A PHASE 1B/2, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF ELRANATAMAB (PF-06863135) IN CHINESE PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY (TRIPLE-CLASS REFRACTORY MM)
Phase: PHASE2
Conditions: Elranatamab, Myeloma, Multiple Myeloma, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, PF-06863135, BCMA, Bispecific, Bispecific Antibody, BCMA-CD3 Bispecific, MagnetisMM-8
Sponsor: Pfizer

PF-06863135 (Elranatamab)
Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021)
Page 1
MAGNETISMM-8
A PHASE 1B/2, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, 
PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 
ELRANATAMAB (PF-06863135) IN CHINESE PARTICIPANTS WITH MULTIPLE 
MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME 
INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 
ANTIBODY (TRIPLE-CLASS REFRACTORY MM)
Study Intervention Number:
PF-06863135
Study Intervention Name:
Elranatamab
US IND Number:
N/A
EudraCT Number:
N/A
ClinicalTrials.gov NCT:
N/A
Protocol Number:
C1071008
Phase:
1b/2
Brief Title:  A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, 
Pharmacodynamics, and Efficacy of Elranatamab (PF-06863135) in Chinese Participants 
With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One 
Anti-CD38 mAb (Triple-Class Refractory MM)
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.
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PF-06863135 (Elranatamab)
Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021)
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Document History
Document
Version Date
Amendment 4
17 Apr 2023
Amendment 3
31 Jan 2023
Amendment 2
16 Mar 2022
Amendment 1
25 June 2021
Original protocol
18 March 2021
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ ECs and any protocol administrative 
clarification letter(s).
Protocol Amendment Summary of Changes Table
Amendment 4 (17 Apr 2023)
Overall Rationale for the Amendment:
Description of 
Change
Brief Rationale
Section # and Name
Substantial Modification(s)
Contraception 
check updated 
from 90 days to 5 
months post last 
dose of study 
intervention for 
WOCBP and 
removed for male 
participants.
IB updates describes a 
longer elranatamab 
terminal half-life. This is 
reflected in longer 
contraception 
requirements for female 
participants. There are no 
longer any contraception 
requirements for male 
participants. 
Section 1.3, SoA;
Section 4.2.3 Choice of 
Contraception/Barrier Requirements;
Section 5.3.1 Contraception;
Section 10.4.1, Section 10.4.2, and 
Section 10.4.4, contraceptive and barrier 
guidance.
Non-Substantial Modification(s)
Updated key 
studies and 
referenced the IB
for details on 
other studies in 
the program
Reflects updates to studies 
included in the recent IB
Section 2.2 Background.
Updated first in 
human studies 
and update other 
clinical studies 
with recent 
clinical data. 
References to the 
Reflects changes in the IB
Section 2.3.1 Risk assessment.
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PF-06863135 (Elranatamab)
Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021)
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Description of 
Change
Brief Rationale
Section # and Name
IB when 
applicable
Added 
“Sensitivity 
analysis will be 
performed to 
evaluate the 
impact of COVID 
if deemed 
necessary.”
Clarify the possible 
sensitivity analysis due to 
the impact of COVID-19 
if necessary.
Section 9.3.1 General considerations.
Update to be 
consistent with 
latest template 
mandatory 
language.
Template update.
Sections 10.1.3, 10.1.4, 10.1.6, 10.1.7, 
10.1.9 appendices.
Editorial and formatting changes and clarifications were made throughout the document.
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PF-06863135 (Elranatamab)
Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021)
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TABLE OF CONTENTS
LIST OF TABLES...................................................................................................................10
1. PROTOCOL SUMMARY...................................................................................................11
1.1. Synopsis ..................................................................................................................11
1.2. Schema ....................................................................................................................17
1.3. Schedule of Activities .............................................................................................18
1.3.1. SCHEDULE OF ACTIVITIES A (Phase 1b and Phase 2) ........................18
1.3.2. SCHEDULE OF ACTIVITIES B (Intensive PK/PD/Biomarker for 
all Phase 1b Participants and 6 Participants from Phase 2)* ...........................30
2. INTRODUCTION ...............................................................................................................32
2.1. Study Rationale .......................................................................................................32
2.2. Background .............................................................................................................32
2.2.1. Multiple Myeloma ......................................................................................32
2.2.2. BCMA and CD3 .........................................................................................34
2.2.3. Elranatamab (PF-06863135).......................................................................34
2.2.3.1. Nonclinical Studies of Elranatamab..........................................34
2.2.3.2. Clinical Overview .....................................................................35
2.3. Benefit/Risk Assessment.........................................................................................36
2.3.1. Risk Assessment.........................................................................................37
2.3.2. Benefit Assessment.....................................................................................39
2.3.3. Overall Benefit/Risk Conclusion................................................................39
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS ...........................................................40
4. STUDY DESIGN.................................................................................................................42
4.1. Overall Design.........................................................................................................42
4.2. Scientific Rationale for Study Design.....................................................................42
4.2.1. Exclusion of Prior BCMA-directed therapy...............................................42
4.2.2. Biomarkers..................................................................................................43
4.2.3. Choice of Contraception/Barrier Requirements .........................................43
4.3. Justification for Dose ..............................................................................................43
4.3.1. Dose Limiting Toxicity (DLT) Definition..................................................45
4.4. End of Study Definition ..........................................................................................47
5. STUDY POPULATION......................................................................................................47
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PF-06863135 (Elranatamab)
Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
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5.1. Inclusion Criteria.....................................................................................................47
5.2. Exclusion Criteria....................................................................................................49
5.3. Lifestyle Considerations..........................................................................................50
5.3.1. Contraception..............................................................................................50
5.4. Screen Failures ........................................................................................................51
6. STUDY INTERVENTION..................................................................................................51
6.1. Study Intervention(s) Administered........................................................................52
6.1.1. Administration............................................................................................52
6.2. Preparation, Handling, Storage and Accountability................................................53
6.2.1. Preparation and Dispensing........................................................................54
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................54
6.3.1. Allocation to Study Intervention ................................................................54
6.4. Study Intervention Compliance...............................................................................55
6.5. Dose Modification...................................................................................................55
6.5.1. Retreatment criteria ....................................................................................55
6.5.2. Dose Modifications for Elranatamab-Related Toxicity and for 
Peripheral Neuropathy .....................................................................................56
6.5.3. Dose Modification Based on Durable Overall Response ...........................58
6.6. Continued Access to Study Intervention After the End of the Study......................58
6.7. Treatment of Overdose............................................................................................59
6.8. Concomitant Therapy..............................................................................................59
6.8.1. Premedication Required for Cytokine Release Syndrome Prophylaxis .....59
6.8.2. Permitted Concomitant Medications/Therapies .........................................60
6.8.3. Prophylaxis for Infections...........................................................................61
6.8.4. Prohibited During the Study.......................................................................61
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................62
7.1. Discontinuation of Study Intervention ....................................................................62
7.2. Participant Discontinuation/Withdrawal From the Study.......................................64
7.2.1. Withdrawal of Consent...............................................................................64
7.3. Lost to Follow-up....................................................................................................64
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................65
8.1. Efficacy Assessments..............................................................................................66
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Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
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8.1.1. Laboratory Assessment for Evaluation of Disease Response.....................66
8.1.2. Bone Marrow Sample Assessments for Evaluation of Disease Status.......67
8.1.3. Imaging Assessments (PET/CT, CT and/or MRI)......................................68
8.1.4. Patient-Reported Outcomes........................................................................69
8.1.5. Disease Characteristics and Treatment History..........................................70
8.2. Safety Assessments .................................................................................................70
8.2.1. Participant Demographics and Other Baseline Characteristics ..................70
8.2.2. Physical Examinations................................................................................70
8.2.3. Vital Signs ..................................................................................................71
8.2.4. Electrocardiograms.....................................................................................71
8.2.5. Echocardiograms/Multigated Acquisition Scans........................................72
8.2.6. Clinical Safety Laboratory Assessments ....................................................72
8.2.7. Pregnancy Testing ......................................................................................73
8.2.8. ECOG Performance Status .........................................................................73
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................74
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......74
8.3.1.1. Reporting SAEs to Pfizer Safety...............................................75
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................75
8.3.2. Method of Detecting AEs and SAEs ..........................................................76
8.3.3. Follow -up of AEs and SAEs......................................................................76
8.3.4. Regulatory Reporting Requirements for SAEs...........................................76
8.3.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................76
8.3.5.1. Exposure During Pregnancy......................................................77
8.3.5.2. Exposure During Breastfeeding ................................................78
8.3.5.3. Occupational Exposure .............................................................79
8.3.6. Cardiovascular and Death Events...............................................................79
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................79
8.3.8. Adverse Events of Special Interest.............................................................79
8.3.8.1. Lack of Efficacy........................................................................80
8.3.9. Medical Device Deficiencies......................................................................80
8.3.10. Medication Errors.....................................................................................80
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Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021)
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8.3.11. Peripheral neuropathy...............................................................................81
8.4. Pharmacokinetics ....................................................................................................82
8.5. Pharmacodynamics..................................................................................................82
8.5.1. Blood to Assess sBCMA Levels.................................................................83
8.6. Genetics...................................................................................................................83
8.6.1. Specified Genetics ......................................................................................83
8.6.2. Banked Biospecimens for Genetics............................................................83
8.7. Biomarkers ..............................................................................................................83
8.7.1. Bone Marrow Aspirate for Minimal Residual Disease (MRD)..................84
8.7.2. Bone Marrow Aspirate for Molecular Profiling.........................................84
8.7.3. Bone Marrow Biopsy to Assess BCMA and/or Immune Cell Protein 
Biomarkers.......................................................................................................84
8.7.4. Cytokine Assessments ................................................................................84
8.7.5. Serum to Assess Circulating Proteins and Metabolite Analysis.................85
8.7.6. Blood for T-cell Receptor (TCR) Sequencing............................................85
8.7.7. Blood or Saliva Sample for Germline Comparator ....................................85
8.8. Immunogenicity Assessments.................................................................................85
8.9. Health Economics ...................................................................................................86
9. STATISTICAL CONSIDERATIONS ................................................................................86
9.1. Statistical Hypotheses .............................................................................................86
9.1.1. Estimands....................................................................................................86
9.2. Analysis Sets ...........................................................................................................87
9.3. Statistical Analyses .................................................................................................88
9.3.1. General Considerations...............................................................................88
9.3.2. Primary Endpoint(s)....................................................................................89
9.3.3. Secondary Endpoint(s)................................................................................89
9.3.3.1. Secondary Efficacy Endpoints ..................................................89
9.3.3.2. Pharmacokinetic Analyses ........................................................91
9.3.3.3. Immunogenicity Analyses.........................................................91
9.3.3.4. Safety Analyses.........................................................................92
9.3.3.5. Electrocardiogram Analyses......................................................92
9.3.4. Exploratory Endpoint(s) .............................................................................92
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Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021)
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9.3.5. Other Analyse(s).........................................................................................93
9.4. Interim Analyses .....................................................................................................93
9.4.1. Interim Safety Assessments........................................................................93
9.5. Sample Size Determination.....................................................................................96
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................97
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............97
10.1.1. Regulatory and Ethical Considerations ....................................................97
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................97
10.1.2. Financial Disclosure .................................................................................98
10.1.3. Informed Consent Process ........................................................................98
10.1.4. Data Protection .........................................................................................99
10.1.5. Committees Structure ...............................................................................99
10.1.5.1. Data Monitoring Committee ...................................................99
10.1.6. Dissemination of Clinical Study Data ......................................................99
10.1.7. Data Quality Assurance ..........................................................................101
10.1.8. Source Documents..................................................................................102
10.1.9. Study and Site Start and Closure ............................................................102
10.1.10. Publication Policy.................................................................................103
10.1.11. Sponsor’s Qualified Medical Personnel ...............................................104
10.2. Appendix 2: Clinical Laboratory Tests ...............................................................105
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ....................................................................107
10.3.1. Definition of AE .....................................................................................107
10.3.2. Definition of SAE...................................................................................108
10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs During 
the Active Collection Period..........................................................................110
10.3.4. Reporting of SAEs..................................................................................113
10.4. Appendix 4: Contraceptive and Barrier Guidance ..............................................114
10.4.1. Male Participant Reproductive Inclusion Criteria..................................114
10.4.2. Female Participant Reproductive Inclusion Criteria...............................114
10.4.3. Woman of Childbearing and Non-Childbearing Potential .....................114
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Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
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10.4.4. Contraception Methods...........................................................................115
10.5. Appendix 5: Genetics..........................................................................................117
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments ......118
10.7. Appendix 7: ECG Findings of Potential Clinical Concern .................................120
10.8. Appendix 8: Alternative Measures During Public Emergencies ........................122
10.8.1. Eligibility................................................................................................122
10.8.2. Telehealth Visits.....................................................................................122
10.8.3. Alternative Facilities for Safety Assessments ........................................123
10.8.3.1. Laboratory Testing ................................................................123
10.8.3.2. Electrocardiograms................................................................123
10.8.4. Study Intervention ..................................................................................123
10.8.5. Adverse Events and Serious Adverse Events.........................................124
10.9. Appendix 9: Subcutaneous Injection Site Locations...........................................125
10.10. Appendix 10: IMWG Response Criteria for Multiple Myeloma ......................126
10.11. Appendix 11: CRS and ICANS Grading, Mitigation, and Management..........129
10.11.1. Cytokine Release Syndrome.................................................................129
10.11.2. Immune effector cell-associated neurotoxicity syndrome (ICANS) ....132
10.12. Appendix 12. Anti-infectious Prophylaxis and Monitoring 40, 41, 42, 43, 44 ..........137
10.13. Appendix 13: Abbreviations .............................................................................139
10.14. Protocol Amendment History............................................................................146
11. REFERENCES ................................................................................................................151
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Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
CT02-GSOP Oncology Clinical Protocol Template (01 March 2021)
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LIST OF TABLES
Table 1.
Efficacy Results from Trials in Similar Patient Population......................33
Table 2.
Hematological and Non-hematological Dose-limiting Toxicities............46
Table 3.
Dose Modifications for Elranatamab-Related Toxicity and for 
Peripheral Sensory or Motor Neuropathya................................................56
Table 4.
Dose Levels for Elranatamab....................................................................58
Table 5.
Staging Systems for Multiple Myeloma...................................................70
Table 6.
Eastern Cooperative Oncology Group (ECOG) Performance Status 
Scale..........................................................................................................74
Table 7.
Minimum Number of Participants With Identified Events That 
Would Prompt Temporary Enrollment Hold............................................94
Table 8.
Minimum Number of Participants With Identified Treatment-
Related Events That Would Prompt Temporary Enrollment Hold 
(GBS/GB-like AEs, Peripheral Neuropathy/IR Neurologic AEs)............95
Table 9.
Protocol Required Safety Laboratory Assessments................................105
Table 10.
ASTCT CRS Grading.............................................................................130
Table 11.
Immune Effector Cell-Associated Encephalopathy (ICE) Score ...........133
Table 12.
ASTCT ICANS Grading.........................................................................133
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Protocol C1071008
Final Protocol Amendment 4, 17 Apr 2023
PFIZER CONFIDENTIAL
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1. PROTOCOL SUMMARY 
1.1. Synopsis 
Brief Title: MAGNETISMM-8, A Phase 1b/2 Study to Evaluate the Safety, 
Pharmacokinetics, Pharmacodynamics, and Efficacy of Elranatamab (PF-06863135) in 
Chinese Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One 
IMiD and One Anti-CD38 mAb (Triple-Class Refractory MM)
Rationale
The purpose of the study is to evaluate the safety, PK, PD and the efficacy of elranatamab in 
Chinese participants with MM who are refractory to at least 1 PI, 1 IMiD and 1 anti-CD38 
mAb (triple-class refractory MM). 
The study will include 2 parts. Phase 1b part is dose confirmation/safety lead-in to establish 
the safety of elranatamab, 76 mg (C1D8) SC QW with a 2 step-up priming dose regimen of 
12 mg (C1D1) and 32 mg (C1D4) SC, in order to confirm the RP2D in Chinese participants. 
After the RP2D is confirmed to be tolerable, the Phase 2 part will be initiated to evaluate the 
efficacy in Chinese participants. Participants who started from the RP2D in the Phase 1b part 
will contribute to the efficacy evaluation together with other participants in Phase 2.
Objectives, Endpoints, and Estimands
Objectives
Endpoints
Primary: 
Primary:
Phase 1b:
To establish the safety profile of elranatamab in 
order to confirm the RP2D in Chinese 
participants
Phase 2:
To determine the efficacy of elranatamab in 
Chinese participants with RRMM
Phase 1b:
DLTs observed in Cycle 1 (4 weeks)
Phase 2:
ORR by BICR per IMWG
Secondary: 
Secondary: 
To further evaluate the efficacy of elranatamab 
in Chinese participants with RRMM
DOR by BICR and investigator per IMWG
CRR by BICR and investigator per IMWG
ORR by investigator per IMWG
DOCR by BICR and investigator per IMWG
PFS by BICR and investigator per IMWG
OS
TTR by BICR and investigator per IMWG
MRD negativity rate (central lab) per IMWG
To determine the safety and tolerability of 
elranatamab
AEs and laboratory abnormalities by type, 
frequency, severity (as graded by NCI CTCAE 
v5.0), timing, seriousness, and relationship to 
study therapy
Severity of CRS and ICANS assessed according to 
ASTCT criteria1
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Objectives
Endpoints
To evaluate the PK of elranatamab
PK parameters of elranatamab: Cmax, Tmax, and 
AUClast
Pre- and post-dose concentrations of elranatamab
To evaluate the immunogenicity of elranatamab 
ADAs and NAbs against elranatamab
To assess the impact of elranatamab on 
patient-reported symptoms and functioning
EORTC QLQ-C30 and MY20 
EORTC QLQ CIPN20
EQ-5D
Exploratory: 
Exploratory: 
To explore correlations between elranatamab 
exposure and efficacy, safety and PD/biomarker 
endpoints
Selected PK, efficacy, safety and PD/biomarker 
endpoints
To explore the relationship between 
elranatamab and the biology of the participant’s 
MM
Measurements of biomarkers (DNA, RNA, plasma 
sBCMA level, protein or defined cell types) 
resulting from analyses of peripheral blood, and/or 
BM biospecimens
Estimands
Primary Estimand in Phase 1b: The safety of elranatamab RP2D measured by DLT rate 
estimated based on data from DLT-evaluable participants during the DLT observation period 
(Cycle 1 which is 4 weeks) in Phase 1b. The estimand has 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 1 dose of study 
intervention in Phase 1b part 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 minimum requirement of the 
planned doses of study intervention for reason other than treatment-related toxicity 
are not evaluable for DLTs. The minimum required exposure for DLT evaluability is 
4 out of 5 planned doses of elranatamab during the DLT observation period.

Variable: Occurrence of DLTs. DLTs are defined in Section 4.3.1.

Population-level summary measure: DLT rate defined as the number of 
DLT-evaluable participants with DLTs in the DLT observation period divided by the 
number of DLT-evaluable participants.
Primary Estimand in Phase 2: The treatment effect of elranatamab on ORR as assessed by 
BICR per the IMWG criteria. The estimand has 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.
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
Variable: Objective response defined as confirmed sCR, CR, VGPR and PR 
according to the IMWG criteria based on BICR assessment, from the date of first 
dose until the first documentation of confirmed PD, death or start of new anticancer 
therapy, whichever occurs first.

Intercurrent event(s): All data collected after an intercurrent event of subsequent 
anticancer therapy will be excluded except if required to confirm PD. All response 
assessments regardless of gaps in disease assessments will be considered. Data will 
be collected regardless of discontinuation from treatment. Participants who do not 
have a post-baseline disease assessment due to early confirmed PD, who receive 
anticancer therapies other than the study intervention prior to achieving an objective 
response, or who die, experience confirmed PD or stop disease assessments for any 
reason prior to achieving an objective response will be counted as nonresponders in 
the assessment of objective response.

Population-level summary measure: ORR defined as the proportion of participants in 
the analysis population with an objective response and 2-sided 90% CI for ORR. 
Overall Design
Study C1071008 is a Phase 1b/2, open-label study to evaluate the safety, PK, PD and the 
efficacy of elranatamab (PF-06863135) in Chinese participants with MM who are refractory 
to at least 1 PI, 1 IMiD and 1 Anti-CD38 mAb (Triple-Class Refractory MM).
The Study will include 2 parts. Phase 1b part is dose confirmation/safety lead-in to establish 
the safety profile in order to confirm the RP2D in Chinese participants. After the RP2D is 
confirmed to be tolerable, the Phase 2 part will be initiated to evaluate the efficacy in 
Chinese participants. Participants who started from the RP2D in Phase 1b part will contribute 
to the efficacy evaluation together with other participants in Phase 2. The primary objective 
for Phase 2 is to determine efficacy of elranatamab with respect to ORR as assessed by BICR 
based on IMWG criteria.
Number of Participants
A target sample size of approximate 36 participants will be enrolled and treated with study 
intervention, including a target of 6 participants in Phase 1b and a target of 30 participants in 
Phase 2. 
Note: "Enrolled" means a participant's, agreement to participate in a clinical study following 
completion of the informed consent process. A participant will be considered enrolled if the 
informed consent is not withdrawn prior to participating in any study activity. Potential 
participants who are screened for the purpose of determining eligibility for the study, but do 
not participate in the study, are not considered enrolled, unless otherwise specified by the 
protocol.
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Study Population and Specific Inclusion/Exclusion Criteria
Chinese participants with MM who are refractory to at least 1 PI, 1 IMiD and 1 Anti-CD38 
mAb (Triple-Class Refractory MM).
Inclusion Criteria 
Participants must meet the following key inclusion criteria to be eligible for enrollment into 
the study:
1. Participants age ≥18 years.
2. Prior diagnosis of MM as defined according to IMWG criteria.2
3. 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)
4. Refractory to at least 1 IMiD.
5. Refractory to at least 1 PI.
6. Refractory to at least 1 anti-CD38 antibody.
7. Relapsed or refractory to last anti-MM regimen.
8. ECOG performance status ≤2. 
9. LVEF ≥40% as determined by a MUGA scan or ECHO.
10. Adequate hepatic function characterized by the following:
a.
Total bilirubin ≤2 × ULN (≤3 × ULN if documented Gilbert’s syndrome);
b. AST ≤2.5 × ULN; and
c.
ALT ≤2.5 × ULN
11. Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min 
(according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine 
clearance, or according to local institutional standard method).
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12. Adequate BM function characterized by the following:
a.
ANC ≥1.0 × 109/L (use of granulocyte-colony stimulating factors 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 
7 days prior to planned start of dosing).
Exclusion Criteria 
Participants with any of the following characteristics/conditions will be excluded:
13. Smoldering MM defined according to IMWG criteria.
14. Active plasma cell leukemia.
15. Amyloidosis. 
16. POEMS syndrome.
17. Stem cell transplant within 12 weeks prior to enrollment or active GVHD.
18. 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, runs of ventricular 
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 triplicate average QTcF >470 msec at screening). 
19. Any active, uncontrolled bacterial, fungal, or viral infection, eg, HBV, HCV, 
SARS-CoV2, HIV, etc. Active infections must be resolved at least 14 days prior to 
enrollment.
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20. Ongoing Grade ≥2 peripheral sensory or motor neuropathy. History of GBS or GBS 
variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
21. Previous treatment with an anti-BCMA directed therapy (eg, BCMA-directed ADC, 
BCMA-directed CAR T-cell therapy or bispecific antibody, either approved or 
investigational). 
Intervention Groups and Duration
Participants will receive SC administration of elranatamab QW. The initial dose of 
elranatamab for both Phase 1b and Phase 2 will be 12 mg (C1D1) and 32 mg (C1D4) and 
will serve as the 2 step-up priming regimen. The dose of elranatamab should be increased to 
76 mg on C1D8 as long as the participant meets the retreatment criteria listed in 
Section 6.5.1. If a participant does not meet these criteria on C1D8, initiation of dosing with 
76 mg should be deferred until the criteria are met.
Six triple-class refractory MM participants will be enrolled to assess the DLT rate of 
elranatamab in Chinese participants as a safety lead-in prior to the initiation of Phase 2. The 
DLT observation period will be Cycle 1 (4 weeks). If the DLT rate is less than 1/3 (ie, 0 or 
1 participant out of 6), Phase 2 part will be initiated at the confirmed monotherapy RP2D 
after the DLT observation period is concluded for all enrolled participants in the Phase 1b 
portion. If the DLT rate at the monotherapy RP2D meets or exceeds 1/3, the enrollment will 
stop for further evaluation of the available data by the sponsor and investigators, and 
following decision will be reflected in a protocol amendment.
If a participant has received QW elranatamab for at least 6 cycles and achieved an IMWG 
response category of PR or better with responses persisting for at least 2 months, the dose 
interval will be changed from QW to Q2W (eg, beginning C7D1) as lower dosing intensity 
might be adequate to maintain the response given the reduced disease burden in these 
participants. If the participant subsequently begins to have an increase of disease burden not 
yet qualifying as PD according to IMWG criteria, dose intervals should return to weekly 
dosing. If the dose interval is changed, cycles should remain the same length (ie, 4 week 
cycles).
Each participant will receive study intervention until confirmed disease progression, 
unacceptable toxicity, withdrawal of consent, or study termination. 
Data Monitoring Committee or Other Independent Oversight Committee: No
Statistical Methods
The study includes 2 parts: Phase 1b part and Phase 2 part.
The primary objective of the Phase 1b part is to confirm the RP2D safety in Chinese 
participants. There will be no formal hypothesis testing in this part. Approximately 
6 participants will be enrolled and treated in Phase 1b. All the analyses will be descriptive.
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The Phase 2 part will test the null hypothesis (H0) that the ORR by BICR as defined by 
IMWG is ≤30% versus the alternative hypothesis (Ha) that the ORR by BICR as defined by 
IMWG is >30% using a single-stage design based on the exact binomial distribution. The 
null hypothesis ORR is based on the results of the DREAMM-2 study3 and the STORM 
study,4 which were conducted in similar multiple myeloma populations with respect to prior 
treatments. A total of at least 36 participants will contribute to the hypothesis testing, which 
includes the participants enrolled and treated in Phase 2 and those participants who start from 
the confirmed RP2D in Phase 1b. The sample size will provide 80% power to reject the null 
hypothesis at a 1-sided significance level of 0.05 assuming the true ORR is ≥51%. 
Based on the design, at the analysis, an observed ORR ≥44.4% (ie, 16 responders out of the 
36 patients) will be needed to reject the null hypothesis, and the cohort has demonstrated that 
the true ORR exceeds 30%. At the time of the analysis, the testing rule will depend on the 
exact number of participants enrolled and treated. The Clopper-Pearson 90% CI will also be 
provided for the ORR. 
The analysis will be conducted once all participants have been followed for response for at 
least 6 months or have otherwise discontinued response assessments within the first 6 months 
of treatment. 
All other analyses will be descriptive. Continuous variables will be summarized using mean, 
standard deviation, minimum, median, and maximum. Categorical variables will be 
summarized using frequency counts and percentages. The time-to-event variable will be 
summarized using Kaplan-Meier methods and displayed graphically if applicable. The 
median, percentile and probabilities at particular time points will be estimated.
1.2. Schema
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1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures.  Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section of the protocol for detailed information on each procedure and assessment required for compliance with the 
protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the participant.
1.3.1. SCHEDULE OF ACTIVITIES A (Phase 1b and Phase 2)
Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
Informed 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
Demography/medical history
X
See Section 8.2.1
Disease characteristics/ treatment history
X
See Section 8.1.5
PROs
X
X
Cycle 1-3
X
X
During the treatment period, 
PROs are administered at 
Days 1 and 15 for Cycles 1-3 
only, then at Day 1 for every 
cycle from Cycle 4 to Cycle 
12, then every 3 cycles 
beginning with Cycle 15. See 
Section 8.1.4
Clinical Procedures/Assessments – Note: During the treatment period, all assessments must done within 72 hours prior to 
dosing
Physical exam
X
X
X
X
See Section 8.2.2
Neurologic exam
X
X
Cycle 1
Cycles 
1-3
Cycles 
1-6
Cycles 
1-3
X
X
See Section 8.2.2
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
ICE score
Cycle 1
See Section 8.2.2
Height/weight
X
See Section 8.2.2
Vital signs (temperature, HR, BP and O2
saturation)
X
X
Cycle 1
Cycle 1
Cycle 1
Cycle 1
X
X
Pre-dose vital signs collected 
on C1D1, C1D4, C1D8, 
C1D15 and C1D22 should be 
reported on the CRF. 
Monitored at least every 4 
hours (± 15 minutes) during 
the first 48 hours after first 
dose of study intervention 
(C1D1) and during first 24 
hours after second dose 
(C1D4). See Section 8.2.3
ECOG PS
X
See Section 8.2.8
Triplicate 
12-Lead ECG
X
Cycles 1, 
2, 4
Cycle 1
X
When PK sample collection 
coincides with ECG, perform 
every ECG prior to pre-dose 
PK sample collection and 
prior to elranatamab 
administration (and 
premedication). ECG 
assessments should be skipped 
if CRS symptoms are 
ongoing. Additional ECGs 
should be performed as 
clinically indicated. See 
Section 8.2.4
ECHO/MUGA
X
See Section 8.2.5
Elranatamab (PF-06863135) 
administration
X
Cycle 1
X
X
X
Two step-up priming doses of 
12 mg on C1D1 then 32 mg 
on C1D4, followed by 76 mg
starting on C1D8 QW.
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
Minimum of 2 days should be 
maintained between the C1D1 
and C1D4 doses, minimum of 
3 days between C1D4 dose 
and the first full dose (C1D8); 
a minimum of 6 days should 
be maintained between doses 
thereafter. 
If participant has received 
QW dosing for at least 6 
cycles and has achieved a PR 
or better persisting for ≥2 
months, the dose interval will 
be changed from QW to Q2W 
(eg, beginning C7D1). If the 
participant subsequently 
begins to have an increase of 
disease burden not yet 
qualifying as PD according to
IMWG criteria, dose intervals 
should return to weekly 
dosing. See Section 6.1
The windows for the different 
administration schedules are ± 
3 days for the QW schedule 
and -3 /+7 days for Q2W. See 
Section 6 (including 
Section 6.5 dose 
modifications)
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
Premedication for CRS
Cycle 1
Cycle 1
Cycle 1
Must be administered 60 
minutes (± 15 minutes) prior 
to elranatamab dose. See 
Section 6.8.1
Hospitalization
Cycle 1
Cycle 1
Hospitalization required for at 
least 2 days (~48 hours) for 
C1D1 and 1 day (~24 hours) 
for C1D4.  Hospitalization 
from C1D1 to C1D5 may be 
considered. See Section 6.1.
AE monitoring
Assess Continuously
See Section 8.3
Concomitant therapy
Assess Continuously
See Section 6.8
Subsequent anti-cancer therapies/date of 
progression
Assess continuously
See Section 7.1
Survival status
X
X
See Section 7.1 May be 
collected by telephone.
Disease response assessment (per IMWG 
criteria)
Cycles 2, 
3, 4, etc
X
To be conducted on a 28-day 
(±1 wk) interval whether dose 
given or not (ie, the 28-day 
[±1wk] interval between 
assessments should be 
maintained regardless of dose 
delays/interruptions).
For participants who 
discontinue study intervention 
without PD: perform at EOT 
visit, then at least Q4W 
(±1 wk) until PD, withdrawal 
of consent, initiation of 
subsequent anticancer therapy, 
participant lost to follow up, 
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
death or defined end of study. 
See Section 8.1 for complete 
details (including 
requirements for repeat testing 
for confirmation of PD).
SPEP, SIFE, serum FLC
X
X
X*
X*
X*
Screening and C1D1 (if not 
done within 72 hours prior to 
dosing). Then, to be 
conducted on a 28-day (±1 
wk) interval whether dose 
given or not (ie, the 28-day 
[±1wk] interval between 
assessments should be 
maintained regardless of dose 
delays/interruptions).
*For participants who 
discontinue study intervention 
without PD: perform at EOT 
visit, then at least Q4W 
(±1 wk) until PD, withdrawal 
of consent/assent, initiation of 
subsequent anti-cancer 
therapy, participant lost to 
follow up-, death or defined 
end of study. See 
Section 8.1.1 for complete 
details (including 
requirements for repeat testing 
for confirmation of PD).
UPEP, UIFE (24-hour urine collection 
required)
X
X
X*
X*
X*
Screening and C1D1 (if not 
done within 72 hours prior to 
dosing). Then, to be 
conducted on a 28-day (±1 
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
wk) interval whether dose 
given or not (ie, the 28-day 
[±1wk] interval between 
assessments should be 
maintained regardless of dose 
delays/interruptions).
*For participants who 
discontinue study intervention 
without PD: perform at EOT 
visit, then Q4W (±1 wk) until 
PD, withdrawal of consent, 
initiation of subsequent anti-
cancer therapy, participant lost 
to follow-up, death or defined 
end of study. For participants 
without measurable disease in 
the urine at baseline, 
UPEP/UIFE is required 
(minimum) at suspected 
VGPR or CR/sCR, or at 
suspected PD. See 
Section 8.1.1 for complete 
details (including 
requirements for repeat testing 
for confirmation of PD).
Imaging 
(PET/CT, CT or MRI)
X
Time points for disease assessments described in notes
At screening, at suspected CR/ 
sCR (if not performed within 
the prior 6 weeks), at 
suspected PD from EMD, and 
annually if not done within 
past 12 months. In addition, 
for participants with EMD at 
screening, every 12 wks (± 1 
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
wk) and also at suspected MR, 
PR or VGPR. Once all EMD 
has resolved/disappeared, 
imaging can be conducted 
every 24 weeks (or earlier if 
clinically indicated) and at 
suspected PD. For participants 
with only skin involvement, 
skin lesions should be 
measured with a ruler every 4 
wks (± 1 wk). Perform until 
PD, WOC, initiation of 
subsequent anticancer therapy, 
participant lost to FU, death, 
or defined EOS. See 
Section 8.1.3
BMA/BMB
X
Time points for disease assessments described in notes
At screening, suspected CR
and then after 6 months, 12 
months, and yearly (± 1 
month) after achieving CR 
(provided CR is maintained 
clinically) until WOC, 
initiation of subsequent 
anticancer therapy, participant 
lost to FU, death, or defined 
EOS. Optional (investigator 
discretion) at suspected PD. If 
all criteria for CR are met 
except percent plasma cells in 
BM, then additional BMA 
should be performed every 3 
months until CR is achieved, 
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
as long as other CR criteria 
are maintained. 
BMB can be used in place of 
BMA; however, the same 
method for quantifying 
plasma cells should be used 
throughout the study where 
feasible. BMA is required for 
central lab MRD analysis. 
BMB can be used in place of 
BMA to assess sCR. See 
Section 8.1.2
BMA for cytogenetics 
(FISH/karyotyping)
X
See Section 8.1.2
Contraception check
X
X
X
X
Only required for WOCBP
through 5 months post last 
dose of study intervention. 
See Section 5.3.1
Pregnancy test (β-hCG)
X
X
X
X
Only required in WOCBP. 
Also to be done whenever 1 
menstrual cycle is missed 
during the active treatment 
period and up to 90 days post 
last dose of study intervention 
(or when potential pregnancy 
is otherwise suspected). See 
Section 8.2.7 and Appendix 2
Table 9
Hematology/chemistry 
X
X
Cycle 1
Cycle 1
Cycle 1
X
X
See Section 8.2.6 and 
Appendix 2 Table 9. For 
Cycle 1 Day 4, hematology 
only.
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
Serum quantitative immunoglobulins 
(IgG, IgM, IgA, IgD, IgE)*
X
X
X
X
*IgD or IgE, if they are 
available at the site, only if the 
heavy chain component of the 
disease is known to be IgE or 
IgD. See Section 8.2.6 and
Appendix 2 Table 9. 
PT/INR
X
See Section 8.2.6 and 
Appendix 2 Table 9.
Blood β-2 microglobulin
X
X
X
Additional samples may be 
taken per local practice.
Virus test (HBV/HCV/HIV/SARS-
CoV2)
X
Active HBV, HCV, SARS-
CoV2, HIV infection should 
be excluded from study.
CMV testing (quantitative
PCR)
X*
*Every 1 to 3 months 
depending on risk factors. 
Section 8.2.6, Appendix 2
Table 9 and Appendix 12.
Cytokine Assessment
X (See Notes)
If CRS is suspected and/or site 
require cytokine information 
for participant management, 
an ad-hoc cytokine sample 
will be collected and all 
samples will be analyzed per 
local site practice. See 
Section 8.7.4 and Appendix 2
Table 9
Genetics and Biomarker Assessments (Central Laboratory)
BMA for MRD 
X
Samples to be collected each time there is a BMA assessment
See Section 8.7.1
BMA for molecular profiling
X
Samples to be collected each time there is a BMA assessment
See Section 8.7.2
BMB for BCMA levels and/or immune 
cell biomarkers
X
Samples to be collected each time there is a BMB assessment
Collection of this sample is 
optional; however, if a 
participant has a BMB 
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
collected for disease 
assessment, collection of this 
sample for biomarker analysis 
is encouraged. 
See Section 8.7.3
Blood sample for sBCMA levels
X
Cycles 1,2, 
3, 7, 10, 
13, etc.
Cycle 1
Cycle 1
Cycles 1
X
Pre-dose, 6 and 24 h post-dose 
on C1D1.
Pre-dose and 24 h post-dose 
on C1D4.
Pre-dose, 6 h post-dose on 
C1D8.
Collect pre-dose only at 
C1D15, C2D1, C3D1, then 
Day 1 of every third cycle 
starting Cycle 7 (ie, C7D1, 
C10D1, C13D1, etc).
Additional sample to be 
collected at EOT and time of 
PD. See Section 8.5.1
Blood sample for circulating proteins and 
metabolite analysis
Cycle 1
Cycle 1
Cycle 1
Cycle 1
Cycle 1
Collect pre-dose and 24 h 
post-dose on C1D1;
Collect pre-dose and 24 h 
post-dose on C1D4.
Collect pre-dose at all other 
time.
If CRS is suspected, 
additional blood samples 
should also be collected for 
cytokine analysis if not 
already scheduled. See 
Section 8.7.5
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
Blood sample for TCR sequencing
X
Cycles
1, 2, 3 
Cycle 1
Collect pre-dose. See
Section 8.7.6
Blood or saliva sample for germline 
comparator
Cycle 1
Collect pre-dose. See 
Section 8.7.7
Pharmacokinetics and Immunogenicity Assessments
Blood sample for PK
Cycles 1-
4, 7, 10, 
etc. 
Cycle 1
Cycle 1 
Cycle 1 
Cycle 1 
X
Pre-dose, 6, and 24 h post-
dose on C1D1;
Pre-dose and 24 h post-dose 
on C1D4.
Pre-dose, 6 h post-dose on 
C1D8; pre-dose only on 
C1D15, C1D22, C2D1, C3D1, 
then every 3rd cycle starting 
Cycle 4 (ie, C4D1, C7D1, 
C10D1, etc). 
If the C1D4 dose (32 mg) 
cannot be administered within 
the protocol-defined window, 
the planned C1D4 pre-dose 
PK/PD sample should be 
collected at any time within 
the C1D4 visit window, If 
CRS is suspected, additional 
PK samples should be 
collected if not already 
scheduled. See Section 8.4
Blood sample for ADAs and NAbs
Cycles 1-
4, 7, 10, 
etc 
X
Pre-dose on C1D1, C2D1, and 
C3D1 and every 3rd cycle 
starting C4 (ie, C4D1, C7D1, 
C10D1, etc). If AE possibly 
related to ADA occurs, 
additional samples for ADA 
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Visit Identifier
Screening
Treatment Period
(Each 28 Day Cycle)
EOT 
Visit
FU 
Visit
LTFU
Notes/Protocol Section
Day 4 visit is Cycle 1 only
Day 1
Day 4
Day 8
Day 15
Day 22
Visit Window
Day -28
to Day -1
Cycles 2 
and later 
± 3D
-1/+3D
Cycle 1
-1/+3D
Cycles 2 
and later 
± 3D
± 3D
± 3D
≤14D 
post-
final 
dose
28 to 
35 
days
post-
final 
dose
Q12W
± 14D
and PK should be collected if 
not scheduled. See Section 8.8
Note: 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 28 days prior to study intervention administration.
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1.3.2. SCHEDULE OF ACTIVITIES B (Intensive PK/PD/Biomarker for all Phase 1b Participants and 6 Participants from 
Phase 2)*
PK, PD, and Biomarker Flowchart 
Visit 
Identifier
Up to 
7 days 
prior 
to 
C1D1
Treatment Period
(Each 28 Day Cycle)
EOT
Cycle 1
Cycle 2
Cycle 3 
Cycle 4
(Every 3rd cycle)
Study Day
D1
D2
D3
D44
D54
D8
D15
D22
D1
D1
D1
Hours Pre/ 
after dosing
0
6
24
48
0
24
0
6
0
0
0
0
0
Collection of 
time window
-1 to 0 
hr
0.5 hr
3 hrs
3 hrs
-1 to 0 
hr
3 hrs
-1 to 0 
hr
0.5 
hr
-1 to 0 
hr
-1 to 0 
hr
-1 to 0 hr -1 to 0 hr
-1 to 0 hr
Visit 
window
0





-1/+3D
-1/+3
D

± 3D
± 3D
± 3D
3 D
D
PK blood 
sampling for 
elranatamab1
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Cytokine 
evaluation in 
serum2
X
X
X
X
X
X
X
X
X
X
X
X
X
9 months 
(14 days) after 
C1D1
Soluble 
BCMA3
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
*For schedules not listed in this flowchart, please follow SoA A.
1.
Blood sample for elranatamab blood level: Approximately 5 mL sample of whole blood (to provide approximately 2 mL of serum) will be collected at each time point for 
PK analysis of elranatamab. From Cycle 4, pre-dose PK samples will be collected only on every 3rd cycle (Cycle 4, Cycle 7, Cycle 10, etc). An additional PK sample should 
also be taken if CRS is suspected, and a PK sample is not already scheduled to be taken (eg, Cycle 4 onwards). All 0 hour samples will be collected prior to study intervention 
administration on days whereby study intervention is to be administered.
2.
Cytokine evaluation in serum: See Cytokine Assessments Section 8.7.4 and Appendix 2 Table 9 for Routine and Ad hoc Central Lab Cytokine Analysis. All samples will 
be analyzed centrally. All 0 hour samples will be collected prior to study intervention administration on days whereby study intervention is to be administered. 
3.
Soluble BCMA: A whole blood sample to provide plasma will be collected at each time point for analysis of soluble BCMA. All 0 hour samples will be collected prior to 
study intervention administration on days whereby study intervention is to be administered. From Cycle 4, pre-dose soluble BCMA samples will be collected only on every 
3rd cycle (Cycle 4, Cycle 7, Cycle 10, etc). An additional soluble BCMA/other factor sample should also be taken if CRS is suspected, and a sample is not already scheduled 
to be taken (eg, Cycle 4 onwards).
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Visit 
Identifier
Up to 
7 days 
prior 
to 
C1D1
Treatment Period
(Each 28 Day Cycle)
EOT
4.
D4 and D5: If the C1D4 dose (32 mg) cannot be administered within the protocol-defined window, the planned C1D4 pre-dose PK/PD sample should be collected at any 
time within the C1D4 visit window, the planned C1D5 24h post dose PK/PD sample shall not be collected but defer to the actual C1D4 dose for collection  
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2. INTRODUCTION
Elranatamab (PF-06863135), a novel BsAb that targets both BCMA on MM cells and CD3 
on T-cells, is currently being developed for the treatment of RRMM.
2.1. Study Rationale 
The purpose of the study is to evaluate the safety, PK, PD and the efficacy of elranatamab in 
Chinese participants with MM who are refractory to at least 1 PI, 1 IMiD and 1 anti-CD38 
mAb (triple-class refractory MM). 
The study will include 2 parts. Phase 1b part is dose confirmation/safety lead-in to establish 
the safety of elranatamab, 76 mg (C1D8) SC QW with a 2 step-up priming dose regimen of 
12 mg (C1D1) and 32 mg (C1D4) SC, in order to confirm the RP2D in Chinese participants. 
After the RP2D is confirmed to be tolerable, the Phase 2 part will be initiated to evaluate the 
efficacy in Chinese participants. Participants who started from the RP2D in Phase 1b part 
will contribute to the efficacy evaluation together with other participants in Phase 2.
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 160,000 new cases and 106,000 deaths per 
year attributed to MM.5 The American Cancer Society estimates that for the US in 2020, 
approximately 32,270 new MM cases will be diagnosed and approximately 12,830 
MM-related deaths will occur.6 The incidence of MM in China increased significantly from 
2006 to 2016. It was estimated that there were 16,500 new cases and 10,300 deaths of MM in
China in 2016. The age-standardized incidence rates and mortality rates per 100,000 
population were 1.03 (95% UI, 0.88-1.17) and 0.67 (95% UI, 0.59-0.77) in 2016.7
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.8 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.9
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 therapy10 and 
other trials have included populations receiving a median of 6 (range 3-18) prior therapies11
and a median of 5 (range 3 to 18) prior therapies.12
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 only 1.5 years.13
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%.14 Results from 
2 trials in patient populations similar to the current protocol are summarized in Table 1. The 
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lack of effective and durable therapeutic options highlights the unmet medical need in the 
RRMM patient population.
Table 1.
Efficacy Results from Trials in Similar Patient Population
Therapy
Prior 
therapy 
(eligibility)
Median number 
of prior therapies
ORR
DOR (months)
Reference
Belantamab 
mafodotin
IMiD, PI, 
anti-CD38
7
31%a
97.5% CI (20.8, 42.6)
6.3a
IQR (3.7, 7.7)
(Lonial et al, 
2020)3
34%b
97.5% CI (23.9, 46.0)
6.9b
IQR (4.8, 7.9)
Selinexor + 
Dexamethasone
IMiD, PI, 
anti-CD38
7
26%
95% CI (19, 35)
4.4
95% CI (3.7, 10.8)
(Chari et al, 
2019)4
a. Data from 2.5 mg/kg Q3W (the approved dosing regimen for belantamab mafodotin) cohort
b. Data from 3.4 mg/kg Q3W cohort
NOTE: For both studies, ORR and DOR were assessed by an independent review committee.
In China, there is no significant difference in disease biology, disease management and 
clinical practice between China and US/EU. China clinical practice is consistent with global 
treatment guidance. In China, NMPA-approved treatments for MM include bortezomib, 
ixazomib, thalidomide, lenalidomide, melphalan, daratumumab and classic chemotherapy. In 
addition, China generic pomalidomide was just approved in China in 2020. However, 
classic/conventional regimens across different treatment lines are used for most patients due 
to currently limited treatment options for RRMM participants. The outcomes of conventional 
treatment regimens used for first-line, second-line treatments and beyond in RRMM patients 
are still quite poor. Use of Ixazomib combinations in Chinese RRMM patients is associated 
with a median PFS of 6.7 months.15 MM remains a fatal disease in the majority of cases. 
Improved treatments through the development of new therapeutic strategies with this 
evolving armamentarium and new drugs are still needed. 
Reported SCT rate was 14.4% in a large real-world study of 940 Chinese NDMM patients.16
The possible reasons for the low SCT rates in China include fears for transplant, financial 
concerns (many fees for SCT, including melphalan, are not covered by health insurance), 
limited drug accessibility (melphalan just commercially entered China in 2019), and shortage 
of qualified medical service (only large reference centers or specialized centers have the 
ability to perform SCT).17
In addition, severe side effects, such as peripheral neuropathy and myelotoxicity of currently 
available drugs remain of concern. For example, the proteasome inhibitor bortezomib has 
become one of the backbone agents in the frontline treatment for MM; however, the non-oral 
administration and concerns in side effects including peripheral neuropathy hampered its 
long-term use in the real-world setting, with a median duration of treatment of only 6 months 
for bortezomib-based frontline therapy in China.17
Overall, there are high unmet medical needs for patients with MM in China. 
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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.18 Cleavage of cell surface BCMA by γ-secretase releases sBCMA19
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.20 sBCMA levels in 
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.21 Moreover, patients in 2 studies with high baseline 
levels of sBCMA appeared to have poorer clinical outcomes.18,21
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.22 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 against 
BCMA and CD3. 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 
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and microscopic findings in the secondary lymphoid tissues. Decreases in circulating 
lymphocytes and serum globulins were also noted. 
2.2.3.2. Clinical Overview
As of January 2023, elranatamab is being evaluated for the treatment of adult patients with 
RRMM or NDMM in 11 on-going studies. For detailed information on these studies, refer to 
the IB.
2.2.3.2.1. First-in-Human Study of Elranatamab (C1071001) 
The safety, efficacy and PK of elranatamab as a single agent are currently being evaluated in 
an ongoing Phase 1 study (C1071001). Part 1 dose escalation includes monotherapy (IV and 
SC) and Part 1.1 includes 2 priming cohorts (SC only). Part 1.1 introduced a priming strategy 
to mitigate CRS which involves a single lower priming dose (600 µg/kg) followed by 
maintenance dosing starting 1 week later at the RP2D (1000 µg/kg) on either a QW or Q2W 
schedule. For detailed information on the safety and efficacy data in this study, refer to the 
IB.
Based on safety, efficacy, PK, and pharmacodynamics data from Study C1071001, the 
recommended Phase 2 dosing regimen has been determined as 76 mg (fixed dose equivalent 
of 1000 µg/kg) QW SC starting from C1D8.
2.2.3.2.2. Clinical Study C1071003
2.2.3.2.2.1. Overview of Study C1071003
Study C1071003 is an ongoing, open-label, multicenter, non-randomized Phase 2 study to 
evaluate the efficacy and safety of elranatamab monotherapy in patients with MM who are 
refractory to at least one PI, one IMiD and one anti-CD38 antibody. The study enrolled 2
independent and parallel cohorts: one with participants who are naïve to BCMA-directed 
therapies (Cohort A) and one with participants who have received previous treatment with 
BCMA-directed therapies (CAR-Ts and/or ADC) (Cohort B).
Details on the safety, efficacy, clinical pharmacology and immunogenicity of elranatamab 
are provided in the IB.
Based on the totality of the safety, efficacy, PK, and PD from Studies C1071001 and 
C1071003, the recommended elranatamab dosing regimen is 2 step-up priming doses of 12 
mg and 32 mg on C1D1 and C1D4 followed by a full dose of 76 mg QW SC starting from 
C1D8.
2.2.3.2.3. Other Elranatamab Studies
The efficacy and safety of erlanatamab is being evaluated as monotherapy in an ongoing 
Phase 3 study (C1071007) in participants with NDMM after transplant and as monotherapy 
and in a combination regimen in an ongoing Phase 3 study in RRMM participants who have 
received at least 1 prior line of therapy (C1071005). Other Phase 1/2 studies are investigating 
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elranatamab as monotherapy and in combination therapy with other immunotherapy or 
standard of care agents.
Updates to these studies will be incorporated in the study C1071008 protocol and the 
Investigator’s Brochure when available.
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 Investigator’s Brochure, 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
CRS 
A known toxicity of therapeutics that function by 
activation of immune effector cells. 
Circulating cytokines are elevated after IV or SC 
administration of elranatamab. 
For further information refer to the IB.
Participants will be hospitalized for at least 2 days after the C1D1 dose and 
1 Day for the C1D4 dose for safety surveillance. Hospitalization from C1D1 to 
C1D5 may be considered. (see Section 6.1.1). 
The priming regimen is expected to mitigate rate, duration, and severity of CRS 
(see Section 4.3).
Guidance for monitoring, grading, and management of CRS per ASTCT criteria 
and guidelines is included in Appendix 11. 
Dose modification/discontinuation in the setting of Grade ≥2 AEs (including 
CRS) is described in Section 6.5.2.
This study will include only participants who are likely to tolerate potential 
events of CRS by excluding participants who are 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). 
Premedication (see Section 6.8.1)
Additional management for Grade ≥3 CRS is described in Section 9.4.1.
ICANS
A known toxicity of therapeutics that function by 
activation of immune effector cells. 
Data from ongoing studies suggest ICANS is 
infrequent. For further information refer to the IB.
Participants will be hospitalized for at least 2 days after the C1D1 dose and 
1 Day for the C1D4 dose for safety surveillance. Hospitalization from C1D1 to 
C1D5 may be considered.(see Section 6.1.1). 
The priming regimen is expected to mitigate the rate, duration, and severity of 
ICANS (see Section 4.3).
Regular neurologic examination 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 11. 
Dose modification/discontinuation in the setting of Grade ≥2 AEs (including 
ICANS) is described in Section 6.5.2. 
Additional management for Grade ≥3 ICANS is described in Section 9.4.1.
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Potential Risk of 
Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention: Elranatamab
Peripheral 
neuropathy 
including GBS
A common complication of multiple myeloma and 
its treatment.
Grade 3 peripheral neuropathy has been observed 
with elranatamab.
For further information refer to the IB.
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 (see 
Section 5.2). 
Regular neurologic examinations will be performed by the investigator (or 
designee) to monitor for emerging signs and symptoms of new or worsening 
peripheral neuropathy (see Section 8.3.11).
The administration of drugs known to cause peripheral neuropathy should be 
carefully considered, and if possible, avoided by the investigator (Section 6.8).
Participants should be closely monitored for signs and symptoms of neuropathy 
following infections or following the administration of any vaccine 
(Section 8.3.11)
Dose modification/discontinuation for peripheral neuropathy is described in 
Section 6.5.2. 
Work-up recommendations for new or worsening peripheral neuropathy 
(Grade ≥2) is described in Section 8.3.11.
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. 
For further information refer to the IB.
See Section 6.8.4 and Appendix 12 for infection prophylaxis.
Monitor participants, especially those with neutropenia, for signs of infection. 
See Section 6.5 for dose modifications for elranatamab.
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2.3.2. Benefit Assessment
The burden of MM increased in China during the past decade (2006-2016), and the mortality 
of MM increased from 2006 to 2014, but remained stable since 2014, regardless of the 
continuous increasing incidence. Improving diagnosis and treatment techniques had a 
positive effect on the mortality of MM, however, there are still many challenges for the 
management of RRMM in China. The classic/conventional regimens across different 
treatment lines are used for most patients due to limited treatment options for RRMM 
treatment in China. The outcomes of conventional treatment regimens used in RRMM 
patients are still quite poor. In addition, treatment-related issues, including drug availability, 
duration of induction and maintenance treatment, rate of transplant and economic burdens, 
are major concerns. Especially for patients who have been heavily treated, few viable options 
remain with limited accessible novel agents (see Section 2.2.1). Based on preliminary data 
from the ongoing Phase 1 study (C1071001), elranatamab has the potential to provide clinical 
benefit to participants with RRMM. In addition, elranatamab monotherapy represents a 
treatment option free of the AEs associated with steroid based SOC therapies. Moreover, data 
from Study C1071001 indicate that SC administration of elranatamab is associated with a 
lower rate of Grade 2 CRS relative to IV administration despite higher exposure in the SC 
cohorts. The SC route also represents a significant convenience benefit to participants 
relative to the IV administration of SOC and other experimental therapies. Lastly, ocular 
toxicity, a common and potentially severe AE with belantamab mafodotin-blmf, a BCMA-
directed ADC,24 has not been observed with elranatamab.
2.3.3. Overall Benefit/Risk Conclusion
Considering the measures taken to minimize risk to study participants, the potential risks 
identified in association with elranatamab are justified by the anticipated benefits that may be 
afforded to participants with RRMM.
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3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS
Objectives
Endpoints
Primary: 
Primary:
Phase 1b:
To establish the safety profile of elranatamab in 
order to confirm the RP2D in Chinese 
participants
Phase 2:
To determine the efficacy of elranatamab in 
Chinese participants with RRMM
Phase 1b:
DLTs observed in Cycle 1 (4 weeks)
Phase 2:
ORR by BICR per IMWG
Secondary: 
Secondary: 
To further evaluate the efficacy of elranatamab 
in Chinese participants with RRMM
DOR by BICR and investigator per IMWG
CRR by BICR and investigator per IMWG
ORR by investigator per IMWG
DOCR by BICR and investigator per IMWG
PFS by BICR and investigator per IMWG
OS
TTR by BICR and investigator per IMWG
MRD negativity rate (central lab) per IMWG
To determine the safety and tolerability of 
elranatamab
AEs and laboratory abnormalities by type, 
frequency, severity (as graded by NCI CTCAE 
v5.0), timing, seriousness, and relationship to 
study therapy
Severity of CRS and ICANS assessed according to 
ASTCT criteria1
To evaluate the PK of elranatamab
PK parameters of elranatamab: Cmax, Tmax, and 
AUClast
Pre- and post-dose concentrations of elranatamab
To evaluate the immunogenicity of elranatamab 
ADAs and NAbs against elranatamab
To assess the impact of elranatamab on 
patient-reported symptoms and functioning
EORTC QLQ-C30 and MY20 
EORTC QLQ CIPN20
EQ-5D
Exploratory: 
Exploratory: 
To explore correlations between elranatamab 
exposure and efficacy, safety and PD/biomarker 
endpoints
Selected PK, efficacy, safety and PD/biomarker 
endpoints
To explore the relationship between 
elranatamab and the biology of the participant’s 
MM
Measurements of biomarkers (DNA, RNA, plasma 
sBCMA level, protein or defined cell types) 
resulting from analyses of peripheral blood, and/or 
BM biospecimens
Estimands
This section defines the estimands associated with the primary endpoint of the study.
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Primary Estimand in Phase 1b: The safety of elranatamab RP2D measured by DLT rate 
estimated based on data from DLT-evaluable participants during the DLT observation period 
(Cycle 1, ie, 4 weeks) in Phase 1b. The estimand has 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 1 dose of study 
intervention in Phase 1b part 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 minimum requirement of the 
planned doses of study intervention for reason other than treatment-related toxicity 
are not evaluable for DLTs. The minimum required exposure for DLT evaluability is 
4 out of 5 planned doses of elranatamab during the DLT observation period.

Variable: Occurrence of DLTs. DLTs are defined in Section 4.3.1.

Population-level summary measure: DLT rate defined as the number of 
DLT-evaluable participants with DLTs in the DLT observation period divided by the 
number of DLT-evaluable participants.
Primary Estimand in Phase 2: The treatment effect of elranatamab on ORR as assessed by 
BICR per the IMWG criteria. The estimand has 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 1 dose of study 
intervention.

Variable: objective response defined as confirmed sCR, CR, VGPR and PR according 
to the IMWG criteria based on BICR assessment, from the date of first dose until the 
first documentation of confirmed PD, death or start of new anticancer therapy, 
whichever occurs first.

Intercurrent event(s): All data collected after an intercurrent event of subsequent 
anticancer therapy will be excluded except if required to confirm PD. All response 
assessments regardless of gaps in disease assessments will be considered. Data will 
be collected regardless of discontinuation from treatment. Participants who do not 
have a post-baseline disease assessment due to early confirmed PD, who receive 
anticancer therapies other than the study intervention prior to achieving an objective 
response, or who die, experience confirmed PD or stop disease assessments for any 
reason prior to achieving an objective response will be counted as nonresponders in 
the assessment of objective response.

Population-level summary measure: ORR defined as the proportion of participants in 
the analysis population with an objective response and 2-sided 90% CI for ORR.  
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4. STUDY DESIGN
4.1. Overall Design
Study C1071008 is a Phase 1b/2, open-label study to evaluate the safety, PK, PD and the 
efficacy of elranatamab in Chinese participants with MM who are refractory to at least 1 PI, 
1 IMiD and 1 anti-CD38 mAb (triple-class refractory MM).
Study C1071008 will investigate elranatamab monotherapy in participants with MM who are 
triple-class refractory. It will include 2 parts. Phase 1b part is the dose confirmation/safety 
lead-in phase to establish the safety profile in order to confirm the RP2D in Chinese 
participants. After the RP2D is confirmed to be tolerable, the participants who started from 
the RP2D in Phase 1b part will contribute to the efficacy evaluation together with other 
participants in Phase 2.
The objective of Phase 1b part is to establish the safety profile in order to confirm the 
monotherapy RP2D (76 mg SC QW with 12 mg (C1D1) and 32 mg (C1D4) as step-up 
priming doses SC) from global available data in Chinese participants before initiation of 
Phase 2 part of the study using a primary endpoint of DLT. Six triple class refractory 
participants with MM who had progression after at least 1 regimen in each category 
(triple-class refractory) will be enrolled and treated at the RP2D to assess the DLT rate of 
elranatamab. The DLT observation period will be Cycle 1 (4 weeks). If the DLT rate is less 
than 1/3 (0 or 1 participant out of 6), Phase 2 part will be initiated after the DLT observation 
period is concluded for all enrolled participants in Phase 1b portion. If the DLT rate at the 
monotherapy RP2D meets or exceeds 1/3, the enrollment will stop until further evaluation of 
sponsor and investigators, and the following decision will be reflected in a protocol 
amendment.
The Phase 2 part is a single stage design to evaluate the efficacy and safety in Chinese 
participants. The primary endpoint in Phase 2 part is ORR by BICR, as defined by IMWG. 
BICR will review data from site sourced components of response assessment (eg, 
hemoglobin, calcium, creatinine, serum protein electrophoresis, urine protein electrophoresis, 
serum free light chain and ratio, select bone marrow pathology report data, imaging report 
summaries) and provide assessment of best response, date of response onset, and date of 
progression (if applicable), while remaining blinded to investigator-assessed responses. 
Additionally, all participants from Phase 1b (6 in total) and approximately 6 participants 
from Phase 2 will undergo intensive PK sampling to obtain the PK profile of elranatamab at 
timepoints specified in Section 1.3.2 SoA B (Additional PK, Immunogenicity and Biomarker 
Flowchart). Sparse PK sampling will also be collected in all participants in the Phase 2 part 
(Section 1.3.1 SoA A).
4.2. Scientific Rationale for Study Design
4.2.1. Exclusion of Prior BCMA-directed therapy
Numerous BCMA-directed therapies are currently under investigation3, 12, 25 and it is likely 
that some potential participants will have previously received at least 1 of these therapies. 
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Considering there is no BCMA-directed therapy approved by NMPA, this study will exclude 
participants who have been previously exposed to BCMA-directed therapy studies.
4.2.2. Biomarkers
The objectives of biomarker sample collections and exploratory analyses will be to evaluate 
candidate predictive biomarkers that may be useful in identifying patients who may benefit 
from treatment with elranatamab and to further evaluate mechanisms of action and/or 
resistance to elranatamab. Results from these exploratory analyses will provide additional 
insights further informing our understanding of the benefit-risk profile and biologic effects of 
the elranatamab.
Biomarker analyses will be performed on BMA samples that are collected at screening and 
those that are collected for disease assessment while on-treatment. MRD will be assessed 
using NGS at a central laboratory. The patient-specific pre-treatment sample analysis detects 
the patient-specific lymphocyte antigen receptor DNA sequences that are a direct measure of 
the malignant B/plasma or T-cell clone. On-treatment BMA samples are used to monitor the 
identified clones and determine MRD positivity or negativity with a threshold of 10-5. The 
IMWG updated MM response categories define MRD-negative responses in the BM 
(assessed by next-generation flow cytometry or NGS) as an independent factor predicting 
prognosis during MM treatment.26 RNA and DNA sequencing analysis of baseline and on-
treatment BMA samples will provide information about gene mutations and/or gene 
signatures that may correlate with response and resistance. A blood or saliva sample will be 
used as a germline comparator to assist in the identification of somatic mutations. Additional 
blood samples will be collected at various time points for exploratory biomarker assessments 
as described in Section 8.7.
4.2.3. Choice of Contraception/Barrier Requirements
Studies to evaluate the development toxicity of elranatamab have not been conducted. 
Therefore, the use of a highly effective method of contraception is required for WOCBP. 
There are no contraception requirements for males (see Appendix 4). The duration of the 
contraception required for WOCBP after the last dose of the study intervention is 5 months. 
4.3. Justification for Dose
The RP2D of elranatamab in the ongoing Study C1071001 is 76 mg QW administered as a 
SC injection with a priming dose of 44 mg for the first dose. 
In Part 1 (dose-escalation) of the first-in-human Study C1071001, body-weight based doses 
ranging from 0.1 µg/kg to 50 µg/kg QW IV infusion and 80 µg/kg to 1000 µg/kg QW SC 
were evaluated in participants with RRMM, the majority of whom were triple-class 
refractory, to estimate the MTD and select the RP2D. A total of 2 participants in the IV 
cohorts had TEAEs that were considered DLTs, while no DLTs were observed in the SC 
cohorts including the highest tested dose of 1000 μg/kg. Therefore, the MTD was not reached 
in Study C1071001. Despite achieving similar or higher exposure levels (Cmax and AUCτ) at 
SC doses ≥130 μg/kg relative to the highest IV dose level of 50 μg/kg, SC dosing appeared in 
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general to be associated with a lower rate of Grade 2 CRS, the most common TEAE. 
Therefore, elranatamab will be dosed via SC route in this study.
Population PK analysis based on concentration-time data from all IV and SC cohorts in the 
dose escalation part of Study C1071001 indicated that body weight is not a clinically relevant 
covariate on elranatamab exposure. Therefore, a fixed dose will be used for further 
development including in study C1071008.
Evidence of clinical efficacy was observed in the Phase 1 study (C1071001), particularly at 
doses ≥215 µg/kg SC with acceptable safety profile across all dose levels in the dose 
escalation cohort. The ORR at the highest tested dose of 1000 µg/kg SC was 83.3% (5 of 6 
participants).The ORR observed at the 1000 µg/kg dose cohort despite the relatively high 
baseline sBCMA levels in this cohort coupled with the acceptable and manageable safety 
profile and preliminary population PK analysis of limited body weight impact on 
elranatamab clearance supported the selection of fixed dose equivalent of 1000 µg/kg dose 
level, 76 mg, as the RP2D with a fixed dose equivalent of 600 µg/kg dose level, 44 mg, as a 
priming dose to be administered on Cycle 1 Day 1.
As indicated in IB, CRS began within the first 3 days of dosing in all participants with CRS. 
Therefore, to maximize the potential for clinical activity while improving the safety margin 
of elranatamab, a fixed dose equivalent of 1000 µg/kg dose level, 76 mg, was selected as the 
RP2D with 2 step-up priming dose regimen implemented during the first week of treatment 
(12 mg on C1D1, 32 mg on C1D4). The rationale for the 2 step-up priming doses is 
described as follows. In the SC cohorts from Study C1071001, CRS events occurred mainly 
after the first dose with only 2 out of 50 participants experiencing CRS after the second dose, 
and no CRS events observed after the third or later doses. The rates of Grade 1 and 2 CRS 
events in participants receiving dose levels ≥600 μg/kg (which is the body weight dosing 
equivalent of 44 mg) are 62.5% and 37.5%, respectively, according to ASTCT grading. The 
maximum severity of CRS was consistently observed after the first dose, including 
participants in the priming cohorts who received a higher dose 7 days after the priming dose, 
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 cohorts (n = 43) 
from Study C1071001 showed an association between elranatamab  Cmax within 24 hours 
post first dose (Cmax-24h) and probability of CRS of All Grades and Grade ≥2 (according to 
ASTCT criteria 1).
To mitigate CRS, the current study will evaluate a regimen that includes premedications as 
well as 2 step-up priming doses of 12 mg on C1D1 and 32 mg on C1D4 before the first full 
elranatamab dose on C1D8. The logistic regression analysis indicates that, after a starting 
dose of 12 mg on C1D1, the predicted probabilities of All Grades and Grade ≥2 CRS are 
55% (95% CI: 29% to 78%) and 14% (95% CI: 5% to 31%), respectively. Furthermore, 
increases in the levels of several cytokines (including IL-6, IL-2, IL-10, and IL-2RA) were 
observed at the predicted Cmax-24h of 12 mg dose. This suggests that the 12 mg dose is 
expected to stimulate the immune system such that CRS events with the second step-up dose 
of 32 mg, if any, would be less frequent and of lower grade. Given the predicted immune 
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stimulation at 12 mg and the CRS profile observed in Study C1071001 where CRS events 
were associated mainly with the first dose and occasionally with the second dose, additional 
CRS events on C1D8 (first full dose and the third dosing instance) are considered unlikely.
Priming dose approaches are commonly applied for T cell engager bispecific medications to 
initially sensitize the immune system at lower doses therefore reducing the rate and grade of 
CRS.
The dose of elranatamab should be increased to 76 mg on C1D8 as long as the participant 
meets the criteria listed in Section 6.5.1. If a participant does not meet these criteria on 
C1D8, initiation of dosing with 76 mg should be deferred until these criteria are met.
If a participant has received QW dosing for at least 6 cycles and has achieved IMWG 
response of a PR or better with responses persisting for at least 2 months, the dose interval 
will be changed from QW to Q2W (eg, beginning C7D1) as a lower dose intensity might be 
adequate to maintain the response given the reduced disease burden in these participants. If 
the participant subsequently begins to have an increase of disease burden not yet qualifying 
as PD according to IMWG criteria, dose intervals should return to weekly dosing.
4.3.1. Dose Limiting Toxicity (DLT) Definition 
Monitoring of DLTs will occur in Phase 1b. The purpose of Phase 1b is to establish the 
safety and tolerability of elranatamab in order to confirm the RP2D in Chinese participants 
before Phase 2 initiation, the DLT observation period will be up to the end of Cycle 1 in each 
participant. Severity of AEs will be graded according to NCI CTCAE v5.0. The severity of 
CRS and ICANS will be assessed according to the modified grading described by ASTCT 
(See Section 10.11).
A participant is classified as DLT-evaluable if he/she meets either criteria. If a participant 
does not meet these criteria, he/she may be replaced.

Experiences a DLT during the DLT observation period (irrespective of whether the 
participant received the minimum requirement of the planned doses and scheduled 
safety assessments during the DLT observation period). 

In the absence of a DLT, receives the minimum requirement of the planned doses of 
each investigational product and has received scheduled safety assessments during 
the DLT observation period.  
The minimum required exposure for DLT evaluability is 4 out of 5 planned doses of 
elranatamab during the DLT observation period. Participants without DLTs who do not 
receive the minimum required exposure for reasons other than treatment-related toxicity are 
not evaluable for DLT assessment and may be replaced.
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 Phase 1b decisions.
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As described in Table 2, any of the following AEs observed within the DLT observation 
period and considered related to elranatamab will be classified as DLTs. Participants with 
dose reductions or missed dose(s) due to treatment-related toxicity not listed in Table 2
during the DLT observation period will be discussed between the investigator and sponsor 
and may 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 (Section 6.5.1).
Table 2.
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.

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
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Table 2.
Hematological and Non-hematological Dose-limiting Toxicities

Confirmed DILI meeting Hy’s law criteria (See Section 10.6).

Grade 3-4 laboratory abnormalities with the exception of:  
o
Grade 3-4 laboratory abnormalities that are not associated with clinical sequelae and improve to 
Grade≤2 with appropriate management or supplementation within 72 hours of their onset.

Grade 2 clinically important or persistent AEs (eg, AEs responsible for significant dose delay) may 
also be considered a DLT following review by the investigators and the Sponsor.

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 ISRa
a.
Allergic reaction, or anaphylaxis will not be considered as a DLT.
4.4. End of Study Definition
This study will be completed when all participants have been followed for OS for at least 
2 years from the date of first dose.
5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled. The 
following eligibility criteria are designed to select participants for whom participation in the 
study is considered appropriate. All relevant medical and nonmedical conditions should be 
taken into consideration when deciding whether a particular participant is suitable for this 
protocol. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. Participants age ≥18 years.

A female participant is eligible to participate if she is not pregnant or 
breastfeeding. Refer to Appendix 4 for 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.
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3. Prior diagnosis of MM as defined according to IMWG criteria.2
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 (as defined in Note below).
6. Refractory to at least 1 PI (as defined in Note below).
7. Refractory to at least 1 anti-CD38 antibody (as defined in Note below).
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, regardless of response.
9. ECOG performance status ≤2. 
10. LVEF ≥40% as determined by a MUGA scan or ECHO.
11. Adequate hepatic function characterized by the following:
a.
Total bilirubin ≤ 2 × ULN (≤3 × ULN if documented Gilbert’s syndrome);
b. AST ≤2.5 × ULN; and
c.
ALT ≤2.5 × ULN
12. Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min 
(according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine 
clearance, or according to local institutional standard method).
13. Adequate BM function characterized by the following:
a.
ANC ≥1.0 × 109/L (use of granulocyte-colony stimulating factors 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
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c.
Hemoglobin ≥8 g/dL (transfusion support is permitted if completed at least 
7 days prior to planned start of dosing).
14. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Informed Consent:
15. 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 defined according to IMWG criteria.
2. Active plasma cell leukemia.
3. Amyloidosis. 
4. POEMS syndrome.
5. Stem cell transplant within 12 weeks prior to enrollment or active GVHD.
6. 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, runs of ventricular 
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 triplicate average QTcF >470 msec at screening). 
7. Ongoing Grade ≥2 peripheral sensory or motor neuropathy. History of GBS or GBS 
variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
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8. Any other active malignancy within 3 years prior to enrollment, except for adequately 
treated basal cell or squamous cell skin cancer, or carcinoma in situ.
9. 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:
10. Previous treatment with an anti-BCMA directed therapy (eg, BCMA-directed ADC , 
BCMA-directed CAR T-cell therapy or bispecific antibody, either approved or 
investigational). 
Prior/Concurrent Clinical Study Experience:
11. Previous administration with an investigational product (eg, 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).  
Diagnostic Assessments:
12. Any active, uncontrolled bacterial, fungal, or viral infection, eg, HBV, HCV, 
SARS-CoV-2, HIV, etc. Known acquired immunodeficiency syndrome 
(AIDS)-related illness or known HIV disease requiring antiviral treatment, active 
hepatitis B (defined as positive HBs antigen and positive hepatitis B viral DNA test 
above the lower limit of detection of the assay), or active hepatitis C (defined as a 
positive hepatitis C antibody result and quantitative (HCV) RNA results greater than 
the lower limits of detection of the assay). Active infections must be resolved at least 
14 days prior to enrollment.
Other Exclusions:
13. Investigator site staff or Pfizer employees directly involved in the conduct of the 
study, site staff otherwise supervised by the investigator, and their respective family 
members. 
14. Known or suspected hypersensitivity to the study intervention or any of its excipients.
15. Live attenuated vaccine within 4 weeks of the first dose of study intervention.
5.3. Lifestyle Considerations
5.3.1. Contraception 
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected an appropriate method of contraception from the permitted list of 
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contraception methods (see Appendix 4 Section 10.4.4) and will confirm that the participant 
has been instructed in its consistent and correct use. At time points indicated in the 
Section 1.3.1 SoA A (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). In addition, 
the investigator or designee will instruct the participant to call immediately if the selected 
contraception method is discontinued or if pregnancy is known or suspected in the 
participant. If a participant is confirmed to be pregnant, treatment should be discontinued.
Contraception check is only required for WOCBP.
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) or 
individuals who consent but are unable to enroll due to study enrollment hold may be 
rescreened.  
6. STUDY INTERVENTION
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 (PF-06863135). 
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6.1. Study Intervention(s) Administered
Intervention Name
Elranatamab (PF-06863135) 
Cohort(s)
All enrolled
Type
Biologic
Unit Dose 
Strength(s)
40 mg/mL in a 6 mL Type I clear glass vial (nominal volume of 
1.9 mL)
Dosage Level(s)
76 mg QW; 12 mg, 32 mg priming doses
(44 mg and 32 mg may be used for management of toxicity.)
Route of 
Administration
SC
Use
Experimental
IMP or NIMP
IMP
Sourcing
Provided centrally by the sponsor.
Packaging and 
Labeling
Study intervention will be provided in a carton containing 1 vial. 
Each vial and carton will be open labeled as required per China’s
requirement.
6.1.1. Administration
Qualified and trained investigator site personnel will administer elranatamab to participants 
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 correct 
dose is delivered.
Elranatamab should be administered to the abdomen, with preference given to the lower 
quadrants when possible. Refer to Appendix 9 for details on administration of multiple 
injections to the abdomen. Study staff should refer to the IP Manual for specific instructions 
on the handling, preparation, and administration of study intervention.
Participants will receive elranatamab as a SC injection administered QW on Days 1, 8, 15 
and 22 of each 28-day cycle. Elranatamab is also administered on C1D4. A minimum of 2 
days should be maintained between the 2 step-up priming doses (C1D1 and C1D4), a 
minimum of 3 days between C1D4 dose and the first full dose (C1D8); a minimum of 6 days 
should be maintained between doses thereafter. If a participant has received QW dosing for 
at least 6 cycles and has achieved an IMWG response category of PR or better persisting for 
at least 2 months, the dose interval will be changed from QW to Q2W (eg, beginning C7D1) 
(see Section 6.5.3). If the participant subsequently begins to have an increase of disease 
burden not yet qualifying as PD according to IMWG criteria, dose intervals should return to 
weekly dosing. If the dose interval is changed, cycles should remain the same length (ie, 
4-week cycles).
Dose modifications may occur according to the guidelines described in Section 6.5. 
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The first doses of study intervention for both Phase 1b and Phase 2 will be 12 mg (C1D1) 
and 32 mg (C1D4), which will serve as priming doses and will be administered on an 
inpatient basis. Participants are required to be hospitalized and monitored for CRS/ICANS 
for at least 2 days (~48 hours) beginning on Cycle 1 Day 1, and for 1 day (~24 hours) for 
C1D4, for both Phase 1b and Phase 2. Hospitalization up to 5 days from C1D1 to C1D5 
inclusive may be considered. 
The dose of elranatamab should be increased to 32 mg on C1D4 and to 76 mg on C1D8 for 
both Phase 1b and Phase 2 as long as the participant meets the redosing criteria listed in 
Section 6.5.1. If a participant does not meet these criteria on C1D4 and C1D8, dosing should 
be deferred until the criteria are met.
For both the priming doses and first full dose (76 mg), premedication for CRS is required 
(see Section 6.8.1)
Each participant will 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.
5. Study interventions should be stored in their original containers.
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6. 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.
7. 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.
Vials are single-use. 
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
Allocation of participants to study intervention will proceed through the use of an IRT 
system (IWR). 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 
randomization number 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, randomization number and DU or container number assigned. The 
confirmation report must be stored in the site’s files. 
Study intervention will be dispensed at the study visits summarized in the SoA A. 
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.
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6.4. Study Intervention Compliance
Participants 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.
A record of the number of study intervention dispensed to and administered to each 
participant must be maintained.
6.5. Dose Modification 
Criteria for dose modification due to toxicity and efficacy are presented in the following 
sections.
The recommended dose modification guidelines for participants who have active confirmed 
(positive by regulatory authority-approved test) or presumed (test pending/clinical suspicion) 
SARS-CoV2 infection can be found in Appendix 8.
6.5.1. Retreatment 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 and 
guidance section below (Section 6.5.2). 
Participants must receive both elranatamab priming doses before receiving the planned full 
dose (76 mg). If the C1D4 dose (32 mg) cannot be administered within the protocol-defined 
window, elranatamab treatment may resume at the planned C1D4 dose (32 mg) upon meeting 
the re-treatment criteria. Upon re-treatment, if the C1D4 dose (32 mg) was tolerable, the 
elranatamab dose should be increased to the planned full dose (76 mg) approximately 4 days 
later, after which QW dosing with the planned full dose (76 mg) should continue (until Q2W 
is permitted, Section 6.1.1).
Dose reductions, as outlined in Section 6.5.2 (Table 3), are only applicable after the first full 
planned dose (76 mg) is administered.
At the start of a cycle: Re-treatment at the start of any new cycle should not occur until all 
of the following parameters have been met:

ANC ≥1.0 × 109/L;
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
Platelets count ≥25 × 109/L;

Recovery of treatment-related nonhematologic toxicities to baseline or Grade ≤1 
severity;

For any dosing day (at start of a cycle or during a cycle [Section 6.5.2]), No ongoing 
CRS or ICANS of any grade;

Recovery of treatment-emergent peripheral neuropathy to Grade ≤1 severity.
6.5.2. Dose Modifications for Elranatamab-Related Toxicity and for Peripheral 
Neuropathy
The recommended dose modifications for elranatamab-related toxicities and peripheral 
neuropathy are presented in Table 3. All dose modifications should be based on the worst 
preceding toxicity and must be recorded on the CRF.
Table 3.
Dose Modifications for Elranatamab-Related Toxicity and for Peripheral 
Sensory or Motor Neuropathya
Toxicity
Grade 1
Grade 2
Grade 3
Grade 4
Elranatamab-related 
Non-hematologic
(excluding 
peripheral Sensory 
or Motor neuropathy 
– see below) a
Continue at 
the same 
dose level.
Continue at the same 
dose level. 
Alternatively, per 
investigator discretion, 
withhold dose until 
toxicity is Grade ≤1, 
then resume at the same 
dose level. 
Withhold dose until 
toxicity is Grade ≤1,
or has returned to 
baseline, then restart with 
the dose reduced by 
1 level.b,f
Permanently 
discontinue.b,f
Elranatamab-related 
Hematologica,c,d
Continue at 
the same 
dose level.
Continue at the same 
dose level.
Withhold dose until 
toxicity is Grade ≤2 or has 
returned to baseline, 
then resume treatment at 
the same dose level.d
If toxicity reoccurs, 
dosing should be reduced 
by 1 dose level. 
If toxicity reoccurs 
despite dose reduction, 
dosing may be reduced by 
1 more dose level. 
If toxicity reoccurs after a 
maximum of 2 dose 
reductions, participant 
will be permanently 
Withhold dose until 
toxicity is Grade ≤2 
or returns to 
baseline, then 
reduce by 1 dose 
level.d
If toxicity reoccurs 
despite dose 
reduction, dosing 
should be reduced by 
1 more dose level. 
If toxicity reoccurs 
after a maximum of 
2 dose reductions, 
participant will be 
permanently 
discontinued from 
treatment.
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Table 3.
Dose Modifications for Elranatamab-Related Toxicity and for Peripheral 
Sensory or Motor Neuropathya
Toxicity
Grade 1
Grade 2
Grade 3
Grade 4
discontinued from 
treatment.
Peripheral Sensory or 
Motor neuropathy (all 
causality)a
See Section 8.3.11
for recommended 
work-up
Continue at 
the same 
dose level
Continue to 
monitor the 
participant 
for signs of 
worsening 
neuropathy
Withhold dose until 
resolution to Grade ≤1, 
then resume at a 
reduced dose level.
Continue to monitor the 
participant for signs of 
worsening neuropathy.e
If Grade ≥2 neuropathy 
reoccurs, permanently 
discontinue 
elranatamab.
Permanently discontinue 
elranatamab. 
Permanently 
discontinue 
elranatamab.
a.
Dose reduction and discontinuation guidance is not applicable following the first and second doses 
(priming doses C1D1 and C1D4). If after the C1D4 priming dose, a participant experiences a 
treatment-related adverse event that leads to dose interruption (ie, dose held on Cycle 1 Day 8), 
elranatamab treatment may restart at the same dose (32 mg) upon meeting the retreatment criteria 
(Section 6.5.1). If the 32 mg was tolerable, the elranatamab dose should be increased to full dose (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. A long-term interruption during priming period within the first cycle may increase the 
risk of developing CRS upon treatment resumption (eg, a longer than 2 weeks of interruption within the 
first cycle between the 32 mg priming dose and the first full dose [76 mg]). Resuming treatment with a 
32 mg dose before administering the first full (76 mg) dose may be considered after consultation with the 
sponsor.
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. For Grade 4 (first occurrence), resume 
at same dose level when platelets ≥25 × 109/L; for Grade 4 (second occurrence), resumption at a reduced 
dose level is recommended when platelets ≥25 × 109/L.
e. Consider additional diagnostic work-up (see Section 8.3.11).
f. Excludes laboratory abnormalities that are not considered clinically relevant.
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.
Missed doses will not be made up and cycles will not be extended to allow for missed doses.  
A minimum of 2 days should be maintained between the 2 step-up doses (C1D1 and C1D4), 
a minimum of 3 days between C1D4 dose and the first full dose (C1D8); a minimum of 6 
days is required between doses thereafter.
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C1D1 will be based on Day 1 of elranatamab dosing. After C1D1, for each cycle, if 
elranatamab cannot be administered on the planned day (within the window prespecified in 
the SoA), 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).  
If re-treatment criteria are not met within 4 weeks 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 for reasons other than treatment-related toxicity 
(eg, elective surgery), treatment resumption will be decided in agreement with the sponsor.
Permitted dose reductions are outlined in Table 4.
Table 4.
Dose Levels for Elranatamab
Dose
Remarks
76 mg
Dose to be administered starting Cycle 1 Day 8 (refer to Section 6.1.1 and 4.2).
44 mg
This dose level may also be used for management of elranatamab-related 
toxicity.
32 mg
Second step-up priming dose to be administered on C1D4. This dose level may 
be used for management of elranatamab-related toxicity.
12 mg
First step-up priming dose to be administered on C1D1 only.
Dose reductions of elranatamab below 32 mg are not allowed (12 mg is only to be used for 
C1D1); participants requiring reductions below 32 mg will be permanently discontinued 
from the treatment. Once a dose has been reduced for a given participant, all subsequent 
doses should be administered at that dose level unless: 1) further dose reduction is required, 
or 2) dose re-escalation is agreed by the investigator and the sponsor, which will only be 
permitted in Phase 2.
The study will be subject to potential amendment if RP2D (76mg SC QW with 12/32 mg SC 
as step-up priming dose) safety is not confirmed in Chinese participants in Phase 1b as 
determined by the study sponsor and investigators.  
6.5.3. Dose Modification Based on Durable Overall Response 
If a participant has received elranatamab QW dosing for at least 6 cycles and has achieved an 
IMWG response category of PR or better persisting for at least 2 months, the dose interval 
should be changed from QW to Q2W (eg, beginning C7D1). If the participant subsequently 
begins to have an increase of disease burden not yet qualifying as PD according to IMWG 
criteria, dose intervals should return to weekly dosing. If the dose interval is changed, cycles 
should remain the same length (ie, 4-week cycles).
6.6. Continued Access to Study Intervention After the End of the Study
No study intervention will be provided to study participants beyond the end of the study.
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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
For this study, if a participant receives a dose ≥10% higher than the planned dose of 
elranatamab, it will be considered an overdose.
There is no 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, including signs of CRS, and 
laboratory abnormalities for at least 28 calendar days after the overdose.  
3. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF.
4. Overdose is reportable to 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.
6.8. Concomitant Therapy
6.8.1. Premedication Required for Cytokine Release Syndrome Prophylaxis
For both the priming doses and first full dose (76 mg), administer these medications 
60 minutes (± 15 minutes) 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 and medication 
administrations per local label are permissible.
Similar premedications for doses at other time points may be given at the discretion of the 
investigator.
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See Appendix 11 for management of CRS and ICANS1,27,28.
6.8.2. Permitted Concomitant Medications/Therapies
All concomitant treatments, including drug and nondrug interventions and blood products, 
will be recorded on the CRF at timepoints as specified in the SoA A. 
Concomitant treatment considered necessary for the participant’s well-being may be given at 
the discretion of the investigator. The concurrent use of herbal medicinal products or herbal 
supplements should be avoided.
Hormonal contraceptives that meet the contraception requirements of this study are allowed 
to be used in participants who are WOCBP (see Appendix 4: Contraceptive and Barrier 
Guidance). 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 11 for management of CRS and ICANS.1,27,28
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, 
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.
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 during study therapy is permitted for the treatment of painful bony 
lesions provided that the lesions were known at the time of study entry and the investigator 
clearly indicates in the medical record that the need for palliative radiotherapy is not 
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indicative of PD. The appropriate interval of time between radiotherapy and study 
intervention has not been determined.
All COVID-19 vaccines are permitted and should be recorded as concomitant medications 
(standard AE collection and reporting processes should be followed).  The timing of 
COVID-19 vaccine administration relative to study intervention is at the discretion of the 
investigator although, if possible, it is best to avoid the DLT observation period and to avoid 
vaccine administration within 48 hours before or after the first and second doses of study 
intervention.
Participants with MM are at increased risk of severe disease and complications from 
COVID-19 infection29, 30. 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 for COVID-19 upon exposure to COVID-19 and at 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 COVID-19 test result 
should be immediately reported to the study investigator and documented as an AE. 
Participants who develop COVID-19 infection while on study should be managed in 
accordance with their treating healthcare provider’s standard of care and local and/or regional 
guidelines, considering all treatments available to study participants, including 
PAXLOVIDTM and monoclonal antibody treatments. 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 COVID-19 test. Where feasible, the sponsor will supply 
PAXLOVIDTM that may be used for treatment of COVID-19 in accordance with prescribing 
information31.
Investigators should ensure that eligible participants are educated on the correct 
administration of PAXLOVID™ and to ensure that access to PAXLOVID™ or other 
approved treatments for COVID-19 is available to all participants.
6.8.3. Prophylaxis for Infections
The administration of antibacterial and/or antiviral agents for infection prophylaxis in 
participants at increased risk of infection should be done in accordance with NCCN, ESMO, 
IMWG guidelines and/or local institutional guidelines. Monitor immunoglobulin levels for 
the occurrence of hypogammaglobulinemia and consider administering intravenous 
immunoglobulin for IgG level < 400 mg/dL. Refer to Section 10.12 Appendix 12 for all 
anti-infectious prophylaxis and monitoring.
6.8.4. Prohibited During the Study 
No additional anticancer therapy (including anticancer Chinese herbal medicine) will be 
permitted while participants are receiving study intervention. 
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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.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
Note: Results from the planned interim analyses (Section 9.4) may be used for sponsor 
decisions regarding termination of the study or for specific cohorts and/or investigator 
decisions regarding discontinuation of individual participants from study intervention or from 
the study.
7.1. Discontinuation of Study Intervention
It may be necessary for a participant to permanently discontinue study intervention 
(definitive discontinuation). Reasons for definitive discontinuation of study intervention 
include the following: 

Participant refused further treatment (Participants will have the option of refusing 
further treatment but will continue in the follow-up period of the study for 
safety/efficacy assessments), See Section 8.1 and Section 8.2;

Global deterioration of health status requiring discontinuation;

Unacceptable toxicity;

AEs requiring discontinuation (as described in Section 6.5.2, Dose Modification for 
Toxicity), or any AE that in the judgement of the investigator compromises the 
participant’s ability to continue study-specific procedures or is considered to not be in 
the participant’s best interest;

Confirmed disease progression (PD as defined by IMWG) (see Appendix 10);

Lack of efficacy (eg, increase of disease burden not qualifying as PD according to 
IMWG criteria).

Pregnancy;

Participant begins breastfeeding;

Significant protocol violation that, in the opinion of the investigator and/or sponsor, 
renders the participant unsuitable for further study intervention administration;
Participant is noncompliant with study procedures or study intervention that in the 
judgment of the investigator or sponsor renders the participant unsuitable for further 
study participation;

Lost to follow-up;

Death;
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
Completed;

Study terminated by sponsor.
Note that discontinuation of study intervention does not represent withdrawal from the study.
If study intervention is definitively discontinued, the participant will remain in the study to 
be evaluated for safety, disease assessments, subsequent anticancer therapies, and survival. 
See below and the SoA A or data to be collected at the time of discontinuation of study 
intervention and follow-up for any further evaluations that need to be completed. Survival 
status can be obtained by any means including telephone, during a visit, chart review, or 
contact with someone who is knowledgeable of the participant’s survival status (eg, relative, 
friend, referring healthcare provider). 
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, post-treatment 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 safety assessments, review of concomitant 
treatments, contraception check, and PROs (see SoA A 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.
Long Term Follow-Up:
Participants will be followed for at least 2 years from enrollment, continuing per End of 
Study Definition (see Section 4.4)
Follow-up will be conducted every 3 months from the last dose of study drug to confirm 
survival status and collect information including new anti-cancer therapies, AEs and 
contraception check (see SoA A, 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 by 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.
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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, initiation of subsequent anticancer therapy, participant 
lost to follow up, death or defined end of study.
7.2. Participant Discontinuation/Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request. Reasons for 
discontinuation from the study include the following:

Refused further study procedures;

Lost to follow-up;

Death;

Completed;

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 (apart from the collection of publicly available information as described in 
Section 7.2.1) 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.
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.
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The following actions must be taken if a participant fails to return to the clinic for a required 
study visit:

The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study.

Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods).  These contact attempts should be documented 
in the participant’s medical record.

Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 
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 A.
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 
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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 A: 28 day (±1 wk) interval whether dose 
given or not (ie, the 28-day interval [±1 wk] between assessments should be maintained 
regardless of dose delays/interruptions).
Disease assessments should continue until confirmed PD, withdrawal of consent, start of new 
anticancer therapy, lost to follow-up, death, or defined end of study (whichever occurs first). 
Efficacy data will be subjected to a BICR. An independent, external committee with 
expertise in myeloma will review data from site-sourced components of response assessment 
(eg, select laboratory assessments, select bone marrow pathology report data) and provide 
overall response assessments at different time points using IMWG response criteria, while 
remaining blinded to investigator-assessed responses as specified in the BICR Charter. 
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 (Appendix 10). Assessments are to be conducted at the 
time points specified in the SoA A. Assessments will include: 

SPEP for the measurement of serum proteins, including M protein..

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 VGPR or CR/sCR and at suspected PD 
(clinical or biochemical).

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, or 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 
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UPEP shows no measurable protein, at suspected VGPR or CR/sCR and at suspected 
PD (clinical or biochemical).

Involved and uninvolved serum FLC analysis, required only when both serum and
urine M components are deemed nonmeasurable (including at suspected CR). Serum 
free kappa, free lambda and free kappa/lambda ratio will be collected. 
Note: For participants treated with daratumumab less than 114 days prior to C1D1, 
daratumumab will 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 
beginning at Cycle 2.
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.
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. 
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 
new positive immunofixation results appearing in participants who have achieved a CR, 
when the isotype is different. This may represent oligoclonal immune reconstitution and 
should not be confused with relapse; these bands typically disappear over time.
8.1.2. Bone Marrow Sample Assessments for Evaluation of Disease Status
BM evaluations will be performed to follow disease status according to IMWG criteria 
(Appendix 10) at the time points specified in the SoA A. 
In addition, screening BMA samples will be evaluated locally by FISH (and karyotyping if 
an adequate sample is obtainable) to report chromosomal abnormalities, including but not 
limited to those defining high-risk MM [eg, t(4;14), t(14;16), t(14;20), del(17/17p), 
gain(1q)].32 In the case of an unevaluable BMA sample, the most recent cytogenetic results 
available should be reported.
BMA samples will be collected and the percentage of plasma cells will be evaluated as per 
the SoA A.
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BMB/BMA samples will be collected as per SoA A to evaluate the percentage of plasma 
cells and in case of suspected sCR, to evaluate the presence/absence of clonal cells by 
immunohistochemistry, immunofluorescence, or flow cytometry analysis (Appendix 10). 
Either BMA or BMB can be used; however, the same method for quantifying plasma cells 
should be used for a participant throughout the study where feasible.
When BM plasma cell infiltration is assessed by both BMA and BMB, the highest value of 
plasma cell infiltration should be utilized for response evaluation.
The same BM location used for disease characterization at baseline should be employed in 
post-baseline BM sampling if clinically feasible. 
When BMA/BMB samples are taken for response evaluation, samples for biomarker analysis 
will also be collected (see Section 8.7). 
BMA obtained while a participant is in suspected or actual CR will be evaluated by a central 
lab for MRD using NGS (see Section 8.7.1).
All relevant reports must be available for source verification and for potential peer review 
(including BICR review). 
8.1.3. Imaging Assessments (PET/CT, CT and/or MRI)
Imaging will be completed for evaluation of disease response according to IMWG criteria 
(Appendix 10) at the time points specified in the SoA A. For participants with only skin 
involvement, skin lesions should be measured with a ruler at timepoints specified in the 
SoA A.
Screening images will be used to determine evaluable target 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. 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.
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 28 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.
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All participant’s files and radiologic images must be available for source verification and for 
potential peer review (including BICR review). 
8.1.4. Patient-Reported Outcomes
Whenever possible, the PROs should be completed at the beginning of the study visit prior to 
receiving any study intervention, prior to any other study assessment or consultation with the 
investigator, and prior to being informed of their current disease status. However, if it’s not 
possible to complete the PROs at the beginning of the study visit, it is acceptable to have the 
participant complete the PROs before the end of the indicated study visit. The PROs will be 
administered at the time points specified in the SoA A.
Cancer-specific global health status and quality of life, functioning, and symptoms data will 
be collected using the EORTC QLQ-C30 and MY20 questionnaires and general health status 
will be assessed using the EQ-5D health questionnaire. The EORTC QLQ CIPN20 assesses 
chemotherapy-induced peripheral neuropathy 33.
EORTC QLQ-C30 is a well-known, reliable and valid self-administered questionnaire used 
in oncology trials.34,35 The QLQ-C30 contains 30 items and is composed of both multi-item 
scales and single-item measures. These include 5 functional scales (physical, role, emotional, 
cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 
6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) 
and a global health status/QoL scale. All the scales and single-item measures range in score 
from 0 to 100. Higher scores on the functional scales represent higher levels of functioning. 
Higher scores on the global health status/quality of life scale represent higher health 
status/quality of life. Higher scores on symptom scales/items represent a greater presence of 
symptoms.
The EORTC MY20 is a myeloma-specific module developed by the EORTC group 
specifically to assess quality of life in patients with multiple myeloma. It contains 20 items 
which can be grouped into a disease symptom subscale (6 items), side effects of treatment 
subscale (10 items), body image (1 item) and future perspective subscale (3 items).36
The EQ-5D is a 6-item patient-completed questionnaire designed to assess health status in 
terms of a single index value or utility score. There are 2 components, a Health State Profile 
which has individuals rate their level of problems in 5 areas (mobility, self-care, usual 
activities, pain/discomfort, and anxiety/depression), and a VAS in which patients rate their 
overall health status from 0 (worst imaginable) to 100 (best imaginable). Published weights 
are available that allow for the creation of a single summary score, Overall scores range from 
0 to 1, with lower scores representing higher levels of dysfunction. All scoring and handling 
of data will follow the User’s Guide defined by the EuroQoL Group.
The EORTC QLQ CIPN20 is a module developed by the EORTC group to assess 
chemotherapy-induced peripheral neuropathy 33. It contains 20 items which can be grouped 
into a sensory subscale (9 items), motor subscale (8 items) and autonomic subscale (3 items).
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8.1.5. 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 5), 
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 5.
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
III
Serum beta-2 microglobulin ≥ 5.5 mg/L
ISS stage III and either: 

high-risk chromosomal abnormalities by 
FISHb
   or

Serum LDH > the upper limit of normal
a.
Standard risk chromosomal abnormalities by FISH = no high-risk chromosomal abnormality.
b.
High risk chromosomal abnormalities by FISH = Presence of del(17p) and/or translocation t(4;14) 
and/or translocation t(14;16)
Source: (Palumbo et al, 2015)37.
8.2. Safety Assessments
Planned time points for all safety assessments are provided in the SoA A. Unscheduled 
clinical laboratory 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 laboratory 
data, ECGs and demographic data collected at screening will be reported on the CRF. 
8.2.1. Participant Demographics and Other Baseline Characteristics
Demographic data and medical history will be collected at screening by the investigator or 
qualified designee, including relevant medical and surgical history, and current illnesses.
8.2.2. Physical Examinations
Physical examinations will be performed at time points specified in the SoA A. At screening, 
a comprehensive physical examination should be conducted including, general appearance, 
head, skin, neck, eyes, ears, nose, throat, mouth, lungs, heart, abdomen, lymph nodes, 
extremities, musculoskeletal, and a thorough neurologic examination (see below). For 
subsequent visits, physical examinations may be targeted as clinically indicated. Investigators 
should pay special attention to clinical signs related to previous serious illnesses. 
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Neurological examinations including assessment of mental state, motor function, sensory 
function, gait, deep tendon reflexes, cranial nerve function, station, and coordination will be 
performed at times specified in the SoA A. All neurological examinations will be reported on 
the CRF.
All physical examinations, including neurological examinations, occurring on dosing days 
must be performed prior to elranatamab administration. Any treatment-emergent abnormal 
physical/neurological examination findings will be recorded as AEs.
Screening weight and height will be reported on the CRF.
Physical examination findings collected during the study (not including neurological 
examinations, see above) will be considered source data and will not be required to be 
reported, unless otherwise noted. Any untoward physical examination findings that are 
identified during the active collection period and meet the definition of an AE or SAE 
(Appendix 3) must be reported according to the processes in Sections 8.3.1 to 8.3.3.
Baseline encephalopathy assessment will be performed using the ICE tool 1 (Appendix 11) at 
C1D1. The ICE tool will also be used as part of assessing each suspected ICANS event.
8.2.3. Vital Signs
Vital signs (temperature, HR or pulse rate, BP and O2 saturation) should be collected per 
institutional standards at time points specified in the SoA A prior to blood collection. Pre-
dose vital signs collected on Day 1, Day 8, Day 15 and Day 22 of Cycle 1 should be reported 
on the CRF. Vital signs associated with AEs should be collected in the CRF. All other vital 
sign data collected during the course of the study will be considered source data only and will 
not be required to be reported on the CRF.
All vital sign measurements occurring on dosing days must be performed prior to 
elranatamab administration (and prior to premedication, as applicable). Abnormal vital sign 
results identified after the first dose of elranatamab constitute an AE if they are considered 
clinically meaningful, induce clinical signs or symptoms, require concomitant therapy or 
require changes in elranatamab dosing. 
Vital signs will be monitored at least every 4 hours (± 15 minutes) during the first 48 hours 
after first dose of study intervention (C1D1) and 24 hours after second dose of study 
intervention (C1D4) (see Appendix 11).
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 A section of this protocol using an ECG machine that 
automatically calculates the heart rate and measures PR, QT, and QTcF intervals and QRS 
complex duration. 15-lead or 18-lead ECGs per local practice is acceptable. For ECG 
machines that do not report QTcF, calculation of QTcF from QT and heart rate, for example 
using online tools, is acceptable. Alternative lead placement methodology using torso leads 
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(eg, Mason-Likar) is not recommended 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 5 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 specified in the SoA A. 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) the change in postdose QTcF interval remains ≥60 msec 
from the baseline and QTcF 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 for accuracy 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 using Appendix 7 as a guide. 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 A. 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 A
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 A. 
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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. 
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) after 
the last dose of study intervention should be repeated until the values return to normal or 
baseline or are no longer considered clinically significant by the investigator or medical 
monitor.
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 A. 
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 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) and at the end of the study. 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 6) will be assessed at Screening. ECOG PS should be obtained on the 
scheduled day, even if study intervention is temporarily discontinued.
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Table 6.
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). 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.
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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 and Pfizer concurs with that assessment.
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 definitively 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 CT SAE Report Form.
Investigators are not obligated to actively seek AEs or SAEs after the participant has 
concluded study participation. However, if the investigator learns of any SAE, including a 
death, at any time after a participant has completed the study, and he/she considers the event 
to be reasonably related to the study intervention, the investigator must promptly report the 
SAE to Pfizer using the CT SAE Report Form.
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 CT SAE Report Form 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 the 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.
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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/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 in 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 
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 towards the safety of participants and the safety of a 
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, 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 
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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.

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 exposure during pregnancy:  

A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by for example, inhalation, or skin 
contact.

A male family member or healthcare provider who has been exposed to the study 
intervention by for example, 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.
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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;

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.  
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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.
8.3.6. Cardiovascular and Death Events
Not applicable. 
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
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 11.
For both the priming doses and first full dose (76 mg), premedication for CRS is required 
(See Section 6.8.1).
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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”.1 It has been 
observed following administration of some CAR T-cells and BsAbs, and can occur 
independently of CRS. 
The severity of ICANS will be graded according to the ASTCT consensus criteria. See 
Appendix 11.
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 CT SAE Report Form. 
Additional management for Grade ≥3 CRS and ICANS is described in Section 9.4.1.
8.3.8.1. 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.
Safety Event
Recorded on the CRF
Reported on the CT SAE Report 
Form to Pfizer Safety Within 24 
Hours of Awareness
Medication errors 
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
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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 a CT SAE Report 
Form only when associated with an SAE.
8.3.11. 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 progressive38. Recently, peripheral 
neuropathy has been described following administration of BCMA-directed bispecific T-cell 
engagers25.
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. 
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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 A. 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. Additionally, participants enrolled 
into Phase 1b and approximately 6 participants from Phase 2 will undergo a relatively 
intensive sampling for PK as specified in SoA B.
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 approximately 2 mL of 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 as well as 
the date and time of the last dose prior to PK sample collection for each sample 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. Collection 
of samples within the visit window specified in the SoA 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 
samples, collection should occur prior to administration of elranatamab on that day. If the 
C1D4 dose (32 mg) can only be administered after the protocol-defined window, the planned 
C1D4 pre-dose PK/PD sample should be collected at any time within the C1D4 visit window
Samples will be used to evaluate the PK of elranatamab. Each serum sample will be divided 
into 2 aliquots, to provide approximately 1 mL serum for each aliquot. Samples collected for 
analyses of elranatamab serum concentration may also be used to evaluate safety or efficacy 
aspects related to concerns arising during or after the study 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.
8.5. Pharmacodynamics
Pharmacodynamics samples will be at the time points specified in the SoA.
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As part of understanding the pharmacodynamics of elranatamab, samples may be used for 
evaluation of the bioanalytical method, as well as for other internal exploratory purposes. 
These data may not be included in the CSR. 
Some samples may be analyzed using a validated analytical method in compliance with 
applicable SOPs while others may be analyzed using a non-characterized assay 
(non-validated). The pharmacodynamics samples must be processed and shipped as indicated 
in the instructions provided to the investigator site to maintain sample integrity. Any 
deviations from the pharmacodynamics 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.
8.5.1. Blood to Assess sBCMA Levels
A whole blood sample, to provide plasma for sBCMA assessment, will be collected at the 
times specified in the SoA (for pre-dose samples, collection should occur prior to 
administration of elranatamab on that day). An additional plasma sample for sBCMA 
assessment should also be collected at the time of PD if a sample is not already scheduled to 
be taken. Collection of samples up to and including 24 hours after dose administration that 
are obtained within 10% of the nominal time relative to dosing (eg, 36 minutes for the 6-hour
post-dose time point and 2 hours and 24 minutes for the 24-hour post-dose time point) will 
not be captured as a protocol deviation, as long as the exact time of the collection is noted on 
the CRF. Instructions for sample collection, processing, storage and shipment will be 
provided in the study manual. sBCMA levels will be measured in plasma at baseline and at 
various time points during study treatment, which may enable correlations between sBCMA 
levels and drug exposure and response.
8.6. Genetics
8.6.1. Specified Genetics
Unless prohibited by local regulations or ethics committee decision, genetic assessments will 
be performed utilizing BMA, blood and/or saliva samples as described in the SoA A. 
Please refer to relevant subsections in Section 8.7. 
8.6.2. Banked Biospecimens for Genetics
No banked biospecimens will be collected according to China regulation.
8.7. Biomarkers
Unless prohibited by local regulations or ethics committee decision, the following samples 
for biomarker research are required and will be collected from all participants in this study as 
specified in the SoA.
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8.7.1. Bone Marrow Aspirate for Minimal Residual Disease (MRD) 
A BMA sample will be taken at the time points specified in the SoA A. Next-generation 
sequencing of the sample taken predose identifies rearranged immune receptors (eg, IgH, 
IgK, and IgL receptor gene sequences), as well as select translocation sequences. This unique 
immunoglobulin receptor repertoire defines the patient-specific malignant plasma cell clone 
(the index clone) and is used as a reference that is compared to subsequent samples collected 
after initiation of treatment. BMA samples will be used to determine the MRD negativity rate 
with a threshold of 10-5 whenever a BMA/BMB sample is taken for disease response 
evaluation. 
At screening, if a freshly collected BMA sample is not available for identification of the 
dominant malignant myeloma clone, the sponsor may request an additional BMA sample 
from the site as long as they were collected after last pre-trial therapy and prior to C1D1 
(ie, no intervening treatment between collection and C1D1).
If the central lab is unable to identify an index malignant myeloma clone with the 
on-treatment sample, the sponsor may request an additional BMA sample from the site.
8.7.2. Bone Marrow Aspirate for Molecular Profiling
A BMA sample will be collected at the times specified in the SoA A, and will be used to 
analyze candidate DNA, RNA, or relevant signature of markers for their ability to identify 
those participants who are most likely to benefit from treatment with the study drug. 
Participants will be required to provide BMA samples whenever a sample is taken for disease 
response evaluation. 
RNA and DNA sequencing analysis will be performed and the data will be used to examine 
correlations between gene mutation status and gene expression signatures with response. As 
samples will be collected while participants are on treatment and at EOT, this analysis may 
also reveal biomarkers that correlate with resistance and relapse. 
8.7.3. Bone Marrow Biopsy to Assess BCMA and/or Immune Cell Protein Biomarkers 
A BMB may be collected at the times specified in the SoA A. BMB sample may be taken at 
suspected PD). This sample will be used for IHC, immunofluorescence or multiplex imaging 
assays to enumerate and assess the distribution of a range of markers implicated in MM (eg, 
BCMA, CD138, CD38, immune cell populations). 
8.7.4. Cytokine Assessments
Samples will be collected for central evaluation of cytokines at the time points specified in 
the SoA A and Appendix 2 unless prohibited by local regulation. Instructions for sample 
collection, processing, storage and shipment will be provided in the study manual. All 
samples will be analyzed centrally. If CRS is suspected and coincides with a day 
pharmacodynamic samples are not collected per the SoA, an ad-hoc cytokine sample should 
be collected (see Appendix 2: Clinical Laboratory Tests). In addition, should the site require 
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cytokine information for participant management, the site will have the option of collecting 
an additional sample for local analysis.  
8.7.5. Serum to Assess Circulating Proteins and Metabolite Analysis 
A blood sample will be collected at time points specified in the SoA A (for predose samples, 
collection should occur prior to administration of elranatamab on that day). This sample will 
be used for circulating protein and/or metabolomics analysis. This sample may also be used 
for additional research based on emerging knowledge of MM biology. See Section 8.5.1 for 
post-dose collection window guidance.
8.7.6. Blood for T-cell Receptor (TCR) Sequencing 
A blood sample will be collected from all participants at the time points described in the 
SoA A (for predose samples, collection should occur prior to administration of elranatamab 
on that day). This sample will be used to assess the clonality, diversity and 
pharmacodynamics of the peripheral blood TCR repertoire. 
8.7.7. Blood or Saliva Sample for Germline Comparator
Unless prohibited by local regulations or ethics committee decision, a blood or saliva sample 
will be collected from all participants on Cycle 1 Day 1 before the first dose of elranatamab, 
and will be used for exploratory targeted and/or whole exome/genome sequencing. These 
samples will be used as a germline comparator to identify somatic tumor DNA mutations and 
will not be used to generate free-standing germline sequencing results.
Specified metabolomic research is not included in this study.
8.8. Immunogenicity Assessments
Blood samples of approximately 5 mL, to provide a minimum of 2 mL serum, will be 
collected for determination of ADA and NAb into appropriately labeled tubes at times 
specified in the SoA A. 
Instructions for the collection and handling of biological samples will be provided in the 
laboratory manual. The actual date and time (24-hour clock time) of each sample will be 
recorded.
Participants having an unresolved AE that is possibly related to anti-elranatamab antibodies 
at their last assessment will be asked to return to the clinic for ADA and drug 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 collected for determination of ADA and NAb may also be used internally for 
additional characterization of the immune response and/or evaluation of the bioanalytical 
method, or for other internal exploratory purposes. 
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Samples will be analyzed using a validated analytical method in compliance with applicable 
SOPs. Samples determined to be positive for ADA may be further characterized for NAb.
The immunogenicity samples must be processed and shipped as indicated in the instructions 
provided to the investigator site to maintain sample 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 determination 
as to whether sample integrity has been compromised.
As part 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 immunogenicity response. These data will be used for internal exploratory purposes 
and will not be included in the CSR.
8.9. Health Economics
Health economics/medical resource utilization and health economics parameters will not be 
evaluated in this study.
9. STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in an 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 primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment.
9.1. Statistical Hypotheses
The Phase 2 part will test the null hypothesis (H0) that the ORR by BICR as defined by 
IMWG is ≤30% versus the alternative hypothesis (Ha) that the ORR by BICR as defined by 
IMWG is >30% using a single-stage design based on the exact binomial distribution. The 
null hypothesis ORR is based on the results of the DREAMM-2 study3 and the STORM 
study,4 which were conducted in similar multiple myeloma populations with respect to prior 
treatments. 
9.1.1. Estimands
This section defines the estimand associated with the primary endpoint of the study.
Primary Estimand in Phase 1b: The safety of elranatamab RP2D assessed by DLT rate 
estimated based on data from DLT-evaluable participants during the DLT observation period 
(Cycle 1) in Phase 1b. The estimand has 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 1 dose of study 
intervention in Phase 1b part and either experience DLT(s) during the DLT 
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observation period or complete the DLT observation period without DLT. 
Participants without DLTs who receive less than the minimum requirement of the 
planned doses of study intervention for reason other than treatment-related toxicity 
are not evaluable for DLTs and will be replaced. The minimum required exposure for 
DLT evaluability is 4 out of 5 planned doses of elranatamab during the DLT 
observation period.

Variable: Occurrence of DLTs. DLTs are defined in Section 4.3.1.

Population-level summary measure: DLT rate defined as the number of 
DLT-evaluable participants with DLTs in the DLT observation period divided by the 
number of DLT-evaluable participants.
Primary Estimand in Phase 2: the treatment effect of elranatamab on ORR as assessed by 
BICR per the IMWG criteria. The estimand has 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 1 dose of study 
intervention.

Variable: objective response defined as confirmed sCR, CR, VGPR and PR according 
to the IMWG criteria based on BICR assessment, from the date of first dose until the 
first documentation of confirmed PD, death or start of new anticancer therapy, 
whichever occurs first.

Intercurrent event(s): All data collected after an intercurrent event of subsequent 
anticancer therapy will be excluded except if required to confirm PD. All response 
assessments regardless of gaps in disease assessments will be considered. Data will 
be collected regardless of discontinuation from treatment. Participants who do not 
have a post-baseline disease assessment due to early confirmed PD, who receive 
anticancer therapies other than the study intervention prior to achieving an objective 
response, or who die, experience confirmed PD, or stop disease assessments for any 
reason prior to achieving an objective response will be counted as nonresponders in 
the assessment of objective response.

Population-level summary measure: ORR defined as the proportion of participants in 
the analysis population with an objective response and 2-sided 95% CI for ORR. 
9.2. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Participant Analysis Set
Description
Safety Analysis Set
All participants enrolled to study intervention and who take 
at least 1 dose of study intervention. 
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Participant Analysis Set
Description
DLT Evaluable Analysis 
Set
All participants enrolled to phase 1b part and who have 
experienced a DLT in the DLT observation period or 
complete the DLT observation period without DLT. 
Participants without DLTs who received less than minimum 
requirement of the planned doses of elranatamab for reason 
other than treatment-related toxicity are not evaluable for 
DLTs and will be replaced. The minimum required exposure 
for DLT evaluability is 4 out of 5 planned doses of 
elranatamab during the DLT observation period, provided a 
dose was not missed due to toxicity attributed to study drug.
PK Analysis Set
The PK analysis set is a subset of the safety analysis set and 
will include participants who have at least one concentration 
measurement.
Immunogenicity Analysis 
Set
The immunogenicity analysis set is a subset of the safety 
analysis set and will include participants who have at least 
one sample tested for ADA.
Biomarker Analysis Set
The biomarker parameter analysis set is a subset of the safety 
analysis set and will include participants who have at least 
one baseline biomarker assessment.
Analysis sets will be defined separately for biomarkers based 
on blood, saliva, and bone marrow aspirate samples. 
PRO Analysis Set
The PRO analysis set will include all participants in the 
safety analysis set who completed a baseline and at least one 
post-baseline PRO assessment.
Note: "Enrolled" means a participant's, agreement to participate in a clinical study following completion of 
the informed consent and was assigned to treatment. Potential participants who are screened for the purpose 
of determining eligibility for the study, but do not participate in the study, are not considered enrolled, unless 
otherwise specified by the protocol.
9.3. Statistical Analyses
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data. 
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints.
9.3.1. General Considerations
The study will include 2 parts: a Phase 1b part to establish the safety profile to confirm the 
RP2D in Chinese participants and a Phase 2 part to determine the efficacy and safety of 
elranatamab in Chinese participants. Efficacy and safety analyses will be conducted on the 
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safety analysis set. Sensitivity analysis will be performed to evaluate the impact of COVID if 
deemed necessary.
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. Categorical variables will be summarized using frequency 
counts and percentages. The time-to-event variables will be summarized using Kaplan-Meier 
methods and displayed graphically if applicable. The median, percentile and probabilities at 
particular time points will be estimated.  
Unless otherwise specified, the calculation of proportions will be based on the sample size of 
the population of interest. Counts of missing observations will be included in the 
denominator and presented as a separate category if not otherwise specified in the SAP.
9.3.2. Primary Endpoint(s)

DLT is the primary endpoint of the Phase 1b part. The occurrence of DLTs observed 
in this part will be used to estimate the DLT rate and confirm the RP2D in Chinese 
participants. DLT rate will be summarized in the DLT evaluable analysis set. Adverse 
events constituting DLTs will be listed.

Objective response defined as confirmed sCR, CR, VGPR and PR according to the 
IMWG criteria based on BICR assessment, from the date of first dose until the first 
documentation of confirmed PD, death or start of new anticancer therapy, whichever 
occurs first, is the primary endpoint of the Phase 2 part. 
ORR by BICR is defined as the proportion of participants with an objective response by 
BICR per IMWG criteria, and will be analyzed in the safety analysis set. The primary 
analysis of ORR will include participants who started from the RP2D (including the 
participants from both Phase 1b and Phase 2 parts). The point estimate of ORR by BICR 
will be calculated along with the 2-sided exact 90% and 95% CIs using the 
Clopper-Pearson method. The null hypotheses will be tested at 1-sided alpha of 0.05 
using exact binomial test. 
9.3.3. Secondary Endpoint(s)
All secondary efficacy endpoints will be analyzed in the safety analysis set. 
9.3.3.1. Secondary Efficacy Endpoints
ORR by investigator is the proportion of participants in the analysis population with an 
objective response as assessed by investigator. Point estimates of ORR by investigator will 
be calculated along with the 2-sided exact 95% CIs using the Clopper-Pearson method.
CRR is the proportion of participants in the analysis population with a CR/sCR according to 
the IMWG criteria. Point estimates of CRR will be calculated along with the 2-sided exact 
95% CIs using the Clopper-Pearson method. 
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CRR by BICR and CRR by investigator will be summarized separately.
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 (confirmed PD or death due to any cause), on the date of the last adequate 
disease assessment before the new anticancer therapy for participants who start a new 
anticancer 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 DOR by BICR and 2-sided 95% CI (based on the 
Brookmeyer-Crowley method) will be provided. 
DOR by BICR and DOR by investigator will be summarized separately.
DOCR is defined, for participants with a CR/sCR per IMWG criteria, as the time from the 
first documentation of CR/sCR 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 
(confirmed PD or death due to any cause), on the date of the last adequate disease assessment 
before the new anticancer therapy for participants who start a new anticancer 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.
DOCR by BICR and DOCR by investigator will be summarized separately. 
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 on the date of the last 
adequate disease assessment for participants who do not have an event (confirmed PD per 
IMWG criteria or death due to any cause), on the date of the last adequate disease assessment 
before the new anticancer therapy for participants who start a new anticancer therapy prior to 
an event, or on the date of the last adequate disease assessment before the gap for participants 
with an event after a gap of 2 or more missing disease assessments. Participants who do not 
have an adequate post-baseline disease assessment will be censored on the date of first dose 
unless death occurs on or before the time of the second planned disease assessment (ie, 
≤70 Days 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. 
PFS by BICR and PFS by investigator will be summarized separately.
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 
participant’s request to discontinue study procedures. All participants who have not 
withdrawn consent for further participation in the study should be followed for survival until 
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the end of the study. OS for participants not known to have died are censored on the date of 
they are last known alive. OS will be summarized using Kaplan-Meier method and displayed 
graphically. Median OS and 2-sided 95% CI will be provided. 
TTR is defined, for participants 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 confirmed. TTR will be summarized using mean, standard deviation, minimum, 
median, and maximum. 
TTR by BICR and TTR by investigator will be summarized separately.
MRD negativity rate is the proportion of participants with negative MRD (assessed by 
central lab) per IMWG sequencing criteria by BMA from the date of first dose until the first 
documentation of confirmed PD, death or start of new anticancer therapy. Point estimates of 
MRD negativity rate will be calculated along with the 2-sided exact 95% CIs using the 
Clopper-Pearson method.
9.3.3.2. Pharmacokinetic Analyses
The PK data will be analyzed using the PK analysis set.
The concentrations of elranatamab will be summarized by descriptive statistics (n, mean,
standard deviation, coefficient of variation, median, minimum maximum, and geometric
mean) by cycle, visit, and nominal time. 
For participants with intensive PK sampling (Phase 1b and 6 participants from Phase 2), 
individual concentration-time data of elranatamab following the Cycle 1 Day 1 dose will be 
analyzed separately using non-compartmental analysis to estimate the PK parameters. The 
PK parameters estimated will include Cmax, time to maximum concentration (Tmax), and area 
under the concentration-time curve from time zero to time of last measurable concentration 
(AUClast). Actual sample collection times will be used for the parameter calculations. 
Individual participant and median profiles of the concentration-time data will be plotted by 
cycle using nominal times. Median profiles will be presented on both linear-linear and log-
linear scales.
For participants with sparse PK sampling only (all rest participants from phase 2), pre-dose 
and post-dose trough elranatamab concentrations will be summarized descriptively by cycle.
In addition, the PK/PD data from this study may be used to develop a population PK model. 
The correlations between elranatamab exposure parameters and pharmacodynamic 
biomarker, efficacy and/or safety outcomes will be explored if data allows. The results of 
these modeling analyses will be reported separately from the clinical study report.
9.3.3.3. Immunogenicity Analyses
For immunogenicity data, the percentage of participants with positive ADA will be 
summarized. Listings and summary tabulations of the ADA data at baseline and after first 
dose will be generated. Samples may also be analyzed for the presence of NAb, and any data 
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will be similarly summarized. For participants with positive ADA or NAb, the magnitude 
(titer), time of onset, and duration of ADA or NAb response will also be described, if data 
permit. The potential impact of immunogenicity on PK and clinical response including 
pharmacodynamic markers, safety/tolerability and efficacy will be explored, if warranted by 
the data.
9.3.3.4. Safety Analyses
All safety analyses will be performed in the safety analysis set. 
9.3.3.4.1. Adverse Events
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 by the 
investigator according to the ASTCT criteria described by Lee et al 20191 (See 
Section 10.11) and coded using MedDRA. AEs will be characterized by type, frequency, 
severity, timing, seriousness, and relationship to elranatamab. AEs will be presented with 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, including CRS and ICANS.
9.3.3.4.2. Laboratory Test Abnormalities
Clinical laboratory data will be classified by grade according to NCI CTCAE version 5.0 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.
9.3.3.5. Electrocardiogram Analyses
The number (%) of participants with maximum postdose QTcF values and maximum 
increases from baseline in the following categories will be tabulated: 
Safety QTcF Assessment
Degree of Prolongation
Mild (msec)
Moderate (msec)
Severe (msec)
Absolute value
≥450-480
>480-500
>500
Increase from baseline
30-60
>60
9.3.4. Exploratory Endpoint(s)
The details of exploratory endpoint (DNA, RNA, plasma sBCMA level, protein or defined 
cell types) analyses will be described in the SAP. The details of exploratory correlation 
between elranatamab exposure and efficacy, safety and PD/biomarker endpoints, if 
performed, will be described and reported separately in PMAPs/PMARs.
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Results from exploratory analyses will be reported in the CSR where possible. However, 
given the exploratory nature of the objective and endpoints, the analyses may not be 
completed at the time of CSR preparation. If results of exploratory endpoint analyses cannot 
be included in the CSR, they will be disseminated as appropriate to the scientific community 
through presentation at scientific meetings and/or publication in peer-reviewed scientific 
journals. 
9.3.5. Other Analyse(s) 
Pharmacogenomic or biomarker data from Banked Biospecimens may be collected during or 
after the trial and retained for future analyses; the results of such analyses are not planned to 
be included in the CSR. 
9.4. Interim Analyses
No formal interim analysis will be conducted for this study. As this is an open-label 
Phase 1b/2 study, the sponsor may conduct unblinded review of the data during the course of 
study for the purpose of dose confirmation and safety assessment.
9.4.1. Interim Safety Assessments
The sponsor will review cumulative safety data during the study conduct. In addition, the 
incidence of Grade 3-4 CRS, Grade 3-4 ICANS, and Grade 4 treatment related 
nonhematologic events (excluding CRS and ICANS), Grade 3-4 treatment-related 
GBS/GB-like AEs, Grade 3-4 treatment-related peripheral motor neuropathy, Grade 4 
treatment-related peripheral neuropathy/immune-related (IR) neurologic events, and Grade 5 
events will each be monitored by the sponsor throughout the study. 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 for sponsor’s further assessment. (See 
Section 10.1.9). 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 temporary enrollment hold are met, written notification 
documenting the reason for temporary enrollment hold (or study termination) will be 
provided by the sponsor to the investigators, the ECs/IRBs, the regulatory authorities, and 
any CRO(s) used in the study (see also Section 10.1.9).
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 3-4 CRS results in a 
posterior probability that the true Grade 3-4 CRS rate exceeding 20% is ≥0.80, 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 
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and ICANS). Table 7 summarizes the minimum number of participants with such identified 
events that would meet the above criteria. 
Table 7.
Minimum Number of Participants With Identified Events That Would 
Prompt Temporary Enrollment Hold
Number of 
Evaluable 
Participants 
(Phase1b+2)
6
7-9
10-13
14-18
19-22
23-26
27-30
31-35
36
Minimum number of 
participants with 
Grade 3-4 CRS 
events that would 
lead to a temporary 
enrollment hold*
2
3
4
5
6
7
8
9
10
Minimum number of 
participants with 
Grade 3-4 ICANS 
events that would 
lead to a temporary 
enrollment hold*
2
3
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
2
3
4
5
6
7
8
9
10
Prior distribution: Beta (0.5,0.5)
Criteria for 36+ 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 ≥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 3 participants experiencing the identified AE out of the 
first 6 evaluable participants, the study will be put on 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. 

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. 
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
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 8 summarizes the minimum number of evaluable participants with such identified 
events that would meet the above criteria.
Table 8.
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 
(Phase1b+2)
17-36 a
Minimum number of participants with 
Grade 3-4 treatment-related GBS/GB-
like events that would lead to a 
temporary enrollment hold*
2
Number of Evaluable Participants 
(Phase1b+2)
6-11
12-19
20-27
28-35
36 b
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
Prior distribution: Beta (0.5,0.5)
a. Criteria for 36+ 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 3% is ≥0.80. 
b. Criteria for 36+ 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 10% is ≥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 2 participants experiencing the identified AE out of the 
first 17 evaluable participants, the study will be put on hold). Before the number of evaluable participants 
reaches 17, if there are 2 participants experience the identified AE then the study will be put on temporary hold. 
In other words, as long as 2 participants with identified AE are observed the study will be put on temporary 
hold regardless of the number of evaluable participants at the time. 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 5 evaluable participants, the study will be put on hold). A minimum of 2 events are required to trigger a 
temporary hold.
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In addition, the study will be put on temporary hold if any of the following criteria are met:

1 Grade 5 event of CRS,

1 Grade 5 event of ICANS,

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).
9.5. Sample Size Determination
The study includes 2 parts: Phase 1b part and Phase 2 part.  
The primary objective of the Phase 1b part is to establish the safety of elranatamab in order 
to confirm the RP2D in Chinese participants. There will be no formal hypothesis testing in 
this part. DLT will be evaluated. If <1/3 DLT observed in the first 6 evaluable participants 
treated from monotherapy RP2D, the study will proceed to Phase 2 part. Otherwise, a lower 
dose level will be evaluated. Approximately 6 participants will be enrolled and treated in 
Phase 1b. All the analyses will be descriptive. 
In the FIP Study C1071001, as of data-cutoff date 07 September 2020, there were 
15 participants who achieved an objective response among the 20 participants who were 
treated at dose level ≥215 ug/kg. The ORR was 75% with the 95% exact CI (51%-91%). 
Therefore, it is assumed that the true ORR with elranatamab will be ≥51%. A total of 
36 participants will be contributed to the hypothesis testing, which includes the participants 
enrolled and treated in Phase 2 and those participants who started from the confirmed RP2D 
in Phase 1b. The sample size will provide 80% power to reject the null hypothesis at a 
1-sided significance level of 0.05 assuming the true ORR is ≥51%.
Based on the design, at the analysis, an observed ORR ≥44.4% (ie, 16 responders out of the 
36 participants) will be needed to reject the null hypothesis, and the cohort has demonstrated 
that the true ORR exceeds 30%. At the time of the analysis, the testing rule will depend on 
the exact number of participants enrolled and treated. 
The analysis will be conducted once all participants have been followed for response for at 
least 6 months or have otherwise discontinued response assessments within the first 6 months 
of treatment. 
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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 (if applicable), European Medical Device Regulation 
2017/745 for clinical device research (if applicable), 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 and answer all questions regarding the 
study. The participant 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 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 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 must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.
The participant must be informed that 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 is fully informed about his or 
her right to access and correct their personal data and to withdraw consent for the processing 
of their personal data.
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.
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Participants 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.
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.
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 
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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 patients) 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 
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 
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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.
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 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 
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 
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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 can be found in the clinical monitoring plan.
Description of the use of 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) 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 the sponsor’s 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.
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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 
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.
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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 Tests
The following safety laboratory tests will be performed at times defined in the SoA A 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.
In addition to safety laboratory tests, serum beta-2 microglobulin is also required.
Table 9.
Protocol Required Safety Laboratory Assessments
Hematology
Chemistry
Other
Hemoglobin
Platelet count
WBC count
Absolute*:
Neutrophils
Eosinophils
Monocytes
Basophils
Lymphocytes
Plasma cell count
(*Reported in percent if absolute values 
are not available. Results will be 
reported as absolute values after 
conversion and graded according to the 
CTCAE v5 criteria)
BUN (or blood urea)
Creatinine
Glucose (non-fasting)
Calcium (total)
Sodium
Potassium
Chloride
Total CO2 (bicarbonate)a
AST, ALT
Total bilirubin
Alkaline phosphatase
Albumin
Total protein
Lactate dehydrogenase (LDH)b
Uric acidb
Serum beta-2 microglobulinb d
PT/INR
Pregnancy test 
(β-hCG)c
IL-6, IL-10, IL-2, 
sIL-2R, IL-12, IL-4, 
IL-5, IL-13, IL-17, 
IL-1b, IL-8, IFNγ, 
and TNF-α
Optional Ad hoc 
Local Lab Cytokine 
Analysisa
IL-6, IL-10, IL-1, 
TNF-α, other 
cytokines per local 
practice 
Serum quantitative 
immunoglobulins 
(IgG, IgM, IgA, 
IgD, IgE).e
CMV testing (by 
quantitative PCR), 
every 1 to 3 months
depending on risk 
factors (see 
Appendix 12)
a.
Not required if not included in the chemistry panel at the site laboratory. Investigators will follow up per 
standard of care of the institution (eg, blood gas analysis) if warranted by required laboratory test results.
b.
At baseline (minimum), and as clinically indicated.
c.
For female participants of childbearing potential only. Pregnancy tests may be urine or serum tests, but 
must have a sensitivity of at least 25 mIU/mL.
d.
Required for multiple myeloma staging.
e.
IgD or IgE, if they are available at the site, only if the heavy chain component of the disease is known to 
be IgE or IgD..
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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 occurrence in a patient or clinical study participant, 
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 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study intervention.
Events Meeting the AE Definition
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator. Any abnormal laboratory 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/surgical intervention.
Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional concomitant 
drug treatment, or other therapy.
Exacerbation of a chronic or intermittent preexisting condition, including either an 
increase in frequency and/or intensity of the condition.
New conditions detected or diagnosed after study intervention administration, even 
though it may have been present before the start of the study.
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming 
intent. Such overdoses should be reported regardless of sequelae.
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Events NOT Meeting the AE Definition
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.
The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the participant’s 
condition.
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE.
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present 
or detected at the start 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 
reported as AEs.
10.3.2. Definition of 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 term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event that 
hypothetically might have caused death if it were more severe.
c. Requires inpatient hospitalization or prolongation of existing hospitalization
In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious.
Hospitalization for elective treatment of a preexisting condition that did not worsen from 
baseline is not considered an AE.
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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 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).
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10.3.3. Recording/Reporting and Follow-up 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 
reporting SAEs on the CT SAE Report Form 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 Report Form for reporting of SAE information is not 
the same as the AE page of the CRF. When the same data are collected, the forms must be 
completed in a consistent manner. AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE 
Report Form for reporting of SAE information.
Safety Event
Recorded on the CRF
Reported 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 
during pregnancy or 
breastfeeding
All AEs/SAEs associated 
with exposure during 
pregnancy or breastfeeding
Note:  Instances of EDP or 
EDB not associated with an 
AE or SAE are not captured 
in the CRF.
All instances of EDP are 
reported (whether or not 
there is an associated SAE)*
All instances of EDB are 
reported (whether or not 
there is an associated SAE). 
**
Environmental or 
occupational exposure to 
the product under study 
to a non-participant (not 
involving EDP or EDB).
None.  Exposure to a study 
non-participant is not 
collected on the CRF.
The exposure (whether or 
not there is an associated 
AE or SAE) must be 
reported.***
* 
EDP (with or without an associated AE or SAE): any pregnancy information 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 reported to Pfizer Safety using the CT SAE Report Form. 
** EDB is reported 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 Form. 
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When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostic reports) 
related to the event.
The investigator will then record all relevant AE or SAE information in the CRF.
It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of completion of the CT SAE Report 
Form/AE or SAE CRF page.
There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the exception 
of the participant number, will be redacted on the copies of the medical records before 
submission to Pfizer Safety.
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE or SAE.
Assessment of Severity
The investigator will make an assessment of severity for each AE reported during the study 
and assign it to 1 of the following 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
MILD AE
2
MODERATE AE
3
SEVERE AE
4
LIFE-THREATENING; urgent intervention indicated
5
DEATH RELATED TO AE
The severity of CRS and ICANS will be graded according to ASTCT criteria.1 See 
Appendix 11.
Assessment of Causality
The investigator is obligated to assess the relationship between study intervention and 
each occurrence of each AE or SAE. The investigator will use clinical judgment to 
determine the relationship.
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A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot be 
ruled out.
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 information, for marketed 
products, in his/her assessment.
For each AE or SAE, the investigator must document 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 occurred and the investigator has 
minimal information 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 
information and send an SAE follow-up report with the updated causality assessment.
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.
If the investigator does not know whether or not the study intervention caused the 
event, then the event will be handled as “related to study intervention” for reporting 
purposes, as defined by the sponsor. In addition, if the investigator determines that an 
SAE is associated with study procedures, the investigator must record this causal 
relationship in the source documents and CRF, and report such an assessment in the 
dedicated section of the CT SAE Report Form and in accordance with the SAE 
reporting requirements.
Follow-up of AEs and SAEs
The investigator is obligated to perform or arrange 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 fully as possible.  
This may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other healthcare providers.
New or updated information 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 information.
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10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool
The primary mechanism for reporting 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) in order to report the event within 24 hours.
The site will enter the SAE data into the electronic system as soon as the data become 
available.
After the study is completed at a given site, the electronic data collection tool will be 
taken off-line to prevent the entry of new data or changes to existing data.
If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form (see next 
section) or to Pfizer Safety by telephone.
SAE Reporting to Pfizer Safety via CT SAE Report Form
Facsimile transmission of the CT SAE Report Form is the preferred method to 
transmit this information to Pfizer Safety.
In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the CT SAE Report Form sent by overnight mail or courier 
service.
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Report Form pages within the designated reporting 
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 used as conservative estimate of exposure that may result in 
serious manifestations of developmental toxicity.
10.4.2. Female Participant Reproductive Inclusion Criteria
The criteria below are part of Inclusion Criterion No. 1 (Age and Sex; Section 5.1) and 
specify the reproductive requirements for including female participants. Refer to 
Section 10.4.4 for a complete list of contraceptive methods permitted in the study. 
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. Premenarchal.
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2. Premenopausal female with 1 of the following:

Documented hysterectomy;

Documented bilateral salpingectomy;

Documented bilateral oophorectomy.
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (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.
3. Postmenopausal female:

A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. In addition, a

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 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.
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5. Vasectomized partner:

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.
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:

Oral;

Intravaginal;

Transdermal.
7. Progestogen-only hormone contraception associated with inhibition of ovulation:

Oral;

Injectable.
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.
In addition, one of the following effective barrier methods must also be used when 
option 6 or 7 are chosen above:

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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10.5. Appendix 5: Genetics
Use/Analysis of DNA

Genetic variation may impact a participant’s response to study intervention, 
susceptibility to, and severity and progression of disease. Therefore, where local 
regulations and IRBs/ECs allow, a blood sample will be collected for DNA analysis.

The results of genetic analyses may be reported in CSR or in a separate study 
summary, or may be used for internal decision making without being included in a 
study report.

The sponsor will store the DNA samples in a secure storage space with adequate 
measures to protect confidentiality. 

The samples will be retained as indicated:

Samples for specified genetic analysis (see Section 8.6.1) will be stored for up to 
15 years or other period as per local requirements beyond the completion of this 
study (eg, CSR finalization).

Samples for genetic research will be labeled with a code. The key between the code 
and the participant’s personally identifying information (eg, name, address) will be 
held securely at the study site.
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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 an “adaptor” 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).
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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.  
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 cases of 
Hy’s law, 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, 
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 and 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 AEs
Marked sinus bradycardia (rate <40 bpm) lasting minutes.
New PR interval prolongation >280 ms.
New prolongation of QTcF to >480 ms (absolute) or by 60 msec 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 short intervals (<30 seconds) of consecutive ventricular 
complexes.
ECG Findings That May Qualify as SAEs
QTcF prolongation >500 ms.
New ST-T changes suggestive of myocardial ischemia.
New-onset left bundle branch block (QRS >120 ms).
New-onset right bundle branch block (QRS >120 ms).
Symptomatic bradycardia. 
Asystole:
In awake, symptom-free patients in sinus rhythm, with documented periods of 
asystole 3.0 seconds or any escape rate <40 bpm, or with an escape rhythm that is 
below the AV node; 
In awake, symptom-free patients with atrial fibrillation and bradycardia with 1 or 
more pauses of at least 5 seconds or longer; 
Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate 
>120 bpm.
Sustained supraventricular tachycardia (rate >120 bpm) (“sustained” = short duration
with relevant symptoms or lasting >1 minute).
Ventricular rhythms >30 seconds’ duration, including idioventricular rhythm (heart 
rate <40 bpm), accelerated idioventricular rhythm (HR 40 bpm to <100 bpm), and 
monomorphic/polymorphic ventricular tachycardia (HR >100 bpm (such as torsades 
de pointes)).
Type II second-degree (Mobitz II) AV block.
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Complete (third-degree) heart block.
ECG Findings That Qualify as SAEs
Change in pattern suggestive of new myocardial infarction. 
Sustained ventricular tachyarrhythmias (>30 seconds’ duration).
Second- or third-degree AV block requiring pacemaker placement.
Asystolic pauses requiring pacemaker placement.
Atrial flutter or fibrillation with rapid ventricular response requiring cardioversion.
Ventricular fibrillation/flutter.
At the discretion of the investigator, any arrhythmia classified as an adverse 
experience.
The enumerated list of major events of potential clinical concern are recommended as “alerts” or 
notifications from the core ECG laboratory to the investigator and Pfizer study team, and not to be 
considered as all inclusive of what to be reported as AEs/SAEs.
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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 in China 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 this study, local clinical practice standards 
for testing should be followed. A participant should be excluded if he/she has a positive test 
result for SARS-CoV-2 infection, 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 Criteria (Section 5.2). When the infection resolves, the 
participant may be considered for re-screening. 
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 Schedule of 
Activities 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 (eg, audio, video, 
video-conferencing software) remotely, allowing the participant and the investigator to 
communicate on aspects of clinical care, including medical advice, reminders, education, and 
safety monitoring. The following assessments may be performed during a telehealth visit: 

Review and record study intervention(s), including compliance and missed doses.

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 
Appendix 2 for a list of safety laboratory evaluations, including pregnancy testing.
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. The ECG may be repeated if lead placements are reversed or 
incorrect.
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. Notify the study team when treatment is restarted.
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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. Left lower quadrant
2. Right lower quadrant
3. Left upper quadrant
4. Right upper 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 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 study CRF. Complete one CRF per injection. See Section 10.3 for AE 
reporting.
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10.10. Appendix 10: IMWG Response Criteria for Multiple Myeloma 
Participants must have measurable disease at enrollment (study entry) as defined by: 

Serum M-protein ≥0.5 g/dL (5 g/L);

Urine M-protein ≥200 mg/24 hours;

Serum FLC assay: involved serum FLC level ≥10 mg/dL, provided serum FLC ratio 
is abnormal. 
Whenever more than 1 parameter 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 starting new 
therapy. To confirm response or PD, 2 discrete samples are required and testing cannot be 
based upon the splitting of a single sample.
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 by 
immunohistochemistry, immunofluorescence, or flow cytometry.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 by immunohistochemistry, immunofluorescence, or 
flow cytometry.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 
plasmacytomas.d
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Responsea
Modified IMWG Criteria
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 at baseline, 
a ≥50% 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 ≥25% from lowest confirmed response value in any 1 or 
more of the following:e,f
Serum M-component (the absolute increase must be ≥0.5 g/dL);
Serum M-protein increase ≥1 g/dL, if the lowest M component was 
≥5 g/dL;
Urine M-protein (the absolute increase must be ≥200 mg/24 h).
In participants without measurable serum and urine M-protein 
levels, the difference between involved and uninvolved serum FLC
levels (absolute increase must be >10 mg/dL);
In patients without measurable serum and urine M-protein levels 
and without measurable involved serum FLC levels, bone marrow 
plasma-cell percentage irrespective of baseline status (absolute 
increase must be ≥10%)
Appearance of a new lesion(s), ≥50% increase from nadir in SPD of 
>1 lesion, or ≥50% increase in the longest diameter of a previous 
lesion >1 cm in short axis.d
≥50% increase in circulating plasma cells (minimum of 200 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 unconfirmed until confirmatory test is performed. 
All categories (stable disease or better) require no known evidence of PD, new bone lesions or EM 
plasmacytomas if imaging studies were performed; imaging studies are not required to satisfy these response 
requirements except for requirement of FDG PET to confirm imaging plus MRD-negative.
b
Bone marrow assessments do not need to be confirmed. Careful attention should be given to new 
positive immunofixation results appearing in participants who have achieved a CR, when the isotype is 
different. This often represents oligoclonal immune reconstitution and should not be confused with relapse; 
these bands typically disappear over time.
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Responsea
Modified IMWG Criteria
c
Presence/absence of clonal cells is based upon the κ/λ ratio. An abnormal κ/λ ratio by IHC or 
immunofluorescence requires a minimum of 100 plasma cells for analysis. An abnormal ratio reflecting 
presence of an abnormal clone is κ/λ of >4:1 or <1:2.
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 determined by the SPD.
e
PD confirmation requires 2 consecutive assessments made at any time prior to the institution of any new 
anticancer therapy. Participants 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 participants who had a measurable 
serum or urine M-spike at baseline, PD cannot be defined by increases in serum FLC alone.
f
For PD, serum M-component increases of ≥1 mg/dL are sufficient to define relapse if starting 
M-component is ≥5 g/dL.
Source: Adapted from Kumar et al, 201626
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10.11. Appendix 11: CRS and ICANS Grading, Mitigation, and Management
10.11.1. 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. (see Section 6.1.1).
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 10).1 For CRS management, published 
treatment guidelines are recommended,27,28 but they may be modified as needed by the 
responsible investigator according to the best practices at their institute.
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Table 10.
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, 20191
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CRS management guidelines by ASTCT Severity Grading27,28
For all participants, during the first 48 hours after the first dose of study intervention, and 
during the first 24 hours after second dose of study intervention: 

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.

Consider tocilizumab 8 mg/kg* 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.
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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 or 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.
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.
10.11.2. 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.1 If ICANS is observed in 
relation to elranatamab, the ASTCT criteria will be used for grading1 and published 
guidelines are recommended for management.1,27,28 These treatment guidelines may be 
modified as needed by the responsible investigator according to the best practices at their 
institute.
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Table 11.
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
Table 12.
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, 20191
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ICANS Management Guidelines Per ASTCT27,28
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. 

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 minutes, 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.
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
Recommended maintenance therapy after resolution of non-convulsive status 
epilepticus are as follows: 

lorazepam 0.5 mg IV every 8 hours for 3 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.

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 3 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 hours. 

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 hours 
while monitoring metabolic profile and serum osmolality every 6 hours, 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 hours, 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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10.12. Appendix 12. Anti-infectious Prophylaxis and Monitoring 40, 41, 42, 43, 44
Participants should receive prophylaxis below. Approved anti-infective treatments may be 
substituted if treatments specified below are not available.
Prophylaxis 
Therapy 
Start 
Stop 
Anti-Bacterial 
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 
(eg history of 
pneumonia, Grade 4 
neutropenia), 
an initial 3-month 
prophylactic course 
of fluoroquinolones is 
recommended
-------------------------
After initial 3 months 
treatment, administer
for participants with 
ANC <1000/µL
Stop after 3 months of 
initial prophylaxis if ANC 
≥1000/µL
-------------------------
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
Anti-Fungal 
Fluconazole - 400 mg daily 
(or equivalent)
-------------------------
Consider switch to 
posaconazole or equivalent
For participants with 
prolonged 
neutropenia (eg. ANC 
<500/µL for >7 days) 
-------------------------
Prolonged ANC 
<500/µL >3 weeks
At neutropenia resolution 
(for example, ANC 
≥500/µL). 
Prophylaxis may be 
extended at the discretion 
of the investigator as 
clinically indicated. 
-------------------------
Until neutropenia 
resolution (ANC ≥500/μl)
Anti-viral
Acyclovir or alternative
Antiviral prophylaxis 
within 1 week after 
starting treatment is 
strongly 
recommended to 
prevent herpes zoster 
reactivation 
Continue for 3 months 
following the end of 
treatment
CMV
CMV testing by PCR is 
required prior to study drug 
administration. On study 
testing should be performed 
on a monthly to every three-
month schedule depending 
on risk factors and baseline 
CMV viral load. 
For participants with 
CMV copy number 
≥1000/mL, or per 
local standard of care, 
initiation of antiviral 
treatment is 
recommended (other 
risk factors including 
the rise in CMV copy 
Continue therapy until two 
consecutive measurements 
at least 14 days apart show 
viral load < 1000/mL and 
resolution of symptoms (if 
present)
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Prophylaxis 
Therapy 
Start 
Stop 
Valganciclovir 900 mg PO 
BID
Alternative (ganciclovir IV 
foscarnet IV.) or other 
approved agents. 
number should be 
considered). 
Treatment is required 
for symptomatic 
participants 
irrespective of viral 
load.
Pneumocystis Pneumonia 
(PCP)
PCP prophylaxis is strongly 
recommended 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 
study intervention 
Suggested duration: 
6 months OR 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.
Hypogammaglobulinemia/ 
Intravenous 
immunoglobulin (IVIG)
Monitor immunoglobulin 
levels for the occurrence of 
hypogammaglobulinemia
Administration of 
immunoglobulin for 
IgG level 
<400 mg/dL is 
strongly 
recommended
Until resolution of 
hypogammaglobulinemia
Neutropenia/G-CSF 
Prophylaxisa
Prophylactic or therapeutic 
administration of G-CSF in 
participants with severe 
neutropenia or serious 
neutropenic complications 
consistent with the ASCO 
guidelines 39 is strongly 
recommended to decrease 
the risk of neutropenia 
specifically in participants 
with baseline extensive BM 
involvement and/or low 
neutrophil counts. 
For participants with 
ANC <1000/µL 
Until resolution of 
neutropenia
a.
Eligibility restricts use of GCSF within 7 days prior to C1D1.
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10.13. Appendix 13: Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
ADA
anti-drug antibody
ADC
antibody-drug conjugate
AE
adverse event
AESI
adverse event of special interest
AIDS
acquired immunodeficiency syndrome 
ALT
alanine aminotransferase
ANC
absolute neutrophil count
APC
antigen-presenting cell
ASCT
allogeneic stem cell transplant
AST
aspartate aminotransferase
ASTCT
American Society for Transplantation and Cellular Therapy
AUCτ
area under the serum concentration-time curve from time zero 
to time τ
AUClast
area under the concentration-time curve from time zero to time 
of last measurable concentration
AV
atrioventricular
BCMA
B-cell maturation antigen
–hCG
beta-human chorionic gonadotropin
BICR
blinded independent central review
BiPAP
bilevel positive airway pressure
BM
bone marrow
BMA
bone marrow aspirate
BMB
bone marrow biopsy
BMMC
bone marrow mononuclear cells
BOR
best overall response
BP
blood pressure
bpm
beats per minute
BsAb
bispecific antibody
BUN
blood urea nitrogen
C
cycle
C1D1
Cycle 1 Day 1
C1D4
Cycle 1 Day 4
C1D8
Cycle 1 Day 8
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Abbreviation
Term
C1D15
Cycle 1 Day 15
C1D22
Cycle 1 Day 22
C12D1
Cycle 12 Day 1
C15D1
Cycle 15 Day 1
CAR
chimeric antigen receptor
CB
clinical benefit
CCR
cumulative complete response
CD38
cluster of differentiation 38
CFR
Code of Federal Regulations
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CMV
cytomegalovirus
Cmax
maximum concentration 
CNS
central nervous system
CO2
carbon dioxide (bicarbonate)
CONSORT
Consolidated Standards of Reporting Trials
CPAP
continuous positive airway pressure
CR
complete response
CRF
case report form
CRO
contract research organization
CRR
complete response rate
CRS
cytokine release syndrome
CSF
cerebrospinal fluid
CSR
Clinical Study Report
CT
clinical trial; computerized tomography
CTCAE
Common Terminology Criteria for Adverse Events
CTIS
Clinical Trial Information System
CYP
cytochrome P450
COVID-19
coronavirus disease-19
DILI
drug-induced liver injury
DLT
dose-limiting toxicity
DMC
data monitoring committee
DNA
deoxyribonucleic acid
DOCR
duration of complete response
DOR
duration of response
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Abbreviation
Term
DU
dispensable unit
DVT
Deep vein thrombosis
EC
ethics committee
ECC
Emergency Contact Card
ECG
electrocardiogram
ECHO
echocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDB
exposure during breastfeeding
EDP
exposure during pregnancy
EEG
electroencephalography
EMA
European Medicines Agency
EM
extramedullary
EMD
extramedullary disease
EMG
electromyography
EORTC MY20
European Organization for Research and Treatment of Cancer 
Multiple Myeloma module 
EORTC QLQ-CIPN20
European Organization for Research and Treatment of Cancer 
Quality of Life Questionnaire- Chemotherapy-induced 
peripheral neuropathy
EORTC QLQ-C30
European Organization for Research and Treatment of Cancer 
Quality of Life of Cancer Patients core module
EOS
end of study
EOT
end of treatment
EQ-5D
EuroQoL 5 Dimensions
ESMO
European Society for Medical Oncology
EU
European Union
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration
FISH
fluorescence in situ hybridization
FLC
free light chain
FSH
follicle-stimulating hormone
FU
follow-up
GBS
Guillain-Barre syndrome
GCP
Good Clinical Practice
gDNA
genomic DNA
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Abbreviation
Term
GGT
gamma-glutamyl transferase
GLP
Good Laboratory Practice
GVHD
graft versus host disease
HA
Health Authority 
HBV
hepatitis B virus
HCV
hepatitis C virus
HIPAA
Health Insurance Portability and Accountability Act
HIV
human immunodeficiency virus
HR
hazard ratio; heart rate
HRT
hormone replacement therapy
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
ICP
intracranial pressure
ICU
intensive care unit
ID
identification
IgA
immunoglobulin A
IgD
immunoglobulin D
IgE
immunoglobulin E
IgG
immunoglobulin G
IgH
immunoglobulin H 
IgK
immunoglobulin K
IgL
immunoglobulin L
IgM
immunoglobulin M
IHC
immunohistochemistry
IL
interleukin
IMiD
immunomodulatory drug
IMP
investigational medicinal product
IMWG
International Myeloma Working Group
IND
investigational new drug
INN
International Non-proprietary Name
INR
international normalized ratio
IP manual
investigational product manual
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Abbreviation
Term
IPAL
Investigational Product Accountability Log
IR
Immune-related
IRB
Institutional Review Board
IRT
interactive response technology
ISS
International Staging System
IV
intravenous(ly)
IWR
interactive Web-based response
LDH
lactate dehydrogenase
LFT
liver function test
LTFU
long term follow-up
LVEF
left ventricular ejection fraction
mAb
monoclonal antibody
MABEL
minimal anticipated biological effect level
MedDRA
Medical Dictionary for Regulatory Activities
MHC
major histocompatibility complex
MM
multiple myeloma
MR
minimal response
MRD
minimal residual disease 
MRI
magnetic resonance imaging
msec
millisecond
MTD
maximum tolerated dose
MUGA
multigated acquisition
N/A
not applicable
NAb 
neutralizing antibody
NCCN
National Comprehensive Cancer Network
NCI CTCAE
National Cancer Institute common terminology criteria for 
adverse events
NCT
unique ID number for a clinical trial from clinicaltrials.gov
NCV
Nerve conduction velocity
NDMM
newly diagnosed multiple myeloma
NGS
next generation sequencing 
NIMP
noninvestigational medicinal product
NMPA
National Medical Products Administration
NSAID
non-steroidal anti-inflammatory drug
OR
objective response
ORR
objective response rate 
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Abbreviation
Term
OS
overall survival
PaCO2
partial pressure of arterial carbon dioxide
PD
pharmacodynamics; progressive disease
PET
positron emission tomography
PFS
progression-free survival
PI
proteasome inhibitor
PK
pharmacokinetic(s)
POEMS
polyneuropathy, organomegaly, endocrinopathy, myeloma 
protein, and skin changes
PMAP
population modeling analysis plan
PMAR
population modeling analysis report
PR
partial response
PRO
patient-reported outcome
PS
performance status
PT
preferred term; prothrombin time
PVC
premature ventricular contraction/complex
QoL
quality of life
QT
time from the beginning of the QRS complex to the end of the 
T wave
QTcF
corrected QT (Fridericia method)
QW
once every week
Q2W
once every 2 weeks
Q3W
once every 3 weeks
Q4W
once every 4 weeks
Q12W
once every 12 weeks
R-ISS
Revised International Staging System
RNA
ribonucleic acid
RP2D
recommended Phase 2 dose
RRMM
relapsed/refractory multiple myeloma
SAE
serious adverse event
SAP
statistical analysis plan
SARS-CoV2
severe acute respiratory syndrome coronavirus 2
sBCMA
soluble BCMA
SC
subcutaneous(ly)
sCR
stringent complete response 
SCT
stem cell transplant
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Abbreviation
Term
SD
stable disease
SIFE
serum immunofixation electrophoresis
SoA
schedule of activities
SOC
standard-of-care
SOP
standard operating procedure
SPD
sum of the products of the maximal perpendicular diameters of 
measured lesions
SPEP
serum protein electrophoresis
SRSD
single-reference safety document
SSC
Study Steering Committee
SUSAR
suspected unexpected serious adverse reaction
TBili
total bilirubin
TCR
T-cell receptor
TEAE
treatment-emergent adverse event
Tmax
maximum time
TNF-α
tumor necrosis factor alpha
TNFr SF 17
tumor necrosis factor receptor superfamily 17
TTR
time to tumor response
UI
uncertainty interval
UIFE
urine immunofixation electrophoresis
ULN
upper limit of normal
UPEP
urine protein electrophoresis 
US
United States
VAS
visual analogue scale
VGPR
very good partial response 
WBC
white blood cell
wk
week
WOC
Withdrawal of consent 
WOCBP
woman of childbearing potential
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10.14. Protocol Amendment History
Document History
Document
Version Date
Summary and Rationale for changes
Amendment 1
25 June 2021
1. As per regulatory requirements (US FDA), and 
to stay consistent with global phase 2 study 
C1071003, updates to describe peripheral 
neuropathy (including GBS) as an important 
potential risk of elranatamab, and measures to 
mitigate 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) were 
fully defined.
2.
Additional information was added in Background 
(Section 2.2) based on Phase 1 results.
3. To mitigate CRS and ICANS, a 2 step-up 
priming dose approach (which includes 
premedication, and administration of 
elranatamab on C1D1 and C1D4 before the 
first full dose of elranatamab) was incorporated 
for the first week of study intervention. 
Relevant updates have been made throughout 
the protocol amendment.
4. An additional visit, hospitalization periods, 
safety assessments, sample collections, and 
PROs are included in the SoA and Section 6.
5. Clarifications have been made in Section 4.3.1, 
Dose Limiting Toxicity (DLT) definition.
6. For participant selection, clarification was 
added around DVT, window for prior 
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Document History
Document
Version Date
Summary and Rationale for changes
transplant, concerns about hypersensitivity to 
study intervention or any of its excipients and 
live attenuated vaccine administration history.
7. Clarification on blood sampling window for 
sBCMA assessment in Section 8.5.1.
8. In order to capture all potential AEs with 
elranatamab, including late onset immune-
related neurologic AEs, the safety reporting 
period after last dose of study intervention has 
been increased to 90 days.
9. Contraception use has been extended from 28 
days to 90 days after the last dose of study 
intervention.
10. Clarified requirements for laboratory 
assessments (Section 8.1.1).
11. Clarified requirements for exposure during 
pregnancy (Section 8.3.5.1).
12. Staging systems for multiple myeloma were 
more explicitly defined.
13. Given the INN name is established, 
PF-06863135 has been replaced with the INN 
name, elranatamab.
14. Clarifications were made throughout, including 
the SoA.
Amendment 2
16 March 2022
1. SoA, Appendix 2, Revised local laboratory 
collections to include serum quantitative 
immunoglobulins and plasma cells.
2. SoA, Revised BMA sampling times; Clarified 
BMA sampling times in cases of CR by all 
other parameters except bone marrow plasma 
cells. Reduced frequency of administration of 
PROs after Year 1. Clarified imaging 
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Document History
Document
Version Date
Summary and Rationale for changes
requirements after EMD 
resolution/disappearance. Removed BOR 
assessment.
3. SoA, Section 8.1.2, 8.7.3, Made BMB sampling 
optional to better align with China clinical 
practice.
4. Section 6.8.3, Add a new section of 
clarification that permitted concomitant 
treatments include infection prophylaxis and 
use of IV immunoglobulins.
5. SoA, Sections 6.5.1, 6.5.2, Table 3, 
Clarification for dose modifications, including 
those for priming doses. Clarifications have 
been made to reflect blood sampling for PK if 
the C1D4 dose cannot be administered within 
the protocol-defined window.
6. Section 7.1, For discontinuation reasons, added 
lack of efficacy.
7. Section 8.1.2, Appendix 10, Added 
immunofluorescence and flow cytometry for 
the determination of sCR to better align with 
China clinical practice.
8. Section 8.2.4, Clarified that 15-lead and 18-
lead ECGs machines are also applicable for 
local practice.
9. Section 8.7.1, Clarified allowed sample types 
for MRD evaluation. Additional samples may 
be requested by sponsor if freshly collected 
samples not available to identify the dominant 
malignant myeloma clone, at screening and 
during the on-treatment period.
10. Section 9.3.3.1, Added more detailed 
description for MRD analysis
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Document
Version Date
Summary and Rationale for changes
11. Section 9.4.1 and Table 7, Updated the 
posterior probability threshold of ≥90% to 
≥80% for Grade 3-4 CRS/ICANS and Grade 4 
treatment related non-hematologic for the 
interim safety assessments. Minimum number 
of participants with identified events that would 
prompt temporary enrollment hold were 
updated where applicable.
12. Editorial and formatting changes and 
clarifications were made throughout the 
document.
Amendment 3
31 Jan 2023
Section 1.1, Added modifier of approximately and 
at least to target sample size of 36.
Section 1.3.1, SoA, Combined description of BMA 
and BMB/BMA collections.
Section 1.3.1, SoA, Changed description of 
frequency of PRO administration from years to 
cycles. 
Section 1.3.1, SoA, Added imaging at VGPR for 
participants with EMD at screening.
Section 1.3.1, SoA and Section 10.2, Clarified that 
IgD or IgE will be tested, if they are available in 
the site, only if the heavy chain component of the 
disease is known to be IgE or IgD.
Section 1.3.1, SoA, Section 10.2 and Section 
10.12, Added CMV testing.
Section 6.8 Concomitant Therapy, 
•
Clarified the concurrent use of herbal 
medicinal products or herbal supplements 
should be avoided. 
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Document History
Document
Version Date
Summary and Rationale for changes
•
Added COVID-19 monitoring and 
treatment guidance to provide specific infection 
prophylaxis and treatment guidance to sites.
Section 8.2.3, Clarify that vital signs included 
pulse should be collected instead of HR.
Section 10.9, Clarify the order of injection site, if 
neither left lower quadrant nor the right is 
available.
Section 2.3.1 and Section 10.12 Appendix 12 
Anti-infectious Prophylaxis and Monitoring, 
Added recommendations for infection prophylaxis 
to provide guidance to investigative sites.
Sections 10.1.1, 10.1.3, 10.1.4, 10.1.6, 10.1.7, 
10.1.9, 10.1.10, Update to be consistent with latest 
template mandatory text.
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11. REFERENCES
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2. Rajkumar SV, Dimopoulos MA, Palumbo A, et al. International Myeloma Working 
Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 
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3. Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory 
multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. 
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4. Chari A, Vogl DT, Gavriatopoulou M, et al. Oral selinexor–dexamethasone for tripleclass 
refractory multiple myeloma. N Engl J Med. 2019;381(8):727-38.
5. Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN 
estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA 
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6. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 
2020;70(1):7-30.
7. Liu J, Liu W, Mi L, et al. Incidence and mortality of multiple myeloma in China, 2006–
2016: an analysis of the Global Burden of Disease Study 2016. J Hematol Oncol. 
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8. Jimenez-Zepeda V, Reece D, Trudel S, et al. Early relapse after single auto-SCT for 
multiple myeloma is a major predictor of survival in the era of novel agents. Bone 
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9. Lopez A, Mateos M-V, Oriol A, et al. Patterns of relapse and outcome of elderly multiple 
myeloma patients treated as front-line therapy with novel agents combinations. Leuk Res 
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