MAGNETISMM-3 AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
Phase: PHASE2
Conditions: Multiple Myeloma
Sponsor: Pfizer

PF-06863135 (Elranatamab)
Protocol C1071003
Final Protocol Amendment 10, 22 March 2023
PFIZER CONFIDENTIAL
Page 1
MAGNETISMM-3
AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF 
ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH 
MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE 
PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE 
ANTI-CD38 ANTIBODY
Study Intervention Number:
PF-06863135
Study Intervention Name:
Elranatamab 
US IND Number:
133940
EudraCT Number:
2020-004533-21
ClinicalTrials.gov NCT:
NCT04649359
Protocol Number:
C1071003
Phase:
2
Sponsor Legal Address
Pfizer Inc.
66 Hudson Boulevard East
New York, NY 10001
Short Title: A Phase 2 Study of Elranatamab (PF-06863135) Monotherapy in 
Participants With MM Who Are Refractory to at Least One PI, One IMiD and 
One Anti-CD38 mAb
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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Final Protocol Amendment 10, 22 March 2023
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Protocol Amendment Summary of Changes Table
Document History
Document
Version Date
Summary and Rationale for Changes
Original protocol
07 October 2020
N/A
Amendment 1
07 January 2021
1.
Throughout: Removed inclusion of participants age 
<18 years and all corresponding assent language 
(including removing reference to “legally 
authorized representative” in Section 10.1.3).  
2.
SoA, Section 8.1.1 and Appendix 10: FLC now 
specified as “serum FLC” for clarity.
3.
SoA, Section 1.1, Section 4.3, Section 6.1.1 and 
Section 6.6.3: Removed investigator’s discretion 
with regard to the transitions between dosing 
intervals (QW, Q2W).
4.
SoA and Section 8.2.4: Clarified timing of ECGs: 
removed “postdose” as there are no scheduled 
postdose collections, and removed the 60-minute 
predose window.  
5.
SoA: Added rows for “Disease response 
assessment (per IMWG criteria)” and “Assessment 
of BOR”
6.
SoA: Added detail around timing of UPEP, UIFE 
and imaging. Additional detail added to align 
optional BMB sampling with optional BMA 
sampling.
7.
SoA and Section 8.2.7: Added  “serum test 
required at screening” for clarity in alignment with 
footnote in Table 8 of Appendix 2.
8.
SoA: Removed “within 2 hour” requirement for 
biomarker sample collection.  
9.
SoA: Added sBCMA samples beyond Cycle 7 to 
characterize the impact of Q2W switch on sBCMA 
levels from Cycle 7 and on. 
10. Section 4.2.1: Modified to remove mention of 
participants in C1071001 who have previously 
received BCMA-directed BsAb.
11. Sections 4.2.2: Added MRD threshold of 10-5, with 
the potential to measure MRD frequency up to 10-6.  
12. Section 4.4: Modified to specify that the study will 
be completed when all participants have been 
followed for OS for at least 2 years from the date 
of enrollment.
13. Section 5.1 (Inclusion criterion #15): Removed 
“except for AEs not constituting a safety risk for 
the participant by investigator judgment”
14. Section 5.2 (Exclusion criteria #2, #3 and #6):
Modified for clarity.
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Final Protocol Amendment 10, 22 March 2023
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15. Section 6.1: Corrected vial size from 2 mL to 
6 mL.
16. Section 6.1.1: Corrected timing of PF-06863135 
administration from Day 21 to Day 22.
17. Section 6.6.1: Updated redosing criteria for clarity.
18. Section 6.6.1 and Table 4: Removed “or is Grade 2 
and is not considered by the investigator to be a 
safety risk to the participant”
19. Table 4 footnote b: Added “or permanent 
discontinuation.”
20. Section 8.1: Removed “assessment of best 
response, date of response onset, and date of 
progression (if applicable)”
21. Section 8.1.1: Minor edits for clarity
22. Section 8.1.5: Added “(as applicable)” to “Best 
response and date of disease progression…”
23. Section 8.2.2: Removed “Any abnormal physical 
examination findings observed prior to 
administration of the first dose of PF-06863135 
should be recorded in the Medical History CRF.”
24. Section 8.3.1: Removed “for survival” from 
“During the long-term follow-up period in this 
study…”
25. Section 8.8.1: Added MRD threshold of 10-5.
26. Section 8.8.4 – Section 8.8.7: Removed sample 
volumes as these will be specified in the laboratory 
manual. Also added “(for predose samples, 
collection should occur prior to administration of 
PF-06863135 on that day)” to clarify that predose 
sample collections are to occur on the same day as 
treatment.
27. Section 9.1.2: Added rationale for hypotheses.
28. Section 9.2: Changed power from 80% to 90% to 
detect ORR of 48% (previously 45%) in Cohort A 
and 34% (previously 31%) in Cohort B.
29. Section 9.4.5: Added section on other safety 
analyses.
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30. Section 9.5 (with references to Section 9.5 added to 
Section 2.3.1 and Section 8.3.8): Added interim 
safety assessment section for Grade ≥3 CRS, Grade 
≥3 ICANS, Grade ≥4 non-hematologic events 
(excluding CRS and ICANS) and Grade 5 
hematologic events. Also added “If the efficacy 
boundary is crossed, enrollment to the study will 
continue up to the specified number of participants, 
and all ongoing participants will continue with 
scheduled visits per the Schedule of Activities” to 
clarify that the study will not be stopped for 
efficacy at IA.
31. Appendix 2 (Table 8): Added LDH to lab 
assessments.
Appendix 10: Removed “Participants will continue 
in the last confirmed response category until there 
is confirmation of progression or improvement to a 
higher response status.”
Amendment 2
14 February 2021
1.
Title (and throughout): added study name and 
generic name (elranatamab).
2.
SoA, Section 8.2.3: clarified vital sign monitoring 
during first 48 hours of first dose.
3.
SoA, Section 6.5.1 (with reference added to 
Section 2.3.1): added premedication for CRS.
4.
SoA, Sections 8.8.1, 8.8.3: clarified optional 
BMA/BMB sample is per investigator discretion.
5.
Section 5.1: clarified bone marrow function 
inclusion criteria (granulocyte colony stimulating 
factors and transfusion support).
6.
Section 6.5.2: clarified COVID-19 vaccines are 
permitted.
7.
Sections 6.6.1, 6.6.2: clarified that dosing will be 
held until resolution of CRS or ICANS.
8.
Section 9.3: added IA and PRO analysis sets. 
9.
Section 9.5.2: revised criteria for temporary 
enrollment hold (required regulatory change).
10. Appendix 2 (Table 8): Clarified calcium (total).
11. Footer: template version added.
Amendment 3
(country-specific:
Belgium, 
Germany,
Poland, Spain) for
VHP procedure
(review of 
Amendment 1)
24 March 2021
1.
Section 5: clarifications to Inclusion Criterion 1, 
Exclusion Criteria 4, 8, and addition of Exclusion 
Criterion 12 (per VHP procedure).
2.
Section 6.1.1: clarified first dose hospitalization is 
mandatory and clarified vital sign monitoring 
during this period aligning with Appendix 11 
(Sections 1.3, 8.2.3) (per VHP procedure).
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Version Date
Summary and Rationale for Changes
3.
Section 6.5.1 (with references in Sections 1.3, 
2.3.1, 6.1.1, 8.3.8, Appendix 11): added 
premedication for CRS.
4.
Section 10.1.1: specified applicable local 
guidances (per VHP procedure).
5.
Footer: template version added.
Amendment 4 
(country-specific: 
United Kingdom) 
per MHRA 
(review of 
Amendment 1)
09 April 2021 
1.
Section 5.2: addition of Exclusion Criterion for 
administration of live attenuated vaccine within 
4 weeks of first dose (per MHRA).
2.
Section 6.1.1, Appendix 11: added guidance for 
second dose 24-hour monitoring for participants 
deemed at risk for CRS (per MHRA); clarified first 
dose hospitalization is required; clarified vital sign 
monitoring during first dose monitoring period 
aligning with Appendix 11 (Sections 1.3, 8.2.3).
3.
Section 6.5.1 (with references in Sections 1.3, 
2.3.1, 6.1.1, 8.3.8, Appendix 11): added 
premedication for CRS.
4.
Section 6.5.2: clarified COVID-19 vaccines are 
permitted.
5.
Footer: template version added
Amendment 5
02 May 2021
This amendment incorporates changes previously 
included in Amendment 2 (which was based on 
Protocol Amendment 1) and country-specific 
Amendments 3 and 4 (which were also based on 
Protocol Amendment 1); therefore Protocol 
Amendment 5 brings all the amendments into one 
document.
Following is a summary of additional changes:
1.
As per regulatory requirements (US FDA), 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.
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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. 
4.
An additional visit, hospitalization periods, safety 
assessments,  sample collections, and PROs are 
included in the SoA and Section 6.  
5.
For participant selection, clarification was added 
around DVT and window for prior transplant.
6.
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.
7.
Contraception use has been extended from 28 days 
to 90 days after the last dose of study intervention 
(as required by France HA).
8.
A Steering Committee, to be involved with general 
oversight of the study, was  established.
9.
Staging systems for multiple myeloma were more 
explicitly defined.
10. Interim analysis set populations (for both cohort A 
and B) were further defined.
11. Given the INN name is established, PF-06863135 
has been replaced with the INN name, elranatamab.
12. Added Appendix 12: Japan Regulatory 
Requirements.
13. Clarifications were made throughout, including the 
SoA. 
Amendment 6
30 May 2021
1. Revised enrollment hold rules per regulatory 
requirement (US FDA):  the posterior probability 
threshold of ≥80% is used for stopping rules for 
safety for treatment-related Grade 3-4 GBS 
(including variants), and treatment-related 
Peripheral Neuropathy/IR Neurologic AEs (section 
9.5.2 and Appendix 13).
2. Exclusion criteria for ongoing Grade ≥2 peripheral 
neuropathy was revised (per regulatory 
requirements, US FDA).
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3. Dose modifications for peripheral neuropathy were 
revised (per regulatory requirements, US FDA).
4. Clarification added for dose delays/interruptions, 
including windows (SoA, section 6.1.1, section 
6.6.2).
5. Clarified imaging schedule, including requirement 
that imaging be conducted every 12 weeks for 
participants with baseline extramedullary disease 
(SoA).  
6. Clarification added for availability of study 
treatment after end of study (section 6.7). 
7. Clarified requirements for laboratory assessments 
(section 8.1.1).
8. Removed requirement for investigator review of 
completed PRO responses (including EORTC QLQ 
CIPN20, as regular neurologic exams are 
performed by the investigator) (section 8.1.4, and 
reference in section 2.3.1). 
9. Clarified requirements for exposure during 
pregnancy (section 8.3.5.1).
10.
Clarifications were made throughout, including 
SoA and Appendices.
Amendment 7
11 November 
2021
1.
The total number of planned participants was 
revised from 150 to 180 participants allowing for 
more robust datasets. Power/sample size 
calculations updated to be based on normal 
distribution from exact method (sections 1, 4.1,  
9.2, 9.5).
2.
Interim analyses (IA) revised to include a more 
robust data set (increased N from 60 to 90 for 
Cohort A) and added efficacy IA for Cohort 
B. IAs to be based on actual number with 
adequate follow-up at time of IA (section 9.5).
3.
The follow-up period for final analysis was 
revised (section 9.2).
4.
Added statement that interim analyses results can 
be used by the sponsor for decision-making and a 
statement about requirements before interim 
analysis can be conducted in accordance with the 
sponsor’s SOPs (sections 7, 9.5).
5.
Clarification that permitted concomitant 
treatments include infection prophylaxis and use 
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of IV immunoglobulins; added further 
considerations for oral contraceptives (section 
6.5.2).
6.
Clarification for dose modifications, including 
those for priming doses (sections 6.6.1, 6.6.2, 
Table 4).
7.
Revised local laboratory collections to include 
serum quantitative immunoglobulins and plasma 
cells (SoA, Appendix 2).
8.
Revised BMA sampling times; clarified  BMA 
sampling times in cases of CR by all other 
parameters except bone marrow plasma cells 
(SoA). 
9.
Made BMB sampling optional to better align with 
global clinical practice (SoA, section 8.1.2, 8.8.3). 
10. Added immunofluorescence and flow cytometry 
for the determination of sCR to better align with 
global clinical practice (section 8.1.2, 
Appendix 10).
11. Clarified allowed sample types for MRD 
evaluation (SoA, section 8.8.1).
12. Added allowance for use of 
 sample 
in the event that the index myeloma clone is not 
identified from screening sample (section 8.8.1)  
13. Reduced frequency of administration of PROs 
after Year 1 (SoA).
14. Clarified imaging requirements after EMD 
resolution/disappearance (SoA).
15. Removed BOR assessment (SoA).
16. For discontinuation reasons, added lack of 
efficacy and completed (sections 7.1 and 7.2).
17. Added more detailed description for MRD 
analysis (section  9.4.3).
18. Clarifications were made throughout multiple 
sections, including section 1, 3-5, 8, SoA and 
Appendices.
Amendment 8
23 December 2021
1.
Added confirmed before PD (Section 1.1, 6.1.1,
and 9.4.2)
2.
Clarified that all participants will still be enrolled 
for the final analysis if the interim efficacy 
boundary is crossed and operating characteristics 
for the design are in the SAP (Section 9.5.1)
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3.
Updated the posterior probability threshold of 
≥90% to ≥80% for Grade 3-4 CRS/ICANS and 
Grade 4 treatment related nonhematologic for the 
interim safety assessments (Section 9.5.2 and 
Table 8)
4.
Editorial update (Appendix 10).
Amendment 9
29 July 2022
1.
Added key secondary endpoint, ORR by BICR 
baseline EMD status (cohort A) (Sections 1.1, 1.2, 
3, 9.1.1, 9.4.3).
2.
Added CMV testing (Section 1.3, Table 10).
3.
Updated alternative BMA sample types (Sections
1.3, 8.8.1).
4.
Updated elranatamab clinical data (C1071001 and 
C1071003 study results) (Section 2.2.3, 4.2.1). 
5.
Added infection as a potential risk of clinical 
significance for elranatamab and made updates to 
summary of data throughout (Section 2.3.1)
6.
Added more detailed guidance for infection 
prophylaxis (Section 6.5.2, and a new appendix, 
Appendix 14).
7.
Added guidance about COVID-19 testing and 
treatment (Section 6.5.2)
8.
Updates to align with SAP, including Interim 
Analysis plans for Cohort B (Section 9)
9.
Additions to Japan Regulatory Requirements 
(Section 10.12.1)
10. Editorial updates (Sections 4.3, 10.15, 11).
Amendment 10
22 March 2023
1.
 
 
 
 
 
2.
Revised elranatamab contraception requirements
(WOCBP: aligned with updated elranatamab PK 
data as described in IB; Men: aligned with 
calculated safety margin between seminal transfer 
and estimated MABEL). (Sections 1.3, 4.2.3, 5.3.1, 
10.4).
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3.
Revised elranatamab clinical study summaries, 
referring protocol users to the IB for the most 
current information (Sections 2.2.3, 2.3.1).
4.
Added more detailed descriptions in Sections 1.3
and 8.1.1 for when serum FLC should be used to 
assess disease response and about repeat sampling 
for confirmation of disease progression to match 
descriptions in Section 10.10.
5.
Added definition of ‘Final Analysis Evaluable Set’ 
to align with statistical analysis plan (Section 9.3).
6.
Revised descriptions throughout Section 10.1 to 
improve clarity/provide additional detail
(including, but not limited to, added description of 
study data collection, processing and storage 
systems [Section 10.1.4]; clarification of protection 
of personally identifiable information [Section 
10.1.5]; description of QTLs [Section 10.1.6];
clarifications for study start and closure [Section 
10.1.8]; clarification of publication policy 
[Section10.1.9]; clarifications about contact card
[Section 10.1.10]).
7.
Removed requirement to notify study team when 
treatment is restarted following SARS-CoV-2 
infection as protocol already includes relevant
guidance (Section 10.8.4).
8.
General editorial revision throughout to specify 
“confirmed” PD in descriptions of study 
intervention discontinuation and disease response 
requirements for consistency with descriptions in 
Sections 6.1.1 and 8.1.
9.
General editorial revisions throughout to correct 
grammatical errors, to maintain consistency, and/or 
to improve clarity.
10. Sponsor legal address added (page 1).
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs and any protocol administrative change 
letter(s).
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TABLE OF CONTENTS
LIST OF TABLES...................................................................................................................17
1. PROTOCOL SUMMARY...................................................................................................18
1.1. Synopsis ..................................................................................................................18
1.2. Schema ....................................................................................................................21
1.3. Schedule of Activities .............................................................................................22
2. INTRODUCTION ...............................................................................................................32
2.1. Study Rationale .......................................................................................................32
2.2. Background .............................................................................................................32
2.2.1. Multiple Myeloma ......................................................................................32
2.2.2. BCMA and CD3 .........................................................................................33
2.2.3. Elranatamab (PF-06863135).......................................................................34
2.2.3.1. Nonclinical Studies of Elranatamab..........................................34
2.2.3.2. Clinical Overview .....................................................................34
2.3. Benefit/Risk Assessment.........................................................................................34
2.3.1. Risk Assessment.........................................................................................35
2.3.2. Benefit Assessment.....................................................................................37
2.3.3. Overall Benefit/Risk Conclusion................................................................37
3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS ...........................................................37
4. STUDY DESIGN.................................................................................................................39
4.1. Overall Design.........................................................................................................39
4.2. Scientific Rationale for Study Design.....................................................................39
4.2.1. Inclusion of Prior BCMA-directed therapy................................................39
4.2.2. Biomarkers..................................................................................................39
4.2.3. Use of Contraceptives.................................................................................40
4.3. Justification for Dose ..............................................................................................40
4.4. End of Study Definition ..........................................................................................42
5. STUDY POPULATION......................................................................................................42
5.1. Inclusion Criteria.....................................................................................................42
5.2. Exclusion Criteria....................................................................................................44
5.3. Lifestyle Considerations..........................................................................................45
5.3.1. Contraception..............................................................................................45
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5.4. Screen Failures ........................................................................................................46
6. STUDY INTERVENTION..................................................................................................46
6.1. Study Intervention(s) Administered........................................................................46
6.1.1. Administration............................................................................................46
6.2. Preparation/Handling/Storage/Accountability ........................................................47
6.2.1. Preparation and Dispensing........................................................................48
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................48
6.3.1. Allocation to Study Intervention ................................................................48
6.4. Study Intervention Compliance...............................................................................49
6.5. Concomitant Therapy..............................................................................................49
6.5.1. Premedication Required for Cytokine Release Syndrome Prophylaxis .....49
6.5.2. Permitted Concomitant Medications/Therapies .........................................50
6.5.3. Prohibited During the Study.......................................................................51
6.6. Dose Modification...................................................................................................51
6.6.1. Redosing criteria.........................................................................................52
6.6.2. Dose Modifications for Elranatamab-Related Toxicity and for 
Peripheral Neuropathy .....................................................................................52
6.6.3. Dose Modification Based on Durable Overall Response ...........................55
6.7. Intervention After the End of the Study..................................................................55
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................55
7.1. Discontinuation of Study Intervention ....................................................................55
7.2. Participant Discontinuation/Withdrawal From the Study.......................................57
7.2.1. Withdrawal of Consent...............................................................................57
7.3. Lost to Follow-up....................................................................................................58
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................58
8.1. Efficacy Assessments..............................................................................................59
8.1.1. Laboratory Assessment for Evaluation of Disease Response.....................59
8.1.2. Bone Marrow Sample Assessments for Evaluation of Disease Status.......61
8.1.3. Imaging Assessments (PET/CT, CT and/or MRI ).....................................61
8.1.4. Patient-Reported Outcomes........................................................................62
8.1.5. Disease Characteristics and Treatment History..........................................63
8.2. Safety Assessments .................................................................................................64
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8.2.1. Participant Demographics and Other Baseline Characteristics ..................64
8.2.2. Physical Examinations................................................................................64
8.2.3. Vital Signs ..................................................................................................65
8.2.4. Electrocardiograms.....................................................................................65
8.2.5. Echocardiograms/Multigated Acquisition Scans........................................66
8.2.6. Clinical Safety Laboratory Assessments ....................................................66
8.2.7. Pregnancy Testing ......................................................................................66
8.2.8. ECOG Performance Status .........................................................................67
8.3. Adverse Events and Serious Adverse Events..........................................................67
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......67
8.3.1.1. Reporting SAEs to Pfizer Safety...............................................68
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................69
8.3.2. Method of Detecting AEs and SAEs ..........................................................69
8.3.3. Follow-up of AEs and SAEs.......................................................................69
8.3.4. Regulatory Reporting Requirements for SAEs...........................................69
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational 
Exposure ..........................................................................................................70
8.3.5.1. Exposure During Pregnancy......................................................70
8.3.5.2. Exposure During Breastfeeding ................................................71
8.3.5.3. Occupational Exposure .............................................................72
8.3.6. Cardiovascular and Death Events...............................................................72
8.3.7. Disease Related Events and/or Disease Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................72
8.3.8. Adverse Events of Special Interest.............................................................72
8.3.8.1. Lack of Efficacy........................................................................73
8.3.9. Medical Device Deficiencies......................................................................73
8.3.10. Medication Errors.....................................................................................73
8.3.11. Peripheral neuropathy...............................................................................74
8.4. Treatment of Overdose............................................................................................74
8.5. Pharmacokinetics ....................................................................................................75
8.6. Pharmacodynamics..................................................................................................76
8.7. Genetics...................................................................................................................76
8.7.1. Specified Genetics ......................................................................................76
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8.7.2. Banked Biospecimens for Genetics............................................................76
8.8. Biomarkers ..............................................................................................................77
8.8.1. Bone Marrow Aspirate for Minimal Residual Disease (MRD)..................77
8.8.2. Bone Marrow Aspirate for Molecular Profiling.........................................78
8.8.3. Bone Marrow Biopsy to Assess BCMA and/or Immune Cell Protein 
Biomarkers.......................................................................................................78
8.8.4. Blood to Assess sBCMA Levels.................................................................78
8.8.5. Serum to Assess Circulating Proteins and Metabolite Analysis.................78
8.8.6. Blood for T-cell Receptor (TCR) Sequencing............................................78
8.8.7. Blood for Immune Cell Profiling................................................................79
8.8.8. Saliva Sample for Germline Comparator ...................................................79
8.9. Immunogenicity Assessments.................................................................................79
8.10. Health Economics .................................................................................................80
9. STATISTICAL CONSIDERATIONS ................................................................................80
9.1. Estimands and Statistical Hypotheses.....................................................................80
9.1.1. Estimands....................................................................................................80
9.1.2. Statistical Hypotheses.................................................................................81
9.2. Sample Size Determination.....................................................................................81
9.3. Analysis Sets ...........................................................................................................82
9.4. Statistical Analyses .................................................................................................83
9.4.1. General Considerations...............................................................................83
9.4.2. Primary Endpoint........................................................................................83
9.4.3. Secondary Endpoint(s)................................................................................84
9.4.3.1. Secondary Efficacy Endpoints ..................................................84
9.4.3.2. Pharmacokinetic Analyses ........................................................85
9.4.3.3. Immunogenicity Analyses.........................................................86
9.4.4. Exploratory Endpoint(s) .............................................................................86
9.4.5. Other Safety Analyses ................................................................................86
9.4.5.1. Adverse Events..........................................................................86
9.4.5.2. Laboratory Test Abnormalities .................................................86
9.4.5.3. Electrocardiogram Analyses......................................................87
9.4.6. Other Analyse(s).........................................................................................87
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9.5. Interim Analyses .....................................................................................................87
9.5.1. Interim Analysis for Futility and Efficacy..................................................87
9.5.2. Interim Safety Assessments........................................................................88
9.6. Data Monitoring Committee or Other Independent Oversight Committee.............91
9.6.1. E-DMC .......................................................................................................91
9.6.2. Steering Committee ....................................................................................91
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................92
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............92
10.1.1. Regulatory and Ethical Considerations ....................................................92
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................92
10.1.2. Financial Disclosure .................................................................................93
10.1.3. Informed Consent Process ........................................................................93
10.1.4. Data Protection .........................................................................................94
10.1.5. Dissemination of Clinical Study Data ......................................................95
10.1.6. Data Quality Assurance ............................................................................96
10.1.7. Source Documents....................................................................................97
10.1.8. Study and Site Start and Closure ..............................................................97
10.1.9. Publication Policy.....................................................................................98
10.1.10. Sponsor’s Medically Qualified Individual..............................................99
10.2. Appendix 2: Clinical Laboratory Tests ...............................................................100
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ....................................................................101
10.3.1. Definition of AE .....................................................................................101
10.3.2. Definition of SAE...................................................................................102
10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs.....................104
10.3.4. Reporting of SAEs..................................................................................107
10.4. Appendix 4: Contraceptive Guidance .................................................................108
10.4.1. Male Participant Reproductive Inclusion Criteria..................................108
10.4.2. Female Participant Reproductive Inclusion Criteria...............................108
10.4.3. Woman of Childbearing Potential ..........................................................108
10.4.4. Contraception Methods...........................................................................109
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10.5. Appendix 5: Genetics..........................................................................................111
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments ......112
10.7. Appendix 7: ECG Findings of Potential Clinical Concern .................................114
10.8. Appendix 8: Alternative Measures During Public Emergencies ........................116
10.8.1. Eligibility................................................................................................116
10.8.2. Telehealth Visits.....................................................................................116
10.8.3. Alternative Facilities for Safety Assessments ........................................116
10.8.3.1. Laboratory Testing ................................................................116
10.8.3.2. Electrocardiograms................................................................117
10.8.4. Study Intervention ..................................................................................117
10.8.5. Adverse Events and Serious Adverse Events.........................................118
10.9. Appendix 9: Subcutaneous Injection Site Locations...........................................119
10.10. Appendix 10: IMWG Response Criteria for Multiple Myeloma ......................120
10.11. Appendix 11: CRS and ICANS Grading, Mitigation, and Management..........122
10.11.1. Cytokine release syndrome...................................................................122
10.11.2. Immune effector cell-associated neurotoxicity syndrome (ICANS) ....125
10.12. Appendix 12: Country Specific Requirements..................................................130
10.12.1. Japan Regulatory Requirements ...........................................................130
10.13. Appendix 13: Summary of Safety Stopping Rules ...........................................132
10.13.1. Treatment-Related Grade 3-4 GBS (Including Variants) per 
posterior probability 0.80 vs 0.90 ..................................................................132
10.13.2. Treatment-Related Grade 4 SN/IR Neurologic AEs (Excluding 
ICANS)/Treatment-Related Grade 3-4 Motor Neuropathy Events per 
posterior probability 0.80 vs 0.90 ..................................................................133
10.14. Appendix 14: Anti-infectious Prophylaxis and Monitoring 
Recommendation.....................................................................................................134
10.15. Appendix 15: Abbreviations .............................................................................136
11. REFERENCES ................................................................................................................142
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LIST OF TABLES
Table 1.
Efficacy Results from Trials in Similar Patient Population......................33
Table 2.
Dose Modifications for Elranatamab-Related Toxicity and for 
Peripheral Sensory or Motor Neuropathy a...............................................53
Table 3.
Dose Levels for Elranatamab....................................................................54
Table 4.
Staging Systems for Multiple Myeloma...................................................63
Table 5.
Eastern Cooperative Oncology Group (ECOG) Performance Status 
Scale..........................................................................................................67
Table 6.
Minimum Number of Participants With Identified Events That 
Would Prompt Temporary Enrollment Hold (CRS, ICANS, Non-
hematologic treatment-related AEs).........................................................89
Table 7.
Minimum Number of Participants With Identified Treatment-
Related Events That Would Prompt Temporary Enrollment Hold 
(GBS/GB-like AEs, Peripheral Neuropathy/IR Neurologic AEs)............90
Table 8.
Protocol Required Safety Laboratory Assessments................................100
Table 9.
ASTCT CRS Grading.............................................................................123
Table 10.
Immune Effector Cell-Associated Encephalopathy (ICE) Score ...........125
Table 11.
ASTCT ICANS Grading.........................................................................125
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1. PROTOCOL SUMMARY 
1.1. Synopsis 
Short Title: MAGNETISMM-3, A Phase 2 Study of Elranatamab (PF-06863135) 
Monotherapy in Participants With MM Who Are Refractory to at Least One PI, One IMiD 
and One Anti-CD38 mAb.
Rationale
The purpose of the study is to evaluate whether single-agent elranatamab can provide clinical 
benefit in participants with RRMM who are refractory to at least one PI, one IMiD and one 
anti-CD38 mAb. Because it is unknown how prior treatment with BCMA-directed therapy 
will affect the activity of elranatamab, this study will enroll one cohort with participants who 
have not previously received a BCMA-directed therapy (Cohort A) and one cohort with 
participants who have received previous treatment with BCMA-directed therapy (Cohort B).
Objectives, Estimands, and Endpoints
Objectives
Endpoints
Primary
To determine the efficacy of elranatamab in 
Cohort A and Cohort B
ORR by BICR per IMWG 
Key Secondary
To determine additional efficacy of elranatamab  in 
Cohort A
ORR by BICR baseline EMD status per IMWG
Secondary
To determine additional efficacy of elranatamab  in 
Cohort A and Cohort B
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 as graded by 
NCI CTCAE v5.0.
Severity of CRS and ICANS assessed according to 
ASTCT criteria (Lee et al, 2019b).
To evaluate the PK of elranatamab 
Pre- and postdose concentrations of elranatamab 
To evaluate the immunogenicity of 
elranatamab  
ADAs and NAbs against elranatamab
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Objectives
Endpoints
Exploratory
To explore the relationship between elranatamab  
and the biology of the participant’s MM
Measurements of biomarkers (DNA, RNA, protein 
or defined cell types) resulting from analyses of 
peripheral blood, saliva and/or BM biospecimens
To explore correlations between elranatamab 
exposure and efficacy, safety and biomarker 
endpoints, if data allow
Selected PK, efficacy, safety and biomarker 
endpoints
To assess the impact of elranatamab on patient-
reported symptoms and functioning
EORTC QLQ-C30 and MY20 
EORTC QLQ CIPN20
EQ-5D
PGI-S and PGI-C
To collect healthcare resource use data
Hospitalizations, including length of stay, ICU 
admissions, transfusions, infections and outpatient 
visits
Primary Estimand: 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.

Variable: OR 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. 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 
OR, or who die, experience confirmed PD or stop disease assessments for any reason 
prior to achieving an OR will be counted as non-responders in the assessment of OR. 

Population-level summary measure: ORR defined as the proportion of participants in 
the analysis population with an OR and 2-sided 95% CI for ORR. 
Overall Design
Study C1071003 is an open-label, multicenter, non-randomized, Phase 2 study to evaluate 
the efficacy and safety of elranatamab in RRMM participants who are refractory to at least 
one PI, one IMiD, and one anti-CD38 mAb. To determine the effects of prior BCMA-
directed therapy on the response to elranatamab monotherapy, this study will enroll 
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2 independent and parallel cohorts: one with participants who are naïve to BCMA-directed 
therapies (Cohort A), and the other with participants who have been previously exposed to 
BCMA-directed therapy, as defined in Section 5.1 (Cohort B). The primary objective for 
each independent cohort will be to determine the efficacy (ie, ORR) of elranatamab as 
assessed by BICR, as defined by IMWG. 
Number of Participants
Approximately 180 participants will be enrolled and treated, including approximately 120 
participants in Cohort A and approximately 60 participants in Cohort B.
Intervention Groups and Duration
Participants will receive SC administration of elranatamab QW. The initial doses of 
elranatamab 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 criteria listed in Section 6.6.1. If a participant does not meet these 
criteria on C1D8, initiation of dosing with 76 mg should be deferred until the criteria are met.
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) and
 
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:
This study will use an E-DMC. The E-DMC is independent of the study team and includes 
only external members. The E-DMC charter describes the role of the E-DMC in more detail.
The E-DMC will be responsible for ongoing monitoring of the efficacy and safety of 
participants in the study according to the charter. The E-DMC will review cumulative safety 
data during the study conduct as well as the interim futility and efficacy analyses.
The recommendations made by the E-DMC to alter the conduct of the study will be 
forwarded to the appropriate Pfizer personnel for final decision. Pfizer will forward such 
decisions, which may include summaries of aggregate analyses of endpoint events and of 
safety data that are not endpoints, to regulatory authorities, as appropriate. 
This study will also use a Steering Committee (consisting of both Sponsor representatives 
and at least 2 participating investigators) (see Section 9.6.2). 
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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. 
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
No PGI-C at screening or C1D1. After Year 1, 
the PROs will be administered once every 3 
cycles (C12D1, C15D1, etc). The PGIC will not 
be administered after Year 1. See Section 8.1.4
Healthcare resource use 
X
X
X
See Section 8.10
Clinical Procedures/Assessments – Note: During the treatment period, all assessments must done within 72 hours prior to dosing (see notes for exceptions)
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
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 
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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
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
Perform ECG prior to PK sample collection and 
prior to elranatamab administration (and 
premedication). ECG assessments should be 
skipped if CRS symptoms are ongoing. 
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.
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). 
 
 
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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
See Section 6 (including Section 6.6 dose 
modifications). 
Premedication for CRS
Cycle 1 Cycle 1
Cycle 1
Must be administered 60 minutes (±15 minutes) 
prior to elranatamab  dose, See Section 6.5.1.
Hospitalization 
Cycle 1 Cycle 1
Hospitalization required for at least 2 days (~48 
hr) for C1D1 and 1 day (~24 hr) 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 6.5
Subsequent anticancer 
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
X*
X*
To be conducted on 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). 
Participants with measurable disease by SPEP or 
UPEP cannot have response assessed by serum 
FLC. Except for sCR, serum FLC levels should 
only be used for response assessment when both 
the serum and urine M component levels are 
deemed not measurable or uninterpretable. Serum 
FLC cannot replace UPEP/UIFE in any situation 
where urine M component is measurable at 
baseline.
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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
*For participants who discontinue study 
intervention without confirmed PD: perform at 
EOT visit, then at least Q4W (±1 wk) until 
confirmed PD, withdrawal of consent, initiation 
of subsequent anticancer therapy, participant lost 
to follow-up, 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 interval (±1 wk) between 
assessments should be maintained regardless of 
dose delays/interruptions). 
*For participants who discontinue study 
intervention without confirmed PD: perform at 
EOT visit, then at least Q4W (±1 wk) until 
confirmed PD, withdrawal of consent, initiation 
of subsequent anticancer 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 wk) interval whether dose given or not 
(ie, the 28-day interval (±1 wk) between 
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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
assessments should be maintained regardless of 
dose delays/interruptions). 
*For participants who discontinue study 
intervention without confirmed PD: perform at 
EOT visit, then at least Q4W (±1 wk) until 
confirmed PD, withdrawal of consent, initiation 
of subsequent anticancer 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. 
If an evaluable 24-hour urine collection is missed, 
another attempt for collection should be made 
within 7 days of the missed assessment.
See Section 8.1.1 for complete details (including 
requirements for repeat testing for confirmation
of PD).
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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
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 wk), and 
also  at suspected MR or PR. 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 confirmed PD, WOC, initiation of 
subsequent anticancer therapy, participant lost to 
FU, death, or defined EOS.
See Section 8.1.3
BMA
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, as long as other CR 
criteria are maintained.
See Section 8.1.2
BMA for cytogenetics 
(FISH/karyotyping)
X
See Section 8.1.2
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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
BMB/BMA
X
Time points for disease assessments described in notes
At screening and to confirm sCR. Either BMA or 
BMB can be used; however, the same method 
should be used for a participant throughout the 
study. Optional (investigator discretion) at 
suspected PD. See Section 8.1.2
Contraception check
X
X
X
X
X
Only required for WOCBP. Through 5 months 
post last dose of study intervention.  See Section 
5.3.1
Pregnancy test
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). Serum 
required at screening. 
See Section 8.2.7 and Table 8.
Hematology/chemistry 
X
X
Cycle1 
Cycle 1
Cycle 1 Cycle 1
X
X
See Section 8.2.6 and Table 8.  For Cycle 1 Day 
4, hematology only.
Serum quantitative 
immunoglobulins (IgG, IgM, 
IgA, IgD, IgE)
X
X
X
X
See Section 8.2.6 and Table 8. 
CMV testing (quantitative 
PCR)
X*
*Every 1 to 3 months depending on risk factors 
See Section 8.2.6, Table 8, and Appendix 14.
PT/INR
X
See Section 8.2.6 and Table 8
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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
Genetics and Biomarker Assessments (Central Laboratory)
BMA for MRD 
X
Samples to be collected each time there is a BMA assessment
At screening a freshy collected frozen BMA 
sample is preferred. If this sample is not 
available, an alternative sample collected at 
screening (
) can be submitted.  Sample 
types permitted include A) Cell pellet/suspension, 
or B) Frozen BMMC dry cell pellet, or C) BMA 
smear slides and/or touch prep slides, or D) Re-
cut slides from BM clot tissue block, or E) Re-cut 
scrolls from a BM clot tissue block, or F) gDNA 
isolated from BMA.
A freshly collected frozen BMA sample is 
preferred for all on-treatment samples. 
Alternative on-treatment samples are A) Cell 
pellet/suspension from BMA, or B) frozen BMMC 
dry cell pellet, or C) gDNA isolated from BMA. 
See Section 8.8.1
BMA for molecular profiling
X
Samples to be collected each time there is a BMA assessment
See Section 8.8.2
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 collected for disease 
assessment,collection of this sample for 
biomarker analysis is encouraged. See 
Section 8.8.3
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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 sBCMA 
levels
X
Cycles 
1, 2, 3, 
7, 10, 
13, etc.
Cycle 1
Cycle 1
Cycles
1, 2
X
Predose, 6 and 24 h postdose on C1D1.
Predose and 24 h postdose on C1D4.  
Predose, 6 h postdose on C1D8. 
Collect predose only at C1D15, C2D1, C2D15, 
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 8.8.4
Blood sample for circulating 
proteins and metabolite 
analysis
Cycle 1 Cycle 1
Cycle 1
Cycle 1 Cycle 1
Collect predose and 24h postdose on C1D1.
Collect predose and 24 hr post dose on C1D4. 
Collect predose at all other times. 
If CRS is suspected, additional blood samples 
should also be collected if not already scheduled. 
See Section 8.8.5
Blood sample for TCR 
sequencing
X
Cycles
1, 2, 3 
Cycle 1
Collect predose. 
See Section 8.8.6
Blood sample for immune cell 
profiling
Cycle 1, 
3
Cycle 1
Cycle 1
Cycle 1 Cycle 1
Collect predose. 
See Section 8.8.7
Pfizer Prep D1 banked 
biospecimen(s) 
Cycle 1
Collect predose. If not collected on the designated 
collection day, collect at the next available time 
point when biospecimens are being collected in 
conjunction with a participant visit. See 
Section 8.7.2
Saliva sample for germline 
comparator
Cycle 1
Collect predose.
See Section 8.8.8
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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
Pharmacokinetics and Immunogenicity Assessments
Blood sample for PK
Cycles 
1-4, 7, 
10, etc 
Cycle 1
Cycle 1 Cycle 1 Cycle 1 
X
Predose, 6 and 24 h postdose on C1D1.
Predose and 24 h postdose on C1D4.  
Predose, 6 h postdose on C1D8; predose only on 
C1D15, C1D22, C2D1, C3D1, then every 3rd
cycle starting Cycle 4 (ie, C4D1, C7D1, C10D1, 
etc). If CRS is suspected, additional PK samples 
should be collected if not already scheduled. See 
Section 8.5
Blood sample for ADAs and 
NAbs
Cycles 
1-4, 7, 
10, etc 
X
Predose 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 and PK should be collected if 
not scheduled. See Section 8.9
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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 whether single-agent elranatamab can provide clinical 
benefit in participants with RRMM who are refractory to at least one PI, one IMiD and one 
anti-CD38 mAb. Because it is unknown how prior treatment with BCMA-directed therapy 
will affect the activity of elranatamab, this study will enroll one cohort with participants who 
have not previously received BCMA-directed therapy (Cohort A) and one cohort with 
participants who have received previous treatment with BCMA-directed therapy (Cohort B). 
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 (Bray et al, 2018). 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 (Siegel et al, 2020). 
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 (Jimenez-Zepeda 
et al, 2015). 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 
(Lopez et al, 2015). 
Moreover, MM patients typically cycle through many lines of treatment, having become 
relapsed/refractory to various therapeutic approaches. Trials that have treated patients with 
BCMA-directed therapy in the RRMM population have included heavily pretreated patients; 
for example, 57% of patients studied by Trudel et al had received ≥5 lines of therapy (Trudel 
et al, 2019) and other trials have included populations receiving a median of 6 (range 3-18) 
prior therapies (Mailankody et al, 2020) and a median of 5 (range 3 to 18) prior therapies 
(Berdeja et al, 2020b).
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 
(Kumar et al, 2004). 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% (Nandakumar et al, 2019). Results from 2 trials in patient populations similar to the 
current protocol are summarized in Table 1. The lack of effective and durable therapeutic 
options highlights the unmet medical need in the RRMM patient population.
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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, 
2020b)
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)
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.
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 (Sanchez et al, 2012b). Cleavage of cell surface BCMA by γ-secretase 
releases sBCMA (Laurent et al, 2015) 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 (Pont et al, 2019). 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 (Ghermezi et al, 2017b). Moreover, patients in 2 studies with high 
baseline levels of sBCMA appeared to have poorer clinical outcomes (Sanchez et al, 2012a; 
Ghermezi et al, 2017a).
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 (Smith-Garvin et al, 2009). 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. 
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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 one 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 three different orthotopic human MM models established in immunodeficient mice 
engrafted with human T-cells, and greater potency was correlated with higher BCMA 
expression levels. In another orthotopic tumor model with low BCMA expression levels, a 
second dosing of elranatamab was found to delay tumor progression. As part of a secondary 
pharmacology assessment, elranatamab induced cytokine release in human whole blood, 
which was expected due to the presence of BCMA-expressing target cells, confirming the 
mechanism of action. Finally, two 1-month GLP toxicology studies in cynomolgus monkeys 
showed mechanism-based effects, including increased T-cell activation, increased cytokines 
and microscopic findings in the secondary lymphoid tissues. Decreases in circulating 
lymphocytes and serum globulins were also noted. 
2.2.3.2. Clinical Overview
As of January 2023, elranatamab is being evaluated for the treatment of adult patients with 
RRMM or newly diagnosed MM in 11 ongoing studies. For detailed information on these 
studies, refer to the IB.
Enrollment in the current study (C1071003) completed in January 2022 with a total of 187 
participants enrolled and treated. Study results on the safety, efficacy, clinical pharmacology 
and immunogenicity of elranatamab are provided in the IB.
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. 
CRS signs and symptoms are expected mainly after 
the first and second dose and occasionally after the 
third dose or later 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 6.6.2.
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 6.5.1).
Additional management for Grade ≥3 CRS is described in Section 9.5.2.
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 6.6.2. 
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Potential Risk of 
Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention: Elranatamab
Additional management for Grade ≥3 ICANS is described in Section 9.5.2
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, and history of prior neuropathy with BCMA-directed drugs (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.
The administration of drugs known to cause peripheral neuropathy should be 
carefully considered, and if possible, avoided by the investigator; effective 
treatment and prophylaxis for infections should be prioritized. (Section 6.5).
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 6.6.2. 
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 9.5.2.
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 6.5 and Appendix 14 for infection prophylaxis.
Monitor participants, especially those with neutropenia, for signs of 
infection. See Section 6.6.2 for dose modifications for elranatamab.
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2.3.2. Benefit Assessment
There are few viable treatment options for RRMM, especially for those patients who are 
refractory to PIs, IMiDs and anti-CD38 mAbs (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 (see IB). 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 (BLENREP (belantamab mafodotin-blmf) USPI, 2020), has 
not been observed with elranatamab (see IB).
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.
3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS
Objectives
Endpoints
Primary
To determine the efficacy of elranatamab in 
Cohort A and Cohort B
ORR by BICR per IMWG 
Key Secondary
To determine additional efficacy of elranatamab in 
Cohort A
ORR by BICR baseline EMD status per IMWG
Secondary
To determine additional efficacy of elranatamab in 
Cohort A and Cohort B
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 as graded by 
NCI CTCAE v5.0.
Severity of CRS and ICANS assessed according to 
ASTCT criteria (Lee et al, 2019).
To evaluate the PK of elranatamab 
Pre- and postdose concentrations of elranatamab
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Objectives
Endpoints
To evaluate the immunogenicity of 
elranatamab 
ADAs and NAbs against elranatamab
Exploratory
To explore the relationship between elranatamab  
and the biology of the participant’s MM
Measurements of biomarkers (DNA, RNA, protein 
or defined cell types) resulting from analyses of 
peripheral blood, saliva and/or BM biospecimens
To explore correlations between elranatamab 
exposure and efficacy, safety and biomarker 
endpoints, if data allow
Selected PK, efficacy, safety and biomarker 
endpoints
To assess the impact of elranatamab on patient-
reported symptoms and functioning
EORTC QLQ-C30 and MY20 
EORTC QLQ CIPN20
EQ-5D
PGI-S and PGI-C
To collect healthcare resource use data
Hospitalizations, including length of stay, ICU 
admissions, transfusions, infections and outpatient 
visits
Estimand
This section defines the estimand associated with the primary endpoint of the study. 
Primary Estimand: 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.

Variable: OR 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. 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 
OR, or who die, experience confirmed PD, or stop disease assessments for any reason 
prior to achieving an OR will be counted as non-responders in the assessment of OR. 

Population-level summary measure: ORR defined as the proportion of participants in 
the analysis population with an OR and 2-sided 95% CI for ORR. 
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The key secondary estimand for ORR by BICR baseline extramedullary disease (EMD) 
status per IMWG for Cohort A is the same as the primary estimand except performed 
separately for participants with and without EMD at baseline per BICR.
4. STUDY DESIGN
4.1. Overall Design
Study C1071003 is an open-label, multicenter, non-randomized, Phase 2 study to evaluate 
the efficacy and safety of elranatamab in RRMM participants who are refractory to at least 
one PI, one IMiD, and one anti-CD38 mAb. To determine the effects of prior BCMA-
directed- therapy on the response to elranatamab monotherapy, this study will enroll 2 
independent and parallel cohorts, one with participants who are naïve to BCMA-directed 
therapies (Cohort A; approximately 120 participants) and the other with participants who 
have been previously exposed to BCMA-directed therapy, as defined in Section 5.1
(Cohort B; approximately 60 participants). The primary objective for each independent 
cohort will be to determine the efficacy (ie, ORR) of elranatamab as assessed by BICR, as 
defined by IMWG. 
4.2. Scientific Rationale for Study Design
4.2.1. Inclusion of Prior BCMA-directed therapy
Numerous BCMA-directed therapies are currently under investigation (Berdeja et al, 2020a; 
Lonial et al, 2020a; Topp et al, 2020a) and it is likely that some potential participants will 
have previously received one of these therapies. Because it is unknown how such prior 
treatment may affect the activity of elranatamab, this study will include a cohort of 
participants who have been previously exposed to BCMA-directed therapy. In the ongoing 
Phase 1 study (C1071001), disease responses of PR or better have been observed in  7 of 13 
(53.8 %) participants who were previously exposed to BCMA-directed ADCs or CAR T-cell 
therapy (see IB). 
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 
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prognosis during MM treatment (Kumar et al, 2016). 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 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 8.8.
Banked Biospecimens will be collected and stored for further analyses which may, for 
example, provide greater understanding of the study intervention.
4.2.3. Use of Contraceptives
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 (see 
Appendix 4). There are no contraception requirements for males.
4.3. Justification for Dose
The RP2D of elranatamab in the current study is 76 mg QW administered as a SC injection 
starting from C1D8.  Priming doses will be used for the first week of treatment. 
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 (see IB). 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 general to be associated with a lower rate of Grade 2 CRS, the most 
common TEAE (see IB). 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 (see IB). Therefore, a fixed dose will be used in study 
C1071003.
Encouraging clinical activity 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 monotherapy
cohorts (see IB). 
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 (starting on C1D8), 
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 
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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 (Lee et al, 2019b)). 
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 
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 6.6.1. 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. 
 
 
 
 
 
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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 enrollment.
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. Male or female participants age ≥18 years.

A female participant is eligible to participate if she is not pregnant or 
breastfeeding. Refer to Appendix 4 for all reproductive criteria for male 
(Section 10.4.1) and female (Section 10.4.2) participants.
Type of Participant and Disease Characteristics:
2. Participants who are willing and able to comply with all scheduled visits, treatment 
plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al, 2014). 
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 one IMiD (as defined in Note below).
6. Refractory to at least one PI (as defined in Note below).
7. Refractory to at least one anti-CD38 antibody (as defined in Note below).
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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. Cohort A: Has not received prior BCMA-directed therapy. 
Cohort B: Has received prior BCMA-directed ADC or BCMA-directed CAR T-cell 
therapy, either approved or investigational.
10. ECOG performance status ≤2. 
11. LVEF ≥40% as determined by a MUGA scan or ECHO.
12. Adequate hepatic function characterized by the following:
a.
Total bilirubin ≤2 x ULN (≤3 x ULN if documented Gilbert’s syndrome);
b. AST ≤2.5 x ULN; and
c.
ALT ≤2.5 x ULN
13. 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).
14. 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).
15. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Informed Consent:
16. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the ICD and in 
this protocol.
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5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. Smoldering MM.
2. Active plasma cell leukemia.
3. 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);
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. 
8. History of any grade peripheral sensory or motor neuropathy with prior 
BCMA-directed therapy (Cohort B).
9. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor 
polyneuropathy.
10. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, 
or viral infection.   Active infections must be resolved at least 14 days prior to 
enrollment. 
11. 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.
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12. 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:
13. Previous treatment with an anti-BCMA bispecific antibody.
Prior/Concurrent Clinical Study Experience:
14. Previous administration with an investigational drug 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). 
Other Exclusions:
15. 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. 
16. Known or suspected hypersensitivity to the study intervention or any of its excipients.
17. Live attenuated vaccine must not be administered 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 is utilizing an appropriate method of contraception for the individual 
participant from the permitted list of 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 SoA (including long term follow-up visit/contacts covering the 
required contraception period [through 5 months post last dose of study intervention for 
WOCBP [Appendix 4 Section 10.4]), 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). 
Contraception check is only required for WOCBP.  In addition, the investigator or designee 
will instruct the participant to call immediately if the selected contraception method is 
discontinued and document the requirement to use an alternate protocol-specified method, 
including if the participant will no longer use abstinence as the selected contraception 
method, or if pregnancy is known or suspected in the participant. If a participant is confirmed 
to be pregnant, study intervention should be discontinued.
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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).
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 vial
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 country 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 
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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 6.6.3). 
 
  
Dose modifications may occur according to the guidelines described in Section 6.6. 
The first doses of study intervention 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 C1D1, and for 1 day (~24 hours) for C1D4. 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  as 
long as the participant meets the redosing criteria listed in Section 6.6.1. 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 6.5.1)
Each participant may receive study intervention until confirmed disease progression, 
unacceptable toxicity, withdrawal of consent, or study termination. 
6.2. Preparation/Handling/Storage/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.
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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.
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, or nurse practitioner) 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 the cohorts will proceed through the use of an IRT system 
(IWR). The site personnel (study coordinator or specified designee) will be required to enter 
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or select information including but not limited to the user’s ID and password, the protocol 
number, and the participant number. The site personnel will then be provided with a 
treatment assignment, enrollment number, and DU or container number when study 
intervention is being supplied via the IRT system. The IRT system will provide a 
confirmation report containing the participant number, 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. 
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.
6.4. Study Intervention Compliance
Participants will receive study intervention directly from the investigator or designee, under 
medical supervision. The date and time of each dose administered in the clinic will be 
recorded in the source documents and recorded in the CRF. The dose of study intervention 
and study participant identification will be confirmed at the time of dosing by a member of 
the study site staff other than the person administering the study intervention. 
The site will complete the required dosage Preparation Record located in the IP manual. The 
use of the Preparation Record is preferred, but it does not preclude the use of an existing 
appropriate clinical site documentation system. The existing clinical site's documentation 
system should capture all pertinent/required information on the preparation and 
administration of the dose. This may be used in place of the Preparation Record after 
approval from the sponsor and/or designee.
Compliance with study intervention will be documented in the source documents and CRF. 
Study intervention start dates, reasons for delays, dose reductions, and/or missed doses will 
be recorded in the CRF. Deviation(s) from the prescribed dosage regimen will be recorded in 
the CRF.
A record of study intervention dispensed to and administered to each participant must be 
maintained. 
6.5. Concomitant Therapy
6.5.1. 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 per local label are 
permissible. 
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Similar premedications for doses at other time points may be given at the discretion of  the 
investigator.
See Appendix 11 for management of CRS and ICANS (Neelapu et al, 2018b; Lee et al, 
2019b; Neelapu, 2019a).
6.5.2. 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. 
Concomitant treatment considered necessary for the participant’s well-being may be given at 
the discretion of the investigator.  The administration of antibacterial, anti-fungal, and/or 
antiviral agents for infection prophylaxis in participants at increased risk of infection in 
accordance with NCCN, IMWG, ESMO, and/or institutional guidelines is strongly 
encouraged (Dimopoulos et al, 2021; Kumar et al, 2020; Raje et al, 2022). Refer to 
Appendix 14 for all anti-infectious prophylaxis and monitoring recommendations.
Monitor immunoglobulin levels and administer intravenous immunoglobulin for IgG level 
<400 mg/dL. See Appendix 14.
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 vaccine administration within 48 hours 
before or after the first and second doses of study intervention.  Individuals with MM are at 
increased risk of severe disease and complications from COVID-19 infection (Chari et al, 
2020; Terpos et al, 2020). 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.  In keeping with 
standard of care practice, it is recommended that participants 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 usual 
standard of care, 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.Hormonal contraceptives that meet the contraception requirements of this study are 
allowed to be used in participants who are WOCBP (see Appendix 4). 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.
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See Appendix 11 for management of CRS and ICANS (Neelapu et al, 2018a; Lee et al, 
2019a; Neelapu, 2019b).
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.  Effective treatment and prophylaxis 
for infections should be prioritized.
Caution is advised on theoretical grounds for any surgical procedures during the study. The 
appropriate interval of time between surgery and study intervention required to minimize the 
risk of impaired wound healing and bleeding has not been determined. Postoperatively, the 
decision to reinitiate study intervention should be based on a clinical assessment of 
satisfactory wound healing and other aspects of surgical recovery.
Palliative radiotherapy 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 
indicative of PD. The appropriate interval of time between radiotherapy and study 
intervention has not been determined.
6.5.3. Prohibited During the Study 
No additional anticancer therapy will be permitted while participants are receiving study 
intervention. 
Chronic systemic corticosteroid use for palliative or supportive purposes is not permitted; 
however, steroid replacement for adrenal insufficiency at doses equivalent to ≤10 mg 
prednisone daily is acceptable. Acute emergency administration, topical applications, inhaled 
sprays, eye drops, or local injections of corticosteroids are allowed.
6.6. Dose Modification
Criteria for dose modification due to toxicity and efficacy are presented in the following 
sections.
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The recommended dose modification guidelines for participants who have active confirmed 
(positive by regulatory authority-approved test) or presumed (test pending/clinical suspicion) 
SARS-CoV-2 infection can be found in Appendix 8.
6.6.1. Redosing criteria
During a cycle: Re-treatment following interruption for treatment-related toxicity and for 
peripheral neuropathy (any causality) within a cycle should follow the dose modification and 
guidance section below (Section 6.6.2). 
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 
  
Dose reductions, as outlined in Section 6.6.2 (Table 2), 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

Platelet 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 6.6.2]), no ongoing 
CRS or ICANS (any grade)

Recovery of treatment-emergent peripheral neuropathy to Grade <1 severity.
6.6.2. Dose Modifications for Elranatamab-Related Toxicity and for Peripheral 
Neuropathy
The recommended dose modifications for elranatamab-related toxicities and for peripheral 
neuropathy are presented in Table 2. All dose modifications should be based on the worst 
preceding toxicity and must be recorded on the CRF.
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Table 2.
Dose Modifications for Elranatamab-Related Toxicity and for Peripheral 
Sensory or Motor Neuropathy a
Toxicity
Grade 1
Grade 2
Grade 3
Grade 4
Elranatamab-
related 
Non-hematologic
(excluding 
peripheral 
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 
Hematologic a,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 
discontinued from 
treatment.
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.
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 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 
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Table 2.
Dose Modifications for Elranatamab-Related Toxicity and for Peripheral 
Sensory or Motor Neuropathy a
mg) upon meeting the redosing criteria (Section 6.6.1). If the 32 mg dose was tolerable, the elranatamab dose 
should be increased to 76 mg.  In case of ongoing CRS or ICANS of any grade on any dosing day, dosing will 
be held until resolution.
b.
Grade 3 or 4 nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy to 
require dose modification or permanent discontinuation.
c.
Excludes lymphopenia which is expected based on the elranatamab mechanism of action. 
d.
For thrombocytopenia: dosing can continue if platelets ≥25 × 109/L. 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.
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 3.
Table 3.
Dose Levels for Elranatamab 
Dose
Remarks
76 mg
Dose to be administered starting Cycle 1 Day 8 (refer to Section 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.
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Table 3.
Dose Levels for Elranatamab 
Dose
Remarks
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 reescalation is agreed by the investigator and the sponsor.
6.6.3. Dose Modification Based on Durable Overall Response 
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). 
 
 
6.7. Intervention After the End of the Study
No study treatment will be provided to study participants after the end of the study.
Availability of study treatment following closure of the study through expanded 
access/compassionate/continued use mechanism if the investigator and participant desire to 
continue treatment and if there is documented continued benefit from study treatment for the 
participant would be at the discretion of the sponsor and subject to study treatment 
availability and compliance with local laws and regulations. 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
Note: Results from the planned interim analyses (Section 9.5) 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. 

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.

AEs requiring discontinuation (as described in Section 6.6.2, Dose Modification for
Toxicity), or any AE that in the judgement of the investigator compromises the 
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participant’s ability to continue study-specific procedures or is considered to not be in 
the participant’s best interest. 

PD as defined by IMWG (see Appendix 10). 

Lack of efficacy (eg, increase of disease burden not qualifying as PD according to 
IMWG criteria).

Participant becomes pregnant or begins breastfeeding.

Significant protocol deviation 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.

Completed.

Death.

Termination of the study by the 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 for data to be collected at the time of discontinuation of study 
intervention and follow-up for any further evaluations that need to be completed.
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 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.
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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,  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.
NOTE: for participants who discontinue study intervention without confirmed disease 
progression,  disease response assessments should continue at least Q4W (±1 wk) until 
confirmed 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 follow-up;

Lost to follow-up;

Death; and

Study terminated by sponsor.

Completed. 
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.
Lack of completion of all or any of the withdrawal/early termination procedures will not be 
viewed as protocol deviations so long as the participant’s safety was preserved.
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 
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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.
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 
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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.
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 
wellbeing of the participant. When a protocol required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.
8.1. Efficacy Assessments
All disease responses will be assessed according to IMWG response criteria (Appendix 10) 
and entered on the CRF. All response categories (except stable disease) require two 
consecutive assessments (confirmation).
Disease assessments are to be conducted per SoA: 28-day (±1 wk) interval whether dose 
given or not (ie, the 28-day interval [±1 wk] 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. Assessments will include: 

SPEP for the measurement of serum proteins, including M proteins.   
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
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.

24-hour UIFE for definitive identification of specific M-proteins (including IgG, IgA, 
IgM, and kappa and lambda light chains). UIFE will be required at baseline, when 
UPEP shows no measurable protein, at suspected 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 non-measurable (including at suspected CR). Serum 
free kappa, free lambda and free kappa/lambda ratio will be collected. Participants 
with measurable disease by SPEP or UPEP cannot have response assessed by serum 
FLC. Except for sCR, serum FLC levels should only be used for response assessment 
when both the serum and urine M component levels are deemed not measurable or 
uninterpretable. Serum FLC cannot replace UPEP/UIFE in any situation where urine 
M component is measurable at baseline.
Note: For participants treated with daratumumab 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. 
In participants with two M-protein bands at baseline, unless the second band is due to 
daratumumab or other therapeutic mAb interference, the sum of the two spikes should be 
used for monitoring of disease. 
PD must be confirmed (unless due to EMD). When PD (clinical or biochemical) is suspected, 
applicable tests (eg, SPEP, SIFE, UPEP, UIFE, serum FLC tests) should be repeated for 
confirmation prior to initiation of new anticancer therapy. To confirm PD, 2 discrete samples 
are required, and testing cannot be based upon the splitting of a single sample.
Note that if a participant had measurable serum or urine M-protein (M-spike) at baseline, 
unless the band is due to/confounded by the presence of daratumumab or other therapeutic 
mAb, PD cannot be defined by increases in serum FLC alone. Serum FLC levels should only 
be used for response assessment when both the serum and urine M-component levels are 
deemed not measurable or uninterpretable. Furthermore, careful attention should be given to 
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.
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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. 
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)] 
(Sonneveld et al, 2016). 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.
BMB/BMA samples will be collected as per SoA 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 should be used for a 
participant throughout the study.
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 8.8). 
BMA obtained while a participant is in suspected or actual CR will be evaluated by a central 
lab for MRD using NGS (see Section 8.8.1).
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.  For participants with only skin 
involvement, skin lesions should be measured with a ruler at timepoints specified in the SoA. 
Screening images will be used to determine evaluable  lesions for each participant. The same 
imaging technique should be used throughout the study (pre- and post-baseline assessments). 
Bone lesions and any soft tissue plasmacytoma documented at baseline must undergo serial 
monitoring. 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 
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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.
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
All PROs will be administered electronically. For each country, PRO translations in the 
official language(s) will be provided. Participants should be offered their choice of language 
from among the official translations for their country. 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.
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 PGI-S and PGI-C will also be 
collected to enable the implementation of anchor-based methods to establish meaningful 
change in PROs according to FDA guidance (FDA, 2014). The EORTC QLQ CIPN20 
assesses chemotherapy-induced peripheral neuropathy (Postma et al, 2005).  
EORTC QLQ-C30 is a well-known, reliable and valid self-administered questionnaire used 
in oncology trials (Aaronson et al, 1993; Osoba et al, 1997). The QLQ-C30 contains 30 items 
and is composed of both multi-item scales and single-item measures. These include five 
functional scales (physical, role, emotional, cognitive and social functioning), three symptom 
scales (fatigue, nausea/vomiting, and pain), six 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 (Cocks et al, 2007). It 
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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).
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 (Rabin & de Charro, 2001). 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 PGI-S is a single-item PRO designed to assess participant’s overall impression of 
disease severity at a given point in time. The PGI-C is a single-item PRO designed to assess 
the participant’s overall sense of whether there has been a change in their disease since 
starting treatment. The PGI-S and PGI-C can be employed as anchors in responder analyses 
of other PRO instruments, to help interpret clinically meaningful changes in scores.
The EORTC QLQ CIPN20 is a module developed by the EORTC group to assess 
chemotherapy-induced peripheral neuropathy (Postma et al, 2005).  It contains 20 items 
which can be grouped into a sensory subscale (9 items), motor subscale (8 items) and 
autonomic subscale (3 items).
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 4),
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 4.
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
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Table 4.
Staging Systems for Multiple Myeloma
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).
8.2. Safety Assessments
Planned time points for all safety assessments are provided in the SoA. 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. All physical 
examination data (not including neurological examinations, see below) collected during the 
course of the study will be considered source data only and will not be required to be 
reported on the CRF. 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. 
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. 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.
Baseline encephalopathy assessment will be performed using the ICE tool (Lee et al, 2019b)
(Appendix 11) at C1D1. The ICE tool will also be used as part of assessing each suspected 
ICANS event.
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8.2.3. Vital Signs
Vital signs (temperature, HR, BP and O2 saturation) should be collected per institutional 
standards at time points specified in the SoA prior to blood collection. Pre-dose vital signs 
collected on Day 1, Day 4, Day 8, Day 15 and Day 22 of Cycle 1 should be reported on the 
CRF. Vital signs associated with AEs may 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 should 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 using an ECG machine that automatically calculates 
the heart rate and measures PR, QT, and QTcF intervals and QRS complex. For ECG 
machines that do not report QTcF, calculation of QTcF from QT and heart rate, for example 
using online tools, is acceptable. Alternative lead placement methodology using torso leads 
(eg, Mason-Likar) should not be used given the potential risk of discrepancies with ECGs 
acquired using standard limb lead placement. All scheduled ECGs should be performed after 
the participant has rested quietly for at least 10 minutes in a supine position. 
A triplicate ECG (3 serial ECGs conducted within approximately 5 to 10 minutes total time) 
will be performed at all time points specified in the SoA. ECG will be performed prior to PK 
sample collection and elranatamab administration (and prior to premedication, as applicable). 
ECG assessments should be skipped if CRS symptoms are ongoing to avoid the confounding 
effects of CRS on ECG measurements.
If mean QTcF is >500 msec, ECGs should be re-evaluated by a qualified person at the 
institution for confirmation. If a) a postdose QTcF interval remains ≥60 msec from the 
baseline and is >450 msec; or b) an absolute QTcF value is ≥500 msec for any scheduled 
ECG for greater than 4 hours (or sooner, at the discretion of the investigator); or c) QTcF 
intervals get progressively longer, the participant should undergo continuous ECG 
monitoring. A cardiologist should be consulted if QTcF intervals do not return to less than 
the criterion listed above after 8 hours of monitoring (or sooner, at the discretion of the 
investigator). 
Abnormal findings reported by the ECG machine should be reviewed by the investigator in 
order to decide if they are clinically significant. Any findings of clinical concern will also be 
reviewed by a cardiologist. New or worsened clinically significant findings in the ECG 
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occurring after the informed consent must be recorded as an AE in the eCRF. ECG tracings 
should be made available if requested by the sponsor.
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality. It is important that leads be placed in the 
same positions each time in order to achieve precise ECG recordings. If a machine read 
QTcF value is prolonged, as defined above, repeat measurements may not be necessary if a 
qualified medical provider’s interpretation determines that the QTcF values are in the 
acceptable range.
ECG values of potential clinical concern are listed in Appendix 7.
8.2.5. Echocardiograms/Multigated Acquisition Scans
ECHO or MUGA will be performed at screening as specified in the SoA. If additional 
assessments are performed, the same method should be used throughout the study.
8.2.6. Clinical Safety Laboratory Assessments 
See Appendix 2 for the list of clinical safety laboratory tests to be performed and the SoA for 
the timing and frequency. All protocol-required laboratory assessments, as defined in 
Appendix 2, must be conducted in accordance with the laboratory manual and the SoA. 
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety issues. 
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF. 
Clinically significant abnormal laboratory findings are those which are not associated with 
the underlying disease, unless judged by the investigator to be more severe than expected for 
the participant's condition.
All laboratory tests with values considered clinically significantly abnormal during 
participation in the study or within the active AE reporting period (see Section 8.3.1) should 
be repeated until the values return to normal or baseline or are no longer considered clinically 
significant by the investigator or medical monitor.
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 
A serum pregnancy test is required at screening; thereafter, pregnancy tests may be urine or 
serum tests, but must have a sensitivity of at least 25 mIU/mL. Pregnancy tests will be 
performed in WOCBP at the times listed in the SoA. Following a negative pregnancy test 
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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), at 
the end of treatment visit and at the follow-up visit. Pregnancy tests may also be repeated if 
requested by IRBs/ ECs or if required by local regulations. If a urine test cannot be 
confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such 
cases, the participant must be excluded if the serum pregnancy result is positive.
8.2.8. ECOG Performance Status
ECOG PS (Table 5) will be assessed at Screening . ECOG PS should be obtained on the 
scheduled day, even if study intervention is being held.
Table 5.
Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
0
Fully active, able to carry on all pre-disease 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 and Serious Adverse Events
The definitions of an AE and an SAE can be found in Appendix 3.
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or 
the participant's legally authorized representative). 
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). 
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, 
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which is obtained before the participant’s participation in the study (ie, before undergoing 
any study-related procedure and/or receiving study intervention), through and including a 
minimum of 90 calendar days, except as indicated below, after the last administration of the 
study intervention.  NOTE, as indicated in Section 8.3.1.2: If a participant begins a new 
anticancer therapy, the recording period for nonserious AEs ends at the time the new 
treatment is started; however, SAEs must continue to be recorded on the CRF during the 
above-indicated active collection period. 
Only SAEs will be actively elicited and collected after completion of the active collection 
period described above. The SAEs will be reported to Pfizer Safety on the CT SAE Report 
Form only if considered reasonably related to elranatamab.
Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator 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 Electronic Data Collection Tool.
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 via the Electronic Data Collection Tool 
immediately upon awareness and under no circumstance should this exceed 24 hours, as 
indicated in Appendix 3. The investigator will submit any updated SAE data to the sponsor 
within 24 hours of it being available.
If a participant begins a new anticancer therapy, SAEs occurring during the above-indicated 
active collection period must still be reported to Pfizer Safety irrespective of any intervening 
treatment. Note that a switch to a commercially available version of the study intervention is 
considered as a new anticancer therapy for the purposes of SAE reporting.
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8.3.1.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF.
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant.
If a participant begins a new anticancer therapy, the recording period for nonserious AEs 
ends at the time the new treatment is started; however, SAEs must continue to be recorded on 
the CRF during the above-indicated active collection period. Note that a switch to a 
commercially available version of the study intervention is considered as a new anticancer 
therapy for the purposes of SAE reporting.
8.3.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.3.3. Follow-up of AEs and SAEs
After the initial AE/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.
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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 (e.g., 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. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the study intervention under study during pregnancy or breastfeeding and 
occupational exposure 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 
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Form. Since the exposure information does not pertain to the participant enrolled in 
the study, the information is not recorded on a CRF; however, a copy of the 
completed CT SAE Report Form is maintained in the investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless pre-
procedure 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 (i.e., ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a liveborn 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
An occupational exposure occurs when a person receives unplanned direct contact with the 
study intervention, which may or may not lead to the occurrence of an AE. Such persons may 
include healthcare providers, family members, and other roles that are involved in the trial 
participant’s care.
The investigator must report occupational exposure to Pfizer Safety within 24 hours of the 
investigator’s awareness, regardless of whether there is an associated SAE. The information 
must be reported using the CT SAE Report Form. Since the information 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 is 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.
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For both the priming doses and first full dose (76 mg), premedication for CRS is required 
(see Section 6.5.1).
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” (Lee et al, 2019b). 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.
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 via the Electronic Data Collection 
Tool.
Additional management for Grade ≥3 CRS and ICANS is described in Section 9.5.2.
8.3.8.1. Lack of Efficacy
Lack of efficacy 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 via the Electronic Data 
Collection Tool to Pfizer Safety 
Within 24 Hours of Awareness
Medication errors 
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
Medication errors include:

Medication errors involving participant exposure to the study intervention;
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
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 via the Electronic Data 
Collection Tool 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 progressive (Richardson et al, 2012). 
Recently, peripheral neuropathy has been described following administration of BCMA-
directed bispecific T-cell engagers (Topp et al, 2020b).  
Peripheral neuropathy (including GBS) is considered an important potential risk of 
elranatamab.
Work-up for new or worsening Grade ≥2 peripheral neuropathy should include a neurology 
consult, imaging (eg MRI of the spine), NCV/EMGs, and lumbar puncture to assess CSF.  In 
consultation with a neurologist, appropriate therapy for peripheral neuropathy (eg, steroids 
and/or IV immunoglobulin) should be considered.
Closely monitor  participants for signs and symptoms of neuropathy following infections or 
following the administration of any vaccine. 
8.4. 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.
The sponsor does not recommend specific treatment for an overdose.
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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 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 plasma sample for PK analysis within 28 days from the date of the last dose 
of elranatamab 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.
8.5. Pharmacokinetics 
All participants will have blood samples collected for PK assessments of elranatamab serum 
concentrations at the time points specified in the SoA. In the event of suspected CRS, 
unexpected or serious AE, or AE leading to discontinuation of study intervention, additional
PK samples should be collected if not already scheduled. The actual date/time of sample 
collection should be documented in the CRF. For each time point, blood samples of 
approximately 5 mL, to provide a minimum of 2 mL serum, will be collected for 
measurement of serum concentrations of elranatamab. Instructions for the collection and 
handling of biological samples will be provided in the laboratory manual or by the sponsor. 
The actual date and time (24-hour clock time) of PK sample collection 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 (see SoA). 
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. For pre-dose PK samples, collection should occur prior to administration of 
elranatamab on that day.
Samples will be used to evaluate the PK of elranatamab. Each serum sample will be divided 
into 2 aliquots, to provide a minimum of 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, or for other internal exploratory purposes.
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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.
8.6. Pharmacodynamics
Biomarker samples may also be used for exploratory pharmacodynamics analyses 
(see Section 8.8) at the time points specified in the SoA.
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.
8.7. Genetics
8.7.1. Specified Genetics
Genetic assessments will be performed utilizing BMA, saliva, and blood samples as 
described in the SoA. 
Please refer to relevant subsections in Section 8.8.
8.7.2. Banked Biospecimens for Genetics
A 4 mL blood sample optimized for DNA isolation Prep D1 will be collected as local 
regulations and IRBs/ECs allow. 
Banked Biospecimens may be used for research related to the study intervention(s) and MM. 
Genes and other analytes (eg, proteins, RNA, nondrug metabolites) may be studied using the 
banked samples. 
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See Appendix 5 for information regarding genetic research. Details on processes for 
collection and shipment of these samples can be found in the lab manual.
8.8. Biomarkers
8.8.1. Bone Marrow Aspirate for Minimal Residual Disease (MRD) 
A BMA sample will be taken at the time points specified in the SoA. Next-generation 
sequencing of the sample taken pre-dose 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 and frozen BMA sample is not available for identification 
of the dominant malignant myeloma clone, the sponsor may request an alternative BMA 
sample type. The alternative BMA sample can be collected during screening or can be 
 
. If a participant has a clonoSEQ® MRD assay result from a previous testing 
that identified the index multiple myeloma clone, and the result is retrievable and useable in 
this study, the sponsor may give approval to use this result instead of submitting an 
alternative BMA sample.
Alternative BMA sample types include:

Cell pellet/suspension from BMA, minimum 1 million cells, or

1 million frozen BMMC dry cells pellet collected from fresh BMA, or

BMA smear slides and/or touch prep slides, 3-5 slides total, or

Re-cut slides from bone marrow clot tissue block, minimum 5 slides, 8 microns thick, 
or

Re-cut scrolls from a bone marrow clot tissue block, minimum 8 scrolls, 5 microns 
thick, or  

gDNA isolated from BMA, fresh samples preferred, minimum 1 μg. 
For MRD tracking samples (i.e. collected after C1D1), if a freshly collected and frozen BMA 
sample is not available, an alternative sample from the list below can be submitted:

Cell pellet/suspension from BMA, minimum 1 million cells, or

5-10 million frozen BMMCs dry cell pellet collected from fresh BMA, or

gDNA isolated from BMA, fresh samples preferred, minimum 28 μg
If the central lab is unable to identify an index malignant myeloma clone with the screening 
(
) sample, or if the central lab is unable to determine MRD status with the on-
treatment sample, the sponsor may request a second BMA sample type from the site. 
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8.8.2. Bone Marrow Aspirate for Molecular Profiling
A BMA sample will be collected at the times specified in the SoA, 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. 
8.8.3. Bone Marrow Biopsy to Assess BCMA and/or Immune Cell Protein Biomarkers
A BMB maybe collected at the times specified in the SoA. 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, immune cell populations). 
8.8.4. 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 predose 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.  
8.8.5. Serum to Assess Circulating Proteins and Metabolite Analysis
A blood sample will be collected at time points specified in the SoA (for pre-dose 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 8.8.4 for 
post-dose collection window guidance. 
8.8.6. Blood for T-cell Receptor (TCR) Sequencing
A blood sample will be collected from all participants at the time points described in the SoA
(for pre-dose 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. 
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8.8.7. Blood for Immune Cell Profiling
A blood sample will be collected from all participants at the time points specified in the SoA
(for pre-dose samples, collection should occur prior to administration of elranatamab on that 
day). This sample will be used to examine the levels and distribution of blood cell 
populations either by RNA sequencing analysis and/or by DNA sequencing and/or by 
specialized epigenetic phenotyping approaches. 
8.8.8. Saliva Sample for Germline Comparator
Unless prohibited by local regulations or ethics committee decision, a 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.
8.9. 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. 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. 
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.
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8.10. Health Economics
Health economics/medical resource utilization will be evaluated in this study.
Healthcare resource utilization will be reported for both scheduled and unscheduled visits, 
covering health care resource use for disease monitoring, treatment monitoring, and 
management of treatment-emergent adverse events. Resource use for scheduled and 
unscheduled visits will be captured via the CRF. If hospital admission has occurred, 
additional information such as reason for admission and length of stay may be collected. 
These data may be supplemented with medical records. All information will be kept 
confidential and will be used exclusively for the study purpose. All records will be de-
identified with individual’s records labeled only with the assigned participant identification 
number.
9. STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in a SAP, which will be maintained by the sponsor. The 
SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment.
9.1. Estimands and Statistical Hypotheses
9.1.1. Estimands
This section defines the estimand associated with the primary endpoint of the study.
Primary Estimand: 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.

Variable: OR 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. 

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. 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 
OR, or who die, experience confirmed PD, or stop disease assessments for any reason 
prior to achieving an OR will be counted as non-responders. 

Population-level summary measure: ORR defined as the proportion of participants in 
the analysis population with an OR and 2-sided 95% CI for ORR. 
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The key secondary estimand for ORR by BICR baseline EMD status per IMWG for Cohort 
A is the same as the primary estimand except performed separately for participants with and 
without EMD at baseline per BICR.
9.1.2. Statistical Hypotheses
This study has two cohorts: Cohort A will enroll participants who are naïve to BCMA-
directed therapies, and Cohort B will enroll participants who have prior exposure to BCMA-
directed therapies. The primary objective of this study is to determine the efficacy in Cohort 
A and Cohort B with respect to ORR by BICR, as defined by IMWG.
In Cohort A, the study will test the null hypothesis that the ORR by BICR as defined by 
IMWG is ≤30% versus the alternative hypothesis that the ORR by BICR as defined by 
IMWG is >30%. The null hypothesis ORR for this cohort is based on the results of the 
DREAMM-2 study (Lonial et al, 2020b) and the STORM study (Chari et al, 2019), which 
were conducted in similar multiple myeloma populations with respect to prior treatments. 
In Cohort B, the study will test the null hypothesis that the ORR by BICR as defined by 
IMWG is ≤15% versus the alternative hypothesis that the ORR by BICR as defined by 
IMWG is >15%. There are currently limited data available on the response rate after 
retreatment with a BCMA antibody drug conjugate or CAR-T therapy, but it is expected that 
the ORR would likely be notably lower than the BCMA naïve population. Thus, a null ORR 
of 15% is anticipated to be a reasonable estimate. 
9.2. Sample Size Determination
The sample size for Cohort A and Cohort B was calculated to provide adequate power for 
testing the statistical hypotheses regarding the primary endpoint of ORR independently in the 
two cohorts using a two-stage design based on the exact binomial distribution. A total of 
120 participants enrolled and treated in Cohort A provides approximately 98% power to 
reject the null hypothesis (ORR by BICR of 30%) when the alternative hypothesis that ORR 
by BICR of 48% is true, with a 1-sided significance level of 0.025. Similarly, a total of 60 
participants enrolled and treated in Cohort B provides approximately 95% power to reject the 
null hypothesis (ORR by BICR of 15%) when the alternative hypothesis that  ORR by BICR 
of 34% is true, with a 1-sided significance level of 0.025.
An IA for both (non-binding) futility and efficacy will be conducted for Cohort A and Cohort 
B; details are described in Section 9.5. 
At the time of the SAP amendment prior to the interim analysis, enrollment had exceeded the 
120 Cohort A and 60 Cohort B participants. Enrollment closed in January 2022 with 123 
Cohort A and 64 Cohort B participants enrolled and treated.
At the time of the final analysis, the rule for rejecting the null hypothesis based on an exact 
binomial test will depend on the number of participants enrolled and treated in each cohort, 
respectively. At the final analysis in Cohort A, if there are ≥48 (39.0%) objective responders 
by BICR observed out of 123 participants enrolled and treated in the cohort, it will be 
concluded that the null hypothesis is rejected, and the cohort has demonstrated that the true 
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ORR by BICR exceeds 30%. At the final analysis in Cohort B, if there are ≥16 (25.0%) 
objective responders by BICR observed out of 64 participants enrolled and treated in the 
cohort, it will be concluded that the null hypothesis is rejected, and the cohort has 
demonstrated that the true ORR by BICR exceeds 15%. 
At the time of the SAP amendment prior to the interim analysis, 31% of Cohort A had EMD 
at baseline. If the null hypothesis for ORR by BICR is rejected for Cohort A, the key 
secondary endpoint of ORR by BICR for those without EMD at baseline will be tested in a 
hierarchical fashion using the gatekeeping procedure that the ORR is ≤38% with a 1-sided 
significance level of 0.025. If the null hypothesis for ORR by BICR for those without EMD 
at baseline is rejected for Cohort A, the key secondary endpoint of ORR by BICR for those 
with EMD at baseline will be tested in a hierarchical fashion using the gatekeeping procedure 
that the ORR is ≤12% with a 1-sided significance level of 0.025.
The final analysis of each cohort will be conducted once all patients have had at least 2 post-
baseline response assessments or have otherwise discontinued response assessments within 
the first 2 months of treatment. 
9.3. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Defined Analysis Set
Description
Safety Analysis Set 
The safety analysis set in each cohort will include all enrolled 
participants in the respective cohort who received at least one dose of 
study intervention. This will be the primary analysis population for 
evaluating participant characteristics, treatment 
administration/compliance and safety endpoints.
Final Analysis Evaluable Set
The final analysis evaluable set in each cohort will include all enrolled 
participants in the respective cohort who received at least one dose of 
study intervention. This will be the primary analysis population for 
evaluating efficacy endpoints. This is the same as the safety analysis 
set thus only the “safety analysis set” terminology will be used.
Interim Analysis Evaluable 
Set A
The interim analysis evaluable analysis set A will include the first 
90 enrolled participants who received at least one dose of study 
intervention in Cohort A. This will be the primary analysis population 
for evaluating efficacy endpoints at the interim analysis for Cohort A.
Interim Analysis Evaluable 
Set B
The interim analysis evaluable analysis set B will include the first 
30 enrolled participants who received at least one dose of study 
intervention in Cohort B. This will be the primary analysis population 
for evaluating efficacy endpoints at the interim analysis for Cohort B.
PK Analysis Set
The PK analysis set is a subset of the safety analysis set and will 
include participants who have at least one postdose 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.
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Defined Analysis Set
Description
Biomarker Analysis Set
The biomarker parameter analysis set in each cohort 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 in each cohort will include all participants in the 
safety analysis set who completed a baseline (last PRO assessment 
prior to or on the first dose of study treatment) 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 process 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.
9.4. 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.
9.4.1. General Considerations
The study will enroll 2 independent and parallel cohorts: one with participants who are naïve 
to BCMA-directed therapies (Cohort A) and one with participants who have prior exposure 
to BCMA-directed therapies (Cohort B). Efficacy analyses will use the Safety Analysis Set 
and be reported for Cohort A and Cohort B separately. Safety analyses will also use the 
Safety Analysis Set and be reported for each cohort and for all cohorts combined. 
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. 
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.
9.4.2. Primary Endpoint
In each of Cohort A and Cohort B, BOR will be assessed based on reported overall responses 
recorded at evaluation time points from the date of first dose until the first documentation of 
confirmed PD, death or start of new anticancer therapy, whichever occurs first.

OR will encompass confirmed sCR, CR, VGPR and PR.

CB will encompass confirmed sCR, CR, VGPR, PR, and MR.
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The primary endpoint of ORR by BICR is defined as the proportion of participants with an 
OR by BICR per IMWG criteria, and will be analyzed in the Safety Analysis Set. Point 
estimates of ORR by BICR in each of Cohort A and Cohort B will be calculated along with 
the 2-sided exact 95% CIs using the Clopper-Pearson method. The null hypotheses will be 
tested at 1-sided alpha of 0.025 independently in the two cohorts using the exact binomial 
test, and the corresponding 1-sided p-value will be provided separately for Cohort A and 
Cohort B. 
9.4.3. Secondary Endpoint(s)
Analyses of secondary efficacy endpoints will use the Safety Analysis Set.
9.4.3.1. Secondary Efficacy Endpoints
ORR by BICR baseline EMD status for Cohort A (key secondary endpoint) is defined the 
same as the primary endpoint except separately for participants with and without EMD at 
baseline per BICR.
ORR by investigator is the proportion of participants in the analysis population with an OR 
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. Point 
estimates of CRR will be calculated along with the 2-sided exact 95% CIs using the Clopper-
Pearson method. 
CRR by BICR and CRR by investigator will be summarized separately.
DOR is defined, for participants with an OR per IMWG criteria, as the time from the first 
documentation of OR 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 
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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 
the end of the study. OS for participants not known to have died are censored on the date 
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 OR per IMWG criteria, as the time from the date of 
first dose to the first documentation of OR 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.
9.4.3.2. Pharmacokinetic Analyses
PK data analyses will include descriptive summary statistics of the pre-dose and post-dose 
serum concentrations of elranatamab by study visit and time point. In addition, the PK 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.
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9.4.3.3. Immunogenicity Analyses
For immunogenicity data, the percentage of patients with positive ADA will be summarized. 
Listings and summary tabulations of the ADA data at baseline and post-randomization will 
be generated. Samples may also be analyzed for the presence of NAb, and any data will be 
similarly summarized. For patients 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.
9.4.4. Exploratory Endpoint(s)
The details of exploratory endpoint analyses, including PROs, will be described in the SAP. 
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. 
9.4.5. Other Safety Analyses
The Safety Analysis Set will be the primary population for evaluating safety.
9.4.5.1. Adverse Events
AEs (except CRS and ICANS) will be graded by the investigator according to NCI CTCAE 
Version 5.0 and coded using MedDRA. CRS and ICANS will be assessed by the investigator 
according to the grading described by Lee et al (Lee et al, 2019b) (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.
9.4.5.2. 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. 
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9.4.5.3. Electrocardiogram Analyses
Changes from baseline for the ECG parameters QT interval, heart rate, QTcF interval, PR 
interval, and QRS complex will be summarized by cohort and time.
The number (%) of participants with maximum postdose QTcF values and maximum 
increases from baseline in the following categories will be tabulated by treatment: 
Safety QTcF Assessment
Degree of Prolongation
Mild (msec)
Moderate (msec)
Severe (msec)
Absolute value
≥450-480
>480-500
>500
Increase from baseline
30-60
>60
9.4.6. 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. 
9.5. Interim Analyses
Interim analyses will be performed to assess futility and/or efficacy as described in details 
below. Participants may be discontinued from the study intervention/study as a result of 
interim analysis outcome, as described in Section 7. Interim analysis results may be used for 
decisions regarding stopping for futility, stopping for early success, or adapting the study 
after the interim analysis.
Before any interim analysis is performed, the details of the objectives, decision criteria, 
dissemination plan, and method of maintaining the study blind as per Pfizer’s SOPs will be 
documented and approved in the EDMC charter.  In addition, the analysis details will be 
documented and approved in the SAP.
9.5.1. Interim Analysis for Futility and Efficacy
An IA for both (non-binding) futility and efficacy will be conducted on ORR by BICR for 
Cohort A based on the first 90 participants enrolled and treated in that cohort. At the IA for 
Cohort A, if there are ≤31 (34.4%) objective responders by BICR observed, accrual may be 
stopped for further evaluation due to futility; if there are ≥38 (42.2%) objective responders 
by BICR observed, the efficacy boundary will be crossed; if the IA crosses neither the futility 
boundary nor the efficacy boundary, Cohort A will proceed as planned to the final analysis as 
described in Section 9.2. If the efficacy boundary is crossed, enrollment to the study will 
continue up to the specified number of participants for the final analysis, and all ongoing 
participants will continue with scheduled visits per the SoA. 
An IA for (non-binding) futility and efficacy will be conducted on ORR by BICR for Cohort 
B based on the first 30 participants enrolled and treated in that cohort. At the IA for Cohort 
B, if there are ≤3 (10.0%) objective responders by BICR observed, accrual may be stopped 
for further evaluation due to futility; if there are ≥11 (36.7%) objective responders by BICR 
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observed, the efficacy boundary will be crossed; if the IA crosses neither the futility 
boundary nor the efficacy boundary, Cohort B will proceed as planned to the final analysis as 
described in Section 9.2. If the efficacy boundary is crossed, enrollment to the study will 
continue up to the specified number of participants for the final analysis, and all ongoing 
participants will continue with scheduled visits per the SoA.
Each respective interim analysis will occur no earlier than the point at which all early 
responders (ie, those who respond within the first 3 post-baseline assessments) among the 
participants to be included have had their responses confirmed. At the time of the interim 
analysis, the testing rule will depend on the actual number of participants included in the 
analysis for each cohort with sufficient follow-up.
At the time of the SAP amendment prior to the interim analysis, 94 Cohort A participants 
were initially dosed at least 4 months prior to the data cutoff and were to be included in the 
interim analysis. The updated boundaries were ≤33 (35.1%) objective responders by BICR 
for futility and ≥41 (43.6%) objective responders by BICR for efficacy. It was determined 
no interim analysis will be performed for Cohort B participants as not enough participants 
have adequate follow-up since Cohort B has a higher incidence of EMD at baseline 
compared to Cohort A. The boundaries at the final analysis for Cohort B do not change if no 
interim analysis is performed.
Operating characteristics (Type I and Type II error) were calculated using the exact binomial 
distribution and are detailed in the SAP. It can be noted that the futility stopping boundary 
for both cohorts at the interim and final analyses use the rho family beta-spending boundary 
with parameter = 3 and that the efficacy stopping boundary for both cohorts at the interim 
and final analyses use the rho family alpha-spending boundary with parameter = 5.
9.5.2. Interim Safety Assessments
An E-DMC will review cumulative safety data during the study conduct and may make 
recommendations to alter the conduct of the study (see Section 9.6). In addition, the 
incidence of Grade 3-4 CRS, Grade 3-4 ICANS, Grade 4 treatment-related non-hematologic 
events (excluding CRS and ICANS), Grade 3-4 treatment-related GBS/GBS-like AEs, 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 pre-specified threshold, the 
study will be placed on a temporary enrollment hold by the Sponsor until discussions can be 
held with the Study Steering Committee and the E-DMC. During any temporary enrollment 
hold, no new participants can be enrolled, nor can any newly enrolled participant start study 
intervention. Pending Steering Committee and E-DMC assessment, 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 
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provided by the sponsor to the investigators, the ECs/IRBs, the regulatory authorities, and 
any CRO(s) used in the study (see also Section 10.1.8).   
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 
and ICANS). Table 6 summarizes the minimum number of participants with such identified 
events that would meet the above criteria. 
Table 6.
Minimum Number of Participants With Identified Events That Would 
Prompt Temporary Enrollment Hold (CRS, ICANS, Non-hematologic 
treatment-related AEs)
Number of Evaluable Participants 
(Cohort A + B)
10-13
14-18
19-22
23-26
27-30
31-35
36-39
Minimum number of participants with 
Grade 3-4 CRS events that would lead to a 
temporary enrollment hold*
4
5
6
7
8
9
10
Minimum number of participants with 
Grade 3-4 ICANS events that would lead 
to a temporary enrollment hold*
4
5
6
7
8
9
10
Minimum number of participants with 
Grade 4 treatment-related non hematologic 
events (excluding CRS and ICANS) that 
would lead to a temporary enrollment 
hold*
4
5
6
7
8
9
10
Prior distribution: Beta (0.5,0.5)
Criteria for 40 or more evaluable participants will be calculated such that the study will be put on temporary 
hold if the posterior probability that the true event rate exceeds 20% is ≥0.80. 
Evaluable participants are defined as those who have received at least 1 dose of study treatment having an 
identified event or those without such an event who have been followed for at least 28 days from first dose. 
* The study will be put on temporary hold as soon as the minimum number of evaluable participants with the 
identified AEs has reached the threshold (eg, if there are 4 participants experiencing the identified AE out of 
the first 6 evaluable participants, the study will be put on hold).
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 7 summarizes the minimum number of evaluable participants with such identified 
events that would meet the above criteria.  (See also Appendix 13 for additional details.)
Table 7.
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 
(Cohort A + B)
20-39
40 -64
65-90
91-
116
117-
144
145-
150a
Minimum number of participants with 
Grade 3-4 treatment-related GBS/GB-like 
events that would lead to a temporary 
enrollment hold*
2
3
4
5
6
7
Number of Evaluable Participants 
(Cohort A + B)
20-27
28-35
36-43
44-52
53-60
61-69
70-78b
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**
4
5
6
7
8
9
10
Prior distribution: Beta (0.5,0.5)
a.Criteria for 151 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  79 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, for GBS/GB-like AEs, if there are 2 participants experiencing 
the identified AE out of the first 10 evaluable participants, the study will be put on hold).
** The study will be put on temporary hold as soon as the minimum number of evaluable participants with 
the identified AEs has reached the threshold (eg, if there are 4 participants experiencing the identified AE out 
of the first 15 evaluable participants, the study will be put on hold).
In addition, the study will be put on temporary hold if any of the following criteria are met:

1 Grade 5 event of CRS,

1 Grade 5 event of ICANS,

1 Grade 5 treatment-related peripheral neuropathy or IR neurologic event, 
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
Any 2 treatment-related Grade 5 events (excluding CRS and ICANS and peripheral 
neuropathy/IR neurologic event). 
9.6. Data Monitoring Committee or Other Independent Oversight Committee
9.6.1. E-DMC
This study will use an E-DMC. The E-DMC is independent of the study team and includes 
only external members. The E-DMC charter describes the role of the E-DMC in more detail.
The E-DMC will be responsible for ongoing monitoring of the efficacy and safety of 
participants in the study according to the charter. The E-DMC will review cumulative safety 
data during the study conduct as well as the interim futility and efficacy analyses.
The recommendations made by the E-DMC to alter the conduct of the study will be 
forwarded to the appropriate Pfizer personnel for final decision. Pfizer will forward such 
decisions, which may include summaries of aggregate analyses of endpoint events and of 
safety data that are not endpoints, to regulatory authorities, as appropriate.
9.6.2. Steering Committee
This study will use an SSC. The SSC (consisting of both Sponsor representatives and at least 
2 participating investigators) will evaluate, upon requirement of the Sponsor, participant 
cases where further discussions of participant management are required (note: any final 
decisions about participant management reside with the investigator). The SSC will also be 
involved with the general oversight of the study, although any final decisions regarding study 
conduct will remain with the Sponsor. 
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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.

In Germany, the provisions of the Medicinal Products Act (AMG), the GCP 
Regulation (GCP-V) and the Guideline for Good Clinical Practice (ICH-GCP E6 
(R2)) apply. Provisions of General Data Protection Regulation (DSGVO) and the 
Federal / State Data Protection Act (BDSG / LDSG BW) are to be complied with.
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents (eg, 
advertisements) must be reviewed and approved by the sponsor and 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 guidelines, the IRB/EC, European regulation 536/2014 
for clinical studies (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 
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information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately. 
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 ICH GCP that the investigator becomes aware 
of.
10.1.2. Financial Disclosure
Investigators and sub-investigators will provide the sponsor with sufficient, accurate 
financial information as requested to allow the sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate regulatory authorities. 
Investigators are responsible for providing information on financial interests during the 
course of the study and for 1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or his/her representative will explain the nature of the study 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 guidelines, HIPAA 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 his/her 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 his or her personal data and to withdraw consent for the 
processing of his or her 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 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 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.
Unless prohibited by local requirements or IRB/EC decision, the ICD will contain a separate 
section that addresses the use of samples for optional additional research. The optional 
additional research does not require the collection of any further samples. The investigator or 
authorized designee will explain to each participant the objectives of the additional research. 
Participants will be told that they are free to refuse to participate and may withdraw their 
consent at any time and for any reason during the storage period. A separate signature will be 
required to document a participant's agreement to allow specimens to be used for additional 
research. Participants who decline to participate in this optional additional research will not 
provide this separate signature.
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 his or her actual identity and medical record identification. 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.
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10.1.5. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT/CTIS, and/or 
www.pfizer.com, and other public registries 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 patient-level data or full CSRs for the purposes 
of “bonafide scientific research” that contributes to the scientific understanding of the 
disease, target, or compound class. Pfizer will make available data from these trials 18 
months after study completion. Patient-level data will be anonymized in accordance with 
applicable privacy laws and regulations. CSRs will have personally identifiable information 
anonymized.
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Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.6. 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 maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password protected or secured in a locked room to 
prevent access by unauthorized third parties.
QTLs are predefined parameters that are monitored during the study. Important deviations 
from the QTLs and any remedial actions taken will be summarized in the CSR.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source records and documents. 
This verification may also occur after study completion. It is important that the 
investigator(s) and their relevant personnel are available during the monitoring visits and 
possible audits or inspections and that sufficient time is devoted to the process.
Monitoring details describing strategy including 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, remote, or onsite monitoring), are provided in the 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.
Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements.
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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 
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.
10.1.7. 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.
10.1.8. 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.
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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.
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 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.
10.1.9. 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 
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regarding interpretation and/or presentation of specific analysis results, resolution of, and 
responsibility for, such disagreements will be the collective responsibility of all authors of 
the publication.
For all publications relating to the study, the investigator and Pfizer will comply with 
recognized ethical standards concerning publications and authorship, including those 
established by the International Committee of Medical Journal Editors. The investigator will 
disclose any relationship with Pfizer and any relevant potential conflicts of interest, including 
any financial or personal relationship with Pfizer, in any publications. All authors will have 
access to the relevant statistical tables, figures, and reports (in their original format) required 
to develop the publication.
If publication is addressed in the clinical study agreement, the publication policy set out in 
this section will not apply.
10.1.10. Sponsor’s Medically Qualified Individual
The contact information for the sponsor's MQI 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 their investigator and the sponsor’s MQI for study-related medical 
questions or problems from nonstudy healthcare professionals, participants are provided with 
an 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 participant and their investigator and site staff, and between the investigator and 
sponsor study team. The ECC is only to be used by healthcare professionals not involved in 
the research study, as a means of reaching the investigator or site staff related to the care of a 
participant. The Pfizer Call Center number is to be used when the investigator and site staff 
are unavailable. The Pfizer Call Center number is not for use by the participant directly; if a 
participant calls that number directly, they 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 locally at times defined in the SoA. 
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 8.
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)

AST, ALT

Total bilirubin

Alkaline phosphatase

Albumin

Total protein

Lactate dehydrogenase (LDH)a

Uric acida

Serum beta-2 microglobulina,c

PT/INR

Pregnancy test 
(β-hCG) b

See Section 10.12.1 for local 
regulatory requirements.

Serum quantitative 
immunoglobulins (IgG, IgM, 
IgA, IgD, IgE)

CMV testing (by quantitative 
PCR), every 1 to 3 months 
(see Appendix 14)
a.
At baseline (minimum), and as clinically indicated.
b.
For female participants of childbearing potential only. Serum test is required at screening; for other time 
points, urine testing will be standard for the protocol unless serum testing is required by local regulation or 
IRB/EC.
c.
Required for multiple myeloma staging
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.

The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will 
be reported as an AE or SAE if they fulfill the definition of an AE or SAE and meet 
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the requirements as per Section 8.3.8.1. Also, “lack of efficacy” or “failure of 
expected pharmacological action” does not constitute an AE or SAE.
Events NOT Meeting the AE Definition

Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.

The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition.

Medical or surgical procedure (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
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study).
An SAE is defined as any untoward medical occurrence that, at any dose:
a. Results in death
b. Is life-threatening
The term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event that 
hypothetically might have caused death if it were more severe.
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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.
d. Results in persistent disability/incapacity

The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.

This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Other situations:

Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the participant or may require medical or surgical intervention to 
prevent one of the other outcomes listed in the above definition. These events 
should usually be considered serious.

Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse.

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 Intensity section).
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
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 patient 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.
10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording adverse events on the CRF 
and for reporting serious adverse events via the Electronic Data Collection Tool or on the 
CT SAE Report Form to Pfizer Safety (see sections 8.3.1, 8.3.5 and 8.3.10 for guidance). 
These requirements are delineated for 3 types of events: (1) SAEs; (2) nonserious adverse 
events (AEs); and (3) exposure to the study intervention under study during pregnancy or 
breastfeeding, and occupational exposure. 
It should be noted that the Electronic Data Collection Tool and the CT SAE Report Form 
for reporting of SAE information are 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 via the 
Electronic Data 
Collection Tool or on the 
CT SAE Report Form to 
Pfizer Safety Within 24 
Hours of Awareness
SAE
All
All
Nonserious AE
All
None
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding, and 
occupational exposure
All AEs/SAEs associated 
with exposure during 
pregnancy or breastfeeding
Occupational exposure is 
not recorded.
All (and EDP supplemental 
form for EDP) 
Note: Include all SAEs 
associated with exposure 
during pregnancy or 
breastfeeding. Include all 
AEs/SAEs associated with 
occupational exposure.
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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/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 Electronic Data 
Collection Tool / CT SAE Report Form/AE/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/SAE.
Assessment of Intensity
The investigator will report severity for each AE and SAE reported during the study based 
on the National Cancer Institute Common Terminology Criteria for Adverse Events 
(CTCAE) Version 5.0. 
GRADE
Clinical Description of Severity
1
MILD adverse event
2
MODERATE adverse event
3
SEVERE adverse event
4
LIFE-THREATENING consequences; urgent intervention indicated
5
DEATH RELATED TO adverse event
The severity of CRS and ICANS will be graded according to ASTCT criteria (Lee et 
al,2019b). See Appendix 11.
Assessment of Causality

The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE.
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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.

The investigator will use clinical judgment to determine the relationship.

Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration, will be considered and investigated.

The investigator will also consult the IB and/or product information, for marketed 
products, in his/her assessment.

For each AE/SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE/SAE and has provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to 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 Electronic Data Collection Tool or 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.
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
If a participant dies during participation in the study or during a recognized follow-
up period, the investigator will provide Pfizer Safety with a copy of any 
postmortem findings including histopathology.

New or updated information will be recorded in the originally completed CRF.

The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the information.
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 Paper 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 Guidance 
10.4.1. Male Participant Reproductive Inclusion Criteria
No contraception methods are required for male participants in this study, as the calculated 
safety margin is ≥100‑fold between the estimated maternal exposure due to seminal transfer 
and the estimated MABEL (minimal anticipated biological effect level) used as conservative 
estimate of exposure that may result in serious manifestations of developmental toxicity.
10.4.2. Female Participant Reproductive Inclusion Criteria
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at 
least 1 of the following conditions applies:

Is not a WOCBP (see definitions below in Section 10.4.3).
OR

Is a WOCBP and using a contraceptive method that is highly effective (with a 
failure rate of <1% per year), as described below, during the intervention period 
and for at least 5 months after the last dose of study intervention, which 
corresponds to the time needed to eliminate any reproductive safety risk of the 
study intervention(s). If a highly effective method that is user dependent is 
chosen, a second effective method of contraception, as described below, must also
be used. The investigator should evaluate the effectiveness of the contraceptive 
method in relationship to the first dose of study intervention.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 
10.4.3. Woman of Childbearing 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.
2. Premenopausal female with 1 of the following:

Documented hysterectomy;

Documented bilateral salpingectomy;
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
Documented bilateral oophorectomy.
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview. The method of documentation should be recorded in the participant’s medical 
record for the study.
3. Postmenopausal female:

A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. In addition, a

high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years of age and not using hormonal 
contraception or HRT. 

Female on HRT and whose menopausal status is in doubt will be required to 
use one of the nonestrogen hormonal highly effective contraception methods 
if they wish to continue their HRT during the study. Otherwise, they must 
discontinue HRT to allow confirmation of postmenopausal status before study 
enrollment.
10.4.4. Contraception Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device.
3. Intrauterine hormone-releasing system.
4. Bilateral tubal occlusion or bilateral tubal ligation.
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.
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6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:

Oral + barrier*;

Intravaginal + barrier*;

Transdermal + barrier*.
7. Progestogen-only hormone contraception associated with inhibition of ovulation:

Oral + barrier*;

Injectable + barrier*.
8. Sexual abstinence:

Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention. The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the study and the preferred and usual 
lifestyle of the participant.
* Acceptable barrier methods to be used concomitantly with options 6 or 7 for the study 
include any of the following:

Male or female condom with or without spermicide;

Cervical cap, diaphragm, or sponge with spermicide;

A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods).
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10.5. 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 scope of the genetic research may be narrow (eg, 1 or more candidate genes) or 
broad (eg, the entire genome), as appropriate to the scientific question under 
investigation.

The samples may be analyzed as part of a multistudy assessment of genetic factors 
involved in the response to elranatamab or study interventions of this class to 
understand treatments for the disease(s) under study or the disease(s) themselves.

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 8.7.1) will be stored for up to 
15 years or other period as per local requirements beyond the completion of this 
study (eg, Clinical Study Report finalization).

Samples for banking will be stored indefinitely or for another period as per local 
requirements.

Participants may withdraw their consent for the storage and/or use of their Banked 
Biospecimens at any time by making a request to the investigator; in this case, any 
remaining material will be destroyed. Data already generated from the samples will 
be retained to protect the integrity of existing analyses.

Banked Biospecimens will be labeled with a code. The key between the code and the 
participant’s personally identifying information (eg, name, address) will be held at the 
study site and will not be provided to the sample bank.
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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).
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 
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The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results. This evaluation should 
include laboratory tests, detailed history, and physical assessment. The possibility of hepatic 
neoplasia (primary or secondary) should be considered.
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 msec.

New prolongation of QTcF to >480 msec (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 msec.

New ST-T changes suggestive of myocardial ischemia.

New-onset left bundle branch block (QRS complex >120 msec).

New-onset right bundle branch block (QRS complex >120 msec).

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.
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
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.

Complete (third-degree) heart block.
ECG Findings That Qualify as SAEs

Change in pattern suggestive of new myocardial infarction. 

Second- or third-degree AV block requiring pacemaker placement.

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.
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10.8. Appendix 8: Alternative Measures During Public Emergencies
The alternative study measures described in this section are to be followed during public 
emergencies, including the COVID-19 pandemic. This appendix applies for the duration of 
the COVID-19 pandemic and will become effective for other public emergencies only upon 
written notification from Pfizer. 
Use of these alternative study measures are expected to cease upon the return of business as 
usual circumstances (including the lifting of any quarantines and travel bans/advisories). 
10.8.1. Eligibility
While SARS-CoV-2 testing is not mandated for 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 possibly an 
accompanying informant) and the investigator to communicate on aspects of clinical care, 
including medical advice, reminders, education, and safety monitoring. The following 
assessments may be performed during a telehealth visit: 

Review and record any AEs and SAEs since the last contact. Refer to Section 8.3. 

Review and record any new concomitant medications or changes in concomitant 
medications since the last contact.

Review and record contraceptive method and results of pregnancy testing. Confirm that 
the participant is adhering to the contraception method(s) required in the protocol. Refer 
to Appendix 4 and Section 10.8.3.1 of this appendix regarding pregnancy tests.
Study participants must be reminded to promptly notify site staff about any change in their 
health status.
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 
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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
If a local laboratory is used, qualified study site personnel must order, receive, and review 
results. Site staff must collect the local laboratory reference ranges and certifications/
accreditations for filing at the site. Laboratory test results are to be provided to the site staff 
as soon as possible.  The local laboratory reports should be filed in the participant’s source 
documents/medical records. Relevant data from the local laboratory report should 
be recorded on the CRF. 
If a participant requiring pregnancy testing cannot visit a local laboratory for pregnancy 
testing, a home urine pregnancy testing kit with a sensitivity of at least 25 mIU/mL may be 
used by the participant to perform the test at home, if compliant with local regulatory 
requirements. The pregnancy test outcome should be documented in the participant’s source 
documents/medical records and relevant data recorded on the CRF. Confirm that the 
participant is adhering to the contraception method(s) required in the protocol. 
10.8.3.2. Electrocardiograms
If the participant is unable to visit the study site for ECGs, the participant may visit an 
alternative facility to have the ECGs performed. Qualified study site personnel must order, 
receive, and review results. 
10.8.4. Study Intervention
If the safety of a trial participant is at risk because they cannot complete required evaluations 
or adhere to critical mitigation steps, then discontinuing that participant from study 
intervention must be considered.
The following is recommended for the administration of study intervention for participants 
who have active confirmed (positive by regulatory authority-approved test) or presumed (test 
pending/clinical suspicion) SARS-CoV2 infection:
For symptomatic participants with active SARS-CoV2 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-CoV2 infection.
Prior to restarting treatment, the participant should be afebrile for 72 hours, and 
SARS-CoV2-related symptoms should have recovered to ≤Grade 1 for a minimum of 
72 hours. 
Continue to consider potential drug-drug interactions as described in Section 6.5 for any 
concomitant medication administered for treatment of SARS-CoV2 infection.
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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 2 unique administration sites distributed across 
the 2 lower abdominal quadrants (up to 1 injection location per quadrant). 
Administer the required number of injections in the following order:
1. Lower Left Quadrant;
2. Lower Right Quadrant.
Injections to the abdomen are preferred. If SC injections in the abdominal location are not 
possible, SC injections can be administered in a distributed manner in the thighs. SC 
injections in the upper extremities (eg, deltoid, upper and lower arm) are not permitted.
Track the participant’s injection site(s) sequentially on this diagram with a red pen and mark 
the injection sites on the participant’s abdomen according to your clinic’s standard practice.
Record the location, time of each injection and any injection site reactions in the participant’s 
source records and study CRF. Complete one CRF per injection.
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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 one 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 plasmacytomasd
Partial Response 
(PR)

≥50% reduction of serum M-protein and reduction in 24 hours urinary M-protein 
by ≥90% or to <200 mg/24 h.

If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the 
difference between involved and uninvolved serum FLC levels is required in place 
of the M-protein criteria.

In addition to these criteria, if present at baseline, a ≥50% reduction in the size 
(SPD) of soft tissue plasmacytomas is also required.d
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Responsea
Modified IMWG Criteria
Minimal 
Response (MR)

≥25% but ≤49% reduction of serum M-protein and reduction in 24h 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.
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 MRI scans, or 
dedicated CT scans where applicable. Measurement of tumor size will be determined by the SPD.
e PD confirmation requires two 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 g/dL are sufficient to define relapse if starting M-component 
is ≥5 g/dL.
Source: Adapted from (Kumar et al, 2016).
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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 6.5.1).
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 9) (Lee et al, 2019b). For CRS management, 
published treatment guidelines are recommended (Neelapu et al, 2018b; Neelapu, 2019a), but 
they may be modified as needed by the responsible investigator according to the best 
practices at their institute.  
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Table 9.
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, 2019b)
CRS management guidelines by ASTCT Severity Grading (Neelapu et al, 2018b; 
Neelapu, 2019a)
For all participants, during the first 48 hours after the first dose of study intervention, and 
during 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.
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
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.
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.
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Grade 4 CRS:

Monitor participant (including continuous ECG monitoring) in an ICU and obtain 
ECHO if not done already.
Hypotension

IV boluses, anti-IL-6 therapy, vasopressors, and hemodynamic monitoring as 
recommended for Grade 3 CRS.

Methylprednisolone 1 g/day IV.
Hypoxia

Supplemental oxygen via positive pressure/mechanical ventilation.

Tocilizumab or siltuximab plus corticosteroids and supportive care, as described 
above for Grade 2 CRS.
10.11.2. 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 (Lee et al, 2019b). If ICANS is 
observed in relation to elranatamab, the ASTCT criteria will be used for grading (Lee et al, 
2019b) and published guidelines are recommended for management (Neelapu et al, 2018a; 
Lee et al, 2019a; Neelapu, 2019b). These treatment guidelines may be modified as needed by 
the responsible investigator according to the best practices at their institute. 
Table 10.
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 11.
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 
Life-threatening prolonged seizure 
(>5 min); or repetitive clinical or electrical 
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Table 11.
ASTCT ICANS Grading
Neurotoxicity 
Domain
Grade 1
Grade 2
Grade 3
Grade 4
seizures on EEG that 
resolve with 
intervention
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, 2019b)
ICANS Management Guidelines Per ASTCT (Neelapu et al, 2018b; Neelapu, 2019a)
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.
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ICANS Grade 2:

Supportive care and neurological work-up as described for Grade 1 ICANS.

Anti-IL-6 therapy if associated with concurrent CRS, as described for Grade 1 
ICANS and if not administered previously.

Dexamethasone 10 mg IV every 6 hours or methylprednisolone 1 mg/kg IV every 
12 hours if refractory to anti-IL-6 therapy, or for ICANS without concurrent CRS.

Consider transferring participant to ICU if ICANS associated with Grade ≥2 CRS.
ICANS Grade 3:

Supportive care and neurological work-up as indicated for Grade 1 ICANS.

ICU transfer is recommended.

If EEG shows non-convulsive status epilepticus:

Assess airway, breathing, and circulation; check blood glucose.

Lorazepam 0.5 mg IV, with additional 0.5 mg IV every 5 min, as needed, up to a 
total of 2 mg to control electrographical seizures.

Levetiracetam 500 mg IV bolus, as well as maintenance doses.

If seizures persist, transfer to ICU and treat with phenobarbital loading dose of 
60 mg IV.

Recommended maintenance therapy after resolution of non-convulsive status 
epilepticus are as follows: 

lorazepam 0.5 mg IV every 8 hours for three doses; 

levetiracetam 1,000 mg IV every 12 hours; duration of therapy per 
investigator/treating physician’s discretion;

phenobarbital 30 mg IV every 12 hours; duration of therapy per 
investigator/treating physician’s discretion.

Lacosamide may also be considered for treatment of seizures should the seizures 
persist. Lacosamide should not be used in participants with concurrent CRS in 
order to avoid arrhythmias and hypotension.

For convulsive status epilepticus:

Assess airway, breathing, and circulation; check blood glucose.

Transfer to ICU.

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.
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
Maintenance doses after resolution of convulsive status epilepticus: 

lorazepam 0.5 mg IV every 8 hours for three doses; 

levetiracetam 1,000 mg IV every 12 hours; duration of therapy per 
investigator/treating physician’s discretion; 

phenobarbital 1-3 mg/kg IV every 12 hours; duration of therapy per 
investigator/treating physician’s discretion.

Lacosamide may also be considered for treatment of seizures should the seizures 
persist. Lacosamide should not be used in participants with concurrent CRS in 
order to avoid arrhythmias and hypotension.

Continuous EEG monitoring should be performed, if seizures are refractory to 
treatment.

High-dose methylprednisolone IV 1 g/day for focal/local edema.

Anti-IL-6 therapy if associated with concurrent CRS, as described for Grade 1 
ICANS and if not administered previously.

Corticosteroids as outlined for Grade 2 ICANS if symptoms worsen despite anti-IL-6 
therapy, or for ICANS without concurrent CRS; continue corticosteroids until 
improvement to Grade 1 ICANS and then taper.
ICANS Grade 4:

Supportive care and neurological work-up as outlined for Grade 1 ICANS.

ICU monitoring; consider mechanical ventilation for airway protection.

Anti-IL-6 therapy and repeat neuroimaging as described for Grade 3 ICANS.

High-dose corticosteroids continued until improvement to Grade 1 ICANS and then 
taper; for example, methylprednisolone IV 1 g/day for 3 days, followed by rapid taper 
at 250 mg every 12 hours for 2 days, 125 mg every 12 hours for 2 days, and 60 mg 
every 12 hours for 2 days.

For convulsive status epilepticus, treat as described for Grade 3 ICANS.

MRI of the spine should be obtained for focal motor weakness.

To manage elevated ICP:

Elevate head of the participant's bed to an angle of 30 degrees.

Hyperventilation to achieve target partial pressure of arterial carbon dioxide 
(PaCO2) of 28–30 mmHg, but maintained for no longer than 24 hrs. 

Hyperosmolar therapy with either mannitol (20 g/dl solution) or hypertonic saline 
(3% or 23.4%, as detailed below):

Mannitol: initial dose 0.5–1 g/kg; maintenance at 0.25–1 g/kg every 6 hrs 
while monitoring metabolic profile and serum osmolality every 6 hrs, and 
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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 
5075 ml/hour while monitoring electrolytes every 4 hrs, and withhold infusion 
if serum Na levels reach ≥155 mEq/l.

For participants with imminent herniation: initial 30 ml of 23.4% hypertonic 
saline; repeat after 15 min, if needed.

If patient has Ommaya reservoir, drain CSF to target opening pressure of <20 mmHg

Consider neurosurgery consultation for ventriculoperitoneal shunt in participants with 
cerebral edema, and IV anesthetics for burst-suppression pattern on EEG.

Metabolic profiling every 6 hours and daily CT scan of head, with adjustments in 
usage of the aforementioned medications to prevent rebound cerebral oedema, renal 
failure, electrolyte abnormalities, hypovolemia, and hypotension.
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10.12. Appendix 12: Country Specific Requirements
10.12.1. Japan Regulatory Requirements
On 05-Mar-2021 a protocol administrative letter was distributed that incorporated the 
following country-specific regulatory requirements to the C1071003 protocol; Amendment 2 
(14 February 2021).
1. Female Participant Reproductive Inclusion Criteria: Female participants who are 
currently breastfeeding and intend to interrupt breastfeeding during the study are also 
excluded.
2. HBV Monitoring During the Study Treatment
For Section 8.2.6. Clinical Safety Laboratory Assessments, the following additional 
laboratory monitoring based on precautionary measures should be followed.
For participants with positive HBsAb and positive HBcAb but with negative HBV DNA test 
at screening, HB viral load should be monitored for re-activation every 12 weeks. If HBV 
relapse is observed, the event should be collected to the AE section of the CRF, but the data 
will not be required to be reported on the CRF. Participants with HBsAb positive who have 
been vaccinated with HBV are exempted from the testing of HB viral load.
A participant who is tested viral load positive for HBV at any time during the study will 
interrupt administration of PF-06863135, and should consider starting nucleoside antagonist 
immediately in parallel with consultation with hepatologist in accordance with the Japan 
Society of Hepatology (JSH) Guidelines for the management of Hepatitis B Virus infection.
3. Supplemental of Appendix 5 Genetics
Given the genetic testing in this study is for exploratory purposes only and following Pfizer 
process, it’s to clarify that there is no expectation to disclose these genetic testing results to 
the study participants, at any time.
It’s to clarify that a participant's participation in a clinical study shall not be conditional on 
his or her informed consent for the use of biospecimens that is not related to a clinical 
endpoint, the study intervention or disease being investigated in the trial, or the 
inclusion/exclusion criteria for the study.
4. SRSDs for tocilizumab
The sponsor lists the study intervention in the following table as safety information for the 
study intervention must be reported to the Japan regulatory authorities and 
investigator(s)/IRB/EC of the investigator site(s) in Japan in accordance with the Japanese 
regulatory requirements. The investigator in Japan provides the sponsor with the safety 
information necessary for safety reporting to the Japan regulatory authorities.
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Intervention Name
Tocilizumab
Type
Biologics
Dose Formulation
Solution for injection
Unit Dose Strength(s)
8 mg/kg (maximum 800 mg)
Dosage Level(s)
Refer to Section 10.11
Route of 
Administration
IV
IMP or NIMP/AxMP
NIMP/AxMP*
Sourcing
Provided centrally by the sponsor. Refer to IP manual.
Packaging and 
Labeling
Study intervention will be provided in carton. Each carton will be labeled as 
required per country requirement.
SRSD
J-PI for Actemra
* In Japan, this product is considered as IMP.
Tocilizumab has been approved for treatment of CRS induced by tumor-specific T cell 
infusion therapy, and the use of tocilizumab to CRS induced by CD3 bispecific antibody has 
not been approved in Japan. Pfizer will supply tocilizumab to Japan study sites. The data 
related to tocilizumab from this study may be used for supplemental NDA of tocilizumab in 
Japan. Therefore, in this study, tocilizumab is a non-IMP, but considered as IMP in Japan.
Tocilizumab should be managed in accordance with IP manual.
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10.13. Appendix 13: Summary of Safety Stopping Rules 
Safety stopping rules were derived based on posterior probability of 0.90 in Protocol 
Amendment 5. Per US FDA recommendation, safety stopping rules were updated based on 
posterior probability of 0.80.
10.13.1. Treatment-Related Grade 3-4 GBS (Including Variants) per posterior 
probability 0.80 vs 0.90 
Number of Evaluable 
Participants
Minimum Number of Evaluable Participants With Treatment-
Related Grade 3-4 GBS (Including Variants)
Posterior Probability ≥0.90
Posterior Probability ≥0.80
20-27
2
2
28-39
3
2
40-47
3
3
48-64
4
3
65-70
4
4
71-90
5
4
91-93
5
5
94-116
6
5
117-118
6
6
119-143
7
6
144
8
6
145-150
8
7
Criteria for 151 or more evaluable participants will be calculated based on the posterior probability of ≥0.90 
and ≥0.80 respectively
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10.13.2. Treatment-Related Grade 4 SN/IR Neurologic AEs (Excluding 
ICANS)/Treatment-Related Grade 3-4 Motor Neuropathy Events per posterior 
probability 0.80 vs 0.90 
Minimum Number of Evaluable Participants With Treatment-
Related Grade 4 SN/IR Neurologic AEs (Excluding 
ICANS)/Treatment-Related Grade 3-4 Motor Neuropathy Events 
that would Prompt Temporary Enrollment Hold
Posterior Probability ≥0.90
Posterior Probability ≥0.80
20-21
4
4
22-27
5
4
28
5
5
29-35
6
5
36
6
6
37-43
7
6
44-51
8
7
52
9
7
53-59
9
8
60
10
8
61-67
10
9
68-69
11
9
70-75
11
10
76-78
12
10
Criteria for  79 or more evaluable participants will be calculated based on the posterior probability of ≥0.90 
and ≥0.80 respectively.
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10.14. Appendix 14: Anti-infectious Prophylaxis and Monitoring Recommendation
Participants should receive antimicrobial prophylaxis as per the recommendations below.
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
Administer
for participants with 
ANC <1000/ µL
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 
ANC <500/µL for >7 
days 
-----------------
Prolonged ANC 
<500/µL for >3 
weeks 
Until neutropenia 
resolution (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
Initiate antiviral 
prophylaxis to 
prevent herpes zoster 
reactivation
Continue for 3 months 
following the end of 
treatment
CMV
On study CMV testing by 
PCR should be performed on 
a monthly to every three-
month schedule depending 
on risk factors.  
Valganciclovir 900 mg PO 
BID
Alternative (ganciclovir i.v., 
foscarnet i.v.) or other 
approved agents. 
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 
number should be 
considered) 
Treatment is required 
for symptomatic 
participants
irrespective of viral 
load
Continue therapy until two 
consecutive measurements 
at least 14 days apart show 
viral load < 1000/mL and 
resolution of symptoms (if 
present)
Pneumocystis jirovecii
Pneumonia (PJP)
Trimethoprim-
sulfamethoxazole DS –
1 tablet PO daily, three times
per week 
For participants CD4 
cell count < 200/µL 
or unknown 
Suggested duration: until 
CD4 count ≥200 cells/µL 
based on 2 consecutive 
measurements at least 14 
days apart.  
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Prophylaxis 
Therapy 
Start 
Stop 
Alternatives: Pentamidine 
(or alternative), or Dapsone
– 100 mg PO daily or 50 mg 
PO BID, or Atovaquone –
1500 mg PO daily
Prophylaxis may be 
extended at the discretion 
of the investigator as 
clinically indicated.
Hypogammaglobulinemia/ 
Subcutaneous or 
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 
Prophylaxis 
Prophylactic or therapeutic 
administration of G-CSF in 
participants with severe
neutropenia or with serious 
neutropenic complications 
should be considered by 
investigators consistent with 
the ASCO guidelines  
(Smith et al, 2015) in order 
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. 
Dimopoulos et al, 2021; NCCN 2022b NCCN 2022c; NCCN 2022a; Smith et al, 2015; Raje et al, 2022.
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10.15. Appendix 15: 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
ALT
alanine aminotransferase
ANC
absolute neutrophil count
APC
antigen-presenting cell
ASCO
American Society of Clinical Oncology
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
AV
Atrioventricular
AxMP
auxiliary medicinal product
BCMA
B-cell maturation antigen
–hCG
beta-human chorionic gonadotropin
BICR
blinded independent central review
BID
twice a day
BM
bone marrow
BMA
bone marrow aspirate
BMB
bone marrow biopsy
BMMC
bone marrow mononuclear cells
BOR
best overall response
bpm
beats per minute
BsAb
bispecific antibody
BUN
blood urea nitrogen
C
Cycle
CAR
chimeric antigen receptor
CAR-T
chimeric antigen receptor T-cell therapy
CB
clinical benefit
CD#
cluster of differentiation and number (eg, CD38)
CFR
Code of Federal Regulations
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
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Abbreviation
Term
Cmax
maximum concentration 
CMV
cytomegalovirus
CO2
carbon dioxide (bicarbonate)
CONSORT
Consolidated Standards of Reporting Trials
COVID-19
coronavirus disease 2019
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
CXDX
Cycle X Day X
CYP
cytochrome P450
D
Day
DILI
drug-induced liver injury
DLT
dose-limiting toxicity
DNA
deoxyribonucleic acid
DOCR
duration of complete response
DOR
duration of response
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
E-DMC
external data monitoring committee
EDP
exposure during pregnancy
EMA
European Medicines Agency
EM
Extramedullary
EMD
extramedullary disease
EMG
Electromyography
EORTC MY20
European Organization for Research and Treatment of Cancer Multiple 
Myeloma module 
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Abbreviation
Term
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 Questionnaire–30 (items)
EOS
end of study
EOT
end of treatment
EQ-5D
EuroQoL 5 Dimensions
ESMO
European Society for Medical Oncology
EU
European Union
EudraCT
European Union Drug Regulating Authorities Clinical Trials (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
G-CSF
granulocyte colony stimulating factor
gDNA
genomic DNA
GGT
gamma-glutamyl transferase
GLP
good laboratory practice
GVHD
graft versus host disease
HA
Health Authority 
HBcAb
hepatitis B core antibody
HBsAb
hepatitis B surface antibody
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 of Technical Requirements for 
Pharmaceuticals for Human Use
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Abbreviation
Term
ICU
intensive care unit
ID
identification
Ig#
immunoglobulin (eg, IgM, IgA, etc)
IMiD
immunomodulatory drug
IMP
investigational medicinal product
IMWG
International Myeloma Working Group
IND
investigational new drug
INR
international normalized ratio
IP manual
investigational product manual
IPAL
Investigational Product Accountability Log
IR
Immune-related
IRB
institutional review board
IRT
interactive response technology
ISR
injection site reaction
ISS
International Staging System
IV
intravenous(ly)
IVIG
intravenous immunoglobulin
IWR
interactive Web-based response
J-PI
Japan prescribing information
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
MHRA
Medicines and Healthcare products Regulatory Agency
MM
multiple myeloma
MQI
medically qualified individual
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
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Abbreviation
Term
NCCN
National Comprehensive Cancer Network
NCI CTCAE
National Cancer Institute common terminology criteria for adverse events
NCV
Nerve conduction velocity
NDA
New drug application
NGS
next generation sequencing 
NIMP
noninvestigational medicinal product
NSAID
non-steroidal anti-inflammatory drug
OR
objective response
ORR
objective response rate 
OS
overall survival
PaCO2
partial pressure of arterial carbon dioxide
PJP
Pneumocystis jirovecii pneumonia
PCR
polymerase chain reaction
PD
progressive disease
PET
positron emission tomography
PFS
progression-free survival
PGI-C
Patient Global Impression of Change
PGI-S
Patient Global Impression of Severity
PI
proteasome inhibitor
PK
pharmacokinetic(s)
PN
peripheral neuropathy
PO
oral (orally)
POEMS
polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin 
changes
PR
partial response
PRO
patient-reported outcome
PS
performance status
PT
preferred term; prothrombin time
PVC
premature ventricular contraction/complex
QT
time from the beginning of the QRS complex to the end of the T wave
QTcF
corrected QT (Fridericia method)
QTL
quality tolerance limit
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
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Abbreviation
Term
RP2D
recommended Phase 2 dose
RRMM
relapsed/refractory multiple myeloma
SAE
serious adverse event
SAP
statistical analysis plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
sBCMA
soluble BCMA
SC
subcutaneous(ly)
sCR
stringent complete response 
SMQ
standardized MedDRA queries
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
TNFr SF 17
tumor necrosis factor receptor superfamily 17
TTR
time to response
UIFE
urine immunofixation electrophoresis
ULN
upper limit of normal
UPEP
urine protein electrophoresis 
US
United States
VAS
visual analogue scale
VHP
voluntary harmonization procedure
VGPR
very good partial response 
WBC
white blood cell
WOC
withdrawal of consent
WOCBP
woman/women of childbearing potential
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11. REFERENCES
Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and 
Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical 
trials in oncology. JNCI: Journal of the National Cancer Institute. 1993;85(5):365-76.
Berdeja JG, Madduri D, Usmani SZ, et al. Update of CARTITUDE-1: A phase Ib/II study of 
JNJ-4528, a B-cell maturation antigen (BCMA)-directed CAR-T-cell therapy, in 
relapsed/refractory multiple myeloma. 2020a;38(15_suppl):8505.
Berdeja JG, Madduri D, Usmani SZ, et al. Update of CARTITUDE-1: A phase Ib/II study of 
JNJ-4528, a B-cell maturation antigen (BCMA)-directed CAR-T-cell therapy, in 
relapsed/refractory multiple myeloma. JCO Global Oncol. 2020b;38(15_suppl):8505 
[abstract].
BLENREP (belantamab mafodotin-blmf) USPI. US Prescribing Information; Aug 2020, 
Research Triangle Park, NC, USA: GlaxoSmithKline. Available from: 
https://gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information
/Blenrep/pdf/BLENREP-PI-MG.PDF. Accessed on: 12 Nov 2020.
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 Cancer J 
Clin. 2018;68(6):394-424.
Chari A, Vogl DT, Gavriatopoulou M, et al. Oral Selinexor-Dexamethasone for Triple-Class 
Refractory Multiple Myeloma. N Engl J Med. 2019;381(8):727-38.
Chari A, Samur MK, Martinez-Lopez J, et al. Clinical features associated with COVID-19
outcome in multiple myeloma: first results from the International Myeloma Society data set. 
Blood. 2020;136(26):3033-40.
Cocks K, Cohen D, Wisløff F, et al. An international field study of the reliability and validity 
of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life 
of patients with multiple myeloma. Eur J Cancer. 2007;43(11):1670-8.
Dimopoulos MA, Moreau P, Terpos E, et al. Multiple myeloma: EHA-ESMO Clinical
Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(3):309-22.
FDA. Food and Drug Administration Guidance for Industry: Expedited Programs for Serious
Conditions – Drugs and Biologics. 2014.
Ghermezi M, Li M, Vardanyan S, et al. Serum B-cell maturation antigen: a novel biomarker 
to predict outcomes for multiple myeloma patients. Haematologica. 2017a;102(4):785-95.
Ghermezi M, Li M, Vardanyan S, et al. Serum B-cell maturation antigen: a novel biomarker 
to predict outcomes for multiple myeloma patients. Haematologica. 2017b;102(4):785-95.
CCI

PF-06863135 (Elranatamab)
Protocol C1071003
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Page 143
Jimenez-Zepeda VH, Reece DE, 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 Marrow 
Transplant. 2015;50(2):204-8.
Kumar SK, Callander NS, Adekola K, et al. Multiple Myeloma, Version 3.2021, NCCN
Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2020;18(12):1685-717.
Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus 
criteria for response and minimal residual disease assessment in multiple myeloma. Lancet 
Oncol. 2016;17(8):e328-e46.
Kumar SK, Therneau TM, Gertz MA, et al. Clinical course of patients with relapsed multiple 
myeloma. Mayo Clin Proc. 2004;79(7):867-74.
Laurent SA, Hoffmann FS, Kuhn PH, et al. gamma-Secretase directly sheds the survival 
receptor BCMA from plasma cells. Nat Commun. 2015;6:7333.
Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release 
syndrome and neurologic toxicity associated with immune effector cells. Biology of Blood 
and Marrow Transplantation. 2019a;25(4):625-38.
Lee DW, Santomasso BD, Locke FL, et al. ASTCT Consensus Grading for Cytokine Release 
Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood 
Marrow Transplant. 2019b;25(4):625-38.
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. The Lancet 
Oncology. 2020a;21(2):207-21.
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. Lancet Oncol. 
2020b;21(2):207-21.
Lopez A, Mateos MV, 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 
Rep. 2015;4(2):64-9.
Mailankody S, Jakubowiak AJ, Htut M, et al. Orvacabtagene autoleucel (orva-cel), a B-cell 
maturation antigen (BCMA)-directed CAR T cell therapy for patients (pts) with 
relapsed/refractory multiple myeloma (RRMM): update of the phase 1/2 EVOLVE study 
(NCT03430011). J Clin Oncol. 2020;38(15_suppl):8504-04 [abstract].
NCCN. NCCN Clinical Practice Guidelines in Oncology, Management of Immunotherapy-
Related Toxicities, Version 1.2022 28 Feb 2022 2022a. Available from: 
https://www.nccn.org/professionals/physician_gls/pdf/immunotherapy.pdf. Accessed on: 13 
Jul 2022.
CCI

PF-06863135 (Elranatamab)
Protocol C1071003
Final Protocol Amendment 10, 22 March 2023
PFIZER CONFIDENTIAL
Page 144
NCCN. NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®): Multiple 
Myeloma. Version 5.2022. 09 Mar 2022 2022b. Available from: 
https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed on: 10 May 
2022.
NCCN. NCCN Clinical Practice Guidelines in Oncology, Prevention and Treatment of 
Cancer-Related Infections, Version 1.2022 02 Jun 2022 2022c. Available from: 
https://www.nccn.org/professionals/physician_gls/pdf/infections.pdf. Accessed on: 13 Jul 
2022.
Nandakumar B, Binder M, Dispenzieri A, et al. Continued improvement in survival in 
multiple myeloma (MM) including high-risk patients. J Clin Oncol. 
2019;37(15_suppl):8039-39 [abstract].
Neelapu SS, Tummala S, Kebriaei P, et al. Chimeric antigen receptor T-cell therapy—
assessment and management of toxicities. Nature reviews Clinical oncology. 2018a;15(1):47.
Neelapu SS, Tummala S, Kebriaei P, et al. Chimeric antigen receptor T-cell therapy -
assessment and management of toxicities. Nat Rev Clin Oncol. 2018b;15(1):47-62.
Neelapu SS. Managing the toxicities of CAR T-cell therapy. Hematol Oncol. 2019a;37 Suppl 
1:48-52.
Neelapu SS. Managing the toxicities of car T‐cell therapy. Hematological oncology. 
2019b;37:48-52.
Osoba D, Aaronson N, Zee B, et al. Modification of the EORTC QLQ-C30 (version 2.0) 
based on content validity and reliability testing in large samples of patients with cancer. 
Quality of life research. 1997;6(2):0-0.
Palumbo A, Avet-Loiseau H, Oliva S, et al. Revised International Staging System for 
Multiple Myeloma: A Report From International Myeloma Working Group. J Clin Oncol. 
2015;33(26):2863-9.
Pont MJ, Hill T, Cole GO, et al. γ-Secretase inhibition increases efficacy of BCMA-specific 
chimeric antigen receptor T cells in multiple myeloma. Blood. 2019;134(19):1585-97.
Postma TJ, Aaronson NK, Heimans JJ, et al. The development of an EORTC quality of life 
questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur 
J Cancer. 2005;41(8):1135-9.
Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann 
Med. 2001;33(5):337-43.
CCI

PF-06863135 (Elranatamab)
Protocol C1071003
Final Protocol Amendment 10, 22 March 2023
PFIZER CONFIDENTIAL
Page 145
Raje NS, Anaissie E, Kumar SK, et al. Consensus guidelines and recommendations for
infection prevention in multiple myeloma: a report from the International Myeloma Working 
Group. Lancet Haematol. 2022;9(2):e143-e61.
Rajkumar SV, Dimopoulos MA, Palumbo A, et al. International Myeloma Working Group 
updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014;15(12):e538-48.
Richardson PG, Delforge M, Beksac M, et al. Management of treatment-emergent peripheral 
neuropathy in multiple myeloma. Leukemia. 2012;26(4):595-608.
Sanchez E, Li M, Kitto A, et al. Serum B‐cell maturation antigen is elevated in multiple 
myeloma and correlates with disease status and survival. British journal of haematology. 
2012a;158(6):727-38.
Sanchez E, Li M, Kitto A, et al. Serum B-cell maturation antigen is elevated in multiple 
myeloma and correlates with disease status and survival. Br J Haematol. 2012b;158(6):727-
38.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70(1):7-30.
Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the Use of WBC Growth 
Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin 
Oncol. 2015;33(28):3199-212.
Smith-Garvin JE, Koretzky GA, Jordan MS. T cell activation. Annu Rev Immunol. 
2009;27:591-619.
Sonneveld P, Avet-Loiseau H, Lonial S, et al. Treatment of multiple myeloma with high-risk 
cytogenetics: a consensus of the International Myeloma Working Group. Blood. 
2016;127(24):2955-62.
Terpos E, Engelhardt M, Cook G, et al. Management of patients with multiple myeloma in
the era of COVID-19 pandemic: a consensus paper from the European Myeloma Network 
(EMN). Leukemia. 2020;34(8):2000-11.
Topp MS, Duell J, Zugmaier G, et al. Anti–B-cell maturation antigen BiTE molecule AMG 
420 induces responses in multiple myeloma. Journal of Clinical Oncology. 2020a;38(8):775-
83.
Topp MS, Duell J, Zugmaier G, et al. Anti-B-Cell Maturation Antigen BiTE Molecule AMG 
420 Induces Responses in Multiple Myeloma. J Clin Oncol. 2020b;38(8):775-83.
Trudel S, Lendvai N, Popat R, et al. Antibody-drug conjugate, GSK2857916, in 
relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion 
phase I study. Blood Cancer J. 2019;9(4):37.
CCI