• 24-hour UIFE for definitive identification of specific M proteins (including IgG, IgA, 
IgM, and kappa and lambda light chains). UIFE will be required at baseline, when 
UPEP shows no measurable protein, at suspected CR/sCR and at suspected PD 
(clinical or biochemical). 
• Involved and uninvolved serum FLC analysis, are required at screening, C1D1 and 
when both serum and urine M-components are deemed non-measurable (including at 
suspected CR). Serum free kappa, free lambda and free kappa/lambda ratio will be 
collected. Participants with measurable disease by SPEP or UPEP cannot have 
response assessed by serum FLC. Except for sCR, serum FLC levels should only be 
used for response assessment when both the serum and urine M component levels are 
deemed not measurable or uninterpretable. Serum FLC cannot replace UPEP/UIFE in 
any situation where urine M component is measurable at baseline. 
• Note: For participants treated with daratumumab, isatuximab and elotuzumab less 
than 114 days prior to C1D1, daratumumab, isatuximab and elotuzumab may 
interfere with SPEP, and SIFE. Therefore, for these participants, serum FLC assay 
should be completed at screening, C1D1, and along with all subsequent disease 
assessments. Serum M-protein (M-spike), if measurable at baseline, should also be 
followed at the same time points as serum FLC with the most representative marker 
of disease status used for IMWG assessment. 
On days of elranatamab administration, all samples will be collected prior to dosing. 
In participants with 2 M-protein bands at baseline, unless the second band is due to 
daratumumab or other therapeutic mAb interference, the sum of the 2 spikes should be used 
for monitoring of disease. 
PD must be confirmed (unless due to EMD). When PD (clinical or biochemical) is suspected, 
applicable tests (eg, SPEP, SIFE, UPEP, UIFE, serum FLC tests) should be repeated for 
confirmation prior to initiation of new anticancer therapy. To confirm PD, 2 discrete samples 
are required, and testing cannot be based upon the splitting of a single sample. 
Note that if a participant had measurable serum or urine M-protein (M-spike) at baseline, 
unless the band is due to/confounded by the presence of daratumumab or other therapeutic 
mAb, PD cannot be defined by increases in serum FLC alone. Serum FLC levels should only 
be used for response assessment when both the serum and urine M-component levels are 
deemed not measurable or uninterpretable. Furthermore, careful attention should be given to 
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when the isotype is different. This may represent oligoclonal immune reconstitution and 
should not be confused with relapse; these bands typically disappear over time. 
 
 
 
 
 
 
 
 
 
 
8.1.3. Imaging Assessments (PET/CT, CT and/or MRI) 
Imaging will be completed for evaluation of disease response according to IMWG criteria at 
the time points specified in the SoA. For paiiicipants with only skin involvement, skin 
lesions should be measmed with a mler at time points specified in the SoA. 

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Screening images will be used to determine evaluable lesions for each participant. The same 
imaging technique should be used throughout the study (pre- and post-baseline assessments). 
Bone lesions and any soft tissue plasmacytoma documented at baseline must undergo serial 
monitoring. Paramedullary disease or plasmacytomas associated with bone are not 
considered EMD. Plasmacytoma measurements should be taken from the CT portion of the 
PET/CT, or MRI scans, or dedicated CT scans where applicable. Any plasmacytoma that has 
been irradiated will not be suitable for response assessment; however, it must be monitored 
for PD. 
Measurement of lesion size will be determined by the SPD. 
Radiologic progression observed within the first month following the first dose of 
elranatamab will not be considered progressive disease. 
Imaging obtained per the participant’s standard of care prior to study enrollment and signing 
of consent do not need to be repeated and are acceptable to be used as baseline evaluation, if, 
(1) obtained within 42 days before start of study intervention, (2) the same technique can be 
used to follow identified lesions throughout the study for a given participant, and (3) 
appropriate documentation is available in the participant’s source notes indicating that these 
assessments were performed as standard of care. 
All participant’s files and radiologic images must be available for source verification. 
8.1.4. Disease Characteristics and Treatment History 
A disease-targeted medical and treatment history will be collected at screening. Details 
regarding the participant’s MM, including date of initial diagnosis, current stage Table 7), 
relevant disease characteristics, and prior treatments including systemic therapy, radiation, 
and/or stem cell transplant will be recorded on the CRF. Best response and date of disease 
progression (as applicable) for each prior treatment regimen will be recorded. 
 
Table 7. 
Staging Systems for Multiple Myeloma 
 
Stage 
International Staging System 
(ISS) 
Revised-ISS (R-ISS) 
I 
Serum beta-2 microglobulin < 3.5 
mg/L, Serum albumin ≥ 3.5 g/dL 
ISS stage I and standard-risk 
chromosomal abnormalities by 
FISHa 
and 
Serum LDH < the upper limit of 
normal 
II 
Not ISS stage I or III 
Not R-ISS stage I or III 

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Table 7. 
Staging Systems for Multiple Myeloma 
 
Stage 
International Staging System 
(ISS) 
Revised-ISS (R-ISS) 
III 
Sernm beta-2 microglobulin 2:: 5.5 
mg/L 
ISS stage III and either: 
- high-risk chromosomal 
abnormalities by FISHb 
or 
-Sernm LDH > the upper limit of 
normal 
a. Standard risk chromosomal abnonnalities by FISH= no high-risk chromosomal abno1mality. 
b. High risk chromosomal abnonnalities by FISH= Presence of del(l 7p) and/or translocation t(4;14) and/or 
translocation t(14;16) 
Source: Palumbo et al, 2015.(45] 
Note: IfFISH results not available, karyotyping results can be used. 
 
 
 
 

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8.2. Safety Assessments 
Planned time points for all safety assessments are provided in SoA. Unscheduled clinical 
laborato1y measurements may be obtained at any time during the study to assess any 
perceived safety issues. 
Data collected at screening that are used for inclusion/exclusion criteria, such as laborato1y 
data, ECGs and demographic data collected at screening will be repo1ied on the CRF. 
8.2.1. Participant Demographics and Other Baseline Characteristics 
Demographic data and medical histo1y will be collected at screening by the investigator or 
qualified designee, including relevant medical and surgical histo1y, and cmTent illnesses. 
8.2.2. Physical Examinations 
Physical examinations will be perfo1med at time points specified in the SoA. All physical 
examination data (not including neurological examinations, see below) collected during the 
course of the study will be considered source data only and will not be required to be 
repo1ied on the CRF. At screening, a comprehensive physical examination should be 
conducted including, general appearance, head, skin, neck, eyes, ears, nose, throat, mouth, 
lungs, heaii, abdomen, lymph nodes, extremities, musculoskeletal, and a thorough neurologic 
examination (see below). For subsequent visits, physical examinations may be tai·geted as 
clinically indicated. Investigators should pay special attention to clinical signs related to 
previous serious illnesses. 
Neurological exaininations including assessment of mental state, motor function, senso1y 
function, gait, station, deep tendon reflexes, cranial nerve function and coordination will be 
peifonned at times specified in the SoA. All neurological examinations will be reported on 
the CRF. 
All physical examinations, including neurological exaininations, occuning on dosing days 
must be perfo1med prior to eh-anatamab administration. Any treatment-emergent abnonnal 
physical/neurological examination findings will be recorded as AEs. 
Screening weight and height will be repo1ied on the CRF. 
Baseline encephalopathy assessment will be performed using the ICE tool (Lee et al 
2019[48]), (Appendix 12) at ClDl. The ICE tool will also be used as pali of assessing each 
suspected !CANS event. 
Physical exainination findings collected during the study will be considered source data and 
will not be required to be reported, unless othe1wise noted. Any untoward physical 
examination findings that are identified during the active collection period and meet the 

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definition of an AE or SAE (Appendix 3) must be reported according to the processes in 
Sections 8.3.1 to 8.3.3. 
8.2.3. Vital Signs 
Vital signs (temperature, HR, BP and O2 saturation) should be collected per institutional 
standards at time points specified in the SoA prior to blood collection (all study parts). Pre- 
dose vital signs collected on C1D1, C1D4, C1D8, C1D15, C1D22 and C2D1 (for Part 2 
only) should be reported in the CRF. If performed, abnormal vital signs associated with AEs 
(eg, CRS or an infection) should be reported in the CRF. 
Vital signs should be monitored at least every 4 hours (±30 minutes) during the first 48 hours 
after first dose of study intervention and 24 hours after second dose of study intervention. For 
participants in Part 2, vital signs should be monitored at least every 4 hours (±30 min) during 
24 hours after dosing on C2D1 (the latter may not be required for Part 2B and Part 2C 
depending on whether CRS is observed after C2D1 dose in Part 2A). In Part 1, an optional 
day of hospitalization may be considered for the first RP2D dosing (116 mg or 152 mg) Q4W 
depending on CRS profile observed in Part 2A and Part 2B. All these vital signs data should 
be reported in the CRF. 
All vital sign measurements occurring on dosing days must be performed prior to 
elranatamab administration (and prior to premedications, as applicable) and blood collection. 
Abnormal vital sign results identified after the first dose of elranatamab and during the active 
collection period (as defined in Section 8.3.1) constitute an AE if they are considered 
clinically meaningful, induce clinical signs or symptoms, require concomitant therapy or 
require changes in elranatamab dosing. 
8.2.4. Electrocardiograms 
Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) should be 
collected at times specified in the SoA using an ECG machine that automatically calculates 
the heart rate and measures PR, QT, and QTcF intervals and QRS complex. For ECG 
machines that do not report QTcF, calculation of QTcF from QT and heart rate, for example 
using online tools, is permitted. Alternative lead placement methodology using torso leads 
(eg, Mason-Likar) should not be used given the potential risk of discrepancies with ECGs 
acquired using standard limb lead placement. All scheduled ECGs should be performed after 
the participant has rested quietly for at least 10 minutes in a supine position. 
A triplicate ECG (3 serial ECGs conducted within approximately 5 to 10 minutes total time) 
will be performed at all time points, except screening (single ECG at screening), as specified 
in the SoA. ECG will be performed prior to PK sample collection and elranatamab 
administration (and prior to premedication, as applicable). ECG assessments should be 
skipped if CRS symptoms are ongoing to avoid the confounding effects of CRS on ECG 
measurements. Additional ECGs should be performed as clinically indicated. 
If mean QTcF is >500 msec, ECGs should be re-evaluated by a qualified person at the 
institution for confirmation. If a) a postdose QTcF interval remains ≥60 msec from the 

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baseline and is ≥450 msec; or b) an absolute QTcF value is ≥500 msec for any scheduled 
ECG for greater than 4 hours (or sooner, at the discretion of the investigator); or c) QTcF 
intervals get progressively longer, the participant should undergo continuous ECG 
monitoring. A cardiologist should be consulted if QTcF intervals do not return to less than 
the criterion listed above after 8 hours of monitoring (or sooner, at the discretion of the 
investigator). 
Abnormal findings reported by the ECG machine should be reviewed by the investigator in 
order to decide if they are clinically significant. Any findings of clinical concern will also be 
reviewed by a cardiologist. New or worsened clinically significant findings in the ECG 
occurring after the informed consent must be recorded as an AE in the eCRF. ECG tracings 
should be made available if requested by the sponsor. 
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality. It is important that leads be placed in the 
same positions each time in order to achieve precise ECG recordings. If a machine-read 
QTcF value is prolonged, as defined above, repeat measurements may not be necessary if a 
qualified medical provider’s interpretation determines that the QTcF values are in the 
acceptable range. 
ECG values of potential clinical concern are listed in Appendix 7. 
8.2.5. Echocardiograms/Multigated Acquisition Scans 
ECHO or MUGA will be performed at screening as specified in the SoA. If additional 
assessments are performed, the same method should be used throughout the study. 
8.2.6. Clinical Safety Laboratory Assessments 
See Appendix 2 for the list of clinical safety laboratory tests to be performed and the SoA for 
the timing and frequency. All protocol-required laboratory assessments, as defined in 
Appendix 2, must be conducted in accordance with the laboratory manual and the SoA. 
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety issues. 
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF. On days 
of study intervention administration, laboratory reports are to be reviewed prior to dosing. 
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 the active AE reporting period (see Section 8.3.1) should 
be repeated until the values return to normal or baseline or are no longer considered clinically 
significant by the investigator or medical monitor. 

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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. 
See Appendix 6 for suggested actions and follow-up assessments in the event of potential 
drug-induced liver injury. 
All safety laboratory tests will be performed locally. 
8.2.7. Pregnancy Testing 
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least 
25 mIU/mL. Pregnancy tests will be performed in WOCBP at the times listed in the SoA. 
Following a negative pregnancy test result at screening, appropriate contraception must be 
commenced and a second negative pregnancy test result will be required at the baseline visit 
prior to the participant’s receiving the study intervention. Pregnancy tests will also be done 
whenever 1 menstrual cycle is missed during the active treatment period (or when potential 
pregnancy is otherwise suspected) at the end of treatment visit and at the follow up visit. 
Pregnancy tests may also be repeated if requested by IRBs/ECs or if required by local 
regulations. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum 
pregnancy test is required. In such cases, the participant must be excluded if the serum 
pregnancy result is positive. 
8.2.8. ECOG Performance Status 
ECOG PS (Table 8) will be assessed at Screening. 
 
Table 8. 
Eastern Cooperative Oncology Group (ECOG) Performance Status Scale 
 
0 
Fully active, able to carry on all predisease performance without restriction. 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or 
sedentary nature, eg, light housework, office work. 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more 
than 50% of waking hours. 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 
4 
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 
5 
Dead 
 
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting 
The definitions of an AE and an SAE can be found in Appendix 3. 
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally 
authorized representative), or they may arise from clinical findings of the Investigator or 
other healthcare providers (clinical signs, test results, etc.). 

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The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study intervention (see Section 7.1). 
During the active collection period as described in Section 8.3.1, each participant will be 
questioned about the occurrence of AEs in a nonleading manner. 
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion. 
8.3.1. Time Period and Frequency for Collecting AE and SAE Information 
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before the participant’s participation in the study (ie, before undergoing 
any study-related procedure and/or receiving study intervention), through and including a 
minimum of 90 calendar days, except as indicated below, after the last administration of the 
study intervention. NOTE, as indicated in Section 8.3.1.2: If a participant begins a new 
anticancer therapy, the recording period for nonserious AEs ends at the time the new 
treatment is started; however, SAEs must continue to be recorded on the CRF during the 
above-indicated active collection period. 
Only SAEs will be actively elicited and collected after completion of the active collection 
period described above. The SAEs will be reported to Pfizer Safety on the CT SAE Report 
Form only if considered reasonably related to elranatamab. 
Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator. 
For participants who are screen failures, the active collection period ends when screen failure 
status is determined. 
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn. 
If a participant permanently discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the Electronic Data Collection Tool. 
Investigators are not obligated to actively seek information on AEs or SAEs after the active 
collection period. However, if the investigator learns of any SAE, including a death, at any 
time after the active collection period, and the investigator considers the event to be 
reasonably related to the study intervention, the investigator must promptly report the SAE to 
Pfizer using the Electronic Data Collection Tool. 

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8.3.1.1. Reporting SAEs to Pfizer Safety 
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the Electronic Data Collection Tool 
immediately upon awareness 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. 
If a participant begins a new anticancer therapy, SAEs occurring during the above-indicated 
active collection period must still be reported to Pfizer Safety irrespective of any intervening 
treatment. Note that a switch to a commercially available version of the study intervention is 
considered as a new anticancer therapy for purposes of SAE reporting. 
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF 
All nonserious AEs and SAEs occurring in a participant during the active collection period 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF. 
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant. 
If a participant begins a new anticancer therapy, the recording period for nonserious AEs 
ends at the time the new treatment is started; however, SAEs must continue to be recorded on 
the CRF during the above-indicated active collection period. Note that a switch to a 
commercially available version of the study intervention is considered as a new anticancer 
therapy for the purposes of SAE reporting. 
8.3.2. Method of Detecting AEs and SAEs 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences. 
8.3.3. Follow-Up of AEs and SAEs 
After the initial AE or SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined Section 7.3). 
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications 

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and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is given in Appendix 3. 
8.3.4. Regulatory Reporting Requirements for SAEs 
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward 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, IRBs/ECs, and investigators. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary. 
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements. 
8.3.5. Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure 
Environmental exposure occurs when a person not enrolled in the study as a participant 
receives unplanned direct contact with or exposure to the study intervention. Such exposure 
may or may not lead to the occurrence of an AE or SAE. Persons at risk for environmental 
exposure include healthcare providers, family members, and others who may be exposed. An 
environmental exposure may include exposure during pregnancy, exposure during 
breastfeeding, and occupational exposure. 
Any such exposure to the study intervention under study are reportable to Pfizer Safety 
within 24 hours of investigator awareness. 
8.3.5.1. Exposure During Pregnancy 
An EDP occurs if: 
• A female participant is found to be pregnant while receiving or after discontinuing 
study intervention. 
• A male participant who is receiving or has discontinued study intervention exposes a 
female partner prior to or around the time of conception. 

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• A female is found to be pregnant while being exposed or having been exposed to 
study intervention due to environmental exposure. Below are examples of 
environmental EDP: 
• A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by inhalation or skin contact. 
• A male family member or healthcare provider who has been exposed to the study 
intervention by inhalation, or skin contact then exposes his female partner prior to 
or around the time of conception. 
• The investigator must report EDP to Pfizer Safety within 24 hours of the 
investigator’s awareness, irrespective of whether an SAE has occurred. The initial 
information submitted should include the anticipated date of delivery (see below 
for information related to termination of pregnancy). 
• 
If EDP occurs in a participant or a participant’s partner, the investigator must report 
this information to Pfizer Safety on the CT SAE Report Form and an EDP Supplemental 
Form, regardless of whether an SAE has occurred. Details of the pregnancy will be collected 
after the start of study intervention and until pregnancy completion (or until pregnancy 
termination). 
• 
If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the CT SAE Report Form and EDP Supplemental Form. 
Since the exposure information does not pertain to the participant enrolled in the study, the 
information is not recorded on a CRF; however, a copy of the completed CT SAE Report 
Form is maintained in the investigator site file. 
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported). 
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a live-born baby, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death), the investigator should follow the procedures 
for reporting SAEs. Additional information about pregnancy outcomes that are reported to 
Pfizer Safety as SAEs follows: 
• Spontaneous abortion including miscarriage and missed abortion; 

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• Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs. In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the study intervention. 
Additional information regarding the EDP may be requested by the sponsor. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays). In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner. The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner. 
8.3.5.2. Exposure During Breastfeeding 
An exposure during breastfeeding occurs if: 
• A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention. 
• A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure). An example of environmental 
exposure during breastfeeding is a female family member or healthcare provider who 
reports that she is breastfeeding after having been exposed to the study intervention 
by inhalation, or skin contact. 
The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours 
of the investigator’s awareness, irrespective of whether an SAE has occurred. The 
information must be reported using the CT SAE Report Form. When exposure during 
breastfeeding occurs in the setting of environmental exposure, the exposure information does 
not pertain to the participant enrolled in the study, so the information is not recorded on a 
CRF. However, a copy of the completed CT SAE Report Form is maintained in the 
investigator site file. 
An exposure during breastfeeding report is not created when a Pfizer drug specifically 
approved for use in breastfeeding women (eg, vitamins) is administered in accord with 
authorized use. However, if the infant experiences an SAE associated with such a drug, the 
SAE is reported together with the exposure during breastfeeding. 
8.3.5.3. Occupational Exposure 
The investigator must report any instance of occupational exposure to Pfizer Safety within 
24 hours of the investigator’s awareness using the CT SAE Report Form regardless of 
whether there is an associated SAE. Since the information about the occupational exposure 
does not pertain to a participant enrolled in the study, the information is not recorded on a 
CRF; however, a copy of the completed CT SAE Report Form must be maintained in the 
investigator site file. 

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8.3.6. Cardiovascular and Death Events 
Please refer to Appendix 7 for ECG findings of clinical significance and to Appendix 3 for 
reporting of deaths. 
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs 
Not applicable. 
8.3.8. Adverse Events of Special Interest 
AESIs are examined as part of routine safety data review procedures throughout the clinical 
trial and as part of signal detection processes. 
All AESIs must be reported as an AE or SAE following the procedures described in 
Sections 8.3.1 through 8.3.4. An AESI is to be recorded as an AE or SAE on the CRF. In 
addition, an AESI that is also an SAE must be reported using the Electronic Data Collection 
Tool. 
8.3.8.1. Cytokine release Syndrome 
CRS is a known toxicity of therapeutics that function by activation of immune effector cells. 
CRS is defined as a supraphysiologic response following any immune therapy that results in 
the activation or engagement of endogenous or infused T-cells and/or other immune effector 
cells. Symptoms can be progressive, must include fever at the onset, and may include 
hypotension, capillary leakage causing hypoxia and end organ dysfunction. Symptoms 
associated with CRS vary greatly and may be difficult to distinguish from other conditions. 
The severity of symptoms can be mild to life threatening, thus there should be a high index of 
suspicion for CRS if these symptoms occur. 
The severity of CRS will be assessed according to the ASTCT consensus criteria. See 
Appendix 12. 
For both the priming doses and first full dose (76 mg), premedication for CRS is required 
(see Section 6.8.1). 
8.3.8.2. Immune Effector Cell-Associated Neurotoxicity Syndrome 
ICANS is a known toxicity of therapeutics that function by activation of immune effector 
cells. ICANS is defined as “a disorder characterized by a pathologic process involving the 
central nervous system following any immune therapy that results in the activation or 
engagement of endogenous or infused T-cells and/or other immune effector cells. Symptoms 
or signs can be progressive and may include aphasia, altered level of consciousness, 
impairment of cognitive skills, motor weakness, seizures, and cerebral edema”.[48] It has 
been observed following administration of some CAR T-cells and BsAbs, and can occur 
independently of CRS. 

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The severity of ICANS will be graded according to the ASTCT consensus criteria. See 
Appendix 12, Section 10.12. 
Additional management for Grade ≥3 CRS and ICANS is described in Section 9.4.1 
8.3.8.3. Peripheral Neuropathy 
Peripheral neuropathy is a common complication of MM and its treatment. Peripheral 
neuropathy can be caused by MM itself, either by the paraneoplastic effects of the 
monoclonal protein (polyneuropathy is an essential feature of POEMS syndrome) or in the 
form of radiculopathy from direct compression, and particularly by certain therapies, 
including IMiDs and proteasome inhibitors. Symptoms are usually symmetric and include 
paresthesias, numbness, burning sensation and muscle weakness; these are generally mild, 
but in rare cases can be disabling or even life-threatening. Treatment-emergent peripheral 
neuropathy symptoms are usually symmetric, distal and progressive.[49] Recently, peripheral 
neuropathy has been described following administration of BCMA-directed bispecific T-cell 
engagers.[30] 
Peripheral neuropathy (including GBS) is considered an important potential risk of 
elranatamab. 
Work-up for new or worsening Grade ≥2 peripheral neuropathy should include a neurology 
consult, imaging (eg MRI of the spine), NCV/EMGs, and lumbar puncture to assess CSF. In 
consultation with a neurologist, appropriate therapy for peripheral neuropathy (eg, steroids 
and/or IV immunoglobulin) should be considered. 
Closely monitor participants for signs and symptoms of neuropathy following infections or 
following the administration of any vaccine. 
8.3.8.4. Lack of Efficacy 
The investigator must report signs, symptoms, and/or clinical sequelae resulting from lack of 
efficacy. Lack of efficacy or failure of expected pharmacological action is reportable to 
Pfizer Safety only if associated with an SAE. 
8.3.9. Medical Device Deficiencies 
Not applicable. 
8.3.10. Medication Errors 
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength. 
Exposures to the study intervention under study may occur in clinical trial settings, such as 
medication errors. 

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Safety Event 
Recorded on the CRF 
Reported Via the Electronic Data 
Collection Tool to Pfizer Safety 
Within 24 Hours of Awareness 
Medication errors 
All (regardless of whether 
associated with an AE) 
Only if associated with an SAE 
 
Medication errors include: 
• Medication errors involving participant exposure to the study intervention; 
• Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant. 
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page. 
In the event of a medication dosing error, the sponsor should be notified within 24 hours. 
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF. 
Medication errors should be reported to Pfizer Safety within 24 hours on via the Electronic 
Data Collection Tool only when associated with an SAE 
8.4. Pharmacokinetics 
All participants will have blood samples collected for PK assessments of elranatamab serum 
concentrations at the time points specified in the SoA. In the event of suspected CRS, 
unexpected or serious AE, or AE leading to discontinuation of study intervention, additional 
PK samples should be collected if not already scheduled. The actual date/time of sample 
collection should be documented in the CRF. For each time point, blood samples of 
approximately 5 mL, to provide a minimum of 2 mL serum, will be collected for 
measurement of serum concentrations of elranatamab. Instructions for the collection and 
handling of biological samples will be provided in the laboratory manual or by the sponsor. 
The actual date and time (24-hour clock time) of PK sample collection will be recorded in the 
CRF. 
The actual times may change, but the number of samples will remain the same. All effort 
should be made to obtain the samples at the exact nominal time relative to dosing (see SoA). 
Collection of samples up to and including 48 hours after dose administration that are 
obtained within 10% of the nominal time relative to dosing will not be captured as a protocol 
deviation, as long as the exact time of the collection is noted on the CRF. For predose PK 

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samples, collection should occur prior to administration of elranatamab (and prior to 
premedications if applicable) on that day. 
Samples will be used to evaluate the PK of elranatamab. Each senun sample will be divided 
into 2 aliquots, to provide a minimum of 1 mL sernm for each aliquot. Samples collected for 
analyses of elranatamab sernm concentration may also be used to evaluate safety or efficacy 
aspects related to concerns arisin durin or after the stud and/or evaluation of the 
bioanalytical method, 
 
Samples collected for measurement of elranatamab concentrations will be analyzed using a 
validated analytical method in compliance with applicable SOPs. 
The PK samples must be processed and shipped as indicated in the instructions provided to 
the investigator site to maintain sample integrity. Any deviations from the PK sample 
handling procedure (eg, sample collection and processing steps, interim storage or shipping 
conditions), including any actions taken, must be documented and reported to the sponsor. 
On a case-by-case basis, the sponsor may make a determination as to whether sample 
integrity has been compromised. 
Refer to the lab manual for detailed collection, processing and shipping procedures. 
 
 
 
 
 

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8.7. Immunogenicity Assessments 
Blood samples of approximately 5 mL, to provide a minimum of 2 mL sennn, will be 
collected for detennination of ADA and NAb into appropriately labeled tubes at times 
specified in the SoA. Instmctions for the collection and handling of biological samples will 
be provided in the laborato1y manual. The actual date and time (24 hour clock time) of each 
sample will be recorded. 
Paiiicipants having an unresolved AE that is possibly related to anti-ekanatainab antibodies 
at their last assessment will be asked to return to the clinic for ADA and diug concentration 
blood sampling at approximately 3-month intervals until the AE or its sequelae resolve or 
stabilize at a level acceptable to the investigator and sponsor. 
 
Samples will be analyzed using a validated analytical method in compliance with applicable 
SOPs. Samples detennined to be positive for ADA may be fmiher chai·acterized for NAb. 
The immunogenicity samples must be processed and shipped as indicated in the instructions 
provided to the investigator site to maintain sainple integrity. Any deviations from the 
immunogenicity sample handling procedure (eg, sample collection and processing steps, 
interim storage, or shipping conditions), including any actions taken, must be documented 
and reported to the sponsor. On a case by case basis, the sponsor may make a detennination 
as to whether sample integrity has been compromised. 
As pa1i of understanding the immunogenicity of the investigational product, samples may be 
used for evaluation of the bioanalytical method and/or additional characterization of an 
observed immuno enici 
res onse. 
 
8.8. Health Economics 
Health economics/medical resource utilization and health economics parameters ai·e not 
evaluated in this study. 
9. STATISTICAL CONSIDERATIONS 
Detailed methodology for summaiy and statistical analyses of the data collected in this study 
is outlined here and fmiher detailed in a SAP, which will be maintained by the sponsor. The 
SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the prima1y endpoint definitions or their analyses will also be reflected in a 
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9.1. Statistical Hypotheses 
The primary endpoint of this study is Grade ≥2 CRS rate for Part 1 & Part 2. No hypothesis 
for statistical significance will be tested. Instead, a Bayesian design will be used to estimate 
the true Grade ≥2 CRS rate in Part 1 and 2. Details are described in Section 9.5. 
9.1.1. Estimands 
9.1.1.1. Primary Estimand 
 
The primary estimand is the treatment effect of elranatamab with a dosing regimen that 
includes 2 step-up priming doses with premedication on the rate of Grade ≥2 CRS as 
assessed by ASTCT criteria. It is defined by the following attributes: 
• Population: RRMM participants, as defined by the inclusion and exclusion criteria to 
reflect the targeted population of the treatment, who received at least one dose of 
study intervention elranatamab. 
• Variable: Incidence of Grade ≥2 CRS as assessed by ASTCT criteria during C1. 
The intercurrent event is treatment discontinuation due to any reason, and is 
addressed by the treatment condition of interest attribute. All data collected after an 
intercurrent event of treatment discontinuation will be excluded 
• Population-level summary: The median and its corresponding 2-sided 90% credible 
interval of Grade ≥2 CRS rate in the analysis population based on the posterior 
distribution. 
9.1.1.2. Secondary Estimand 
The secondary estimand is DLT rate estimated based on data from DLT-evaluable 
participants in Part 2A and Part 2C during the DLT observation period. It is defined by the 
following attributes: 
• Population: RRMM participants, as defined by the inclusion and exclusion criteria to 
reflect the targeted population of the treatment and either experience DLT(s) during 
the DLT observation period or complete the DLT observation period without DLT. 
Participants without DLTs who receive less than the planned doses of the study 
intervention are not evaluable for DLTs. 
• Variable: Occurrence of DLTs during the DLT observation period. 
• Treatment condition: At least 1 dose of study intervention of elranatamab. 
• Population-level summary measure: DLT rate defined as the number of DLT- 
evaluable participants with DLTs in the DLT observation period divided by the 
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9.2. Analysis Sets 
For pmposes of analysis, the following analysis sets are defined for Pait 1 and Pait 2, 
respectively. 
 
Partici ant Anal 1sis Set 
Descri tion 
Safety Analysis Set 
All emolled paiticipants who receive at least 1 dose of study 
inteivention. 
DLT Evaluable Set 
All emolled paiticipants in Pait 2A and Pait 2C who received the 
planned 2 doses of 116 mg or 152 mg of study inteivention dming the 
DLT obseivation pedod or who received at least 1 dose of 116 mg or 
152 mg of study inteivention and expeiience DLT(s) dming the DLT 
obseivation eriod. 
PK Analysis Set 
The PK analysis set will include all paiticipants in the safety analysis 
set who have at least 1 postdose concentration measmement. 
The PK pai·ameter analysis set will include all paiticipants in the 
safety analysis set who have at least 1 of the PK pai·ameters of interest 
for eh·anatamab. 
 
 
 
 
 
Immunogenicity Analysis 
le 
 
Note: "Emolled" means a paiticipant's, or his or her legally auth01ized representative's, agreement 
to paiticipate in a clinical study following completion of the infoimed consent process and was 
assigned to treatment. Potential paiticipants who ai·e screened for the pmpose of deteimining 
eligibility for the study, but do not pa1ticipate in the study, are not considered emolled, unless 
otheiwise specified by the protocol. 
9.3. Statistical Analyses 
The SAP will be developed and finalized before any analyses ai·e peifonned and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data. 
This section is a sUilllnaiy of the planned statistical analyses of the primaiy and secondaiy 
endpoints. 
 

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9.3.1. General Considerations 
Unless otherwise specified, all analyses will be performed for each part (Part 1, Part 2) 
separately and for Part 1 and Part 2 combined. All efficacy analyses and safety analyses will 
be performed using the Safety Analysis Set. 
No formal statistical testing will be conducted on this study. In general, descriptive 
summaries will be presented for the efficacy and safety variables collected. Continuous 
variables will be summarized using mean, standard deviation, minimum, median, and 
maximum. Qualitative variables will be summarized by frequency counts and percentages. 
Unless otherwise specified, the calculation of proportions will include the missing category. 
Therefore, counts of missing observations will be included in the denominator and presented 
as a separate category. Time to event variables will be summarized using Kaplan-Meier 
estimates (product-limit estimates) together with a summary of associated statistics including 
the median time with 2-sided 95% CIs. Probabilities of an event at particular time points may 
be estimated with corresponding 2-sided 95% CIs. 
9.3.2. Primary Endpoint/Estimand/Analysis 
Grade ≥2 CRS rate during C1 
The primary endpoint for Part 1 & Part 2 combined is Grade ≥2 CRS rate during C1, defined 
as the proportion of participants in the Safety Analysis Set experiencing Grade ≥2 CRS as 
assessed by ASTCT criteria. 
The median and its corresponding 2-sided 90% credible interval based on the posterior 
distribution of Grade ≥2 CRS rate will be calculated. In addition, point estimates of Grade ≥2 
CRS rate will be calculated along with the 2-sided 90% CIs using the Clopper-Pearson 
method (exact CI for a binomial proportion). 
9.3.3. Secondary Endpoints/Estimands/Analyses 
9.3.3.1. Secondary Safety Endpoint 
Incidence of DLTs (Part 2A and Part 2C only) 
The number and proportion of participants experiencing DLTs during the DLT observation 
period will be summarized and listed by dose level. Analyses of DLT will be performed on 
DLT Evaluable Analysis Set (as defined in Section 9.2). 
Overall Safety Profile and Tolerability 
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to 
elranatamab (Part 1 and Part 2). Laboratory abnormalities as characterized by type, 
frequency, severity and timing. 
AEs (except CRS and ICANS) will be graded by the investigator according to NCI 
CTCAE v5.0 and coded using MedDRA. CRS and ICANS will be assessed according to the 
ASTCT criteria (See Appendix 13) and coded using MedDRA. AEs will be presented with 

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and without regard to causality based on the investigator’s judgment. The frequency of 
overall toxicity, categorized by toxicity Grades 1 through 5, will be described. 
Additional summaries will be provided for AEs that are observed with higher frequency and 
for AESIs identified in Section 8.3.8. 
Clinical laboratory data will be classified by grade according to NCI CTCAE v5.0 and will 
be analyzed using summary statistics. The worst on-treatment grades during the treatment 
period will be summarized. Shifts in toxicity grading from baseline to highest grade during 
the on-treatment period will be displayed. Results for laboratory tests that are not part of NCI 
CTCAE will be presented as below, within, or above normal limits. Only participants with 
post-baseline laboratory values will be included in these analyses. Further details of analyses 
for all the laboratory parameters will be provided in the SAP. 
9.3.3.2. Secondary Efficacy Endpoints 
Objective Response Rate 
ORR is defined as the proportion of participants in the Safety Analysis Set with an objective 
response per IMWG response criteria as determined by investigator. 
Complete Response Rate 
CRR is defined as the proportion of participants in the Safety Analysis Set with a BOR of 
confirmed sCR/CR per IMWG response criteria as determined by investigator. 
Point estimates of CRR will be calculated along with the 2-sided exact 95% CIs using the 
Clopper-Pearson method. 
Duration of Response 
DOR is defined, for participants with an objective response per IMWG criteria, as the time 
from the first documentation of objective response that is subsequently confirmed, until 
confirmed PD per IMWG criteria, or death due to any cause, whichever occurs first. 
DOR will be censored on the date of the last adequate disease assessment for participants 
who do not have an event (PD or death due to any cause), on the date of the last adequate 
disease assessment before the new anti-cancer therapy for participants who start a new anti- 
cancer therapy prior to an event, or on the date of the last adequate disease assessment before 
the 2 or more missing disease assessments for participants with an event after 2 or more 
missing disease assessments. 
DOR will be summarized using Kaplan Meier method and displayed graphically. Median 
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Duration of Complete Response 
DOCR is defined, for participants with a BOR of confirmed sCR/CR per IMWG criteria, as 
the time from the first documentation of sCR/ CR that is subsequently confirmed, until 
confirmed PD per IMWG criteria, or death due to any cause, whichever occurs first. 
DOCR will be censored on the date of the last adequate disease assessment for participants 
who do not have an event (PD or death due to any cause), on the date of the last adequate 
disease assessment before the new anti-cancer therapy for participants who start a new anti- 
cancer therapy prior to an event, or on the date of the last adequate disease assessment before 
the 2 or more missing disease assessments for participants with an event after 2 or more 
missing disease assessments. 
DOCR will be summarized using Kaplan Meier method and displayed graphically. Median 
DOCR and 2 sided 95% CI will be provided. 
Progression-free Survival 
PFS is defined as the time from the date of first dose until confirmed PD per IMWG criteria 
or death due to any cause, whichever occurs first. 
PFS will be censored as follows: 
• For participants who do not have an event (PD per IMWG criteria or death due to any 
cause), censoring will occur on the date of the last adequate disease assessment; 
• For participants who start a new anticancer therapy prior to an event, censoring will 
occur on the date of the last adequate disease assessment before the new anticancer 
therapy; 
• For participants with an event after a gap of 2 or more missing disease assessments, 
censoring will occur on the date of the last adequate disease assessment before the 
gap; 
• Participants who do not have an adequate post-baseline disease assessment will be 
censored on the date of first dose of study intervention unless death occurs on or 
before the time of the second planned disease assessment (ie, ≤8 weeks after the date 
of first dose) in which case the death will be considered an event. 
PFS will be summarized using Kaplan Meier method and displayed graphically. Median PFS 
and 2-sided 95% CI will be provided. 
Overall Survival 
OS is defined as the time from the date of first dose until death due to any cause. Survival 
status is expected to be collected irrespective of study intervention discontinuation or 

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paiticipant's request to discontinue study procedures. All paiticipants who have not 
withdrawn consent for fmther paiticipation in the study should be followed for survival until 
the end of the study. OS for paiticipants not known to have died are censored on the date of 
last known alive. 
OS will be summarized using Kaplan Meier method and displayed graphically. Median OS 
and 2-sided 95% CI will be provided. 
 
Time to Response 
TTR is defined, for paiticipants with an objective response per IMWG criteria, as the time 
from the date of first dose to the first documentation of objective response that is 
subsequently confinned. 
TTR will be summarized using mean, standai·d deviation, minimum, median, and maximum. 
 
 
 
9.3.3.3. Pharmacokinetic Analyses 
PK data analyses will include descriptive smnmai·y statistics of the predose and postdose 
sernm concentrations of eh-anatamab by cohort, study visit and time point. In addition, the 
PK data from this study may be pooled with other studies to develop a population PK model. 
The coITelation between eh-anatainab Cmax-24 after the first step-up dose (ie, 4 mg) and the 
probability of All Grade and Grade 2 and higher CRS will be evaluated; other relevant PK 
meti·ics may be explored. The results of these analyses coITelating eh-anatamab exposure to 
probability of CRS will be repo1ted in the clinical study repo1t or a sepai·ate modeling repo1t. 
The coITelations between eh-anatamab exposure parameters and phaimacodynainic biomarker 
including cytokine data, efficacy and/or other safety outcomes will also be explored. The 
results of these modeling analyses may be repo1ted separately from the clinical study repo1t. 
9.3.3.4. Immunogenicity Analyses 
For illllllunogenicity data, the percentage of participants with at least one positive, post dose 
ADA will be smnmarized. Listings and Sllllllnaiy tabulations of the ADA data at baseline and 
post-first dose will be generated. Samples testing ADA positive will also be analyzed for the 
presence of NAb, and results will be similai·ly Sllllllnai·ized. For paiticipants with positive 
ADA or NAb, the magnitude (titer), time of onset, and duration of ADA or NAb response 
will also be described. The potential impact of immunogenicity on PK and clinical response 

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including phannacodynamic markers, safety/tolerability and efficacy will be explored, if 
wairnnted by the data. 
 
 
9.3.5. Other Safety Analyses 
All safety analyses will be perfo1med on the Safety Analysis Set. 
AEs, ECGs and safety laborato1y data will be reviewed and summarized on an ongoing basis 
during the study to evaluate the safety of paiiicipants. Any clinical laborato1y, ECG and PR 
abnonnalities of potential clinical concern will be described. Safety data will be presented in 
tabular and/or graphical fonnat and summarized descriptively, where appropriate. 
Medical histo1y and physical exainination and neurological examination infonnation, as 
applicable, collected during the course of the study will be considered source data and will 
not be required to be repo1ied, unless othe1wise noted. However, any untoward findings 
identified on physical and/or neurological exaininations conducted during the active 
collection period will be captured as AEs, if those findings meet the definition of an AE. 
Data collected at screening that ai·e used for inclusion/exclusion criteria, such as laborato1y 
data, ECGs, and vital signs, will be considered source data, and will not be required to be 
repo1ied, unless othe1wise noted. Demographic data collected at screening will be repolied. 
9.3.5.1. Electrocardiogram Analyses 
Changes from baseline for the ECG pai·aineters QT interval, heaii rate, QTcF interval, PR 
interval, and QRS complex will be smmnai·ized by treatment and time. 

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The number (%) of pa1ticipants with maximum postdose QTcF values and maximum 
increases from baseline in the following categories will be tabulated by treatment: 
 
Safety QTcF Assessment 
Degree of 
Prolongation 
Mild (msec) 
Moderate (msec) 
Severe (msec) 
Absolute value 
c::450-480 
>480-500 
>500 
Increase from baseline 
30-60 
>60 
fu addition, the number of paiticipants with uncorrected QT values >500 msec will be 
summarized. 
9.3.5.2. Adverse Events 
AEs (except CRS and ICANS) will be graded by the investigator according to NCI CTCAE 
version 5.0 and coded using Med.ORA. CRS and ICANS will be assessed according to 
ASTCT criteria (See Appendix 12) and coded using Med.ORA. AEs will be characterized by 
type, frequency, severity, timing, seriousness, and relationship to ehanatamab. AEs will be 
presented with and without regai·d to causality based on the investigator's judgment. The 
frequency of overall toxicity, categorized by toxicity Grades 1 through 5, will be described. 
Additional summaries will be provided for AEs that ai·e observed with higher frequency and 
for AESis identified in Section 8.3.8, including CRS and ICANS. 
9.3.5.3. Laboratory Test Abnormalities 
Clinical laborato1y data will be classified by grade according to NCI CTCAE version 5.0 and 
will be analyzed using summaiy statistics. The worst on-treatment grades during the 
treatment period will be summarized. Shifts in toxicity grading from baseline to highest 
grade during the on-treatment period will be displayed. Results for laborato1y tests that ai·e 
not pa1t of NCI CTCAE will be presented as below, within, or above n01mal liinits. Only 
paiticipants with post-baseline laborato1y values will be included in these analyses. Fmther 
details of analyses for all the laborato1y pai·ameters will be provided in the SAP. 
 
9.4. Interim Analyses 
9.4.1. Interim Safety Assessments 
futerim safety assessments will be perfonned on this study and will be perfo1med on Pait 1 
and 2 combined. 

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An internal safety review team will review cumulative safety data during the study conduct 
(see Section 10.1.5.1). In addition, the incidence of the following events will each be 
monitored by the Sponsor throughout the study. The review results and decisions will be 
documented in the study TMF. 
• Grade 3-4 CRS; 
• Grade 3-4 ICANS; 
• Grade 4 treatment-related non-hematologic events (excluding CRS and ICANS); 
• Grade 3-4 treatment-related GBS/GB-like AEs; 
• Grade 4 treatment-related sensory neuropathy/other IR neurologic AEs (excluding 
ICANS) 
• Grade 3-4 treatment-related motor neuropathy 
• Grade 5 events. 
If the number of participants observed to have such identified events exceeds a prespecified 
threshold, the study will be placed on a temporary enrollment hold by the sponsor. During 
any temporary enrollment hold, no new participants can be enrolled, nor can any newly 
enrolled participants start study intervention. Participants who have already started study 
intervention may continue treatment only if the benefit/risk assessment for the participant is 
judged to be positive by the investigator in consultation with the sponsor. In the event that 
any criteria for the temporary enrollment hold are met, written notification documenting the 
reason for the temporary hold and/or termination will be provided by the sponsor to the 
investigators, the EC/IRBs, the regulatory authorities, and any CRO(s) used in the study. 
The criteria for placing the study on temporary hold for the following safety reasons are 
based on Bayesian posterior probabilities. Using a non-informative Beta (0.5, 0.5) prior 
distribution, if the number of participants observed to have Grade 3 or 4 CRS results in a ≥ 
0.80 posterior probability that the true Grade 3 or 4 CRS rate exceeds 20%, the study will be 
put on a temporary hold. Separate but similar criteria will be used for participants with Grade 
3-4 ICANS and treatment-related Grade 4 non-hematologic events (excluding CRS and 
ICANS). Table 9 summarizes the minimum number of participants with such identified 
events that would meet the above criteria. 
 
Table 9. Minimum Number of Participants With Identified Events That Would 
Prompt Temporary Enrollment Hold (CRS, ICANS, Non-hematologic 
treatment-related AEs) 
 
Number of Evaluable Participants 
10-13 
14-18 
19-22 
23-26 
27-30 
31-35 
36-39 
Minimum number of participants with Grade 
3-4 CRS events that would lead to a temporary 
enrollment hold* 
4 
5 
6 
7 
8 
9 
10 

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Table 9. Minimum Number of Participants With Identified Events That Would 
Prompt Temporary Enrollment Hold (CRS, ICANS, Non-hematologic 
treatment-related AEs) 
 
Number of Evaluable Participants 
10-13 
14-18 
19-22 
23-26 
27-30 
31-35 
36-39 
Minimum number of participants with Grade 
3-4 ICANS events that would lead to a 
temporary enrollment hold* 
4 
5 
6 
7 
8 
9 
10 
Minimum number of participants with Grade 4 
treatment-related non-hematologic events 
(excluding CRS and ICANS) that would lead 
to a temporary enrollment hold* 
4 
5 
6 
7 
8 
9 
10 
Prior distribution: Beta (0.5,0.5) 
Criteria for 40 or more evaluable participants will be calculated such that the study will be put on temporary 
hold if the posterior probability that the true event rate exceeds 20% is greater than or equal to 0.80. 
Evaluable participants are defined as those who have received at least 1 dose of study treatment having an 
identified event or those without such an event who have been followed for at least 28 days from first dose. 
* The study will be put on temporary hold as soon as the minimum number of evaluable participants with the 
identified AEs has reached the threshold (eg, if there are 4 participants experiencing the identified AE out of 
the first 6 evaluable participants, the study will be put on hold). A minimum of 4 events are required to 
trigger a temporary hold. 
 
The criteria for placing the study on temporary hold for the following safety reasons are 
based on Bayesian posterior probabilities using a non-informative Beta (0.5, 0.5) prior 
distribution. Specifically, 
• if the number of evaluable participants observed to have treatment-related Grade 3-4 
GBS/GB-like AEs results in a posterior probability that the true rate of such events 
exceeding 3% is ≥0.80, the study will be put on a temporary hold; 
• if the number of evaluable participants observed to have treatment-related Grade 4 
sensory neuropathy/other IR neurologic AEs (excluding ICANS) or treatment-related 
Grade 3-4 motor neuropathy results in a posterior probability that the true rate of such 
events exceeding 10% is ≥0.80, the study will be put on a temporary hold. 
Table 10 summarizes the minimum number of evaluable participants with such identified 
events that would meet the above criteria. 

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Table 10. Minimum Number of Participants With Identified Treatment-Related 
Events That Would Prompt Temporary Enrollment Hold (GBS/GB-like 
AEs, Peripheral Neuropathy/IR Neurologic AEs) 
 
Number of Evaluable 
Participants 
20-39 
40-64 
65-90 
- 
- 
- 
- 
- 
- 
Minimum number of 
participants with Grade 3-4 
treatment-related GBS/GB-like 
events that would lead to a 
temporary enrollment hold* 
2 
3 
4 
- 
- 
- 
- 
- 
- 
Number of Evaluable 
Participants 
6-11 
12-19 
20-27 
28-35 
36-43 
44-52 
53-60 
61-69 
70-78 
Minimum number of 
participants with Grade 4 
treatment-related sensory 
neuropathy /IR neurologic AE 
(excluding ICANS) or Grade 3- 
4 treatment-related motor 
neuropathy events that would 
lead to a temporary enrollment 
hold** 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Prior distribution: Beta (0.5,0.5) 
Evaluable participants are defined as those who have received at least 1 dose of study treatment having an 
identified event or those without such an event who have been followed for at least 28 days from first dose. 
*The study will be put on temporary hold as soon as the minimum number of evaluable participants with the 
identified AEs has reached the threshold (eg, for GBS/GB-like AEs, if there are 2 participants experiencing the 
identified AE out of the first 10 evaluable participants, the study will be put on hold). A minimum of 2 events 
are required to trigger a temporary hold. 
** The study will be put on temporary hold as soon as the minimum number of evaluable participants with the 
identified AEs has reached the threshold (eg, if there are 2 participants experiencing the identified AE out of the 
first 4 evaluable participants, the study will be put on hold). A minimum of 2 events are required to trigger a 
temporary hold. 
 
 
In addition, the study will be put on temporary hold if any of the following criteria are met: 
• 1 Grade 5 event of CRS (by ASTCT criteria); 
• 1 Grade 5 event of ICANS (by ASTCT criteria); 
• 1 Grade 5 treatment-related peripheral neuropathy or IR neurologic event; 
• Any 2 treatment-related Grade 5 events (excluding CRS and ICANS and peripheral 
neuropathy/IR neurologic event). 

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9.4.2. Interim Analysis for Futility 
An interim analysis for futility will be performed on the 30 participants enrolled and treated 
in Part 1 to assess the safety of elranatamab in terms of CRS rate using a dose regimen with 
2 step-up priming doses. The primary endpoint of Grade ≥2 CRS rate during C1 will be 
evaluated at this analysis using a futility boundary based on the predictive probability 
assuming a Beta (0.7, 1.3) prior. More specifically, the study may stop for futility if the 
predictive probability of observing 20 or fewer participants with Grade ≥2 CRS events in 
76 participants at the primary analysis based on the data observed at the interim analysis is 
less than 10%. With 30 participants at the interim analysis, if there are 11 or more 
participants with Grade ≥2 CRS events, further accrual may be stopped for the study. 
Otherwise, the study will proceed as planned to the primary analysis as described in 
Section 9.3.2. 
The interim futility analysis will be conducted once the 30 participants in Part 1 either 
complete C1 of study intervention or discontinued the study intervention prior to C1. The 
exact futility boundary will be updated prior to the time of the analysis based on the actual 
number of participants enrolled and treated. 
The interim analysis may also be performed at other time points for the purpose of safety 
assessment and/or supporting clinical development. The exact futility boundary will be 
updated prior to the time of the analysis based on the actual number of participants enrolled 
and treated. Table 11 summarizes the futility boundary in terms of number of participants 
with Grade ≥2 CRS events at the interim analysis. 
 
Table 11. Futility Boundary (Number of Participants with Grade ≥2 CRS Events) at 
the Interim Analysis 
 
Number of participants at the 
interim analysis 
15-17 
18-21 
22-24 
25-27 
28-31 
32-35 
36-38 
39-42 
Minimum # of participants with 
Grade ≥2 CRS events at the 
interim analysis to stop the study 
for futility 
7 
8 
9 
10 
11 
12 
13 
14 
The internal core study team will review the interim futility analysis results and document all 
decisions in the study TMF. The analysis details will be documented and approved in the 
SAP. 
9.5. Sample Size Determination 
A sufficient number of participants will be screened to achieve approximately 76 participants 
enrolled and treated in both Part 1 and Part 2. This sample size is based on the primary 
endpoint of rate of Grade ≥2 CRS as assessed by ASTCT criteria during Cycle 1 
(Section 9.3.2). Approximately 30 participants will be enrolled and treated in Part 1, 
approximately 8 to 16 participants will be enrolled in Part 2A for DLT evaluation, 
approximately 22 participants will be enrolled to have at least 15 participants treated for 2 
cycles in Part 2B and approximately 8 participants will be enrolled and treated in Part 2C. 

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The actual number of participants in each part may change depending on the tolerability 
assessment in Part 2A. If Dose level 1 in Part 2A is deemed intolerable, the study will 
complete the enrollment in Part 1 only for a total of approximately 76 participants. 
9.5.1. Primary Endpoint 
A Bayesian dual-criterion design [3] will be used to estimate the primary endpoint of the true 
Grade ≥2 CRS rate during C1. With this design, the following criteria are defined: 
• Bayesian statistical significance: Substantial evidence that the true Grade ≥2 CRS rate 
exceeds a pre-specified value. For this study, Bayesian statistical significance will be 
achieved if the posterior probability of the true Grade ≥2 CRS rate exceeding 35% is 
<10%; 
• Clinical relevance: The maximum number Grade ≥2 CRS events threshold that could 
justify further clinical development. For this study, it is defined as the median of the 
posterior distribution of the true Grade ≥2 CRS rate is ≤ 27%. 
The analysis will use a Beta-binomial model (binomial sampling for number of Grade ≥2 
CRS events and a beta prior distribution). A minimally informative beta prior distribution of 
the true Grade ≥2 CRS rate will be used. It is assumed a priori that the true mean Grade ≥2 
CRS rate is 35%, so the prior distribution will be Beta (0.7, 1.3). Using this prior and based 
on the dual criteria defined above, approximately 76 participants will be enrolled and treated 
and a maximum of 20 participants with Grade ≥2 CRS events is allowed to meet the dual 
criteria in 76 participants. If exactly 20 participants in 76 participants experience Grade ≥2 
CRS events, the observed Grade ≥2 CRS rate is 26.3% with median 26.3% and 90% credible 
interval of (18.7%, 35.0%) based on the posterior distribution. 
The primary analysis will be conducted once all participants have completed Cycle 1 of study 
intervention or have otherwise discontinued the study intervention. 
Table 12 presents the operating characteristics of this 2-stage design, ie, the probability of 
early trial termination at the interim futility analysis and the probability of observing the 
critical number of Grade ≥2 CRS (ie ≤ 20 participants with Grade ≥2 CRS events in 
76 participants) at the primary analysis if the true Grade ≥2 CRS rate is 20%, 21%, 22%, 
23%, 27% and 35%, respectively. For example, if the true Grade ≥2 CRS rate = 22%, the 
probability of stopping the study due to futility at the interim analysis is 0.048, and the 
probability of observing ≤ 20 participants with Grade ≥2 CRS rate at the primary analysis is 
0.835. 

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Table 12. Operating Characteristics of Bayesian 2-Stage Dual-Criterion Design for 
Grade ≥2 CRS rate 
 
True Grade 
≥2 CRS 
Rate 
Prob of Exceeding 
Futility Boundary at the 
Interim 
(R1/N1 ≥11/30) 
Prob of GO Decision 
at the Primary 
Analysis* 
(R/N ≤ 20/76 and 
R1/N1 <11/30) 
Prob of No-GO Decision 
at the Primary Analysis* 
(R/N > 20/76 and R1/N1 
<11/30) 
20% 
0.026 
0.919 
0.055 
21% 
0.036 
0.882 
0.082 
22% 
0.048 
0.835 
0.116 
23% 
0.064 
0.779 
0.157 
27% 
0.161 
0.488 
0.351 
35% 
0.492 
0.065 
0.443 
* The study does not meet futility criteria at the interim analysis and continues to the primary analysis. 
CRS = cytokine release syndrome; 
R1 = Number of participants with Grade ≥2 CRS events required at the interim futility analysis to stop the 
study for futility; 
N1 = Number of participants at the interim analysis; 
R = Number of participants with Grade ≥2 CRS events required to meet the dual criteria at the primary 
analysis; 
N = Number of participants at the primary analysis. 
At the time of the primary analysis, the critical number of participants with Grade ≥2 CRS 
events to be observed will be updated based on the actual number of participants enrolled and 
treated. 
An interim analysis for non-binding futility will be conducted on the 30 participants enrolled 
and treated in Part 1 of the study. Details are described in Section 9.4.2. 
9.5.2. Part 2A and Part 2C 
In Part 2A and 2C, approximately 8 participants at each dose level will be enrolled and 
treated to ensure at least 6 DLT evaluable participants (as defined in Section 9.2) to be 
evaluated. If any participant is deemed non-evaluable for DLT, additional participants may 
be enrolled to ensure there are a sufficient number of evaluable participants in Part 2A. 
A BLRM will be utilized for dose determination in Part 2A as well as dose opening in 
Part 2C. The dosing decision and estimation of the RP2D of elranatamab will be guided by 
the estimation of the posterior probability of DLT in the DLT observation period. Other 
evidence such as safety data beyond DLT window, clinical activity, PK, and PD data will 
also be evaluated in determining RP2D. After each dosing cohort of participants completes 
the DLT observation period, the posterior distribution for the risk of DLT for each dose level 
will be evaluated. The posterior distributions will be summarized to provide the posterior 
probability that the risk of DLT lies within the following intervals. 

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• Underdosing: [0, 0.16); 
• Target toxicity: [0.16, 0.33); 
• Excessive toxicity: [0.33, 1]. 
Dosing decisions are guided by the EWOC principle.[50] A dose level may only be used for 
the next dosing cohort of participants if the risk of excessive toxicity ([0.33, 1]) at that dose 
level is less than 25%. 
Table 13 shows some hypothetical dose escalation data scenarios and the corresponding 
recommendations for the next dose. For example, in Scenario 1, if 1 participant experiences a 
DLT out of 6 DLT-evaluable participants at 116 mg Q2W dose level, the recommendation is 
to escalate to the next dose level (152 mg Q2W) with probability of overdosing of 0.083 at 
152 mg dose level. In Scenario 3, if 3 participants experience DLTs out of 6 DLT-evaluable 
participants at 116 mg Q2W dose level, the dose level is deemed too toxic, and the dose 
finding process will stop with no RP2D identified. 
For Part 2C, the dose level to be explored (116 mg QW or 152 mg QW) depends on the 
toxicity profile observed in Part 2A. For example, if there is 0 DLT in 6 DLT-evaluable 
participants at both Dose level 1 and Dose level 2 in Part 2A, respectively, then 152 mg QW 
may be evaluated in Part 2C. However, if there is 1 DLT observed in 6 DLT-evaluable 
participants at both Dose level 1 and Dose level 2 in Part 2A, respectively, then 116 mg QW 
may be evaluated in Part 2C. 
 
Table 13. Data Scenarios, Next Dose Recommendation, and the Interval Probability 
of Target Toxicity and Overdosing at Next Dose 
 
Scenarios 
Elranatamab 
Dose Evaluated 
(mg; SC) 
D/N 
Elranatamab 
Next Dose 
(mg; SC) 
Pr(TT) at 
Next Dose 
Pr(OD) at Next 
Dose 
1 
116 Q2W 
1/6 
152 Q2W 
0.362 
0.083 
2 
116 Q2W 
2/6 
116 Q2W 
0.461 
0.161 
3 
116 Q2W 
3/6 
N/A 
N/A 
N/A 
4 
152 Q2W 
1/6 
152 Q2W 
0.199 
0.010 
116 Q2W 
0/6 
5 
152 Q2W 
1/6 
152 Q2W 
0.408 
0.048 
116 Q2W 
1/6 
6 
152 Q2W 
2/6 
152 Q2W 
0.555 
0.147 
116 Q2W 
1/6 
7 
152 Q2W 
3/6 
116 Q2W 
0.582 
0.167 
116 Q2W 
1/6 

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Table 13. Data Scenarios, Next Dose Recommendation, and the Interval Probability 
of Target Toxicity and Overdosing at Next Dose 
 
Scenarios 
Elranatamab 
Dose Evaluated 
(mg; SC) 
D/N 
Elranatamab 
Next Dose 
(mg; SC) 
Pr(TT) at 
Next Dose 
Pr(OD) at Next 
Dose 
8 
152 Q2W 
0/6 
152 QW 
0.283 
0.058 
116 Q2W 
0/6 
9 
152 Q2W 
1/6 
116 QW 
0.519 
0.188 
116 Q2W 
1/6 
Abbreviations: D=number of participants with DLT, N=number of DLT-evaluable participants; 
mg=milligrams; Pr(TT)=probability of target toxicity; Pr(OD)=probability of overdosing; QW=once weekly; 
Q2W=once every two weeks; SC=subcutaneous. 

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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations 
10.1.1. Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with the following: 
• Consensus ethical principles derived from international guidelines, including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines; 
• Applicable ICH GCP guidelines; 
• Applicable laws and regulations, including applicable privacy laws. 
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor, submitted to an IRB/EC 
by the investigator, and reviewed and approved by the IRB/EC before the study is initiated. 
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants. 
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard to 
study participants. 
The investigator will be responsible for the following: 
• Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC. 
• Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures. 
• Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH GCP guidelines, the IRB/EC, European regulation 
536/2014 for clinical studies, European Medical Device Regulation 2017/745 for 
clinical device research , and all other applicable local regulations. 
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP 
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately. 

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In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of the ICH GCP that the investigator becomes 
aware of. 
10.1.2. Financial Disclosure 
Investigators and subinvestigators 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. 
10.1.3. Informed Consent Process 
The investigator or the investigator’s representative will explain the nature of the study, 
including the risks and benefits, to the participant or their legally authorized representative 
and answer all questions regarding the study. The participant or their legally authorized 
representative should be given sufficient time and opportunity to ask questions and to decide 
whether or not to participate in the trial. 
Participants must be informed that their participation is voluntary. Participants or their 
legally authorized representative (if allowed by local regulations) will be required to sign a 
statement of informed consent that meets the requirements of 21 CFR 50, local regulations, 
ICH GCP guidelines, privacy and data protection requirements, where applicable, and the 
IRB/EC or study center. 
The investigator must ensure that each study participant or their legally authorized 
representative is fully informed about the nature and objectives of the study, the sharing of 
data related to the study, and possible risks associated with participation, including the risks 
associated with the processing of the participant’s personal data. 
The participant or their legally authorized representative must be informed that their 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 or their legally authorized 
representative. 
The participant or their legally authorized representative must be informed that their medical 
records may be examined by Clinical Quality Assurance auditors or other authorized 
personnel appointed by the sponsor, by appropriate IRB/EC members, and by inspectors 
from regulatory authorities. 
The investigator further must ensure that each study participant or their legally authorized 
representative is fully informed about their right to access and correct their personal data and 
to withdraw consent for the processing of their personal data. 

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The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date on which the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICD. 
Participants or their legally authorized representative must be reconsented to the most current 
IRB/EC version of the IRB/EC-approved ICD(s) during their participation in the study as 
required per local regulations. 
A copy of the ICD(s) must be provided to the participant or their legally authorized 
representative (if allowed by local regulations). 
Participants who are rescreened are required to sign a new ICD. 
10.1.4. Data Protection 
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data. 
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password-protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible 
for determining whether a personal data breach has in fact occurred and, if so, providing 
breach notifications as required by law. 
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to their actual identity and medical record ID. In case of data 
transfer, the sponsor will protect the confidentiality of participants’ personal data consistent 
with the clinical study agreement and applicable privacy laws. 
Information technology systems used to collect, process, and store study-related data are 
secured by technical and organizational security measures designed to protect such data 
against accidental or unlawful loss, alteration, or unauthorized disclosure or access. 
The sponsor maintains SOPs on how to respond in the event of unauthorized access, use, or 
disclosure of sponsor information or systems. 
10.1.5. Committees Structure 
10.1.5.1. Data Monitoring Committee 
This study will not use a DMC. 

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An internal safety review team will monitor safety and tolerability on an ongoing basis, and 
the internal core study team will review and evaluate the safety data including Grade ≥ 2 
CRS incidence at the interim futility analysis. 
10.1.6. Dissemination of Clinical Study Data 
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT/CTIS, and/or 
www.pfizer.com, and other public registries and websites in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs. 
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted. 
www.clinicaltrials.gov 
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in participants) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted. These results are 
submitted for posting in accordance with the format and timelines set forth by US law. 
EudraCT/CTIS 
Pfizer posts clinical trial results on EudraCT/CTIS for Pfizer-sponsored interventional studies 
in accordance with the format and timelines set forth by EU requirements. 
www.pfizer.com 
Pfizer posts CSR synopses and plain-language study results summaries on www.pfizer.com 
for Pfizer-sponsored interventional studies at the same time the corresponding study results 
are posted to www.clinicaltrials.gov. CSR synopses will have personally identifiable 
information anonymized. 
Documents within marketing applications 
Pfizer complies with applicable local laws/regulations to publish clinical documents included 
in marketing applications. Clinical documents include summary documents and CSRs 
including the protocol and protocol amendments, sample CRFs, and SAPs. Clinical 
documents will have personally identifiable information anonymized. 
Data sharing 
Pfizer provides researchers secure access to participant-level data or full CSRs for the 
purposes of “bona-fide scientific research” that contributes to the scientific understanding of 
the disease, target, or compound class. Pfizer will make data from these trials available 

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18 months after study completion. Participant-level data will be anonymized in accordance 
with applicable privacy laws and regulations. CSRs will have personally identifiable 
information anonymized. 
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes. 
10.1.7. 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 (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF. 
Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document. 
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password-protected or secured in a locked room to 
prevent access by unauthorized third parties. 
QTLs are predefined parameters that are monitored during the study. Important deviations 
from the QTLs and any remedial actions taken will be summarized in the CSR. 
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source records and documents. 
This verification may also occur after study completion. It is important that the 
investigator(s) and their relevant personnel are available during the monitoring visits and 
possible audits or inspections and that sufficient time is devoted to the process. 
Monitoring details describing strategy, including the definition of study critical data items 
and processes (eg, 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, virtual, or on-site monitoring), are provided in the data management plan and 
monitoring plan maintained and utilized by the sponsor or designee. 
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data. 
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion 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. The 

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investigator must ensure that the records continue to be stored securely for as long as they are 
maintained. 
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems. 
The investigator(s) will notify the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study. Furthermore, the investigator will cooperate 
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the sponsor or its agent, whenever feasible, to be present during the inspection. The 
investigator site and investigator will promptly resolve any discrepancies that are identified 
between the study data and the participant's medical records. The investigator will promptly 
provide copies of the inspection findings to the sponsor or its agent. Before response 
submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings. 
10.1.8. 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 site. 
Data reported on the CRF or entered in the eCRF that are 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 and its origin can be found in the Study 
Monitoring Plan which is maintained by the sponsor. 
Description of the use of the computerized system is documented in the Data Management 
Plan, which is maintained by the sponsor. 
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. 
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, the ICH GCP guidelines, and all applicable regulatory requirements. 
10.1.9. Study and Site Start and Closure 
The study start date is the date of the first participant’s first visit.. 
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor, including (but not limited to) 

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regulatory authority decision, change in opinion of the IRB/EC, or change in benefit-risk 
assessment. 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 upon notification to the sponsor 
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants. 
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to: 
• Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor's procedures, or the ICH GCP 
guidelines; 
• Inadequate recruitment of participants by the investigator; 
• Discontinuation of further study intervention development. 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up. 
Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights. 
10.1.10. Publication Policy 
For multicenter trials, the primary publication will be a joint publication developed by the 
investigator and Pfizer reporting the primary endpoint(s) of the study covering all study sites. 
The investigator agrees to refer to the primary publication in any subsequent publications. 
Pfizer will not provide any financial compensation for the investigator’s participation in the 
preparation of the primary congress abstract, poster, presentation, or primary manuscript for 
the study. 
Investigators are free to publish individual center results that they deem to be clinically 
meaningful after publication of the overall results of the study or 12 months after primary 
completion date or study completion at all sites, whichever occurs first, subject to the other 
requirements described in this section. 
The investigator will provide Pfizer an opportunity to review any proposed publication or 
any other type of disclosure of the study results (collectively, “publication”) before it is 
submitted or otherwise disclosed and will submit all publications to Pfizer 30 days before 
submission. If any patent action is required to protect intellectual property rights, the 

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investigator agrees to delay the disclosure for a period not to exceed an additional 60 days 
upon request from Pfizer. This allows Pfizer to protect proprietary information and to provide 
comments, and the investigator will, on request, remove any previously undisclosed 
confidential information before disclosure, except for any study intervention or Pfizer-related 
information necessary for the appropriate scientific presentation or understanding of the 
study results. For joint publications, should there be disagreement regarding interpretation 
and/or presentation of specific analysis results, resolution of, and responsibility for, such 
disagreements will be the collective responsibility of all authors of the publication. 
For all publications relating to the study, the investigator and Pfizer will comply with 
recognized ethical standards concerning publications and authorship, including those 
established by the International Committee of Medical Journal Editors. The investigator will 
disclose any relationship with Pfizer and any relevant potential conflicts of interest, including 
any financial or personal relationship with Pfizer, in any publications. All authors will have 
access to the relevant statistical tables, figures, and reports (in their original format) required 
to develop the publication. The results of this study may be published or presented at 
scientific meetings by the investigator after publication of the overall study results or 1 year 
after the end of the study (or study termination), whichever comes first. 
10.1.11. Sponsor’s Qualified Medical Personnel 
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the supporting study 
documentation/study portal or other electronic system. 
To facilitate access to appropriately qualified medical personnel for study-related medical 
questions or problems, participants are provided with an Emergency Contact Card (ECC) at 
the time of informed consent. The ECC contains, at a minimum, (a) protocol and study 
intervention identifiers, (b) participant’s study identification number, (c) site emergency 
phone number active 24 hours/day, 7 days per week, and (d) Pfizer Call Center number. 
The ECC is intended to augment, not replace, the established communication pathways 
between the investigator, site staff, and study team. The ECC is to be used by healthcare 
professionals not involved in the research study only, as a means of reaching the investigator 
or site staff related to the care of a participant. The Pfizer Call Center number should only be 
used when the investigator and site staff cannot be reached. The Pfizer Call Center number is 
not intended for use by the participant directly; if a participant calls that number directly, he 
or she will be directed back to the investigator site. 

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10.2. Appendix 2: Clinical Laboratory Assessments 
The following safety laboratory tests will be performed at times defined in the SoA section of 
this protocol. Additional laboratory results may be reported on these samples as a result of 
the method of analysis or the type of analyzer used by the clinical laboratory, or as derived 
from calculated values. These additional tests would not require additional collection of 
blood. Unscheduled clinical laboratory measurements may be obtained at any time during the 
study to assess any perceived safety issues. 
Table 14. Protocol Required Safety Laboratory Assessments (locally performed) 
 
Hematology 
Chemistry 
Other 
• Hemoglobin 
• Platelet count 
• WBC count 
• Plasma cell count 
Absolute: 
• Neutrophils 
• Eosinophils 
• Monocytes 
• Basophils 
• Lymphocytes 
• Plasma cells 
Database should be constructed to 
allow capture of WBC differential 
counts as percent and absolute 
values but only 1 or the other 
should be used by the site to 
collect data. Results will be 
reported as absolute values after 
conversion and graded according 
to the CTCAE criteria 
• BUN (or blood urea) 
• Creatinine 
• Glucose (non-fasting) 
• Total Calcium 
• Sodium 
• Potassium 
• Chloride 
• Magnesium 
• Phosphorus or Phosphates 
• AST, ALTc 
• Total bilirubin 
• Alkaline phosphatase 
• Albumin 
• Chloride 
• Total CO2 (bicarbonate) 
• Total Protein 
• Lactate dehydrogenase (LDH)a 
• Uric acida 
• Serum beta-2 microglobulina,d 
• CMV by quantitative PCR 
• PT/INR 
• For female participants of 
childbearing potential 
Pregnancy test 
(β-hCG) b 
• HBV tests (HBsAg and 
HBcAb, HBsAb) eHCV Abe 
• SARS-CoV-2 testingf 
a. 
At baseline (minimum) and as clinically indicated. 
b. For female participants of childbearing potential only. Serum test is required at screening; for other time 
points, urine testing will be standard for the protocol unless serum testing is required by local regulation 
or IRB/EC. 
c. 
For Hy’s law potential cases, in addition to repeating AST and ALT, laboratory tests should include 
albumin, creatine kinase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, 
prothrombin time (PT)/INR, and alkaline phosphatase. 
d. Required for multiple myeloma staging. 
e. 
To be performed at screening or as clinically indicated per PI assessment throughout study period. In the 
case of apparent ongoing HBV or HCV infection, reflex serum DNA or RNA viral load testing, 
respectively, will be performed if required by local regulation. 
f. 
From protocol amendment 4, PCR or antigen test are required predose on Day 1 (CXD1) and upon 
suspected exposure to SARS-CoV-2 and at signs or symptoms of COVID-19 infection. 
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF. 

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10.3. Appendix 3: Adverse Events: Definitions and Procedures for 
Recording, Evaluating, Follow-Up, and Reporting 
10.3.1. Definition of AE 
 
AE Definition 
• 
An AE is any untoward medical occunence in a patient or clinical study 
pa1ticipant, temporally associated with the use of study intervention, whether or not 
considered related to the study intervention. 
• 
 Note: An AE can therefore be any unfavorable and unintended sign (including an 
abnonnal laborato1y finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention. 
 
 
Events Meeting the AE Definition 
• 
Any abnonnal laborato1y test results (hematology, clinical chemistiy, or minalysis) or 
other safety assessments (eg, ECG, radiological scans, vital sign measmements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator. Any abnonnal laborato1y test 
results that meet any of the conditions below must be recorded as an AE: 
• 
Is associated with accompanying symptoms; 
• 
Requires additional diagnostic testing or medical/smgical intervention; 
• 
 Leads to a change in study dosing (outside of any protocol-specified dose adjustments) 
or discontinuation from the study, significant additional concomitant dmg treatment, or 
other therapy. 
• 
 Exacerbation of a chronic or intennittent preexisting condition, including either 
an increase in :frequency and/or intensity of the condition. 
• 
New condition detected or diagnosed after study intervention administi·ation, 
even though it may have been present before the strut of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected dmg-dmg interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either 
study inte1vention or a conc01nitant medication. Overdose per se will not be 
reported as an AE or SAE unless it is an intentional overdose taken with 
possible suicidal/self-haiming intent. Such overdoses should be repo1ted 
regai·dless of sequelae. 

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Events 
Meeting the AE Definition 
• 
 Any clinically significant abnonnal laborato1y findings or other abnonnal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the paiiicipant's condition. 
• 
The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the paiiicipant's 
condition. 
• 
 Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
• 
 Situations in which an untowai·d medical occunence did not occur (social and/or 
convenience admission to a hospital). 
• 
 Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present or 
detected at the sta1i of the study that do not worsen. 
• 
 Worsening of signs and symptoms of the malignancy under study should be recorded 
as AEs in the appropriate section of the CRF. Disease progression assessed by 
measurement of malignant lesions on radiographs or other methods should not be 
repolied as AEs. 
10.3.2. Definition of an SAE 
 
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or 
more of the criteria listed below: 
a. Results in death 
b.  Is life-threatening 
The te1m "life-threatening" in the definition of "serious" refers to an event in which 
the paiticipant was at risk of death at the time of the event. It does not refer to an 
event that hypothetically inight have caused death if it were more severe. 
c. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the paiiicipant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency wai·d 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 AEs. If a 
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serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious. 
Hospitalization for elective treatment of a preexisting condition that did not worsen 
from baseline is not considered an AE. 
d. Results in persistent or significant 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 (eg, sprained ankle), that may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption. 
e. Is a congenital anomaly/birth defect. 
f. 
Is a suspected transmission via a Pfizer product of an infectious agent, 
pathogenic or non-pathogenic, is considered serious. 
The event may be suspected from clinical symptoms or laboratory findings indicating 
an infection in a participant exposed to a Pfizer product. The terms “suspected 
transmission” and “transmission” are considered synonymous. These cases are 
considered unexpected and handled as serious expedited cases by pharmacovigilance 
personnel. Such cases are also considered for reporting as product defects, if 
appropriate. 
g. Other situations: 
• Medical or scientific judgment should be exercised by the investigator in deciding 
whether SAE reporting is appropriate in other situations, such as significant 
medical events that 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. 
• 
Progression of the malignancy under study (including signs and symptoms of 
progression) should not be reported as an SAE unless the outcome is fatal within 
the active collection period. Hospitalization due to signs and symptoms of disease 
progression should not be reported as an SAE. If the malignancy has a fatal 
outcome during the study or within the active collection period, then the event 

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leading to death must be recorded as an AE on the CRF, and as an SAE with 
CTCAE Grade 5 (see the Assessment of Severity section). 
 
10.3.3. Recording/Reporting and FollowUp of AEs and/or SAEs During the Active 
Collection Period 
 
AE and SAE Recording/Reporting 
The table below summarizes the requirements for recording AEs on the CRF and for 
repo1iing SAEs on the CT SAE Repo1i Fo1m to Pfizer Safety throughout the active 
collection period. These requirements are delineated for 3 types of events: (1) SAEs; (2) 
nonserious AEs; and (3) exposure to the study intervention under study during pregnancy 
or breastfeeding, and occupational exposure. 
It should be noted that the CT SAE Repo1i Fo1m for repo1iing of SAE information is not 
the same as the AE page of the CRF. When the same data are collected, the fonns must be 
completed in a consistent manner. AEs should be recorded using concise medical 
tenninology and the same AE te1m should be used on both the CRF and the CT SAE 
Repo1i Fo1m for repo1iing of SAE infonnation. 
Safety Event 
Recorded on the CRF 
Reported Via the 
Electronic Data 
Collection Tool or on the 
CT SAE Report Form to 
Pfizer Safety Within 24 
Hours of Awareness 
SAE 
All 
All 
Nonserious AE 
All 
None 
Exposure to the study 
intervention under study 
All AEs/SAEs associated 
with exposure during 
All instances of EDP are 
repo1ied (whether or not 
there is an associated 
SAE)* 
All instances ofEDB are 
repo1ied (whether or not 
there is an associated SAE). 
** 
during pregnancy or 
pregnancy or breastfeeding 
breastfeeding 
Note: Instances of EDP or 
EDB not associated with an 
AE or SAE are not captured 
in the CRF. 
Environmental or 
occupational exposure to 
the product under study 
to a non-paiiicipant (not 
involving EDP or EDB). 
None. Exposure to a study 
non-pa1iicipant is not 
collected on the CRF. 
The exposure (whether or 
not there is an associated 
AE or SAE) must be 
repo1ied.*** 

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* 
EDP (with or without an associated AE or SAE): any pregnancy infonnation is reported to Pfizer 
Safety using CT SAE Report Form and EDP Supplemental Form; if the EDP is associated with an 
SAE, then the SAE is repo1ted to Pfizer Safety using the CT SAE Repo1t Form. 
** EDB is repo1ted to Pfizer Safety using the CT SAE Report Form which would also include details 
of any SAE that might be associated with the EDB. 
*** Environmental or Occupational exposure: AEs or SAEs associated with occupational exposure are 
reported to Pfizer Safety using the CT SAE Report Fo1m. 
• When an AE or SAE occurs, it is the responsibility of the investigator to review 
all documentation (eg, hospital progress notes, laborato1y repo1is, and 
diagnostic reports) related to the event. 
• The investigator will then record all relevant AE or SAE info1mation in the 
CRF. 
• It is not acceptable for the investigator to send photocopies of the paiiicipant's 
medical records to Pfizer Safety in lieu of completion of the Electronic Data 
Collection Tool/CT SAE Repo1i Fonn/AE or SAE CRF page. 
• There may be instances when copies of medical records for ce1iain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 
exception of the paiticipant number, will be redacted on the copies of the 
medical records before submission to Pfizer Safety. 
•  The investigator will attempt to establish a diagnosis of the event based on 
signs, symptoms, and/or other clinical info1mation. Whenever possible, the 
diagnosis (not the individual signs/symptoms) will be documented as the AE or 
SAE. 
Assessment of Severity 
The investigator will make an assessment of severity for each AE repo1ied during the study 
and assign it to 1 of the categories listed below (as defined by the NCI CTCAE system). 
An event is defined as "serious" when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe. 
GRADE
Clinical Description of Severity 
1 
MILDAE 
2 
MODERATEAE 
3 
SEVEREAE 
4 
LIFE-THREATENING; urgent intervention indicated 
5 
DEATH RELATED TO AE 
The severity of CRS and ICANS will be graded according to ASTCT criteria.[48] See 
Appendix 12. 

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Assessment of Causality 
• 
The investigator is obligated to assess the relationship between study intervention 
and each occmTence of each AE or SAE. The investigator will use clinical 
judgment to detennine the relationship. 
• 
 A "reasonable possibility" of a relationship conveys that there are facts, evidence, 
and/or arglllllents to suggest a causal relationship, rather than a relationship cannot 
be mled out. 
• 
 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 IB and/or product infonnation, for marketed 
products, in his/her assessment. 
• 
For each AE or SAE, the investigator !!!!!.ll doclllllent in the medical notes that 
he/she has reviewed the AE or SAE and has provided an assessment of causality. 
• 
There may be situations in which an SAE has occmTed and the investigator has 
minimal infonnation to include in the initial report to the sponsor. 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 the sponsor. 
• 
The investigator may change his/her opinion of causality in light of follow-up 
infonnation and send an SAE follow-up repo1i with the updated causality 
assessment. 
• 
The causality assessment is one of the criteria used when determining regulato1y 
reporting requirements. 
• 
 If the investigator does not know whether or not the study inte1vention caused the 
event, then the event will be handled as "related to study inte1vention" for repo1iing 
pmposes, as defined by the sponsor. In addition, if the investigator dete1mines that 
an SAE is associated with study procedures, the investigator must record this 
causal relationship in the source documents and CRF, and repo1i such an 
assessment in the dedicated section of the Electronic Data Collection Tool or CT 
SAE Repo1i Fo1m and in accordance with the SAE repo1iing requirements. 

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Follow-Up of AEs and SAEs 
• 
 The investigator is obligated to perfo1m or atTange for the conduct of supplemental 
measurements and/or evaluations, as medically indicated or as requested by the 
sponsor, to elucidate the nature and/or causality of the AE or SAE as folly as 
possible. This may include additional laborato1y tests or investigations, 
histopathological examinations, or consultation with other healthcare providers. 
• 
New or updated info1mation will be recorded in the originally submitted 
documents. 
• 
The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the infonnation. 
 
 
10.3.4. Reporting of SAEs 
 
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool 
• 
The primaiy mechanism for repo1ting an SAE to Pfizer Safety 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) to repo1t the event within 24 hours. 
• 
The site will enter the SAE into the electronic data collection tool (ie eSAE) or 
paper fonn (as applicable) as soon as the data ai·e available. 
• 
After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the enby of new data or changes to existing data. 
• 
If a site receives a repo1t of a new SAE from a study paiticipant or receives updated 
data.on a previously repo1ted SAE after the electi·onic data.collection tool has been 
taken off-line, then the site can repo1t this info1mation on a paper SAE fonn (see 
next section) or to Pfizer Safety by telephone. 

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SAE Reporting to Pfizer Safety via CT SAE Report Form 
• 
Facsimile trnnsmission of the CT SAE Repo1i Fo1m is the preferred method to 
transmit this infonnation to Pfizer Safety. 
• 
In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the CT SAE Repo1i Form sent by overnight mail or 
. 
. 
couner service. 
• 
 Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Repo1i Fo1m pages within the designated repo1iing 
time frames. 

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10.4. Appendix 4: Contraceptive and Barrier Guidance 
10.4.1. Male Participant Reproductive Inclusion Criteria 
No contraception methods are required for male participants in this study, as the calculated 
safety margin is ≥100‑fold between the estimated maternal exposure due to seminal transfer 
and the estimated MABEL (minimal anticipated biological effect level) used as conservative 
estimate of exposure that may result in serious manifestations of developmental toxicity. 
10.4.2. Female Participant Reproductive Inclusion Criteria 
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at 
least 1 of the following conditions applies: 
• Is not a WOCBP (see definitions below in Section 10.4.3). 
OR 
• Is a WOCBP and using a contraceptive method that is highly effective (with a failure 
rate of <1% per year), as described below, during the intervention period and for at 
least 5 months after the last dose of study intervention, which corresponds to the time 
needed to eliminate any reproductive safety risk of the study intervention(s). If a 
highly effective method that is user dependent is chosen, a second effective method of 
contraception, as described below, must also be used. The investigator should 
evaluate the effectiveness of the contraceptive method in relationship to the first dose 
of study intervention. 
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. 
10.4.3. Woman of Childbearing and Non-Childbearing Potential 
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below). 
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered. 
Women in the following categories are not considered WOCBP: 
1. Premenopausal female with 1 of the following: 
• Documented hysterectomy; 
• Documented bilateral salpingectomy; 

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• Documented bilateral oophorectomy. 
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry. 
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview. The method of documentation should be recorded in the participant’s medical 
record for the study. 
2. Postmenopausal female: 
• A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. In addition, 
• A high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years of age and not using hormonal 
contraception or HRT. 
• A female on HRT and whose menopausal status is in doubt will be required to 
use one of the nonestrogen 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. 
10.4.4. Contraception Methods 
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials. 
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation. 
2. Intrauterine device. 
3. Intrauterine hormone-releasing system. 
4. Bilateral tubal occlusion (eg, bilateral tubal ligation). 
5. Vasectomized partner: 
• A 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. The spermatogenesis 
cycle is approximately 90 days. 

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6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation: 
• Oral + barrier*; 
• Intravaginal + barrier*; 
• Transdermal + barrier*; 
7. Progestogen-only hormone contraception associated with inhibition of ovulation: 
• Oral + barrier*; 
• Injectable + barrier*. 
8. Sexual abstinence: 
• 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. 
* Acceptable barrier methods to be used concomitantly with options 6 or 7 for the study 
include any of the following: 
• Male or female condom with or without spermicide; 
• Cervical cap, diaphragm, or sponge with spermicide; 
• A combination of male condom with either cervical cap, diaphragm, or sponge 
with spermicide (double-barrier methods). 

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10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments 
Potential Cases of Drug-Induced Liver Injury 
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome. These participants fail to adapt and therefore are 
"susceptible" to progressive and serious liver injury, commonly referred to as DILI. 
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are “adaptors” or are “susceptible.” 
In the majority of DILI cases, elevations in AST and/or ALT precede TBili elevations (>2 × 
ULN) by several days or weeks. The increase in TBili typically occurs while AST/ALT 
is/are still elevated above 3 × ULN (ie, AST/ALT and TBili values will be elevated within 
the same laboratory sample). In rare instances, by the time TBili elevations are detected, 
AST/ALT values might have decreased. This occurrence is still regarded as a potential DILI. 
Therefore, abnormal elevations in either AST OR ALT in addition to TBili that meet the 
criteria outlined below are considered potential DILI (assessed per Hy’s law criteria) cases 
and should always be considered important medical events, even before all other possible 
causes of liver injury have been excluded. 
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions. Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values: 
• Participants with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value 
>2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available. 
For participants with baseline AST OR ALT OR TBili values above the ULN, the following 
threshold values are used in the definition mentioned above, as needed, depending on which 
values are above the ULN at baseline: 
• Preexisting AST or ALT baseline values above the normal range: AST or ALT values 
>2 times the baseline values AND >3 × ULN; or >8 × ULN (whichever is smaller). 
• Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches >3 × ULN 
(whichever is smaller). 
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 

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The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results. This evaluation should 
include laboratory tests, detailed history, and physical assessment. 
In addition to repeating measurements of AST and ALT and TBili for suspected Hy’s law 
cases, additional laboratory tests should include albumin, CK, direct and indirect bilirubin, 
GGT, PT/INR, total bile acids, and alkaline phosphatase. Consideration should also be given 
to drawing a separate tube of clotted blood and an anticoagulated tube of blood for further 
testing, as needed, for further contemporaneous analyses at the time of the recognized initial 
abnormalities to determine etiology. A detailed history, including relevant information, such 
as review of ethanol, acetaminophen/paracetamol (either by itself or as a coformulated 
product in prescription or over-the-counter medications), recreational drug, or supplement 
(herbal) use and consumption, family history, sexual history, travel history, history of contact 
with a jaundiced person, surgery, blood transfusion, history of liver or allergic disease, and 
potential occupational exposure to chemicals, should be collected. Further testing for acute 
hepatitis A, B, C, D, and E infection, liver imaging (eg, biliary tract), and collection of serum 
samples for acetaminophen/paracetamol drug and/or protein adduct levels may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found. Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities. 
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology. 

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10.7. Appendix 7: ECG Findings of Potential Clinical Concern 
 
ECG Findings That May Qualify as AE 
• 
Marked sinus bradycardia (rate <40 bpm) lasting minutes. 
• 
New PR interval prolongation >280 ms. 
• 
New prolongation of QTcF to >480 ms (absolute) or by60 ms from baseline. 
• 
New-onset atrial flutter or fibrillation, with controlled ventricular response rate: 
ie, rate <120 bpm. 
• 
New-onset type I second-degree (Wenckebach) AV block of>30 seconds' duration. 
• 
 Frequent PVCs, triplets, or sho1i intervals (<30 seconds) of consecutive ventricular 
complexes. 
ECG Findings That May Qualify as Serious AE 
• 
QTcF prolongation >500 ms. 
• 
New ST-T changes suggestive of myocardial ischemia. 
• 
Newonset left bundle branch block (QRS complex>120 ms). 
• 
Newonset right bundle branch block (QRS complex>120 ms). 
• 
Symptomatic bradycardia. 
• 
Asystole: 
• 
 In awake, symptom-free paiiicipants in sinus rhythm, with documented periods of 
asystole3.0 seconds or any escape rate <40 bpm, or with an escape rhythm that 
is below the AV node. 
• 
In awake, symptom-free paiiicipants with atrial fibrillation and bradycardia with 1 
or more pauses of at least 5 seconds or longer. 
• 
Atrial flutter or fibrillation, with rapid ventriculai·response rate: rapid = rate 
>120 bpm. 
• 
Sustained supraventricular tachycai·dia (rate>120 bpm) ("sustained" = sho1i duration 
with relevant symptoms or lasting >1 minute). 
• 
Ventricular rhythms >30 seconds' duration, including idioventriculai·rhythm (heali 
rate <40 born). accelerated idioventriculai·rhvthm (HR >40 born to <100 born) and 

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monomo1phic/polymo1phic ventricular tachycardia (HR>100 bpm (such as torsades 
de pointes)). 
• Type II second-degree (Mobitz II) AV block. 
• Complete (third-degree) heali block. 
ECG Findings That Qualify as SAE 
• Change in pattern suggestive of new myocardial infarction. 
• Sustained ventricular tachyaiThythmias (>30 seconds' dmation). 
• Second- or third-degree AV block requiring pacemaker placement. 
• Asystolic pauses requiring pacemaker placement. 
• Atrial flutter or fibrillation with rapid ventricular response requiring cai·dioversion. 
• Ventricular fibrillation/flutter. 
•  At the discretion of the investigator, any aiThythmia classified as an adverse 
expenence. 

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10.8. Appendix 8: Alternative Measures During Public Emergencies 
The alternative study measures described in this section are to be followed during public 
emergencies, including the COVID-19 pandemic. This appendix applies for the duration of 
the COVID-19 pandemic and will become effective for other public emergencies only upon 
written notification from Pfizer. 
Use of these alternative study measures are expected to cease upon the return of business as 
usual circumstances (including the lifting of any quarantines and travel bans/advisories). 
10.8.1. Eligibility 
While SARS-CoV-2 testing is not mandated for entry into this study, local clinical practice 
standards for testing should be followed. A participant should be excluded if they have a 
positive test result for SARS-CoV-2 infection within 14 days prior to enrollment, is known to 
have asymptomatic infection, or is suspected of having SARS-CoV-2. Participants with 
active infections are excluded from study participation as per exclusion criterion 12 When 
the infection resolves, the participant may be considered for re-screening. Also See 
Section 6.8.8. 
10.8.2. Telehealth Visits 
In the event that in-clinic study visits cannot be conducted, every effort should be made to 
follow up on the safety of study participants at scheduled visits per the SoA or unscheduled 
visits. Telehealth visits may be used to continue to assess participant safety and collect data 
points. Telehealth includes the exchange of healthcare information and services via 
telecommunication technologies (e.g., audio, video, video-conferencing software) remotely, 
allowing the participant (and possibly an accompanying informant) and the investigator to 
communicate on aspects of clinical care, including medical advice, reminders, education, and 
safety monitoring. The following assessments must be performed during a telehealth visit: 
• Review and record any AEs and SAEs since the last contact. Refer to Section 8.3. 
• Review and record any new concomitant medications or changes in concomitant 
medications since the last contact. 
• Review and record contraceptive method and results of pregnancy testing. Confirm 
that the participant is adhering to the contraception method(s) required in the 
protocol. Refer to Appendix 4 and Section 10.8.3.1 of this appendix regarding 
pregnancy tests. 
Study participants must be reminded to promptly notify site staff about any change in their 
health status. 

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10.8.3. Alternative Facilities for Safety Assessments 
10.8.3.1. Laboratory Testing 
If a study participant is unable to visit the site for protocol-specified safety laboratory 
evaluations, testing may be conducted at a local laboratory if permitted by local 
regulations. The local laboratory may be a standalone institution or within a hospital. The 
following safety laboratory evaluations may be performed at a local laboratory: 
See Section 10.2. 
If a local laboratory is used, qualified study site personnel must order, receive, and review 
results. Site staff must collect the local laboratory reference ranges and certifications/ 
accreditations for filing at the site. Laboratory test results are to be provided to the site staff 
as soon as possible. The local laboratory reports should be filed in the participant’s source 
documents/medical records. Relevant data from the local laboratory report should 
be recorded on the CRF. 
If a participant requiring pregnancy testing cannot visit a local laboratory for pregnancy 
testing, a home urine pregnancy testing kit with a sensitivity of at least 25 mIU/mL may be 
used by the participant to perform the test at home, if compliant with local regulatory 
requirements. The pregnancy test outcome should be documented in the participant’s source 
documents/medical records and relevant data recorded on the CRF. Confirm that the 
participant is adhering to the contraception method(s) required in the protocol. 
10.8.3.2. Electrocardiograms 
If the participant is unable to visit the study site for ECGs, the participant may visit an 
alternative facility to have the ECGs performed. Qualified study site personnel must order, 
receive, and review results. 
10.8.4. Study Intervention 
If the safety of a trial participant is at risk because they cannot complete required evaluations 
or adhere to critical mitigation steps, then discontinuing that participant from study 
intervention must be considered. 
The following is recommended for the administration of study intervention for participants 
who have active confirmed (positive by regulatory authority-approved test) or presumed (test 
pending/clinical suspicion) SARS-CoV-2 infection: 
• For symptomatic participants with active SARS-CoV-2 infection, study intervention 
should be delayed for at least 14 days from the start of symptoms. This delay is 
intended to allow the resolution of symptoms of SARS-CoV-2 infection. 
• Prior to restarting treatment, the participant should be afebrile for 72 hours, and 
SARS-CoV-2-related symptoms should have recovered to ≤Grade 1 for a minimum 
of 72 hours. 

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• Continue to consider potential drug-drug interactions as described in Section 6.8 for 
any concomitant medication administered for treatment of SARS-CoV-2 infection 
10.8.5. Adverse Events and Serious Adverse Events 
If a participant has COVID-19 during the study, this should be reported as an adverse event 
(AE) or serious adverse events (SAE) and appropriate medical intervention provided. 
Temporary discontinuation of the study intervention may be medically appropriate until the 
participant has recovered from COVID-19. 
It is recommended that the investigator discuss temporary or permanent discontinuation of 
study intervention with the medical monitor. 

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10.9. Appendix 9: Subcutaneous Injection Site Locations 
 
Injection site locations include a maximum of 4 unique administration sites distributed across 
the 2 lower and the 2 upper abdominal quadrants (up to 1 injection location per quadrant). 
Administer the required number of injections in the following order: 
1. Lower left quadrant; 
2. Lower right quadrant 
3. Upper left quadrant 
4. Upper right quadrant 
Injections to the abdomen are preferred. If SC injections in the abdominal location are not 
possible, SC injections can be administered in a distributed manner in the thighs. SC 
injections in the upper extremities (eg, deltoid, upper and lower arm) are not permitted. 
Track the participant’s injection site(s) sequentially on this diagram with a red pen and mark 
the injection sites on the participant’s abdomen according to your clinic’s standard practice. 
Record the location, time of each injection and any injection site reactions in the participant’s 
source records and CRF. See Section 10.3 for AE reporting. 

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10.10. Appendix 10: IMWG Response Criteria for Multiple Myeloma 
Paiiicipants must have measurable disease at emollment (study ent:Iy) as defined by: 
 
• 
Sernm M-protein ::::o.5 g/dL (5 g/L); 
 
• 
Urine M-protein ::::200 mg/24 hours; 
 
• 
 Sernm FLC assay: involved sennn FLC level ::::10 mg/dL, provided serum FLC ratio 
is abnonnal. 
Whenever more than 1 pai·aineter is used to assess response, the overall assigned level of 
response is determined by the lowest level of response. 
All response assessments will be entered on the CRF. 
All response categories require 2 consecutive assessments made any time before sta1iing new 
therapy. To confiim response or PD, 2 discrete samples ai·e required and testing cannot be 
based upon the splitting of a single sainple. 
 
Table 15.  IMWG MRD Criteria 
 
Response 
IMWG MRD Criteria (requires a CR as defined below) 
 
Flow MRD-negative 
• 
CR as defined below plus: 
• 
Absence of phenotypically aberrant clonal plasma cells by NGF on BMA 
using the EuroFlow standard procedure for MRD detection in MM (or 
validated equivalent method) with a minimum sensitivity of 1 in 
105 nucleated cells 
Sequencing MRD- 
• 
CR as defined below plus: 
negative 
• 
Absence of clonal plasma cells by NGS on BMA in which presence of a 
clone is defined as less than 2 identical sequencing reads obtained after 
DNA sequencing ofBMA using the LymphoSIGHT platfo1m (or validated 
e uivalent method with a minimum sensitivi  of 1 in 105 nucleated cells 
Imaging plus MRD- 
• 
CR as defined below plus: 
negative 
• 
MRD negativity as defined by NGF or NGS plus disappearance of every 
area of increased tracer uptake found at baseline or a preceding PET/CT or 
decrease to less mediastinal blood pool SUV or decrease to less than that of 
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Table 16. Modified IMWG Response Criteria 
 
Responsea 
Modified IMWG Criteria 
Stringent 
Complete 
Response (sCR) 
CR as defined below plus: 
• Normal serum FLC ratio and absence of clonal cells in 
BMB/BMA b by immunohistochemistry or immunofluorescence 
(κ/λ ratio ≤4:1 or ≥1:2 for κ and λ participants, respectively, after 
counting ≥100 plasma cells).b,c 
• If the only measurable disease is by serum FLC levels, sCR is 
defined as normal serum FLC ratio of 0.26 to 1.65 plus absence 
of clonal cells in BMB/BMA b by immunohistochemistry or 
immunofluorescence (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ 
participants, respectively, after counting ≥100 plasma cells).b,c 
Complete 
Response (CR) 
• Negative immunofixation on serum and urine, disappearance of 
any soft tissue plasmacytomas and <5% plasma cells in BMA.b,d 
• If the only measurable disease is by serum FLC levels, CR is 
defined as normal serum FLC ratio of 0.26 to 1.65, plus criteria 
listed above.b,d 
Very Good Partial 
Response (VGPR) 
• Serum and urine M-protein detectable by immunofixation but not 
on electrophoresis. 
OR 
• 
≥90% reduction in serum M-protein plus urine M-protein level 
<100 mg/24 h. 
• If the only measurable disease is by serum FLC levels, VGPR is 
defined as a ≥90% decrease in the difference between involved 
and uninvolved serum FLC levels. 
• In addition to these criteria, if present at baseline, a >90% 
reduction compared with baseline in the size (SPD) of soft tissue 
plasmacytomasd 
Partial Response 
(PR) 
• 
≥50% reduction of serum M-protein and reduction in 24 hours 
urinary M-protein by ≥90% or to <200 mg/24 h. 
• If the serum and urine M-protein are unmeasurable, a 
≥50% decrease in the difference between involved and 
uninvolved serum FLC levels is required in place of the 
M-protein criteria. 
• In addition to these criteria, if present at baseline, a ≥50% 
reduction in the size (SPD) of soft tissue plasmacytomas is also 
required.d 
Minimal 
Response (MR) 
• ≥25% but ≤49% reduction of serum M-protein and reduction in 
24-h urine M-protein by 50–89%. In addition to these, if present 

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Table 16.  Modified IMWG Response Criteria 
 
Response• 
Modified IMWG Criteria 
at baseline, a50% reduction in the size (SPD) of soft tissue 
plasmacytomas is also required.d 
No Change/Stable 
Disease (SD) 
• 
Not meeting criteria for sCR, CR, VGPR, PR, MR or PD. 
Progressive 
Disease (PD)b,e.f 
Any one or more of the following criteria: 
• 
Increase of c::25% from lowest confomed response value in any 1 or 
more of the following:e,f 
Semm M-component (the absolute increase must be 0.5 g/d.L); 
Semm M-protein increase c::1 g/d.L, if the lowest M component was 
c::5 g/d.L; 
Urine M-protein (the absolute increase must be c::200 mg/24 h). 
In paiiicipants without measurable semm and urine M-protein levels, 
the difference between involved and uninvolved semm FLC levels 
(absolute increase must be>10mg/d.L); 
In patients without measurable semm and mine M- rotein levels and 
without measurable involved semm FLC levels, 
 
- 
percentage inespective of baseline status (absolute 
increase must be10%) 
• 
Appearance of a new lesion(s), 50% increase from nadir in SPD of 
>1 lesion, o5
r 0% increase in the longest diaineter of a previous 
lesion>1 cm in short axis.d 
• 
 50% increase in circulating plasma cells (minimum of200 cells per 
µL) if this is the only measure of disease 
a All response categories require 2 consecutive assessments made any time before starting new therapy. 
Each category (except stable disease) will be considered unconfumed until confumatory test is perfonned. 
All categories (stable disease or better) require no known evidence of PD, new bone lesions or EM 
plasmacytomas if imaging studies were perfonned; imaging studies are not required to satisfy these 
response requirements except for requirement of FDG PET to confinn imaging plus MRD-negative. 
 
c  Presence/absence of clonal cells is based upon the Kl>., ratio. An abno1mal Kl>., ratio by IHC or 
immunofluorescence requires a minimum of 100 plasma cells for analysis. An abnonnal ratio reflecting 
presence of an abno1mal clone is Kl>.,of>4:1 or <l :2. 
d  Plasmacytoma measurements should be taken from the CT portion of the PET/CT, or dedicated CT scans 
where applicable. Measurement of tumor size will be dete1mined by the SPD. 
e  PD confumation requires 2 consecutive assessments made at any time prior to the institution of any new 
anticancer therapy. If alternate therapy is sta1ted before confinning PD, any additional testing during 
subsequent therapy can be used to confinn PD. Pa1ticipants will be considered to have PD if they meet the 
criteria for progression by a variable that was not considered measurable at baseline; however, for 

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Table 16. Modified IMWG Response Criteria 
 
Responsea 
Modified IMWG Criteria 
participants who had a measurable serum or urine M- protein (M-spike) at baseline, PD cannot be defined 
by increases in serum FLC alone. 
f For PD, serum M-component increases of ≥1 g/dL are sufficient to define relapse if starting M-component 
is ≥5 g/dL. 
 
ADDITIONAL NOTES: 
• If participants do not have measurable disease at baseline they can only be assessed for CR or PD. 
• Except for sCR, serum FLC levels should only be used for response assessment when both the serum and 
urine M-component levels are deemed not measurable or uninterpretable . 
• In cases where SPEP is found to be unreliable (eg, IgA,IgD myelomas) for M-protein assessment, 
quantitative immunoglobulin measurements are preferred for disease assessment; the same percentage 
changes apply as for serum M-protein. If used, quantitative immunoglobulin assessment must be used 
exclusively for a participant (ie, quantitative immunoglobulin and SPEP cannot be used interchangeably 
for disease assessment of the same participant). 
Source: Adapted from Kumar et al, 2016.[51] 

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10.11. Appendix 11: Prior Lines of Therapy 
The following guidelines (adapted from [52]) are to be used to quantitate the number of prior 
lines of anti-MM therapy a participant has received. 
 
Line of Therapy 
A line of therapy consists of at least 1 complete cycle of a single agent, a regimen consisting 
of a combination of several drugs, or a planned sequential therapy of various regimens (eg, 
3-6 cycles of initial therapy with bortezomib-dexamethasone followed by SCT consolidation, 
and lenalidomide maintenance is considered 1 line). 
 
New line of Therapy 
A treatment is considered a new line of therapy if any of the following conditions are met: 
• Start of a new line of treatment after discontinuation of a previous line. If a 
treatment regimen is discontinued for any reason and a different regimen is started, it 
should be considered a new line of therapy. A regimen is considered to have been 
discontinued if all the drugs in that given regimen have been stopped. A regimen is 
not considered to have been discontinued if some of the drugs of the regimen, but not 
all, have been discontinued. 
The reasons for discontinuation, addition, substitution, or SCT do not influence how 
lines are counted. It is recognized that reasons for change may include end of planned 
therapy, toxicity, progression, lack of response, inadequate response, etc. 
• The unplanned addition or substitution of 1 or more drugs in an existing 
regimen. Unplanned addition of a new drug or switching to a different drug (or 
combination of drugs) due to any reason is considered a new line of therapy. 
• SCT. In patients undergoing >1 SCT, except in the case of a planned tandem SCT 
with a predefined interval (such as 3 months), each SCT (autologous or allogeneic) 
should be considered a new line of therapy regardless of whether the conditioning 
regimen used is the same or different. 
A planned tandem SCT is an exception and is considered 1 line. Planned induction 
and/or consolidation, maintenance with any SCT (frontline, relapse, autologous or 
allogeneic) is considered 1 line. 
 
Interruptions and dose modifications 
• If a regimen is interrupted or discontinued for any reason and the same drug or 
combination is restarted without any other intervening regimen, then it should be 
counted as a single line. 
• However, if a regimen is interrupted or discontinued for any reason, and then 
restarted at a later time point but 1 or more other regimens were administered in 

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between, or the regimen is modified through the addition of 1 or more agents, then it 
should be counted as 2 lines. 
 
• Modification of the dosing of the same regimen should not be considered a new line 
of therapy. 

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10.12. Appendix 12: CRS and ICANS Grading, Mitigation, and Management 
10.12.1. Cytokine release syndrome 
Participants are required to be hospitalized and monitored for CRS/ICANS for at least 2 days 
(~48 hours) beginning on C1D1, and for 1 day (24 hours) for C1D4. Hospitalization up to 5 
days from C1D1 to C1D5 may be considered. 
For both the priming doses and first full dose (76 mg), premedication for CRS is required 
(see Section 6.8.1). 
CRS is a non-antigen-specific cytokine-associated toxicity that occurs as a result of 
high-level immune activation. CRS is a potentially life-threatening toxicity that has been 
observed following administration of immune-base therapies for cancer (antibodies and 
adoptive T-cell therapies). CRS is likely to be a common toxicity that can be managed 
through supportive care and anti-cytokine interventions. 
In cases of suspected CRS, a serum sample should be provided for cytokine release assay 
analysis by the local lab as long as the sampling does not interfere with the medical treatment 
of the participant. If CRS is suspected, additional blood samples should also be collected for 
central cytokine analysis if not already scheduled. 
Early intervention should be undertaken at the first sign of CRS; signs may include pyrexia, 
tachycardia, tachypnea and/or hypotension, and are temporally related to elranatamab in the 
absence of alternative etiologies. 
CRS grading will follow ASTCT criteria (Table 17). For CRS management, published 
treatment guidelines are recommended[35,36], but they may be modified as needed by the 
responsible investigator according to the best practices at their institute. In case of Grade 2 or 
higher CRS event, the medical monitor may be contacted for further guidance. 

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Table 17. ASTCT CRS Grading 
 
CRS 
parameter: 
Fevera 
With Hypotension 
And/orb Hypoxia 
Grade 1 
Temp ≥38°C 
None 
None 
Grade 2 
Not requiring vasopressors 
Requiring low-flowc nasal cannula, 
low-flowc facemask or blow-by 
Grade 3 
Requiring a vasopressor with or 
without vasopressin 
Requiring high-flowc nasal cannula, 
high-flowc facemask, nonrebreather 
mask, or Venturi mask 
Grade 4 
Requiring multiple vasopressors 
(excluding vasopressin) 
Requiring positive pressure (eg, 
CPAP, BiPAP, intubation and 
mechanical ventilation) 
Note: Organ toxicities associated with CRS should be graded according to CTCAE v5.0 and do not influence 
CRS grading. 
a Fever: Temp ≥38°C and not attributable to any other cause. In participants who have CRS then receive 
antipyretic or anti-cytokine therapy such as tocilizumab or steroids, fever is no longer required to grade 
subsequent CRS severity. In this case, CRS grading is driven by hypotension and/or hypoxia. 
b CRS grade is determined by the more severe event: hypotension or hypoxia not attributable to any other 
cause. For example, a participant with Temp of 39.5°C, hypotension requiring 1 vasopressor, and hypoxia 
requiring low-flow nasal cannula is classified as Grade 3 CRS. 
c Low-flow nasal cannula or facemask is defined as oxygen delivered at ≤6 L/min. Low flow also includes 
blow-by oxygen delivery, sometimes used in pediatrics. High-flow nasal cannula or facemask is defined as 
oxygen delivered at >6 L/min. This is modified from original ASTCT criteria to differentiate between low- 
flow and high-flow facemask. 
Source: (Lee et al, 2019)[48] 
 
10.12.1.1. CRS management guidelines by ASTCT Severity Grading[35,36] 
Participants will be hospitalized for at least 2 days after the first dose (C1D1) and at 
least 1 day after the second dose (C1D4) for safety surveillance. 
Monitor vital signs every 4 hours, minimally, for worsening of condition. Fever, regardless 
of grade of CRS, is managed as described under Grade 1 CRS. 
Grade 1 CRS: 
Fever 
• Acetaminophen/paracetamol and hypothermia blanket for the treatment of fever. 
• NSAIDs such as ibuprofen can be used as second treatment option for fever if not 
contraindicated. 
• Assess for infection using blood and urine cultures, and chest radiography. 
• Empiric broad-spectrum antibiotics and filgrastim if neutropenic. 
• Maintenance IV fluids for hydration. 
• Symptomatic management of constitutional symptoms or organ toxicity. 

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• Consider tocilizumab 8 mg/kg (maximum dose 800 mg) IV or siltuximab 
11 mg/kg IV for persistent (lasting >3 days) and refractory fever. 
Grade 2 CRS: 
• Monitor vital signs every 4 hours, minimally, for worsening of condition. 
Hypotension 
• IV fluid bolus of 500-1000 ml of normal saline. Consider giving a second fluid 
bolus if systolic BP remains <90 mmHg. 
• Consider tocilizumab 8 mg/kg (maximum dose 800 mg) IV or siltuximab 
11 mg/kg IV for treatment of hypotension refractory to fluid boluses; tocilizumab 
can be repeated after 6 hours if needed. 
• If hypotension persists after 2 fluid boluses and anti-IL-6 therapy, start 
vasopressors, consider transfer to ICU, obtain ECHO, and initiate other methods 
of hemodynamic monitoring. 
• In participants at high-risk (bulky disease, older age and/or comorbidities) or if 
hypotension persists after 1-2 doses of anti-IL-6 therapy, dexamethasone can be 
used at 10 mg IV every 6 hrs. 
Hypoxia 
• Supplemental oxygen. 
• Tocilizumab or siltuximab ± corticosteroids and supportive care, as indicated for 
hypotension. 
Grade 3 CRS: 
• Monitor participant (including continuous ECG monitoring) in an ICU and obtain 
ECHO if not done already. 
Hypotension 
• IV boluses, as needed, as recommended for Grade 2 CRS. 
• Tocilizumab and siltuximab as recommended for Grade 2 CRS if not 
administered previously. 
• Vasopressors as needed. 
• Dexamethasone 10 mg IV every 6 hrs; if refractory, increase to 20 mg IV every 
6 hrs. 
Hypoxia 
• Supplemental oxygen including high-flow oxygen delivery. 
• Tocilizumab or siltuximab plus corticosteroids and supportive care, as described 
above for Grade 2 CRS. 

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Grade 4 CRS: 
• Monitor participant (including continuous ECG monitoring) in an ICU and obtain 
ECHO if not done already. 
Hypotension 
• IV boluses, anti-IL-6 therapy, vasopressors, and hemodynamic monitoring as 
recommended for Grade 3 CRS. 
• Methylprednisolone 1 g/day IV. 
Hypoxia 
• Supplemental oxygen via positive pressure/mechanical ventilation. 
• Tocilizumab or siltuximab plus corticosteroids and supportive care, as described 
above for Grade 2 CRS. 
10.12.2. Immune effector cell-associated neurotoxicity syndrome (ICANS) 
Although less commonly seen than CRS, ICANS has been observed with some T-cell 
directed therapies and may manifest as aphasia, delirium, encephalopathy, lethargy, difficulty 
concentrating, agitation, tremor, seizures, and cerebral edema. If ICANS is observed in 
relation to elranatamab, the ASTCT criteria (Table 18 and Table 19) will be used for grading 
and published guidelines are recommended for management. These treatment guidelines may 
be modified as needed by the responsible investigator according to the best practices at their 
institute. 
 
Table 18. Immune Effector Cell-Associated Encephalopathy (ICE) Score 
 
Category 
Task 
Points 
Orientation 
Orientation to year, month, city, 
hospital 
4 
Naming 
Ability to name 3 objects 
3 
Following 
commands 
Ability to follow simple commands 
1 
Writing 
Ability to write a standard sentence 
1 
Attention 
Ability to count backwards from 100 
by 10 
1 

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Table 19. ASTCT ICANS Grading 
 
Neurotoxicity 
Domain 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
ICE scorea 
7-9 
3-6 
0-2 
0 (unarousable and unable to perform ICE) 
Depressed 
level of 
consciousnessb 
Awakens 
spontaneously 
Awakens 
to voice 
Awakens only to 
tactile stimulus 
Unarousable or requires vigorous or 
repetitive tactile stimuli to arouse. Stupor 
or coma 
Seizure 
N/A 
N/A 
Any clinical seizure 
that resolves rapidly 
or non-convulsive 
seizures on EEG that 
resolve with 
intervention 
Life-threatening prolonged seizure 
(>5 min); or repetitive clinical or electrical 
seizures without return to baseline in 
between 
Motor 
findingsc 
N/A 
N/A 
N/A 
Deep focal motor weakness such as 
hemiparesis or paraparesis 
Elevated 
ICP/cerebral 
edema 
N/A 
N/A 
Focal/local edema on 
neuroimagingd 
Diffuse cerebral edema on neuroimaging; 
decerebrate or decorticate posturing; or 
cranial nerve VI (abducens nerve ) palsy; 
or papilledema; or Cushing’s triad 
Note: ICANS grade is determined by the most severe event (ICE score, level of consciousness, seizure, 
motor findings, raised ICP/cerebral edema) not attributable to any other cause; for example, a 
participant with an ICE score of 3 who has a generalized seizure is classified as Grade 3 ICANS. 
a A participant with an ICE score of 0 may be classified as Grade 3 ICANS if awake with global aphasia, 
but a participant with an ICE score of 0 may be classified as Grade 4 ICANS if unarousable. 
b Depressed level of consciousness should be attributable to no other cause (eg, no sedating medication). 
c Tremors and myoclonus associated with immune effector cell therapies may be graded according to 
CTCAE v5.0; these symptoms do not influence ICANS grading. 
d Intracranial hemorrhage with or without associated edema is not considered a neurotoxicity feature and is 
excluded from ICANS grading. It should be graded according to CTCAE v5.0. 
Source: (Lee et al, 2019) [48] 
 
10.12.2.1. ICANS Management Guidelines Per ASTCT[35,36] 
ICANS Grade 1: 
• Vigilant supportive care; aspiration precautions; IV hydration. 
• Withhold oral intake of food, medicines, and fluids; assess swallowing. 
• Convert all oral medications and/or nutrition to IV if swallowing is impaired. 
• Avoid medications that cause CNS depression. 
• Neurology consultation. 
• If suspected, evaluate for elevated ICP with fundoscopic exam for papilledema and 
lumbar puncture for CSF opening pressure. 
• MRI of the brain with and without contrast; CT scan of the brain can be performed if 
MRI is not feasible. 

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• Daily 30 min EEG until symptoms resolve. 
• Consider anti-IL-6 therapy with tocilizumab 8 mg/kg (maximum 800 mg) IV or 
siltuximab 11 mg/kg IV in case of concurrent CRS. 
ICANS Grade 2: 
• Supportive care and neurological work-up as described for Grade 1 ICANS. 
• Anti-IL-6 therapy if associated with concurrent CRS, as described for Grade 1 
ICANS and if not administered previously. 
• Dexamethasone 10 mg IV every 6 hours or methylprednisolone 1 mg/kg IV every 
12 hours if refractory to anti-IL-6 therapy, or for ICANS without concurrent CRS. 
• Consider transferring participant to ICU if ICANS associated with Grade ≥2 CRS. 
ICANS Grade 3: 
• Supportive care and neurological work-up as indicated for Grade 1 ICANS. 
• ICU transfer is recommended. 
• If EEG shows non-convulsive status epilepticus: 
• Assess airway, breathing, and circulation; check blood glucose. 
• Lorazepam 0.5 mg IV, with additional 0.5 mg IV every 5 min, as needed, up 
to a total of 2 mg to control electrographical seizures. 
• Levetiracetam 500 mg IV bolus, as well as maintenance doses. 
• If seizures persist, transfer to ICU and treat with phenobarbital loading dose of 
60 mg IV. 
• Recommended maintenance therapy after resolution of non-convulsive status 
epilepticus are as follows: 
• lorazepam 0.5 mg IV every 8 hours for three doses; 
• levetiracetam 1,000 mg IV every 12 hours; duration of therapy per 
investigator/treating physician’s discretion; 
• phenobarbital 30 mg IV every 12 hours; duration of therapy per 
investigator/treating physician’s discretion. 
• Lacosamide may also be considered for treatment of seizures should the 
seizures persist. Lacosamide should not be used in participants with 
concurrent CRS in order to avoid arrhythmias and hypotension. 
• For convulsive status epilepticus: 
• Assess airway, breathing, and circulation; check blood glucose. 
• Transfer to ICU. 

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• Lorazepam 2 mg IV, with additional 2 mg IV to a total of 4 mg to control 
seizures. 
• Levetiracetam 500 mg IV bolus, as well as maintenance doses. 
• If seizures persist, add phenobarbital at a loading dose of 15 mg/kg IV. 
• Maintenance doses after resolution of convulsive status epilepticus: 
• lorazepam 0.5 mg IV every 8 hours for three doses; 
• levetiracetam 1,000 mg IV every 12 hours; duration of therapy per 
investigator/treating physician’s discretion; 
• phenobarbital 1-3 mg/kg IV every 12 hours; duration of therapy per 
investigator/treating physician’s discretion. 
• Lacosamide may also be considered for treatment of seizures should the 
seizures persist. Lacosamide should not be used in participants with 
concurrent CRS in order to avoid arrhythmias and hypotension. 
• Continuous EEG monitoring should be performed, if seizures are refractory to 
treatment. 
• High-dose methylprednisolone IV 1 g/day for focal/local edema. 
• Anti-IL-6 therapy if associated with concurrent CRS, as described for Grade 1 
ICANS and if not administered previously. 
• Corticosteroids as outlined for Grade 2 ICANS if symptoms worsen despite anti-IL-6 
therapy, or for ICANS without concurrent CRS; continue corticosteroids until 
improvement to Grade 1 ICANS and then taper. 

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ICANS Grade 4: 
• Supportive care and neurological work-up as outlined for Grade 1 ICANS. 
• ICU monitoring; consider mechanical ventilation for airway protection. 
• Anti-IL-6 therapy and repeat neuroimaging as described for Grade 3 ICANS. 
• High-dose corticosteroids continued until improvement to Grade 1 ICANS 
and then taper; for example, methylprednisolone IV 1 g/day for 3 days, 
followed by rapid taper at 250 mg every 12 hours for 2 days, 125 mg every 12 
hours for 2 days, and 60 mg every 12 hours for 2 days. 
• For convulsive status epilepticus, treat as described for Grade 3 ICANS. 
• MRI of the spine should be obtained for focal motor weakness. 
• To manage elevated ICP: 
• Elevate head of the participant's bed to an angle of 30 degrees. 
• Hyperventilation to achieve target partial pressure of arterial carbon dioxide 
(PaCO2) of 28–30 mmHg, but maintained for no longer than 24 hrs. 
• Hyperosmolar therapy with either mannitol (20 g/dl solution) or hypertonic 
saline (3% or 23.4%, as detailed below): 
• Mannitol: initial dose 0.5–1 g/kg; maintenance at 0.25–1 g/kg every 6 hrs 
while monitoring metabolic profile and serum osmolality every 6 hrs, and 
withhold mannitol if serum osmolality is ≥320 mOsm/kg, or the 
osmolality gap is ≥40. 
• Hypertonic saline: initial 250 ml of 3% hypertonic saline; maintenance at 
50-75 ml/hour while monitoring electrolytes every 4 hrs, and withhold 
infusion if serum Na levels reach ≥155 mEq/l. 
• For participants with imminent herniation: initial 30 ml of 23.4% 
hypertonic saline; repeat after 15 min, if needed. 
• If patient has Ommaya reservoir, drain CSF to target opening pressure of <20 
mmHg 
• Consider neurosurgery consultation for ventriculoperitoneal shunt in 
participants with cerebral edema, and IV anesthetics for burst-suppression 
pattern on EEG. 
• Metabolic profiling every 6 hours and daily CT scan of head, with 
adjustments in usage of the aforementioned medications to prevent rebound 
cerebral oedema, renal failure, electrolyte abnormalities, hypovolemia, and 
hypotension. 

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10.13. Appendix 13: Concomitant Medications That May Result in DDI 
Treatment with efranatamab has a potential for resulting in modest and transient increase in 
the exposure of concomitant medications that are substrates for major CYP enzymes (eg, 
CYP3A4 and CYP2C9). Caution should be used upon concomitant use of sensitive substrntes 
of CYP enzymes with naiTow therapeutic index, listed in the table, especially during the 
initial treatment cycle. If the use of waifarin is clinically necessaiy, caution and additional 
INR monitoring is recommended during the initial treatment cycle. 
The Pfizer study teain is to be notified of any prohibited medications taken during the study. 
After consulting with the sponsor, the investigator will make a judgement on the ongoing 
paiticipation of any paiticipant with prohibited medication use during the study. 
This list of diugs prohibited for potential DDI concerns with the IMP may be revised dming 
the course of the study with written notification from sponsor, to include or exclude specific 
diugs or diug categories for vai·ious reasons (eg, emerging DDI results for the IMP, 
availability of new information in literatme on the DDI potential of other diugs). 
This is not an all-inclusive list. Site staff should consult with the sponsor or designee with 
any questions regarding potential DDI. 
 
Drug Category 
Drugs 
CYP3A4 Substrate 
alfentanil 
cyclosporine 
dihydroergotamine 
ergotamine 
fentanyl 
pimozide 
quinidine 
sirolimus 
tacrolimus 
CYP2C9 Substrate 
Phenytoin 
warfarin 
 
Investigators should consult the product prescribing infonnation for any other medication 
used dming the study for infonnation regarding medication that is prohibited for concomitant 
use. 

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10.14. Appendix 14: Country specific requirements 
10.14.1. Japan 
Japan Regulato1y Requirements 
For Section 8.2.6. Clinical Safety Laborato1y Assessments, the following additional 
laborato1y HBV monitoring during study treatment should be followed as a precaution: 
• 
For paiiicipants with a positive HBsAb and positive HBcAb test but with a negative 
HBV DNA test at screening, HB viral load should be monitored for re-activation eve1y 12 
weeks. If HBV relapse is observed, the event should be collected in the AE section of the 
CRF, but the test data will not be required to be repo11ed on the CRF. Paiiicipants with an 
HBsAb positive test who have been vaccinated with HBV ai·e exempt from the testing of HB 
viral load. 
• 
Administration of study inte1vention will be intem.1pted for a paiticipant with an HBV 
viral load positive test at any time during the study. Staiiing nucleoside antagonist 
administration immediately should be considered in parallel with consultation with a 
hepatologist in accordance with the Japan Society ofHepatology (JSH) Guidelines for the 
management of Hepatitis B Vims infection. 
 
 
 
Premedications 
The sponsor lists each of the study inte1ventions in the following table because safety 
infonnation for these study inte1ventions must be repo11ed to the Japan regulato1y authorities 
and investigator(s)/IRB/EC of the investigator site(s) in Japan in accordance with the 
Japanese regulato1y requirements. The investigator in Japan provides the sponsor with the 
safety infonnation necessaiy for safety repo11ing to the Japan regulato1y authorities. 
 
Intervention Name 
Acetaminoohen 
Diohenhvdramine 
Dexamethasone 
Tvoe 
Drng 
Drng 
Drng 
Dose Formulation 
Tablet 
Tablet or Solution for 
iniection 
Tablet or Solution for 
iniection 
Unit Dose 
Stremz:th(s) 
650 mg (or equivalent) 
25 mg (or equivalent) 
20 mg (or equivalent) 

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Route of 
Administration 
PO 
PO or IV 
PO or IV 
IMP or NIMP 
NIMP/AxMP 
NIMP/AxMP 
NIMP/AxMP 
Sourcing 
Provided locally by the 
trial site. 
Provided locally by the trial 
site. 
Provided locally by the 
trial site. 
SRSD 
Ireland SmPC for 
Paracetamol/Diphenhy 
dramine Hydrochloride 
Ireland SmPC for 
Paracetamol/Diphenhydramin 
e Hydrochloride 
EU SmPC for 
Neofordex 
10.14.2. United States 
The informed consent cannot be provided by a legally authorized representative in the US. 
Only participants who are capable of giving informed consent by themselves are eligible to 
participate in the study. 

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10.15. Appendix 15: Anti-infectious Prophylaxis and Monitoring 
Participants should receive antimicrobial prophylaxis as detailed below. 
 
Risk factors 
Prophylaxis/ 
Treatment/ Testing/ 
Monitoring 
Start 
Stop 
Required/ 
Recommended 
HSV/VZV 
Acyclovir or 
alternative 
Antiviral prophylaxis 
within 1 week after 
starting treatment is 
required to prevent 
herpes zoster 
reactivation 
Continue for 3 
months following the 
end of treatment 
Continue for 3 
months following the 
end of treatment 
Required 
CMV 
CMV testing by PCR 
is required at 
screening. On study 
testing should be 
performed either 
monthly or every 1 to 
3 cycles depending 
on risk factors and 
baseline CMV viral 
load 
Valganciclovir 900 
mg PO BID 
Alternative 
(ganciclovir IV 
foscarnet IV) or other 
approved agents. 
Initiation of antiviral 
treatment is 
recommended for 
participants with CMV 
copy number 
≥1000/mL, or per local 
standard of care (other 
risk factors including 
the rise in CMV copy 
number should be 
considered). 
Treatment is required 
for symptomatic 
participants 
irrespective of viral 
load. 
Continue therapy 
until two consecutive 
measurements at least 
14 days apart show 
viral load < 1000/mL 
and resolution of 
symptoms (if present) 
Required 
Pneumocystis 
jirovecii 
Pneumonia 
(PJP) 
PJP prophylaxis is 
required for all 
participants for at 
least 6 months 
Trimethoprim- 
sulfamethoxazole DS 
1 tablet PO daily, 
three times per week 
Alternatives: 
Pentamidine (or 
alternative), or 
Dapsone – 100 mg 
PO daily or 50 mg 
PO BID, or 
Atovaquone – 1500 
mg PO daily 
Day 1 of first dose of 
elranatamab 
Suggested duration: 
until CD4 count ≥200 
cells/µL based on 2 
consecutive 
measurements at least 
14 days apart 
(whichever is longer). 
Prophylaxis may be 
extended at the 
discretion of the 
investigator as 
clinically indicated. 
Required 
SARS-CoV-2 
Starting with protocol 
Initiate treatment (eg 
For participants with 
Required 
amendment 4, PCR 
PAXLOVIDTM, 
SARS-CoV-2 
or antigen test are 
remdesivir) as soon as 
infection, study 
required predose on 
possible, ideally 
intervention should 
Day 1 (CXD1), upon 
within 24 hours 
be delayed for at least 
suspected exposure to 
following a positive 
14 days from the start 
SARS-CoV-2 and at 
SARS-CoV-2 test 
of symptoms or 
signs or symptoms of 
positive test result. 

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COVID-19 infection 
(eg, new or 
worsening fever, 
cough, sore throat, 
shortness of breath or 
fatigue). 
In addition, the 
participant should be 
afebrile for 72 hours, 
and COVID-19 - 
related symptoms 
should have 
recovered to ≤Grade 
1 for a minimum of 
72 hours 
Hypogamma- 
Monitor 
Administration of 
Until resolution of 
Recommended 
globulinemia/ 
immunoglobulin 
immunoglobulin for 
hypogammaglobuline 
Immunoglo- 
levels for the 
IgG level < 400 mg/dL 
mia 
bulin 
occurrence of 
is strongly 
replacement : 
hypogammaglobuli- 
recommended 
intravenous 
nemia/ immune 
(excluding M-spike in 
immunoglo- 
paresis 
participants with IgG 
bulin (IVIG) 
myeloma). In 
or 
participants with IgG 
subcutaneous 
myeloma, evaluation 
immunoglo- 
of uninvolved 
bulin (SCIG) 
immunoglobulins 
[IgA, IgM] can also be 
used to determine 
immune-paresis and 
the requirement for 
immunoglobulin 
replacement.) 
Bacterial 
infection 
Fluoroquinolones 
(levofloxacin - 500 
mg PO or IV daily, or 
equivalent) 
Suggested alternative 
for participants with 
allergy to quinolones: 
Cefpodoxime - 200 
mg PO twice a day 
For all participants at 
high risk of infections 
during course of 
treatment (eg history 
of pneumonia, Grade 4 
neutropenia), an initial 
3-month prophylactic 
course of 
fluoroquinolones is 
recommended 
Stop after 3-months 
of initial prophylaxis 
if ANC ≥1000/µL 
Recommended 
After initial 3-month 
treatment, administer 
for 14 days for ANC 
<1000/µL 
Prophylaxis may be 
extended at the 
discretion of the 
investigator as 
clinically indicated 

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Fungal 
Infection 
Fluconazole - 400 mg 
daily (or equivalent) 
For participants with 
prolonged neutropenia 
(eg, ANC <500/µL for 
>7 days) 
At neutropenia 
resolution (for 
example, ANC 
≥500/µL). 
Prophylaxis may be 
extended at the 
discretion of the 
investigator as 
clinically indicated. 
Recommended 
Consider switch to 
posaconazole or 
equivalent 
Prolonged ANC 
<500/µL >3 weeks 
Until neutropenia 
resolution (ANC 
≥500/μl) 
Other viral 
infections 
While on study 
treatment, as 
clinically indicated, 
in patients with 
suspected infection, 
consider testing for 
other potential 
viruses such as 
adenovirus and EBV. 
For participants with 
positive test, initiate 
treatment/supportive 
care as per local 
standard of care and 
hold study 
interventions 
Until resolution of 
signs and symptoms 
or per local standard 
of care 
Recommended 
Neutropenia/ 
Prophylactic or 
For participants with 
Until resolution of 
Recommended 
G-CSF 
therapeutic 
ANC <1000/µL 
neutropenia 
Prophylaxisa 
administration of G- 
CSF in participants 
with severe 
neutropenia or 
serious neutropenic 
complications is 
strongly 
recommended 
consistent with the 
ASCO guidelines[53] 
to decrease the risk of 
neutropenia 
specifically in 
participants with 
baseline extensive 
BM involvement 
and/or low neutrophil 
counts. 
a. Eligibility restricts use of G-CSF within 7 days prior to start of study intervention. Note 
that primary prophylactic use of G-CSF is not permitted during Cycle 1 and 2 of Part 2A 
and Part 2C, but may be used to treat treatment emergent neutropenia [54-58]. 

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10.16. Appendix 16: Protocol Amendment History 
The protocol amendment sUIIllnaiy of changes table for the cmTent amendment is located 
directly before the TOC. The protocol amendment sUIIllnaiy of changes tables for past 
amendment(s) can be found below: 
Amendment 3 (22 Nov 2022) 
Overall Rationale for the Amendment: 
 
detailed guidance for infection prophylaxis. Additional coITections or revisions were made to 
clai·ify or more completely define processes. 
 
Section # and Name 
Description of Change 
Brief 
Rationale 
Substantial 
(YIN) 
Section 1.1, Synopsis, 
Overall Design; Section 
Updated schematic study design and 
overall desi 
b addin Pait 3 
To reflect study 
design change 
in multiple 
sections 
Y 
1.2 Schema; 
Section 4.1, Overall 
Desi 
Section 1.1, Synopsis; 
Updated statistical section related to 
To reflect 
Y 
number of paiticipants, 
 Pait 3, coITection of the DLT 
Statistical methods, 
evaluable set for emolled paiticipants 
Section 3, Objectives, 
in Pait 2A and Pait 2C (Section 9.2) 
Endpoints, And 
statistical 
changes in 
multiple 
sections 
Estimands; Section 9, 
regarding the 
Statistical 
Considerations (9.1, 9.2 
addition of Pait 
3 and to clarify 
Analysis sets; 9.3, 9.4, 
9.5, Sample Size 
Detennination (Pait 1, 2 
the definition 
of the DLT 
evaluable set 
and3 
Section 1.1, Synopsis, 
Section 5.2 
criteria 
Modified the EC #12: "Paiticipants 
with positive anti-HBcAb but 
negative HBsAg and negative anti- 
HBsAb profile ai·e eligible if HBV 
DNA is not detected." Also added 
"COVID-19" and "or AIDS-related 
illness" and "While SARS-CoV-2 
testing is not mandated for entiy into 
this study, testing should follow local 
clinical practice standai·ds. If a 
paiticipant has a positive test result 
for SARS-CoV-2 infection within 14 
To clarify 
Y 
eligibility 
criteria for 
HBV, COVID- 
19 and AIDS 
related illness 
at baseline 

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Section # and Name 
Description of Change 
Brief 
Rationale 
Substantial 
(YIN) 
days prior to enrolhnent, is known to 
have asymptomatic infection or is 
suspected of having SARS-CoV-2, 
the paiticipant is excluded. 
Section 1.1, Synopsis, 
To ensure 
y 
Section 5.2 Exclusion 
criteria #13 and #18-20 
pa1ticipants are 
excluded in 
Pait 3 
the Synopsis. Modified the EC #20: 
"Investigator site staff or Pfizer 
To align with 
employees directly involved in the 
conduct of the study and their family 
members, site staff othe1wise 
Section 5.2 
supervised by the investigator, and 
sponsor and sponsor delegate 
employees directly involved in the 
conduct of the study and their 
respective fainily members." To align 
with new  rotocol tem late 
Section 1.3 Schedule of 
Activities (Pait 1, 2 and 
Part 3) 
Added CMV assessment by 
quantitative PCR. For pa1ticipants 
ah-eady enrolled and treated under 
Pait 1 and Pait 2, a CMV testing 
should be perfo1med as a baseline 
reference for CMV status at the next 
scheduled dosing visit and repeated 
either monthly or eve1y 1 to 3 cycles 
depending on risk factors and 
baseline CMV viral load as clinically 
indicated. Removed CMV testing at 
C2 for Pait 2 and removed CMV 
testing at C2-C6 and C7+ for Pali 1 
(to align Paits 1, 2 and 3 with the 
note in each SoA) 
ToaddCMV 
testing at 
screenmg or 
prior to first 
administration 
of study diug 
for safety 
monitoring and 
at different 
timepoints as 
clinically 
indicated (Pait 
1, 2 and 3) and 
ensure that 
pa1ticipants 
ah-eady 
enrolled will 
getaCMV 
testin  durin 
y 

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Section # and Name 
Description of Change 
Brief 
Rationale 
Substantial 
(YIN) 
their next 
scheduled visit, 
as clinically 
indicated (Pait 
1 and Pait 2. 
Section 6.8.7, 
Prophylaxis for 
Infections 
Reference to Appendix 15 for anti- 
infectious prophylaxis and 
monitoring. 
Revised guidance for the use of IV 
irmnunoglobulins and 
h o amma lobulinernia. 
Added required 
treatment as per 
Dear 
Investigator 
Letter dated 08 
Jul 2022. 
y 
Section 6.8.8 COVID- 
19 
Creation of a new section, alignment 
with BCMA program, Revised 
guidance for COVID-19 testing and 
treatment for paiticipants with 
COVID-19 positive tests. 
Clai·ification 
for 
investigators as 
perPACL 
dated 25 May 
2022. 
y 
Section 10.15 Appendix 
15-Anti infectious 
Prophylaxis and 
Monitoring 
Added anti infectious prophylaxis/ 
hypogammaglobulinernia/neutrnpenia 
guidance 
Provide 
guidance to 
investigative 
sites as per 
Dear 
Investigator 
Letter dated 08 
Jul 2022. 
y 
Section 6.8.2 
Concomitant Therapy 
Added guidance for administration of 
mugs known to cause peripheral 
neuropathy, added: "Effective 
treatment and prophylaxis for 
infections should be prioritized" 
Avoid conflict 
with di11gs 
recormnended 
in anti- 
infectious 
prophylaxis and 
monitoring 
guidance 
A 
endix 15 . 
y 
Section 2.3.1- 
Added infections as a potential risk of 
Benefit/Risk assessment  clinical si ificance for ekanatainab, 
 
Suppo1ted by 
clinical data 
from 
ekanatamab 
and other 
therapies with 
sirnilai· 
y 

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Section # and Name 
Description of Change 
Brief 
Rationale 
Substantial 
(YIN) 
 
mechanism of 
 
 
 
 
 
 
 
 
 
 
Section 2.3.1- 
Benefit/Risk assessment 
 
 
 
 
 
 
 
Study title and brief 
title, Section 1.1, 
Added that "effective ti·eatment and 
prophylaxis for infections should be 
prioritized" in the risk section for 
peripheral nemopathy 
To avoid 
y 
conflict with 
chugs 
recommended 
in anti- 
infectious 
prophylaxis 
guidance 
A 
endix 15 
y 
Synopsis, 
for evaluation 
of the safety 
and efficacy of 
 
 
 
 
 
 
 
Schedule 1.3 Schedule 
of Activities -Part 3- 
Hospitalization (Paii 1 
and Paii 3) 
 
Added SoA table for Pait 3, added a 
potential hospitalization for the first 
RP2D elranatamab dose at C7D1 
(116 or 152 mg) Q4W 
needed 
To reflect study 
y 
design change 
on SoA specific 
to Pait 3 and 
allow potential 
hospitalization 
for safety 
management at 
RP2DQ4Win 
Pait 1 and Paii 
3 

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Section # and Name 
Description of Change 
 Brief 
Rationale 
Substantial 
(YIN) 
y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Section 6.5 Dose 
Modification 
 
 
Section 6.5.1 Dose 
Modification 
When 20 mg eh-anatamab priming 
dose is repeated after treatment 
intenuption for >2 weeks, escalation 
to 76 m should occur 1 week later 
For Q2W regimen, the window 
between consecutive <losings is 
changed to (-1/+6 days) 
Align with SoA 
y 
cycles 
 
Align with SoA 
y 
cycles and 
respect a 
minimumof6 
days between 
doses 

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Section # and Name 
 
 
Section 6.5.1.2 
 
 
 
 
Section 6.8.1 
Premedications 
Required for Cytokine 
Release Syndrome- Part 
3 
Description of Change 
 
 
Removed 'recommended' from 
description of dose modification for 
eh-anatamab-related toxicities 
 
 
Addition of Pali 3 pre-medication for 
CRS 
Brief 
Rationale 
 
The dose 
modifications 
for eh-anatamab 
are required per 
rotocol 
To clarify the 
use of 
Substantial 
(YIN) 
y 
 
 
 
 
y 
 
 
 
Section 6.8.3.1 
Prohibited medication 
during study 
New section added to include 
prohibited medication with 
dexamethasone 
To clarify 
y 
prohibited 
medication 
with 
dexamethasone 
and added live 
attenuated 
vaccine period 
of prohibition -+--- 
 
 
 
 
Schedule 1.3 Schedule 
of Activities (Pait 1, 2 
and 3) and Section 8.2.3 
Vital signs 
 
Section 1.3 Schedule of 
Activities (Paits 1 and 
2); disease assessment - 
Notes for SPEP, SIFE, 
FLC, UPEP, UIFE, 
Sennn quantitative 
immunoglobulins, 
rmagmg 
To request vital signs collection in 
CRF for the periods of scheduled 
hospitalizations and if abnonnal and 
associated with AEs (eg, CRS or an 
infection 
Clarified that disease assessment, 
SPEP, SIFE, FLC, UPEP, UIFE, 
Sennn quantitative immunoglobulins, 
imaging are conducted eve1y 28 days 
from ClDl, Clarification that once 
all EMD has resolved/disappeai·ed, 
imaging can be conducted annually 
(or earlier if clinically indicated) and 
at sus ected PD 
Align with 
N 
program-level 
updates 
 
 
Align with 
N 
program-level 
updates 

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Section # and Name 
Description of Change 
Brief 
Rationale 
Substantial 
(YIN) 
Section 1.3 Schedule of 
Activities (Pait 1, 2, 3) 
Appendix 10: IMWG 
Response Criteria for 
Multiple Myeloma 
Added semm FLC to be used for 
response assessment only when 
senun and urine M protein are non- 
measurable or uninte1pretable, except 
for sCR 
Distinguish 
performing 
FLC analysis 
from using 
FLC results for 
response 
assessment 
N 
Schedule 1.3 Schedule 
of Activities (Pait 1, 2 
and 3) - Clinical 
Procedures/Assessments 
Clarified that during the treatment 
period, all assessments must be done 
within 72 hours prior to dosing, 
except for disease assessments which 
are to be done eve1y 28 days from 
ClDl 
Align with 
program-level 
updates 
N
 
Section 1.3 Schedule of 
Added that sta1ting C2D1 up to end 
Align with 
N 
Activities (Pait 2, 3)- 
of C6, neurological exain is to be 
 Q2W dosing of 
Neurolo ic exain 
 erfo1med biweekl 
eh-anatamab 
Section 2.2- 
Added as more clinical data become 
Align with 
N 
Background 
available 
program-level 
info1mation- Table 4 
u dates. 
Section 6.8.3- 
Added that administration of live 
Align with 
N 
Prohibited during the 
attenuated vaccines is prohibited 
 program-level 
study 
 during study treatment, and for 90 
updates 
days after the last dose of study 
treatment. Annual inactivated 
influenza vaccines ai·e allowed. 
Section 7.1.1 Potential 
Guidance added for actions in cases 
Align with 
N 
Cases of Kidney fujmy 
of acute kidney injmy. 
program-level 
u dates. 
Section 8.1.3 -hnaging 
Added that "radiologic progression 
Align with 
N 
assessments 
observed within the first month 
program-level 
following the first dose of 
updates and to 
eh-anatainab will not be considered 
 align with 
progressive disease and that imaging 
 imaging section 
is acce table to be used as baseline 
in SOA. 

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Section # and Name 
Description of Change 
Brief 
Rationale 
Substantial 
(Y/N) 
evaluation, if can be obtained within 
42 days before start of study 
intervention. Added that bone lesions 
and any soft tissue plasmacytoma 
documented at baseline must undergo 
serial monitoring. Paramedullary 
disease or plasmacytomas associated 
with bone are not considered EMD. 
Section 10.2. Appendix 
2: Clinical Laboratory 
Assessments- Table 17 
Addition of CMV by quantitative 
PCR 
Align with new 
guidance 
Anti-infectious 
Prophylaxis 
(Appendix 15) 
N 
Section 10.14 Japan 
Tocilizumab 
Added additional information for 
tocilizumab 
Satisfies safety 
reporting 
requirements in 
Japan 
N 
Section 10.14 United 
States 
Added US-specific requirements that 
LAR are not allowed for informed 
consent process 
To address US 
IRB request as 
per PACL 
dated 03 
August 2022. 
N 
Global 
Minor administrative, editorial, 
typographical, new bibliographic 
references, abbreviations list or 
formatting changes. 
Updated for 
grammatical 
correctness, 
consistency, 
references, 
and/or clarity. 
N 
 
Amendment 2 (10-June-2022) 
Overall Rationale for the Amendment: 
Changes are mainly to align study procedures and statistical analysis across ongoing clinical 
studies conducted with elranatamab, to revise eligibility criteria to improve participant 
recruitment, to allow participants enrolled in Part 1 to switch to a Q4W regimen and to 
correct or clarify inconsistencies identified in the previous version of the C1071009 protocol. 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Substan 
tial 
(Y/N) 
1.2 Schema 
(Study Design) 
Rules for transitioning from 
Part 2A to Part 2C revised 
Clarify the criteria for 
opening Part 2C 
Y 
1.2 Schema 
(Study Design), 
synopsis, 3 
Objectives, 
Endpoints, and 
Estimands, 4.1 
Overall Design, 
4.3.3 Definition 
of DLT, 9.5.2 
Part 2A and Part 
2C 
Revised DLT observation 
period definition to 28 days 
starting on the first dose of 
116 or 152 mg. 
Clarify the DLT period to 
ensure that it includes the 
time period after initiation of 
the higher dose of 
elranatamab 
Y 
1.2 Schema 
(Study Design), 
Synopsis, 1.3. 
Part 1 Schedule 
of Assessments, 
2.1 Study 
Rationale, 2.3.1 
Risk 
Assessment, 
2.3.2 Benefit 
Assessment, 4.1 
Overall Design, 
4.2 Scientific 
Rationale for 
Study Design, 
4.3.2 
Justification for 
Evaluation of 
Higher 
Elranatamab 
Doses, 4.3.4 
Definition of 
RP2D for Part 
2B and Part 1 
from C7, 6.1 
Study 
Intervention(s) 
Administered, 
6.5.2 Dose 
Participants enrolled in Part 
1 should be switched to the 
RP2D identified in Part 2A 
(116 mg or 152 mg) 
administered Q4W after 6 
cycles if PR or better is 
persisting for ≥ 2 months. 
Gain additional elranatamab 
monotherapy data using 
higher dose and longer 
dosing interval. 
Y 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Substan 
tial 
Modifications 
for Ehanatamab- 
Related Toxicity 
and Peripheral 
Neuro ath . 
1.3 Schedule of 
Clarifications on 
Provide clarity to 
y 
Activities 
requirements for laborato1y 
investigative sites and 
disease assessments 
hannonize across ongoing 
urine and 
eh-anatamab studies 
una m 
Increased window for vital 
Provide flexibility to the 
y 
signs measurements during 
hospitalization period 
sites 
Clarified EMD defmition 
and revised frequency of 
unagmg. 
Updated data from 
C1071001 study and added 
data from C1071003 stud 
Updated clinical data from 
ongoing Phase 1 
(C1071001) and Phase 2 
(C1071003) studies to align 
with the annual IB update. 
Clarified the mies to open 
Pali2C 
Timeframe between 
transfusion suppo1t and G- 
CSF suppo1t and planned 
C1D1 was extended 
Revised to better align with 
Standard of Care and to 
provide clarity to the sites. 
Updated to reflect cunent 
available clinical data on 
eh-anatamab 
Update sites on clinical 
experience with ehanatamab 
in the Study C1071009 target 
patient population 
Clarify the process for 
opening Pait 2C 
• Ha1monize across 
elranatamab studies 
y 
y 
y 
y 
y 
Section 1.3 SOA 
and 8.1.3 
hnaging 
Assessments 
2.2.3.2 Clinical 
Overview 
Both 
Section 2.2.3.2 
Ehanatamab 
Clinical 
Overview 
and 
Benefit/Risk 
Assessment 
Section 4.1 
Overall Design 
and Section 4.3.5 
Dose Level in 
Pait 2C 
5.1 Inclusion 
criteria: Criteria 
#13 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Substan 
tial 
(Y/N) 
• Improve participant 
recruitment 
5.2 Exclusion 
criteria: 
Added: 
• Waldenström’s 
macroglobulinemia (#5) 
Revise target participant 
population and harmonize 
across elranatamab studies 
Y 
• Known active CNS 
involvement or clinical 
signs of myelomatous 
meningeal involvement 
(#6) 
5.2 Exclusion 
criteria #14 
Clarified text pertaining to 
active malignancy 
Provide clarity to 
investigative sites and 
harmonize across ongoing 
elranatamab studies 
Y 
5.2 Exclusion 
criteria #16 
Added BCMA CAR-T cell 
therapy 
Revise target participant 
population 
Y 
6.5.2 Dose 
Modifications 
for Elranatamab- 
related Toxicity 
and for 
Peripheral 
Neuropathy 
Added guidance in case the 
116 mg or 152 mg is not 
tolerated 
Guidance was missing in the 
previous version of the 
protocol 
Y 
Section 6.5.2, 
Added the procedure for 
Added to mitigate CRS risk 
Y 
Dose 
restarting elranatamab 
and to align across the 
Modifications 
treatment for participants 
clinical elranatamab 
for Elranatamab- 
who have a dose 
program. 
Related Toxicity 
interruption >2 weeks 
and associated 
within the 1st cycle. 
table. 
Removed instructions for 
To clarify dose modification 
Y 
dose reductions. 
guidance and to align across 
the clinical elranatamab 
program and standard 
approaches for management 
of TEAEs with an immuno- 
oncology agent. 
Section 6.5.3, 
Dose Reductions 
Updated to indicate that 
dose reduction of 
To clarify dose modification 
guidance and to align across 
the clinical elranatamab 
Y 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Substan 
tial 
eh-anatamab below 76 mg is 
program and standard 
no longer pennitted. 
approaches for management 
ofTEAEs with an immuno- 
oncolo 
a ent. 
6.8 Concomitant 
Therapy 
Added Section 6.8.7 
Infection Prophylaxis 
Guidance added to all 
ongoing studies in the 
eh-anatamab program. This 
guidance will reduce the risk 
of infection for study 
aitici ants. 
y 
8.1.1 Laborato1y 
Assessment for 
Evaluation of 
Disease 
Response 
Added sennn quantitative 
immunoglobulins and 
clarified timepoints for 
other parameters 
Suppo1t monitoring of 
disease response for 
paiticipants with IgA/IgD 
MM and monitoring of 
hypogammaglobulinemia; 
Haimonize with ongoing 
eh-anatainab studies 
y 
8.3.8 Adverse 
Events of 
Special Interest 
Peripheral neuropathy 
 Peripheral neuropathy added 
added as an AES!. 
as an AES! across all 
ongoing clinical studies in 
 
 the prograin. 
y 
 
 
 
 
 
9.4.1. Interim 
Safety 
Assessments 
Revised criteria for placing 
enrollment on a tempora1y 
hold. 
For haimonization with 
y 
Study C1071003 using 
posterior probability of 0.8 
 
instead of 0.9. 
 
9.5.2 Sample 
Size 
Detennination 
 
 
9.5.2 Pait 2A 
and Pait 2C 
Added mies for DLT 
frequencies and 
characteristics for dose 
recommendations for 
Pait 2C 
Clai·ified BLRM approach 
applies to Pait 2A and Pait 
2C and revised mies for Part 
2C 
Clarify the criteria for 
y 
opening Pait 2C 
 
 
Clarify the process for 
y 
opening Pait 2C 
Appendix 2: 
Clinical 
Added collection of plasma 
Changes made across all 
y 
cell count, magnesium, and 
ongoing eh-anatamab studies 
ates to to enhance safe 
monitorin 

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Section # and 
Description of Change 
Brief Rationale 
Substan 
Name 
 
 
 
tial 
 
Laborato1y 
list of required safety 
Assessments 
laborato1 assessments 
Appendix 8, 
Revised eligibility 
Clarification for 
y 
section 10.8.1 
timeframe for paiiicipants 
investigators 
with COVID-19 positive 
tests. 
Appendix 10 
Criteria for IMWG response 
Changes made across all 
y 
IMWG 
criteria revised 
ongoing ekanatamab studies 
Response 
to allow BMA for assessing 
Criteria for 
sCR. 
Multiple 
M eloma 
Appendix 14, 
Added info1mation on 
Added required text due to 
y 
Section 10.14.2 
SRSD for tocilizumab and 
new Japan regulation. 
remedications 
1.2 Schema 
RemovedMTD 
Clarify that RP2D will be 
N 
(Study Design), 
identified as MTD may not 
3 Objectives, 
be reached. 
Endpoints and 
estimands, 4.1 
Overall Design, 
Section 4.3.4 
Definition of 
RP2D for Paii 
2B; 9.5.2. Pali 
2AandPaii2C 
1.3 Schedule of 
 Added the enrollment in 
Provide clarity to the sites 
N 
Activities 
IRTonClDl 
 
 
 
 
 
Section 3 
Objectives, 
Endpoints and 
Estimands 
Changed naine of CCRR 
and DOCCR to CRR and 
DOCR, respectively 
 
-----+ 
Haimonize with ongoing 
N 
ekanatainab studies to 
remove the tenn 
'Cumulative' and provide a 
better clai·ity. 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Substan 
tial 
5.1 Inclusion 
Recommended fonnula for 
Alignment with cmTent best 
N 
criteria: Criteria 
#12 
assessing eGFR was 
u dated 
practices for assessing renal 
function 
5.2 Exclusion 
criteria: Criteria 
#12 
Clarified text pertaining to 
SARS-CoV2 infection. 
Provide clarity to 
investigative sites 
N 
6.1.1 
Revised windows 
Administration 
Haimonize across ongoing 
eh-anatainab studies 
N 
6.3.1 Allocation 
Revised to clai-ify the 
To reflect the cohort 
N 
to Study 
Intervention 
process for pa1ticipant slot 
assignment for Pali 2A and 
management plan that 
applies for Pait 2A and 
Pait 2C 
Pait 2C 
Section 6.7, 
Treatment of 
Overdose No. 2 
Modified monitoring 
requirements for AEs/SAEs. 
Aligned with safety repo1ting 
period. 
N 
6.8.1 
Premedication can be 
To align with the change in 
N 
Premedications 
administered on the day of a 
Required for 
dose higher than 76 mg is 
DLT observation period. 
Cytokine 
administered. 
Release 
s drome 
6.8.2 Pennitted 
Concoinitant 
Revised guidance on 
palliative radiotherapy to 
Guidance revised for all 
ongoing studies in the 
N 
Medications/The 
rap1es 
more clearly state that this is 
allowed when considered 
eh-anatainab program to 
ensme that investigators 
medically necessaiy 
provided that disease 
understand when palliative 
radiotherapy is pe1missible. 
progression has been rnled 
out 
6.8.2 Pennitted 
Concoinitant 
Medications/The 
rap1es 
Added guidance on testing 
and treatment for 
pa1ticipants who may be 
exposed to COVID-19 or 
may develop a COVID-19 
Guidance added as MM 
patients ai·e at increased risk 
of severe disease and 
complications from COVID- 
19 infection. 
N 
infection 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Substan 
tial 
8.1.4 Disease 
Characteristics 
and Treatment 
Histo1y 
FISH and/or kaiyotyping 
can be perfo1med 
Allow flexibility to the sites, 
haimonize across ongoing 
eh-anatainab studies 
N 
 
 
 
 
 
8.2.3 Vital signs 
Increased window for vital 
signs measurements during 
hos italization  eriod 
Provide flexibility to the 
sites 
N 
 
8.2.6 Clinical 
Safety 
Added guidance to review 
laborato1y repo1is prior to 
To ensure sites are checking 
that paiticipants ai·e meeting 
N 
Laborato1y 
dosing 
dosing criteria 
Assessments 
8.3.1 Time 
Clai·ified end of AE and 
Updated to ensure 
N 
Period and 
SAE collection period 
consistencies throughout 
Frequency for 
protocol 
Collecting AE 
and SAE 
Info1mation 
8.4 
Clai·ified that predose 
Haimonize across ongoing 
N 
Phaimacokinetic 
samples should be collected 
eh-anatainab studies 
s 
prior to premedications if 
an. 
8.4 
Removal of the date and 
To reflect the data cmTently 
N 
Phaimacokinetic 
s 
time of the last dose prior to 
PK sample collection for 
each sample 
collected in the eCRF 

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Section # and 
Name 
Description of Change 
Brief Rationale 
Substan 
tial 
 
 
 
 
 
 
 
 
 
9.1.1.1 Primaiy 
Clai·ified intercurrent event 
Clarify primaiy analysis 
N 
Estimand 
handlin 
9.1.1.2 
Removed intercurrent event 
Clarify secondaiy analysis 
N 
Secondaiy 
Estimand 
9.1.1.2 
Secondaiy 
Definition ofDLT evaluable 
pa1ticipant clai·ified 
Updated to provide better 
clarity to the site. 
N 
Estimand 
9.2 Analysis Sets 
Clai·ified DLT Evaluable 
Specify that this applies to 
N 
 
Set 
Pait 2A and Pait 2C 
9.3.3.2 
Changed naine of CCRR 
Haimonize with ongoing 
N 
Secondaiy 
and DOCCR to CRR and 
eh-anatainab studies to 
Efficacy 
DOCR, respectively 
remove the tenn 
Endpoints 
'Cumulative' and provide a 
better clai·ity. 
9.3.5.1 
Revised threshold for QTcF 
Haimonize with ongoing 
N 
Electrocai·diogra 
Assessment 
eh-anatainab studies 
m Anal sis 
10.1.3 Info1med 
Added Legally authorized 
Reflect current version of the 
N 
Consent Process 
re resentative 
Info1med Consent Document 
Appendix 11 
Added guidelines on prior 
Haimonization with 
N 
lines of therapy 
C1071003 and C1071005 
stud 
rotocols 
Appendix 13 
Added guidelines on 
Haimonization with 
N 
concomitant medications 
C1071003 and C1071005 
that ma  result in DDI 
stud 
rotocols 
Appendix 14 
Sponsor will provide 
To satisfy local requirement 
N 
tocilizumab to investigative 
sites in Ja an 
Multiple sections 
Co1Tection of 
Improve clai·ity of protocol 
N 
inconsistencies and 
for investi ator sites 

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Elranatamab 
Protocol C1071009 
Final Protocol Amendment 4, 20 Dec 2023 
 
Section # and 
Name 
Description of Change 
Brief Rationale 
Substan 
tial 
(Y/N) 
typographical errors 
identified in Protocol 
Amendment 1 
 
 
Amendment 1 (09-June-2022) 
Overall Rationale for the Amendment: As per regulatory requirements (US FDA), updates 
are included to describe peripheral neuropathy (including GBS) as an important potential risk 
of elranatamab and measures to mitigate the risk including (a) addition of various new safety 
monitoring measures; (b) modification to participant selection (exclusion) for those 
potentially at higher risk; (c) addition of dose modification rules for peripheral neuropathy; 
(d) addition of recommended work-up for peripheral neuropathy; and (e) addition of 
considerations regarding concomitant medications. In addition, the criteria for placing the 
study on temporary hold (specifically related to neuropathy or other IR neurological AEs) 
have been defined. 
In addition, the safety reporting period after last dose of study intervention has been 
increased to 90 days in order to capture all potential AEs, including late onset immune- 
related neurologic AEs. The contraception use after the last dose of study intervention has 
also been extended from 28 days to 90 days (as required by some HAs for another 
elranatamab study and to align across the elranatamab clinical program). 
Furthermore, the 2 step-up priming doses regimen have been reduced to 4 mg on C1D1 and 
20 mg on C1D4 to assess whether lowering initial doses will further mitigate the risk of 
Grade 2 or higher CRS during the first week of treatment with elranatamab. 
In addition, before starting the Dose Determination Part for full doses higher than 76 mg 
(formerly Part 1A), data on this new step-up priming dose regimen will be first collected 
along with the 76 mg full dose regimen. Now, the former Part 2 of the study has become 
Part 1 of the study. 
Some eligibility criteria have been revised including the exclusion of participants previously 
treated with BCMA targeted therapy which is now restricted to participants previously 
treated with anti-BCMA bispecific antibody. 
Time points for disease response assessment have been clarified and staging systems for 
multiple myeloma have been explicitly defined. 
Discrepancies identified in the initial Final Approved Protocol have been corrected. 

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Eh-anatamab 
Protocol Cl071009 
Final Protocol Amendment 4, 20 Dec 2023 
 
Section# and Name 
Description of Change 
Brief Rationale 
Synopsis, Section 1.3 
(Schedule of Activities), 
Added text describing 
peripheral neuropathy 
Per regulato1y requirements (US 
FDA) because of the new 
Section 2.2.3.2.1 (Summaiy 
of Clinical Safety: Study 
in paiiicipants in the 
C1071001 Phase 1 
important risk of peripheral 
neuropathy. 
C1071001), Section 2.3.1 
study and measures to 
(Risk Assessment), Section 
5.2 (Exclusion criteria), 
mitigate this risk 
including additional 
Section 6.5.1 (Redosing 
criteria), Section 6.5.2 
neurological 
examinations, 
(Dose Modifications for 
Ekanatamab-Related 
exclusion of 
paiiicipants who may 
Toxicity and for Peripheral 
be at higher risk for 
Neuropathy), Section 6.8.2 
(Pe1mitted Concomitant 
peripheral neuropathy, 
new redosing criteria, 
Medicationsffherapies), 
new dose modification 
Section 8.2.2 (Physical 
exaininations), Section 8.2.9 
guidance and new 
stopping mles for 
(Peripheral neuropathy), 
Section 9.4.1 (Interim 
peripheral neuropathy. 
Safety Assessments) and 
Section 11 (References) 
Synopsis, Section 1.3 
(Schedule of Activities), 
Section 3 (Objectives, 
End oints and Estimands), 
Section 1.3 (Schedule of 
 The safety reporting 
Activities), Section 8.2.6 
 period after last dose 
(Clinical Safety Laborato1y 
of study intervention 
Assessments), Section 8.3.1 
 has been increased 
(Time Period and Frequency  from 28 days to 90 
for Collecting AE and SAE 
 days. 
info1mation) 
In order to capture all potential 
AEs, including late onset immune- 
related neurologic AEs. 
Section 1.3 (Schedule of 
Activities), Section 5.3.1 
(Contraception), Section 
8.3.5.1 Ex osure Durin 
Contraception use has 
been extended from 
28 days to 90 days 
after the last dose of 
Required by some HAs for 
another study and aligned across 
the ekanatamab clinical program. 

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Elranatamab 
Protocol C1071009 
Final Protocol Amendment 4, 20 Dec 2023 
 
Section # and Name 
Description of Change 
Brief Rationale 
pregnancy), Section 10.4. 
(Contraceptive and Barrier 
Guidance) 
study intervention. 
Pregnancy data 
collected until 
pregnancy completion 
or termination. 
Synopsis, Section 1.2 
Schema, Section 2.3.1 (Risk 
Assessment), Section 2.3.2 
(Benefit Assessment), 
Section 4.1 (Overall 
Design), Section 4.3.1 
(Justification for the 2 Step- 
up Priming Doses 
Regimen), Section 6.1 
(Study Intervention(s) 
Administered), Section 
6.5.3 (Dose Reductions), 
Section 6.5.2 (Dose 
Modifications for 
Elranatamab-Related 
Toxicity and for Peripheral 
Neuropathy) and Section 
6.8.1 (Premedications 
Required for Cytokine 
Release Syndrome) 
Step-up priming doses 
reduced from 12 mg to 
4 mg on C1D1 and 
from 32 mg to 20 mg 
on C1D4. 
To assess whether lowering initial 
doses will further mitigate the risk 
of Grade 2 or higher CRS during 
the first week of treatment with 
elranatamab. 
Synopsis, Section 1.2 
(Schema), Section 1.3 
(Schedule of Activities), 
Section 2.1 (Study 
Rationale), Section 2.3.1 
(Risk Assessment), Section 
2.3.2 (Benefit Assessment), 
Section 3 (Objectives, 
Endpoints and Estimands), 
Section 4 (Study design), 
Section 6.1 (Study 
Intervention Administered), 
Section 6.3.1 (Allocation to 
Study Intervention), Section 
6.5.3 (Dose Reductions), 
Section 6.8.6 
(Hematopoietic Growth 
Factor), Section 8.2.3 (Vital 
Part 2 of the initial 
approved protocol 
becoming Part 1 and 
futility analysis to be 
conducted after 
enrollment in Part 1 is 
completed. 
To assess the revised step-up 
priming dose regimen along with 
the 76 mg Full dose regimen 
before starting the Dose 
Determination Part with full doses 
higher than 76 mg. 

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Section# and Name 
Description of Change 
Brief Rationale 
Signs), Section 9.1.1.2 
(Seconda1y Estimand), 
Section 9.3.3.1 (Seconda1y 
Safety Endpoints), Section 
9.4.2 (Interim Analysis for 
Futility), Section 9.5 
(Sample Size 
Detennination) 
Section 1.3 Schedule of 
Activities and Section 8.2.4 
Electrocardiograms 
Added that ECG can 
be pei0f 1med as 
clinically indicated. 
As per US FDA request to ensure 
participant's safety. 
Synopsis 
Added inclusion 
criterion on sennn 
calcium and extended 
the timeframe for 
transfusion and use of 
G-CSF from 7 to 
28 days. 
To align across the eh-anatamab 
clinical program. Hypercalcemia 
is an important complication of 
Multiple Myeloma, which should 
be coITected prior to study 
participation. Exclusion of 
transfusions and growth factors 
within 28 days is necessa1y to 
ensure nonnal organ function. 
Synopsis 
Revision of exclusion 
criterion on BCMA 
targeted therapy. 
To improve paiiicipant 
recrnitment with a less restrictive 
criterion. 
Synopsis 
Added that active 
infection must be 
resolved at least 
14 days prior to 
emolhnent 
To clai·ify exclusion criterion 
related to infections and to align 
across the eh-anatamab clinical 
program. 
Section 1.3 (Schedule of 
Activities) 
Revision of time 
points for imaging, 
added hepatitis B and 
C testing at screening, 
hematology only to be 
done at C1D4. 
To align across the eh-anatamab 
clinical program. 
 

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Section# and Name 
Description of Change 
Brief Rationale 
Section 2.2.3.2 (First-in- 
Human Study of 
Eh-anatamab (C1071001)) 
Revision of 
background 
info1mation based on a 
new cut-off date of 15 
April 2021. 
To align with the revised 
fuvestigator Brochure. 
 
Section 4.3.3 (Definition of 
Use of G-CSF, allergic  To align across the eh-anatamab 
DLT) 
reaction and 
clinical program. 
anaphylactic reaction 
are no longer defined 
as DLT. Confomed 
DILi defined as DLT 
and other changes for 
Grade 3 non- 
hematologic AEs. 
Section 5.1 (fuclusion 
 Added inclusion 
 To align across the eh-anatamab 
criteria) 
criterion on sennn 
clinical program. Hypercalcemia 
calcium and extended 
is an important complication of 
the timeframe for 
 Multiple Myeloma, which should 
transfusion and use of 
 be co1Tected prior to study 
G-CSF from 7 to 28 
participation. Exclusion of 
days. 
 transfusions and growth factors 
within 28 days is necessa1y to 
ensure nonnal organ function. 
Section 5.2 (Exclusion 
Revision of exclusion 
To improve paiiicipant 
criteria) 
criterion on BCMA 
 recrnitment with a less restrictive 
targeted therapy. 
criterion. 
Section 5.2 (Exclusion 
Guidance added for 
To clai·ify the expectations in 
criteria) 
COVID-19/SARS- 
 te1ms of SARS-CoV2 testing. 
CoV2 infection. 
Section 5.2 (Exclusion 
Added that active 
To clai·ify exclusion criterion 
criteria) 
 infection must be 
 related to infections and to align 
resolved at least 14 
 across the eh-anatamab clinical 
days prior to 
program. 
emolhnent 
Section 6.1.1 
 Guidance added for 
 To align across the eh-anatamab 
(Administration) 
the minimum of days 
clinical program. 

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Elranatamab 
Protocol C1071009 
Final Protocol Amendment 4, 20 Dec 2023 
 
Section # and Name 
Description of Change 
Brief Rationale 
between elranatamab 
doses. 
Section 6.6 
Added guidance for 
treatment access at the 
end of the study 
participation. 
To align across the elranatamab 
clinical program. 
Section 6.8.1 Permitted 
Concomitant 
Medications/Therapies 
Clarified that oral 
contraceptives are 
metabolized by CYP 
enzymes and thus 
cytokines released 
during elranatamab 
treatment may cause 
drug-drug interaction 
with hormonal oral 
contraceptives and 
may accentuate the 
associated side effects 
As per US FDA request to protect 
participant’s safety. 
Section 7.1 (Discontinuation 
of Study Intervention) 
Clarifications on 
Follow-up Visit and 
Survival Long Term 
Follow-up 
To be consistent with the 
Schedule of Activities and to align 
across the elranatamab clinical 
program. 
Section 1.3 (Schedule of 
Activities) and Section 8.1 
(Efficacy Assessments) 
Time points for 
Disease response 
assessments were 
clarified (every 28 
days whether a dose is 
given or not). 
To align across the elranatamab 
program and to make a distinction 
between elranatamab dosing and 
disease response assessment. 
Section 8.1.1 (Laboratory 
Assessment for Evaluation 
of Disease Response) 
Only M-protein will be 
collected. 
To align across the elranatamab 
program. 
Section 8.1.3 (Imaging 
Assessments) 
Removal of ‘target’ 
lesions and addition of 
guidance for 
participants with only 
skin lesions. 
To align across the elranatamab 
program. 
Section 8.1.4 (Disease 
Characteristics and 
Treatment History) 
Added Table on 
Staging Systems for 
Multiple Myeloma. 
To more explicitly define staging 
system. 

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Eh-anatamab 
Protocol Cl071009 
 Final Protocol Amendment 4, 20 Dec 2023 
 
 
Section# and Name 
Description of Change 
Brief Rationale 
Section 1.3 (Schedule of 
Activities) and Section 8.2.4 
(Electrocardiograms) 
ECG to be perfonned 
prior to 
premedications 
administration if 
applicable. 
To clarify time points. 
Section 8.3.8 (Adverse 
Events of Special Interest) 
Added clarifications 
on premedications and 
AESI management. 
To align across the elranatamab 
clinical program. 
 
Section 10.2 (Appendix 2 
 Added beta-2 
 To align across the elranatamab 
Clinical Laborato1y 
microglobulin for 
clinical program. 
Assessments) 
 multiple myeloma 
staging, mic acid and 
hepatitis B and C 
testing. 
Section 10.4 (Appendix 4 
Removed 'Injectable' 
To comply with contraception 
Contraceptive and BaiTier 
 for combined estrogen 
guidance. 
Guidance) 
 and progestogen 
contraception. 
Section 10.9 (Appendix 9) 
 Added that injection 
 As per US FDA request to 
Subcutaneous Injection Site 
site location will be 
 evaluate the impact of injection 
Locations 
 recorded in eCRF. 
sites on elranatamab PK. 
Section 10.10 (Appendix 10 
 Complete Response 
 To comply with the IMWG 
IMWG Response Criteria 
 criteria revised when 
 Response criteria for multiple 
for Multiple Myeloma 
the only measmable 
myeloma. 
disease is by semm 
FLC levels. 
Section 10.11 (Appendix 11 
 Added hospitalization 
 Upon request of some HAs for 
CRS and!CANS Grading, 
and premedications 
another clinical study with 
Mitigation and 
 requirements for CRS 
 elranatamab; to align across the 
Management) 
 mitigation and 
 clinical program. 
management. 

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Protocol C1071009 
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Section # and Name 
Description of Change 
Brief Rationale 
Section 10.12 (Appendix 12 
Country specific 
requirements) 
Added guidance for 
Japan. 
To monitor potential HBV 
infection during study treatment 
and to specify that there is no 
expectation to disclose genetic 
testing results to the study 
participants, at any time. 
Section 11 (References) 
Added references 
related to the 
peripheral neuropathy 
risk 
To align with protocol section 
text. 
Global 
Inconsistencies in final 
approved protocol 
corrected, minor 
administrative 
changes. 
To align protocol section text. 

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Protocol C1071009 
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10.17. Appendix 17: Abbreviations 
The following is a list of abbreviations that may be used in the protocol. 
 
Abbreviation 
Term 
AABB 
American Association of Blood Banks 
ADA 
antidrug antibodies 
AE 
adverse event 
AESI 
adverse events of special interest 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
APC 
antigen presenting cell 
ASCO 
American Society of Clinical Oncology 
ASCT 
autologous stem cell transplant 
AST 
aspartate aminotransferase 
ASH 
American Society of Hematology 
ASTCT 
American Society for Transplantation and Cellular Therapy 
AUC 
area under the concentration-time curve 
AV 
atrioventricular 
AxMP 
Auxiliary medicinal product 
β-hCG 
beta-human chorionic gonadotropin 
BCMA 
B-cell maturation antigen 
BICR 
Blinded Independent Central Review 
BID 
twice daily 
BITE 
bi-specific T-cell engager 
BLRM 
Bayesian logistic regression model 
BM 
bone marrow 
CCI 
BMI 
body mass index 
CCI 
BOR 
best overall response 
BP 
blood pressure 
bpm 
beats per minute 
BsAb 
bispecific antibody 
BUN 
blood urea nitrogen 
C 
cycle 
C#D# 
cycle and day (eg, C1D1 = Cycle 1 Day 1) 
CAR-T 
chimeric antigen receptor T-cell therapy 
CRR 
complete response rate 
CD# 
cluster of differentiation and number (eg, CD3) 
CCI 
 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 

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Abbreviation 
Term 
CK 
creatine kinase 
CKD 
chronic kidney disease 
CKD-EPI 
Chronic Kidney Disease Epidemiology Collaboration 
CL 
clearance 
Cmax 
maximum observed concentration 
Cmax-24h 
maximum observed concentration within 24 hours postdose 
CMC 
Chemistry, Manufacturing, and Controls 
CMV 
cytomegalovirus 
CNS 
central nervous system 
CO2 
carbon dioxide 
CONSORT 
Consolidated Standards of Reporting Trials 
COVID-19 
coronavirus disease 2019 
CR 
complete response 
CRF 
case report form 
CRO 
contract research organization 
CRP 
c-reactive protein 
CRR 
complete response rate 
CRS 
cytokine release syndrome 
CSF 
cerebrospinal fluid 
CSR 
clinical study report 
CT 
clinical trial; computed tomography 
CTC 
circulating tumor cells 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTIS 
Clinical Trial Information System 
CTMS 
clinical trial management system 
Ctrough 
trough concentration 
CXDX 
Cycle X Day X 
CYP 
cytochrome P450 
D 
day 
DCR 
disease control rate 
DCT 
data collection tool 
DDI 
drug-drug interaction 
DILI 
drug-induced liver injury 
DL 
dose level 
DLRM 
dose level review meeting 
DLT 
dose-limiting toxicity 
DMC 
data monitoring committee 
DNA 
deoxyribonucleic acid 
DOCR 
duration of complete response 
CCI 
DOR 
duration of response 
DU 
dispensable unit 

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Abbreviation 
Term 
for Blood and MaiTow Trans lantation 
ethics committee; exclusion criteria 
ele 
Emopean Myeloma Network 
end of treatment 
DVT 
EBMT 
EBV 
EC 
ECC 
ECG 
ECHO 
ECOG 
eCRF 
EDB 
EDP 
EEG 
eGFR 
EMA 
EMD 
EMG 
EMN 
EOT 
eSAE 
electrnnic data collection tool for serious adverse event 
EU 
Emo ean Union 
EudraCT 
Emopean Union Dmg Regulating Authorities Clinical Trials 
 
mo ean Clinical Trials Database 
FA 
 
FAS 
 
FDA 
 
nited States 
FDG 
 
FFPE 
 
FISH 
fluorescence in situ h bridization 
FLC 
free li ht chain 
FSH 
 
FU 
 follow-u 
GBS 
 
G-CSF 
 
stimulatin  factor 
GCP 
 
 DNA 
 
GGT 
 

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Abbreviation 
Term 
GI 
gastrointestinal 
GLP 
good laboratory practice 
GVHD 
graft versus host disease 
HA 
Health Authority 
HBcAb 
hepatitis B core antibody 
HBsAb 
hepatitis B surface antibody 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
Hgb 
hemoglobin 
HIV 
human immunodeficiency virus 
HR 
hazard ratio; heart rate 
HRQoL 
health-related quality of life 
HRT 
hormone replacement therapy 
HSV 
herpes simplex virus 
IA 
interim analysis 
IB 
Investigator’s Brochure 
ICANS 
immune effector cell-associated neurotoxicity syndrome 
ICD 
informed consent document 
ICE 
immune effector cell-associated encephalopathy 
ICH 
International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use 
ICP 
intracranial pressure 
ICU 
intensive care unit 
ID 
identification 
IFN 
interferon-gamma 
Ig 
immunoglobulin 
IgG2 
immunoglobulin G2 
IHC 
immunohistochemistry 
IL 
interleukin 
IMiD 
immunomodulatory imide drug 
IMP 
investigational medicinal product 
IMWG 
International Myeloma Working Group 
IND 
investigational new drug 
INR 
international normalized ratio 
IP manual 
investigational product manual 
IPAL 
Investigational Product Accountability Log 
IQR 
interquartile range 
IR 
Immune-related 
irAE 
immune-related adverse events 
IRB 
Institutional Review Board 
IRC 
internal review committee 

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Abbreviation 
Term 
IRR 
infusion related reaction 
IRT 
Interactive Response Technology 
ISO 
International Organization for Standardization 
ISR 
injection site reaction 
ISS 
International Staging System 
IV 
intravenous 
IVIG 
intravenous immunoglobulins 
IWR 
interactive Web-based response 
J-PI 
Japan prescribing information 
LBBB 
left bundle branch block 
LD 
low dose 
LDH 
lactate dehydrogenase 
LFT 
liver function test 
LLN 
lower limit of normal 
LTFU 
long term follow-up 
LVEF 
left ventricular ejection fraction 
mAB 
monoclonal antibody 
mDOR 
Median duration of response 
MABEL 
minimal anticipated biological effect level 
MAD 
maximum administered dose 
MAP 
meta-analytic-predictive 
MD 
multiple dose 
MDR 
medical device regulation 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
milligram 
MHC 
major histocompatibility complex 
MM 
multiple myeloma 
mmHg 
millimeters of mercury 
mos 
months 
MR 
minimal response 
MRD 
minimal residual disease 
MRI 
magnetic resonance imaging 
MUGA 
multiple gated acquisition 
MY20 
myeloma quality of life questionnaire 
N or n 
number 
N/A 
not applicable 
NAb 
neutralizing antibodies 
NCI 
National Cancer Institute 
NCV 
Nerve conducting velocity 
NDMM 
Newly Diagnosed Multiple Myeloma 
NE 
not evaluable 
NGF 
Next generation flow 

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Abbreviation 
Term 
NGS 
next generation sequencing 
NIMP 
non-investigational medicinal product 
NKF 
National Kidney Foundation 
NOAEL 
no-observed-adverse-effect level 
NSAID 
nonsteroidal anti-inflammatory drug 
OD 
overdose 
ORR 
objective response rate 
OS 
overall survival 
PACL 
protocol administrative change letter 
PCR 
polymerase chain reaction 
PD 
pharmacodynamics(s); progressive disease 
PET 
positron emission tomography 
PFS 
progression-free survival 
PGIC 
Patient Global Impression of Change 
PGIS 
Patient Global Impression of Severity 
PI 
principal investigator; proteasome inhibitor 
PJP 
Pneumocystis Jiroveci Pneumonia 
PK 
pharmacokinetic(s) 
PN 
Peripheral neuropathy 
POEMS 
polyneuropathy, organomegaly, endocrinopathy, myeloma protein, 
and skin changes 
PO 
Per Os 
PPP 
pregnancy prevention program 
PR 
partial response 
PR (interval) 
Period, measured in milliseconds, that extends from the beginning 
of the P wave (the onset of atrial depolarization) until the beginning 
of the QRS complex (the onset of ventricular depolarization) 
CCI 
Pr(OD) 
probability of overdosing 
Pr(TT) 
probability of target toxicity 
PS 
performance status 
PT 
prothrombin time; preferred term 
PTT 
partial thromboplastin time 
PVC 
premature ventricular contraction/complex 
QD 
every day 
QLQ-### 
Quality of Life Questionnaire – Version or variant 
QT 
time from the beginning of the QRS complex to the end of the T 
wave 
QTc 
corrected QT 
QTcF 
corrected QT (Fridericia method) 
QTL 
quality tolerance limit 
Qual 
qualitative 

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Abbreviation 
Term 
Q#W 
every # week (eg Q2W = every 2 weeks) 
Rac 
accumulation ratio 
RECIST 
Response Evaluation Criteria in Solid Tumors 
REMS 
risk evaluation and mitigation strategy 
RFS 
relapse-free survival 
R-ISS 
Revised International Staging System 
RNA 
ribonucleic acid 
ROW 
rest of world 
RP2D 
recommended Phase 2 dose 
RR 
response rate; relapsed/refractory 
RRMM 
Relapsed or refractory multiple myeloma 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SAS 
safety analysis set 
CCI 
SC 
subcutaneous 
SCIG 
subcutaneous immunoglobulin 
SCr 
Serum Creatinine 
sCR 
stringent complete response 
SD 
stable disease 
SF 
superfamily 
SIFE 
serum protein immunofixation electrophoresis 
SJS 
Stevens-Johnson syndrome 
SmPC 
Summary of Product Characteristics 
SMQ 
Standardized MedDRA Queries 
CCI 
SoA 
schedule of activities 
SOC 
standard of care 
SOP 
standard operating procedure 
SPD 
sum of the products of diameters 
SPEP 
serum protein electrophoresis 
SRSD 
single-reference safety document 
SUSAR 
suspected unexpected serious adverse reaction 
SWOG 
Southwest Oncology Group 
t1/2 
terminal elimination half-life 
TBD 
to be determined 
TBili 
total bilirubin 
TBR 
tumor background ratio 
TCR 
t-cell receptor 
TEAE 
treatment-emergent adverse event 
TEN 
toxic epidermal necrolysis 

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Abbreviation 
Term 
TNF 
tumor necrosis factor 
Tmax 
time to maximum concentration 
TME 
tumor microenvironment 
TMF 
trial master file 
TNFr SF17 
tumor necrosis factor receptor superfamily 17 
TOC 
table of contents 
TT 
target toxicity 
TTP 
time to progression 
TTR 
time to tumor response 
UIFE 
urine immunofixation electrophoresis 
ULN 
upper limit of normal 
UPEP 
urine protein electrophoresis 
US 
United States 
USPI 
United States Package Insert 
Vd/F 
apparent volume of distribution 
VGPR 
very good partial response 
VZV 
varicella zoster virus 
WBC 
white blood cell 
WOC 
withdrawal of consent 
WOCBP 
woman/women of childbearing potential 

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