Conditions: Relapsed or Refractory Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.

Detailed description:

Arms:
arm 1: BCMA-CD3 bispecific antibody

Interventions: intervention 1: Elranatamab (PF-06863135)
Intervention descriptions: intervention 1: BCMA-CD3 bispecific antibody

Protocol document:
Prot_000.pdf: 
PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 1 
 
MAGNETISMM-2 
A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY AND 
PHARMACOKINETIC OF ELRANATAMAB (PF-06863135), A B-CELL 
MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE 
AGENT IN JAPANESE PARTICIPANTS WITH RELAPSED/REFRACTORY 
ADVANCED MULTIPLE MYELOMA 
  
Study Intervention Number: 
PF-06863135 
Study Intervention Name: 
Elranatamab 
US IND Number: 
N/A 
EudraCT Number: 
N/A 
ClinicalTrials.gov NCT: 
NCT04798586 
Protocol Number: 
C1071002 
Phase: 
1 
Short Title: MAGNETISMM-2, A Phase 1 Study of Elranatamab (PF-06863135) in 
Japanese Participants with Multiple Myeloma 
 
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. 
 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 2 
Protocol Amendment Summary of Changes Table 
Document History 
Document 
Version Date 
 
Summary and Rationale for Changes 
Original protocol
06 October 2020
N/A
Amendment 1 
03 December 2020 
The primary purpose of this amendment is 
to incorporate changes/clarifications 
requested by the PMDA following agency 
review. 
Objectives and Endopoints in Section 1.1. 
Synopsis and Section 3. Objectives and 
Endpoints: Corrected PK parameter of the 
secondary endpoint to Vz/F. 
Section 1.3.1 Schedule of Activities for 
Q1W Dose Interval and 1.3.2 Schedule of 
Activities for Q2W Dose Interval: Added 
HB viral load monitoring every 12 weeks 
for participants who are HBV DNA 
negative but HBsAb and HBcAb positive 
at screening. Added urine pregnancy test 
to the footnote.  
Section 1.3.2. Schedule of Activities for 
Q2W Dose Interval: Removed post-dose 
PK sampling from footnote 18 as a typo. 
Section 4.3.3. Dose Limiting Toxicity 
Definition: Clarified the DLT definition 
for dose delay. 
Section 5.2. Exclusion Criteria: Added 
clarification that known or suspected 
hypersensitivity to component of 
PF-06863135 is also excluded. 
Section 8.2.5. Clinical Safety Laboratory 
Assessments: Added HB viral load 
monitoring every 12 weeks for 
participants who are HBV DNA negative 
but HBsAb and HBcAb positive at 
screening and guidance when re-activaiton 
of HBV is suspected. 


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PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 4 
Document History 
Document 
Version Date 
 
Summary and Rationale for Changes 
clarification that women who are currently 
breastfeeding and intend to interrupt 
breastfeeding are excluded.  Extended the 
required contraception period of EDP 
from 28 days to 56 days from the last 
dose. 
Section 10.4.4. Contraception Methods: 
Add clarification that oral progestogen 
only hormone contraception has not been 
approved in Japan. 
In addition, other clarifications, 
administrative, and typographical 
modifications were made. 
Amendment 2 
10 June 2021 
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.  
Section 2.2.6: Additional information and 
updates were added based on Phase 1 
results (C1071001). 
Section 2.3.1: Risk assessment was 
updated based on the current data. 
Section 6.5: Clarification and 
recommendation for administration of 
COVID-19 vaccines were added. 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 5 
Document History 
Document 
Version Date 
 
Summary and Rationale for Changes 
Section 6.5.2: Requirement of 
premedication for CRS mitigation was 
added. 
Section 8.3.1: 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. 
Section 8.3.5.1 and Section 10.4: 
Contraception use has been extended from 
56 days to 90 days after the last dose of 
study intervention. 
Given the INN is established, 
PF-06863135 has been replaced with the 
INN name, elranatamab. 
Clarifications and typo corrections were 
made throughout. 
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs. 


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PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 7 
1. PROTOCOL SUMMARY  
1.1. Synopsis  
Short Title: MAGNETISMM-2, A Phase 1 study of Elranatamab (PF-06863135) in Japanese 
Participants with Multiple Myeloma  
Background and Rationale 
Elranatamab is a bispecific monoclonal antibody targeting both B-cell maturation antigen 
(BCMA, also known as tumor necrosis factor receptor superfamily member 17 [TNFRSF17] 
or cluster of differentiation [CD] 269) on multiple myeloma (MM) cells and CD3 on T-cells.  
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.  Elranatamab 
is currently in clinical development for MM. 
Study C1071001 is an ongoing Phase 1, first-in-human, open-label study to evaluate the 
safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and 
clinical activity of elranatamab as monotherapy and in combination with other agents.  The 
dose escalation phase of Study C1071001 is currently ongoing with doses up to 1000 µg/kg 
once weekly (Q1W) via subcutaneous (SC) administration have been evaluated.  Once 
weekly (Q1W) intravenous (IV) dosing was also explored in earlier dose escalation part of 
the study.  Dose-limiting toxicities (DLTs) of febrile neutropenia Grade 3 and 
electrocardiogram QT prolonged Grade 1 were observed at 30 and 50 μg/kg IV, respectively.  
However, no dose limiting toxicities (DLTs) were observed for all SC dose cohorts in Study 
C1071001.  Based on the safety, tolerability, PK, PD, and clinical activity of elranatamab in 
non-Japanese population in Study C1071001, 1000 µg/kg SC Q1W have been selected as the 
recommended Phase 2 dose (RP2D) and regimen in non-Japanese population.  While 
1000 µg/kg SC showed tolerable and manageable safety profile, a priming dose approach 
may mitigate the consequences of CRS which is mainly observed after the initial dose, and a 
minimal impact on achieving efficacious exposure threshold is predicted in a priming dose 
approach.  For further evaluation in elranatamab studies, a priming dose approach is planned 
to be used.   
The primary purpose of this Phase 1 study (C1071002) is to confirm the safety and 
tolerability of elranatamab 1000 µg/kg SC Q1W with a priming dose of 600 µg/kg SC in 
Japanese participants.  Japanese participants with relapsed or refractory MM will be enrolled 
to permit Japan participation in pivotal studies including but not limited to the phase 2 
registrational study in participants with triple-class refractory MM. 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary:  
Primary:  
 
To assess the safety and tolerability at the RP2D with 
a priming dose approach of single-agent elranatamab 
administered to Japanese participants 
 
First cycle including a priming dose (4 weeks) Dose 
Limiting Toxicities (DLTs) 


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 CCI


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 9 
Overall Design 
This is a Phase 1, open-label, multi-center study to evaluate the safety, tolerability, PK, PD, 
and clinical activity of elranatamab monotherapy.  Approximately  4-6 Japanese participants 
are expected to be enrolled overall in this study, and the RP2D (1000 g/kg) which was 
declared in non-Japanese participants in the study C1071001 with a priming dose 
(600 g/kg) will be administered to each participant. 
DLTs through the first dose (a priming dose) to the end of the first cycle (total 4 weeks) will 
be evaluated with the target DLT rate of 25%. 
The study population consists of Japanese adult participants with relapsed or refractory MM 
who have received at least 3 prior therapies, including immunomodulatory drug (IMID), 
proteasome inhibitor (PI) and anti-CD38 antibody, with measurable disease based on IMWG 
guidelines, aged 20 years. 
The study will be conducted with approximately 5 study sites in Japan. 
Number of Participants 
A maximum of approximately 6 participants will be enrolled to study intervention (see 
Section 9.2).  However, the total number of participants will depend on the number of 
participants evaluable for DLT.  A participant is classified as DLT-evaluable if he/she 
experiences a DLT (irrespective of whether they received all of the planned doses of 
investigational product and study intervention and scheduled safety assessments during the 
DLT window) or if he/she otherwise in the absence of a DLT receives all of the planned 
doses of investigational product and study intervention and has received scheduled safety 
assessments during the DLT window.  If a participant fails to meet these criteria, he/she may 
be replaced. 
Note: "Enrolled" means a participant’s, or his or her legally authorized representative’s, 
agreement to participate in a clinical study following completion of the informed consent 
process.  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.  
Intervention Groups and Duration 
The initial dose will be 600 g/kg SC which will be injected on Cycle 0 Day 1 (7 days prior 
to Cycle 1 Day 1) as a priming dose.  During treatment cycle (full dose from Cycle 1 Day 1 
and thereafter), 1000 g/kg SC will be given weekly in 3 week cycles.  Treatment will 
continue until progressive disease (PD), unacceptable toxicity, withdrawal from treatment, 
investigator decision, or study termination, whichever occurs first. 
Dose modification information is provided in the Section 6.6. 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 10 
Data Monitoring Committee or Other Independent Oversight Committee: 
This study will not use a DMC. 
Statistical Methods 
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in a statistical analysis plan (SAP), which will be 
maintained by the sponsor. 
Sample Size Determination 
The total number of participants will depend on the absence/presence of DLT in the initial 4 
participants and the number of participants evaluable for DLT.  Additional 2 participants will 
be enrolled to verify the toxicity in Japanese population if at least one DLT is observed in the 
initial 4 participants.  Thus, maximum 6 evaluable participants may be enrolled in this study.  
The actual sample size may be smaller than 6 but not less than 4, depending on the 
underlying dose toxicity profile. 
Although the sample size is not based on any statistical considerations, the study would have 
>55% chance to declare the RP2D determined in C1071001 with a priming dose to have 
exceeded the maximum tolerated dose (MTD) in Japanese participants if the true DLT rate 
for Japanese participants is over 30%.  Especially, the study would have 74.6% and 87.5% 
chance if the true DLT rate is 40% and 50%, respectively.  It is determined that the RP2D 
with a priming dose exceeds the MTD in the Japanese population if ≥2 DLTs are observed in 
this study. 
Statistical Analysis for Primary Endpoint 
DLT is the primary endpoint of this study.  The occurrence of DLTs observed in the dosing 
cohorts is used to confirm the safety and tolerability of the RP2D with a priming dose.  
Adverse events constituting DLTs will be listed. 
Confirmation of RP2D in Japanese participants 
If there is either no DLT in the initial 4 participants or one DLT in 6 participants, the RP2D 
which were declared in non-Japanese participants with a priming dose will be confirmed to 
be tolerable in Japanese participants.  If DLT is observed in ≥2 of the initial 4 participants or 
6 participants, a lower dose cohort may be explored, if deemed necessary. 
Interim Analyses 
No formal interim analysis will be conducted for this study.  As this is an open-label study, 
the sponsor may conduct unblinded reviews of the data during the course of the study for the 
purpose of safety assessment. 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 11 
1.2. Schema 
 
 
 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 12 
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 assessment required for compliance with the protocol.  
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the participant.  
1.3.1. Schedule of Activities for Q1W Dose Interval 
Schedule of Activities  
Visit Identifiera 
Screening1 
Treatment Period 
28 Days 
Follow-up
33 
Survival 
Follow-up
35 
Study Day 
Within 28 
days prior 
to 
treatment 
Cycle 0 
(single priming dose) 
(7 days) 
Cycle 1 
(1 Cycle = 3 weeks) 
Cycle 2 onwards
EOT
34 
1 
2 
3 
4*
1 
2 
3 
4*
8 
15
1 
8 
15
 
Visit Window (days) 
 
 
 
 
 
1
 

 
3 
3
3
3
3
 
+7 
14 
Informed consent2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Myeloma history3 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history4 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseline signs and symptoms5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility Criteria and 
Registration6 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant hospitalization7 
 
X 
X 
X 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
Clinical Evaluation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examination8 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Brief physical examination8 
 
X 
X 
 
 
X 
X 
 
 
X 
X 
X
X8
X8
X 
X 
 
Neurological examination9 
X 
X 
X 
 
 
X 
X 
 
 
X 
X 
X
X 
X 
X 
X 
 
Weight10 
X 
X 
 
 
 
X 
 
 
 
 
 
X
 
 
X 
 
 
Vital signs11 
X 
X 
X 
 
 
X 
X 
 
 
X 
X 
X
X 
X 
X 
X 
 
ECOG performance status12 
X 
X 
 
 
 
X 
 
 
 
X 
X 
X
 
 
X 
 
 
(12 lead) ECG13 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
X
X13
X13
X 
 
 
Echo or MUGA14 
X 
If there is a history of cardiac events, perform when clinically indicated. 
X 
 
 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 13 
Schedule of Activities  
Visit Identifiera 
Screening1 
Treatment Period 
28 Days 
Follow-up
33 
Survival 
Follow-up
35 
Study Day 
Within 28 
days prior 
to 
treatment 
Cycle 0 
(single priming dose) 
(7 days) 
Cycle 1 
(1 Cycle = 3 weeks) 
Cycle 2 onwards
EOT
34 
1 
2 
3 
4*
1 
2 
3 
4*
8 
15
1 
8 
15
 
Visit Window (days) 
 
 
 
 
 
1
 

 
3 
3
3
3
3
 
+7 
14 
Hematology15 
X 
X 
X 
 
 
X 
X 
 
 
X 
X 
X
X15
X15
X 
X 
 
Blood Chemistry16 
X 
X 
X 
 
 
X 
X 
 
 
X 
X 
X
X16
X16
X 
X 
 
Coagulation17 
X 
X 
 
 
 
X 
 
 
 
X 
X 
X
X17
X17
X 
X 
 
Hepatitis assessment18 
X 
 
 
 
 
 
 
 
 
 
 
X (If applicable)
 
 
 
Urinalysis19 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
Pregnancy test and 
contraception check20 
X 
X 
 
 
 
 
 
 
 
 
 
X
 
 
X 
X 
X 
Treatment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment with elranatamab21 
 
X 
 
 
 
X 
 
 
 
X 
X 
X
X 
X 
 
 
 
Premedication for CRS22 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Disease assessments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Genetic analysis  bone 
marrow aspirate23 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SPEP, SIFE, serum FLC 
ratio, beta-2 microglobulin 
(local)24 
X 
X 
 
 
 
X 
 
 
 
 
 
X
 
 
X 
 
If obtained 
as SOC 
prior to 
subsequent 
treatment35
UPEP, UIFE (local)25 
X 
X 
 
 
 
X 
 
 
 
 
 
X
 
 
X 
 
Bone marrow collection and 
assessments-aspirates26 
 
X 
At 1, 3 and 9 months after C0D1, every 6 months thereafter, at suspected CR and optional 
at disease progression.  Collection at 9 months after C0D1 and onwards will be optional 
for participants who experience a plateau or CR. Check for MRD at CR. 
 
Bone marrow collection and 
assessments-biopsies26 
 
X 
At 1, 3 (optional) and 9 (optional) months after C0D1, every 6 months  
thereafter (optional), at suspected sCR and optional at disease progression. Collection at 9 
months after C0D1 and onwards will be optional for participants who experience a plateau 
or CR. 
 
Disease assessments by PET/ 
CT27 
X 
 
At 1, 3 and 9 months after C0D1 and every 6 months thereafter, and at suspected 
CR or PD, and when clinically indicated. 
X 
 


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PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 16 
9. Neurological examination: From Cycle 0 to Cycle 3, neurological examination should be performed on Day 1, Day 8 and Day 15. From Cycle 4 onward, it 
should be performed on Day 1.  In addition, from Cycle 0 to Cycle 1, neurological examination should be performed on Day 2.  See Section 8.2.1 for the 
required neurological examination. 
10. Weight: Weight will be measured prior to dosing. 
11. Vital Signs: Includes temperature, blood pressure (BP), and pulse rate to be recorded in the sitting position after 5 minutes of rest. 
12. Performance Status: Use Eastern Cooperative Oncology Group (ECOG) – see Section 10.12. 
13. 12-Lead electrocardiogram (ECG): At each time point except at screening (see the schedule of activities), 3 consecutive ECGs will be performed at 
approximately 2 minutes apart to determine the mean QTc interval.  At screening, single 12-lead ECG will be performed.  On C0D1 until C2D15, triplicate 
12-lead ECGs will be performed to determine mean QTcF interval.  On Day 1 of Cycle 0, Day 1, 8 and 15 of Cycles 1 and 2, ECGs will be performed prior 
to investigational product administration (and premedication), and the end of subcutaneous injection.  From Cycle 3 onwards, single 12-lead ECG will be 
performed on Day 1 of each cycle prior to investigational product administration (and premedication, if applicable).  When coinciding with blood sample 
draws for pharmacokinetics (PK), ECG assessment should be performed prior to blood sample collection, such that the blood sample is collected at the 
nominal time.  If the mean QTcF is prolonged (>500 msec), the ECGs should be re-evaluated by a qualified person at the institution for confirmation.  
Additional triplicate ECGs may be performed as clinically indicated.  When CRS symptoms are observed, ECG should be skipped until the symptoms are 
resolved. 
14. Echocardiogram (Echo) or multigated acquisition scan (MUGA): Echo or MUGA will be evaluated in participants with previous history of cardiac 
events.  For these participants, an Echo or MUGA will be performed at screening, when clinically indicated and at the end of treatment (EOT) visit. 
15. Hematology: No need to repeat on C0D1 if baseline assessment performed within 3 days prior to that date.  Assessment on Day 8 and Day 15 is not 
required in Cycle 3 onward.  All samples will be collected prior to investigational product administration on days whereby investigational product is to be 
administered.  See Section 10.2 for Laboratory Tests list. 
16. Blood Chemistry: No need to repeat on C0D1 if baseline assessment performed within 3 days prior to that date.  Assessment on Day 8 and Day 15 is not 
required in Cycle 3 onward.  All samples will be collected prior to investigational product administration on days whereby investigational product is to be 
administered.  See Section 10.2 for Laboratory Tests list. 
17. Coagulation: No need to repeat on C0D1 if baseline assessment performed within 3 days prior to that date.  Assessment on Day 8 and Day 15 is not 
required in Cycle 3 onward.  All samples will be collected prior to investigational product administration on days whereby investigational product is to be 
administered.  See Section 10.2 for Laboratory Tests list. 
18. Hepatitis assessment: Screening tests for hepatitis B (HBV) and C (HCV) should be performed including hepatitis B surface antigen (HBsAg), hepatitis B 
core antibody (HBcAb), hepatitis B surface antibody (HBsAb) and hepatitis C virus (HCV) antibody.  In the case of apparent ongoing HBV or HCV 
infection, reflexive serum DNA or RNA viral load testing, respectively, will be performed.  Participants with positive HBsAb and positive HBcAb are 
allowed to participate in the study if they have negative HBV DNA test at screening but HB viral load should be monitored for re-activation every 12 weeks.  
Participants with HBsAb positive who have been vaccinated with HBV are exempted from the testing of HB viral load. See Section 10.2 for Laboratory 
Tests list. 
19. Urinalysis: Dipstick is acceptable.  Microscopic analyses if dipstick abnormal.  No need to repeat on C0D1 if baseline assessment performed within 3 days 
prior to that date.  Following C0D1, only obtain as clinically indicated until EOT.  See Section 10.2 for Laboratory Tests list. 
20. Pregnancy Test and contraception check: Serum or urine pregnancy test for females of childbearing potential (see Pregnancy Testing Section 8.2.6).  
Contraception use for males and women of childbearing potential (WOCBP) will be checked to confirm that contraception is used consistently and correctly. 
21. Treatment with investigational product elranatamab: Investigational product as a priming dose will be administered on C0D1 (7 days prior to C1D1).  
After the priming dose, investigational product as a full dose of 1000 µg/kg will be administered Day 1, 8 and 15 of each cycle (see Administration Section 
6.1).  If a participant has received treatment with every week dosing (Q1W) elranatamab for at least 6 months, and disease assessments have remained stable 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 17 
over at least 2 months, consideration may be given to increasing dose intervals from weekly to every 2 weeks after consultation with sponsor.  If the 
participant subsequently begins to have increase of disease burden, dose intervals should return to weekly dosing.  If the dose intervals is increased from 
weekly to every 2 weeks, see Schedule of Activities for Q2W for subsequent cycles. 
22. Premedication for CRS:  Must be administered 60 minutes (±15 minutes) prior to elranatamab dose, See Section 6.5.2. 
23. Genetic Analysis: Bone marrow aspirates taken on C0D1 will be evaluated for t(4;14)(p16;q32), t(14;16)(q32;q23), 17p13 deletions, t(11;14)(q13;q32), 
chromosome 13 deletion, ploidy category, and chromosome 1 abnormalities, unless data is available from tests conducted within 6 months or less of 
participant enrollment.  Sample for C0D1 may be taken up to 7 days before study treatment. 
24. Serum immunofixation electrophoresis (SIFE), serum protein electrophoresis (SPEP), serum free light chain analysis (FLC) tests and beta-2 
microglobulin tests: No need to repeat on C0D1 if baseline assessment performed within 3 days prior to that date.  See Assessments Section 8.1.1.1 for 
laboratory disease assessment tests list.  Beta-2 microglobulin will only be collected on C0D1.  Note that SIFE will be completed at baseline, when 
electrophoresis shows no measurable protein, at suspected CR/sCR, and at suspected progression (clinical or biochemical).  When a CR/sCR or a clinical or 
biochemical progression is suspected, SPEP, SIFE, and serum free light chain analysis (FLC) tests will be repeated within 1 to 4 weeks.  All samples will be 
collected prior to investigational product administration on days whereby investigational product is to be administered. 
25. 24 hr urine immunofixation electrophoresis (UIFE), 24 hr urine protein electrophoresis (UPEP): No need to repeat on C0D1 if baseline assessment 
performed within 3 days prior to that date.  See Assessments Section 10.2 for laboratory tests list.  Note that UIFE will be completed at baseline, when 
electrophoresis shows no measurable protein, at suspected CR/sCR, and at suspected progression (clinical or biochemical).  When a CR/sCR or a clinical or 
biochemical progression is suspected, UPEP and UIFE will be repeated within 1 to 4 weeks.  If samples collection day coincides with days whereby 
investigational product is to be administered, samples will be collected prior to investigational product administration. 
26. Bone Marrow Collection and Assessments: For C0D1 and on-treatment bone marrow collections and assessments, see Section 8.1.1.2.  Sample for C0D1 
may be taken up to 7 days before study treatment.  Bone marrow collections and local plasma cell assessments should be fixed according to the calendar, 
regardless of treatment delays.  Bone marrow evaluation consisting of bone marrow aspirate and/or bone marrow biopsies will be performed to follow 
disease response.  When bone marrow plasma cell infiltration is assessed by both bone marrow aspirate and by bone marrow biopsy, the highest value of 
bone marrow plasma cell infiltration should be utilized for response evaluation.  Bone marrow aspirates will also be collected and plasma cells will be 
evaluated at time of suspected CR and optional at time of suspected disease progression.  Bone marrow biopsy will also be collected and plasma cells will be 
evaluated when confirmation of sCR is required.  For participants who experience a plateau or CR, additional bone marrow aspirates at 9 months after C0D1 
and onwards will be optional.  Optional bone marrow aspirate and biopsy samples will also be taken at disease progression if a sample was not taken within 
the past 4 weeks.  Minimal residual disease (MRD) will be evaluated by high-throughput sequencing using a next generation sequencing (NGS) assay, if CR 
is observed; a sample taken on C0D1 will be used as a reference. Samples at 1 and 3 months after C0D1 will be collected 7 days; samples at 9 months after 
C0D1 and later will be collected 14 days. 
27. Disease assessments by fluorodeoxyglucose (FDG) positron emission tomography (PET)/ computed tomography (CT): See Section 8.1.1.3.  
Radiographic assessments obtained per the patient’s standard of care prior to enrollment into the study do not need to be repeated and are acceptable to be 
used as baseline evaluation, if, (1) obtained within 28 days before C0D1, (2) the same technique/modality can be used to follow identified lesions throughout 
the trial for a given participant, and (3) appropriate documentation indicating that these radiographic tumor assessments were performed as standard of care 
is available in the participant’s source notes.  Images may also be required at suspected CR, when disease progression is suspected (eg, symptomatic 
deterioration), and when otherwise clinically indicated.  Images at 1 and 3 months after C0D1 will be collected 7 days; images at 9 months after C0D1 and 
later will be collected 14 days.  For participants with only skin involvement, skin lesions should be measured with a ruler. 
28. Adverse Event (AE) Assessments: AEs should be documented and recorded at each visit using the NCI CTCAE version 5.0.  However, the severity of 
cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity (ICANS) will be assessed according to the ASTCT grading22 (See 


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PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 21 
1.3.2. Schedule of Activities for Q2W Dose Interval 
Schedule of Activities  
Visit Identifiera 
Treatment Period (at least 6 months after C1D1)
28 Days 
Follow-up25
Survival  
Follow-up26
1 Cycle = 4 weeks
EOT24
Study Day 
Day 1 
Day 15 
Visit Window (days) 
3/+7 
3/+7 
 
+7 
14 
Clinical Evaluation 
 
 
 
 
 
Brief  physical examination 
X 
 
X 
X 
 
Neurological examination 
X 
 
 
 
 
Weight1 
X 
 
X 
 
 
Vital signs (BP/pulse rate/Temp)2  
X 
X 
X 
X 
 
ECOG performance status3 
X 
X 
X 
 
(12 lead) ECG4 
X 
 
X 
 
Echo or MUGA5 
If there is a history of cardiac events, perform when clinically indicated. 
X 
 
 
Safety Laboratory 
 
 
 
 
 
Hematology6 
X 
 
X 
X 
 
Blood Chemistry7 
X 
 
X 
X 
 
Coagulation8 
X 
 
X 
X 
 
Hepatitis assessment9 
If applicable 
 
 
 
Urinalysis10 
If clinically indicated 
X 
X 
 
Pregnancy test and contraception check11 
X 
 
X 
X 
X 
Treatment 
 
 
 
 
 
Treatment with elranatamab12 
X 
X 
 
 
 
Disease assessments 
 
 
 
 
 
SPEP, SIFE, serum FLC ratio, beta-2 
microglobulin (local)13  
 
 
X 
 
If obtained as 
SOC prior to 
subsequent 
treatment26 
UPEP, UIFE (local)14  
 
 
X 
 
Bone marrow collection and 
assessments- aspirates15 
At 9 months after C0D1, every 6 months thereafter, at suspected CR and optional at disease 
progression.  Collection at 9 months after C0D1 and onwards will be optional for participants who 
experience a plateau or CR. Check for MRD at CR. 
 


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PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 23 
3. Performance Status: Use Eastern Cooperative Oncology Group (ECOG) – see Section 10.11. 
4. 12-Lead electrocardiogram (ECG): From Cycle 3 onwards, single 12-lead ECG will be performed on Day 1 of each cycle prior to investigational product 
administration (and premedication, if applicabl).  When coinciding with blood sample draws for pharmacokinetics (PK), ECG assessment should be 
performed prior to blood sample collection, such that the blood sample is collected at the nominal time.  If the QTcF is prolonged (>500 msec), the ECGs 
should be re-evaluated by a qualified person at the institution for confirmation.  Additional triplicate ECGs may be performed as clinically indicated.  When 
CRS symptoms are observed, ECG should be skipped until the symptoms are resolved. 
5. Echocardiogram (Echo) or multigated acquisition scan (MUGA): Echo or MUGA will be evaluated in participants with previous history of cardiac 
events.  For these participants, an Echo or MUGA will be performed at screening, when clinically indicated and at the end of treatment (EOT) visit. 
6. Hematology: All samples will be collected prior to investigational product administration on days whereby investigational product is to be administered.  
See Section 10.2 for Laboratory Tests list. 
7. Blood Chemistry: All samples will be collected prior to investigational product administration on days whereby investigational product is to be 
administered.  See Section 10.2 for Laboratory Tests list. 
8. Coagulation: All samples will be collected prior to investigational product administration on days whereby investigational product is to be administered.  
See Section 10.2 for Laboratory Tests list. 
9. Hepatitis assessment: For participants with negative HBV DNA test but positive HBsAb and positive HBcAb at screening, HB viral load should be 
monitored for re-activation every 12 weeks.  Participants with HBsAb positive who have been vaccinated with HBV are exempted from the testing of HB 
viral load. 
10. Urinalysis: Dipstick is acceptable.  Microscopic analyses if dipstick abnormal.  Obtain as clinically indicated until EOT.  See Section 10.2 for Laboratory 
Tests list. 
11. Pregnancy Test and contraception check: Serum or urine pregnancy test for females of childbearing potential (see Pregnancy Testing Section 8.2.6).  
Contraception use for males and WOCBP will be checked to confirm that contraception is used consistently and correctly. 
12. Treatment with investigational product elranatamab: Investigational product will be administered on Day 1 and 15 of each cycle (see Administration 
Section 6.1).  Cycles would remain the same length with any skipped weekly doses noted.  If the participant subsequently begins to have increase of disease 
burden, dose intervals should return to weekly dosing. 
13. SIFE, SPEP, FLC tests and beta-2 microglobulin tests: See Assessments Section 8.1.1.1 for laboratory disease assessment tests list.  Beta-2 
microglobulin will only be collected on C0D1.  Note that SIFE will only be completed at baseline, when electrophoresis shows no measurable protein, at 
suspected CR/sCR, and at suspected progression (clinical or biochemical).  When a CR/sCR or a clinical or biochemical progression is suspected, SPEP, 
SIFE, and serum free light chain analysis (FLC) tests will be repeated within 1 to 4 weeks.  All samples will be collected prior to investigational product 
administration on days whereby investigational product is to be administered. 
14. 24 hr UIFE, 24 hr UPEP: See Assessments Section 10.2 for laboratory tests list.  Note that UIFE will only be completed at baseline, when electrophoresis 
shows no measurable protein, at suspected CR/sCR, and at suspected progression (clinical or biochemical).  When a CR/sCR or a clinical or biochemical 
progression is suspected, UPEP and UIFE will be repeated within 1 to 4 weeks.  If samples collection day coincides with days whereby investigational 
product is to be administered, samples will be collected prior to investigational product administration. 
15. Bone Marrow Collection and Assessments: See Section 8.1.1.2.  Bone marrow collections and local plasma cell assessments should be fixed according to 
the calendar, regardless of treatment delays.  Bone marrow evaluation consisting of bone marrow aspirate and/or bone marrow biopsies will be performed to 
follow disease response.  When bone marrow plasma cell infiltration is assessed by both bone marrow aspirate and by bone marrow biopsy, the highest value 
of bone marrow plasma cell infiltration should be utilized for response evaluation.  Bone marrow aspirates will also be collected and plasma cells will be 
evaluated at time of suspected CR and optional at time of suspected disease progression.  Bone marrow biopsy will also be collected and plasma cells will be 
evaluated when confirmation of sCR is required.  For participants who experience a plateau or CR, additional Bone marrow aspirates at 9 months after C0D1 


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CCI
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occurs, then an ad hoc sample for central analysis is not required/collected.  However, an ad hoc sample for local analysis may still be collected for 
participant management. 
24. End of Treatment (EOT) Visit: Obtain these assessments if not completed in the last week (last 4 weeks for disease assessments).  
25. 28 days follow-up: At least 28 calendar days, and no more than 35 calendar days, after discontinuation of treatment, participants will return to undergo 
review of concomitant treatments, vital signs, and assessment for resolution of any treatment-related toxicity.  Participants continuing to experience toxicity 
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. 
26. Survival follow-up: Following discontinuation of study treatment (unless participants are lost to follow-up, consent is withdrawn, or study is discontinued 
by the sponsor), survival status will be collected by telephone every 3 months until death, or at least 12 months after first treatment of the last participant, 
whichever comes first.  Subsequent anti-cancer therapies and relevant transplant information will also be collected.  Any standard of care (SOC) disease 
assessments obtained between EOT and subsequent anti-cancer therapy will be collected.  Information of AEs and contraception check will also be collected 
until the end of active AE reporting period as defined in Section 8.3.1, and contraception check period in Section 10.4. 
 


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2. INTRODUCTION 
Elranatamab is a bispecific monoclonal antibody against B-cell maturation antigen (BCMA, 
also known as tumor necrosis factor receptor superfamily member 17 [TNFRSF17] or cluster 
of differentiation [CD] 269) and CD3 that is currently being investigated in adult participants 
with relapsed or refractory multiple myeloma (MM).  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. 
2.1. Study Rationale  
The purpose of the study is to confirm safety and tolerability at the RP2D of elranatamab 
with an initial single priming dose administered subcutaneously on weekly dosing schedule 
(Q1W) in monotherapy setting in Japanese participants with relapsed or refractory MM. 
2.2. Background  
2.2.1. Multiple Myeloma 
MM is a hematological malignancy that is characterized by uncontrolled expansion of bone 
marrow plasma cells.  Approximately 114,000 new cases of MM are diagnosed worldwide 
each year, and 80,000 patients will die from their disease.1  In Japan, 7,880 cases were newly 
diagnosed as MM in 2017 and the mortality of patients with MM were 4,209 in 2018.2 
MM is a disease that evolves from a pre-malignant stage of monoclonal gammopathy of 
undetermined clinical significance (MGUS), to asymptomatic smoldering myeloma, to 
symptomatic active myeloma.3  During the active stage of disease, a majority of patients 
develop painful bone lesions and organ dysfunction, leading to anemia, renal insufficiency 
and hypercalcemia.  Whilst patients with smoldering myeloma do not require primary 
therapy, the treatment regimen for patients with active disease is currently dependent on the 
patient’s eligibility to receive an autologous stem cell transplant (ASCT).  For patients 
<70 years old with no comorbidities, induction therapy (either proteasome inhibitor-based or 
immunomodulation-based regimens) combined with an ASCT is the suggested approach, 
with 2-year survival achieved in 80% of patients.3,4  Still, even in this younger age group, the 
rate of toxicity following transplant is high, with 5% mortality due to adverse events reported 
in clinical studies.5  In older patients ie, those >70 years, adverse event related mortalities 
following ASCT is a staggering 19%.5  Though in theory allogeneic stem cell transplant has a 
curative potential, it is not a recommended regimen for this population as no survival 
advantages have been demonstrated in randomized studies due to increased toxicities.6  For 
transplant ineligible patients, immunomodulation based regimen of bortezomib, 
lenalidomide, and dexamethasone is the primary preferred treatment option as it was 
demonstrated in the Phase III Southwest Oncology Group (SWOG) S0777 study that an 
objective response rate (ORR), of 71%, and progression free survival (PFS) of 43 months can 
be achieved.4,7  However, toxicity remains to be a concern, with Grade 3 or higher 
neuropathy reported in 24% of patients. 
Despite a number of recent advances, the majority of patients are expected to relapse, even 
for those who respond initially to treatment.  Even for patients who are eligible to receive 


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autologous stem cell transplants (ASCTs), the median time to relapse was 17.2 months.8  
Similarly, for patients that are treated with novel proteasome inhibitor-based or 
immunomodulation-based combination regimens as front line treatment, the median time to 
relapse is 16.4 months.9 
Patients with relapsed or refractory MM who respond poorly to proteasome inhibitor-based 
or immunomodulation-based regimens show a median overall survival (OS) of only 
1.5 years.10  In this relapsed setting, approximately 50% treatment-related adverse events 
(AE) and 20% serious adverse events (SAE) have been reported.11  Furthermore, each 
subsequent line of therapy renders the patient more refractory to treatment.  For example, 
patients who are double-refractory to proteasome inhibitor-based or immunomodulation 
regimens have a median OS of 9 months.12  It is therefore clear that additional treatment 
approaches are required for relapsed/refractory MM. 
2.2.2. Bispecific Antibodies 
Functional local and systemic immunity is often suppressed in a MM patient.  Impaired 
immunity results from the disruption of normal hematopoiesis following bone marrow 
invasion by plasma clones.  The potential for T-cell based immunotherapy for MM has been 
highlighted by the ability for graft immune reactive T-cells to eradicate myeloma cells 
following allogeneic stem cell transplantation.13  It may therefore be possible to restore 
immune-reactive T-cells, prevent malignant cell growth and decrease disease recurrence with 
immunotherapeutic approaches. 
Bispecific antibodies offer a novel immunotherapeutic approach that allows the direct 
targeting of cytotoxic T-cells to tumor cells.  These antibodies are engineered with two 
separate antigen recognition domains; one that recognizes a tumor antigen and another that 
recognizes CD3 expressed on T-cells.  Simultaneous binding of CD3 and the tumor antigen 
initiates a cytotoxic response towards the bound tumor cell.  Unlike normal T-cell 
cytotoxicity, bispecific antibody mediated cytotoxicity is independent to the presence of 
antigen presenting cells (APCs), expression of major histocompatibility complex (MHC) 
I molecules by the tumor, and the presence of costimulatory molecules.  Blinatumomab, a 
CD19/CD3 bispecific antibody, was the first bispecific antibody to be approved by the 
United States (US) Food and Drug Administration (FDA).14  In a Phase 2 trial of relapsed or 
refractory B cell acute lymphoblastic leukemia (ALL) patients, 33% achieved complete 
response (CR) and 10% achieved CR with incomplete hematological recovery.14  It may 
therefore be possible to use the same approach for MM with a myeloma-restricted antigen. 
BCMA is a candidate for bispecific antibody-based immunotherapy.  BCMA expression is 
upregulated during B-cell maturation into plasma blasts and plasma cells, but it is not 
expressed on naïve B cells, hematopoietic stem cells or normal tissues such as the heart, lung, 
kidney, or tonsil.15,16  BCMA knockout mice show normal development, and are able to elicit 
a normal humoral immune response.17,18  In MM, BCMA expression was identified at each 
disease stage, and on patients with differing cytogenetic risks.15  Furthermore, BCMA 
expression was not influenced by treatment with ASCT or chemotherapy.15,16  In vivo, 
bispecific antibodies against BCMA have been shown to induce T-cell activation, reduce 
tumor burden and prolong survival.19,20,21   


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Elranatamab is a heterodimeric humanized full-length bispecific antibody comprised of one 
BCMA binding arm and one CD3 binding arm paired through hinge mutation technology.  It 
utilizes a modified human IgG2a fragment crystallizable (Fc) region.  The half-life of 
elranatamab was 3 days in a non-human primate model, and elranatamab has a projected 
terminal half-life of 10 days in humans. 
2.2.3. Nonclinical Pharmacology 
Using fresh bone marrow aspirates from myeloma patients, elranatamab eliminated myeloma 
cells in a dose-dependent manner (see Figure 1A).  There was a modest correlation between 
effective concentration 50 (EC50) and number of BCMA receptors on the cell surface when 
MM cell lines with varying BCMA cell surface receptor levels were used in a cytotoxicity 
assay (Figure 1B).  BCMA is shed from the surface of myeloma cells, and soluble BCMA in 
patient serum may decrease activity of elranatamab by acting as a sink.  Bone marrow 
stromal cells are known to protect MM cells from drug treatment and induce myeloma cell 
growth.  In the case that either of these suppressive mechanisms negatively impact 
elranatamab activity.  
Figure 1. Elranatamab Activity In Vitro 
 
Abbreviations: EC50 = half maximal effective concentration; E:T = effector (T-cells) to 
target (myeloma cells) ratio; nM = nanomolar; pM = picomolar; sABC = specific 
antibody-binding capacity 
2.2.3.1. Anti-tumor Efficacy of Elranatamab in Orthotopic Multiple Myeloma Models 
Tumor Models 
Activity of elranatamab was also evaluated in MM orthotopic tumor models.  MM cell line 
(OPM-2), myeloma cells were injected into NOD scid gamma (NSG) mice.  Fourteen days 
following OPM-2 injection, the mice received an intraperitoneal injection of CD3+ T-cells 
and a single dose of elranatamab two additional days later.  As shown in Figure 2, 
elranatamab dose dependently inhibited tumor growth, and elimination of myeloma cells was 
observed on Day 24.  At the highest dose level of 300 g/kg, tumor growth reduction was 
sustained up to Day 55 when the study was terminated.  Similar results were observed using 
MM1.S (a glucocorticoid sensitive MM cell line) and MOLP-8 (a MM cell line with 
t(11;14)(q13;q32) chromosomal abnormality and negative for CD28) tumor models.  


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Elranatamab also showed enhanced tumor activity in the combination with anti-PD-1 
antibody or lenalidomide, suggesting the potential for synergy in the human setting. 
Figure 2. Elranatamab Activity in an OPM-2 MM Orthotropic Tumor Model 
 
2.2.4. Nonclinical Pharmacokinetics and Metabolism 
Single-dose pharmacokinetics (PK) and repeat-dose toxicokinetics were evaluated in 
cynomolgus monkeys following intravenous (IV) and subcutaneous (SC) dosing of 
elranatamab.  After single IV dosing up to 0.01 mg/kg, the PK of elranatamab in cynomolgus 
monkeys were characterized by low clearance (CL), and low volume of distribution (Vss), 
resulting in mean terminal elimination half-life (t½) values ranging from approximately 4 to 
6 days.  After once weekly IV dosing at doses 0.01 elranatamab to 0.3 mg/kg, systemic 
exposure increased with increasing doses and was higher after repeat dosing. 
After once weekly SC dosing of elranatamab at 0.3 mg/kg, the mean Tmax values on Day 1 
and 22 were 56 and 25 hours, respectively.  In general, there were no apparent sex-related 
differences in exposure.  Induction of anti-drug antibodies (ADA) was observed in 1 animal 
after repeated dosing. 
See Section 5.2 of the elranatamab Investigator’s Brochure (IB) for detailed information on 
nonclinical studies. 
2.2.5. Nonclinical Safety 
In nonclinical safety studies conducted in cynomolgus monkeys with elranatamab 
administered by either the IV or SC route for up to 1-month in duration, the key effects were 
cytokine elevations that were occasionally accompanied by emesis during the first 6 hours 
after the first drug administration and minimal to moderate inflammation at the injection site.  
Decreases in B cells and plasma cells as well as fluctuations in peripheral T-cell numbers 
were observed in IV studies where immunophenotyping measurements were included.  All of 
these effects were considered related to the mechanism of action.  In addition, red skin 


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discoloration was noted in a subset of animals administered elranatamab by the IV route.  
None of the effects were considered adverse.  Thus, the no-observed-adverse-effect level 
(NOAEL) in the pivotal toxicity study was 0.3 mg/kg in monkeys [highest dose tested; 
maximum concentration (Cmax) of 10.4 g/mL and area under the curve (AUC168) of 
715 g∙h/mL].  A detailed summary of the nonclinical safety programs is provided in the 
current IB. 
2.2.6. Clinical Overview 
Elranatamab is being evaluated as a single agent in Study C1071001.  Part 1 dose escalation 
includes monotherapy (IV and SC) and Part 1.1 includes 2 priming cohorts (SC only).  As of 
04 February 2021, 53 participants were enrolled in Part 1 with 23 participants in the range of 
0.1 to 50 μg/kg Q1W IV cohort and 30 participants in the range of 80 to 1000 μg/kg Q1W 
SC cohort.  DLTs of febrile neutropenia Grade 3 and electrocardiogram QT prolonged 
Grade 1 were observed at 30 and 50 μg/kg IV, respectively.  However, there were no DLTs 
observed in the SC dosing cohort across the dose range from 80 to 1000 μg/kg.  There was 
no maximum tolerated dose (MTD) identified.  Given the acceptable safety profile observed 
at the 1000 μg/kg Q1W together with encouraging clinical activity, this dose level was 
selected as the RP2D for further exploration in subsequent pivotal trials.  More details on the 
safety profile during dose escalation is provided in the Investigator Brochure. 
Priming Cohorts: 
Part 1.1 in Study C1071001introduced a priming strategy to mitigate CRS which involves a 
single lower priming dose (600 µg/kg) followed by maintenance dosing starting 1 week later 
at the RP2D (1000 µg/kg) on either a QW or Q2W schedule.  As of 04 February 2021, 20 
participants have been treated in the Part 1.1 SC priming cohorts. 
Preliminary data are available from 2 priming cohorts (Part 1.1, cutoff date: 04 February 
2021).  Across the Part 1.1 priming cohorts (n=20), the most common TEAEs regardless of 
causality included CRS (all grades 100%, Grade ≥3 0%), neutropenia (all grades 65%, Grade 
≥3 45%), thrombocytopenia (all grades 45%, Grade ≥3 15%), injection site reaction (all 
grades 45%, Grade ≥3 0%), and anemia (all grades 40%, Grade ≥3 20%) (Table 1).  
According to ASTCT criteria, both CRS (Grade 1 55%, Grade 2 45%) and ICANS (Grade 1 
5%, Grade 2 10%) were limited to Grade ≤2 with median duration of 2.5 and 3 days, 
respectively.  Additional Grade ≥3 TEAEs regardless of causality occurring in ≥10% of 
participants included lymphopenia (Grade 3 0%, Grade 4 20%), leukopenia (Grade 3 10%, 
Grade 4 5%), AST increased (Grade 3 15%, Grade 4 0%), ALT increased (Grade 3 10%, 
Grade 4 0%), hypophosphatemia (Grade 3 10%, Grade 4 0%), and plasma cell myeloma 
(Grade 5 10%). Grade ≥3 infections regardless of causality included 1 event of sepsis (Grade 
5) which was not related to study treatment by investigator.  Treatment-emergent SAEs 
regardless of causality included CRS (n=3), hypercalcemia (n=2), plasma cell myeloma 
(n=2), and 1 each for acute kidney injury, asthenia, and sepsis; with the exception of CRS, 
none of these SAEs were judged by investigators as related to study treatment.  Fatal TEAEs 
included plasma cell myeloma (n=2) and sepsis (n=1), none of which was considered related 
to study treatment by the investigator.  With the introduction of a priming dose, the median 
duration of CRS decreased by 37.5% (from 4 days to 2.5 days) compared to that observed in 


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the 1000 μg/kg SC cohort with no priming dose. CRS incidence has been limited to the 
priming (Grade 1 55%, Grade 2 45%) and the initial full doses (Grade 1 10%).  For 
participants receiving doses ≥ 600 μg/kg including the dose escalation cohorts (600 and 
1000 μg/kg cohorts) and the 2 priming cohorts, CRS was observed in 97% of participants 
(61% Grade 1 and 35% Grade 2). 
CRS began within the first 3 days of dosing in all participants with CRS.  In participants 
experiencing CRS events across both IV and SC cohorts (n = 54), CRS occurred on Day 1 
(n = 40, 74%), Day 2 (n = 13, 24%), and Day 3 (n = 1, 2%) after the first dose indicating the 
onset of CRS is predominantly within the first 2 days.  In the SC cohort, only 1 participant 
experienced CRS after the second dose and no CRS events were observed after the third or 
later doses. 
In summary, all cases of CRS during dose escalation or in the 2 priming cohorts were either 
Grade 1 or 2 according to ASTCT criteria, were managed by supportive care, and none 
resulted in permanent treatment discontinuation or dose reductions.  
Peripheral Neuropathy including Guillain Barré Syndrome (GBS) 
Peripheral neuropathy (including GBS) is considered an important potential risk of 
elranatamab.  Between March and April 2021, 3 participants treated in Phase 1 Study 
C1071001 experienced serious adverse events of Grade 3 peripheral neuropathy, which was 
reported in 1 case as a variant of GBS, in 1 case as peripheral motor neuropathy and in 1 case 
as muscular weakness.  Two of these participants had received elranatamab in combination 
with pomalidomide, and 1 participant had received elranatamab as single agent.  For these 3 
participants, they first experienced sensory neuropathy and subsequently experienced motor 
neuropathy involving the lower extremities.  Time to onset of lower extremity weakness was 
approximately 3 to 8 weeks.  All 3 participants showed evidence of anti-myeloma response 
which, based on changes in paraprotein levels, was evident as early as 1 week after initiation 
of study treatment.  All participants were hospitalized for diagnostic evaluation.  The 
participant diagnosed with GBS received empiric treatment with IV immunoglobulins with 
improvement of peripheral neuropathy to Grade 2; 1 participant had peripheral neuropathy 
improved to Grade 2; and 1 participant has stable peripheral neuropathy (at time of this 
amendment).  Study treatment was permanently discontinued in the participant diagnosed 
with GBS and in the participant with muscular weakness. 
The pathophysiology of peripheral neuropathy for these 3 participants remains to be 
elucidated.  However, the 3 participants have some common features: all had pre-existing 
peripheral neuropathy, had received extensive prior treatment with IMiDs and proteasome 
inhibitors, had anti-myeloma response to elranatamab in combination with pomalidomide (2 
participants) or as a single agent (1 participant), and had recent infections treated with 
antibiotics that are known to cause peripheral neuropathy (ciprofloxacin, levofloxacin, 
nitrofurantoin) less than a month before the onset of the peripheral neuropathy. 
See Section 6.5.2 for additional guidance for peripheral neuropathy. 


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Table 1. 
Table 3. Study C1071001: TEAEs Occurring in >15% of SC Participantsa 
(All Causalities by MedDRA PT and Maximum CTCAE Grade by Part 1 SC Cohorts; Safety Analysis Set) 
 
Part 1 SC Cohorts QW Dosing (N=30) 
Part 1.1 SC Priming Cohorts (N=20) 
Preferred Term 
Grade 1 
Grade 2
Grade 3
Grade 4
Grade 5
Total 
Grade 1 
Grade 2
Grade 3
Grade 4
Grade 5
Total 
n (%) 
n (%) 
n (%) 
n (%) 
n (%)
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
With Any Adverse Event 
0  
0 
7 (23.3)
20 (66.7)
3 (10.0) 30 (100.0)
0 
3 (15.0)
8 (40.0)
7 (35.0)
2 (10.0)
20 (100.0)
Lymphopenia 
0  
0  
6 (20.0)
18 (60.0)
0 
24 (80.0)
0 
1 (5.0) 
0 
4 (20.0)
0 
5 (25.0) 
CRSb 
17 (56.7) 
5 (16.7)
0 
0 
0 
22 (73.3)
11 (55.0) 
9 (45.0)
0 
0 
0 
20 (100.0)
Anaemia 
0  
3 (10.0)
14 (46.7)
0 
0 
17 (56.7)
1 (5.0) 
3 (15.0)
4 (20.0)
0 
0 
8 (40.0) 
Injection site reaction 
14 (46.7) 
2 (6.7) 
0 
0 
0 
16 (53.3)
8 (40.0) 
1 (5.0) 
0 
0 
0 
9 (45.0) 
Thrombocytopenia 
3(10.0) 
2 (6.7) 
5 (16.7)
6 (20.0)
0 
16 (53.3)
2 (10.0) 
4 (20.0)
2 (10.0)
1 (5.0) 
0 
9 (45.0) 
Neutropenia 
0  
0 
5 (16.7)
9 (30.0)
0 
14 (46.7)
0 
4 (20.0)
6 (30.0)
3 (15.0)
0 
13 (65.0)
Leukopenia 
3 (10.0) 
2 (6.7) 
5 (16.7)
1 (3.3) 
0 
11 (36.7)
0 
1 (5.0) 
2 (10.0)
1 (5.0) 
0 
4 (20.0) 
Nausea 
7 (23.3) 
3 (10.0)
1 (3.3) 
0 
0 
11 (36.7)
3 (15.0) 
3 (15.0)
0 
0 
0 
6 (30.0) 
AST increased 
5 (16.7) 
2 (6.7) 
3 (10.0)
0 
0 
10 (33.3)
2 (10.0) 
1 (5.0) 
3 (15.0)
0 
0 
6 (30.0) 
ALT increased 
5 (16.7) 
1 (3.3) 
3 (10.0)
0 
0 
9 (30.0)
2 (10.0) 
2 (10.0)
2 (10.0)
0 
0 
6 (30.0) 
Diarrhoea 
6 (20.0)  
2 (6.7) 
1 (3.3) 
0 
0 
9 (30.0)
5 (25.0) 
2 (10.0)
0 
0 
0 
7 (35.0) 
Decreased appetite 
5 (16.7) 
2 (6.7) 
0 
0 
0 
7 (23.3)
3 (15.0) 
1 (5.0) 
0 
0 
0 
4 (20.0) 
Vomiting 
6 (20.0) 
1 (3.3) 
0 
0 
0 
7 (23.3)
5 (25.0) 
1 (5.0) 
0 
0 
0 
6 (30.0) 
Hypokalaemia 
2 (6.7) 
4 (13.3)
1 (3.3) 
0 
0 
7 (23.3)
0 
5 (25.0)
1 (5.0) 
0 
0 
6 (30.0) 
Arthralgia 
3 (10.0) 
2 (6.7) 
1 (3.3) 
0 
0 
6 (20.0)
2 (10.0) 
0 
0 
0 
0 
2 (10.0) 
Dry skin 
4 (13.3) 
2 (6.7) 
0 
0 
0 
6 (20.0)
4 (20.0) 
0 
0 
0 
0 
4 (20.0) 
ICANS 
3 (10.0) 
3 (10.0)
0 
0 
0 
6 (20.0)
1 (5.0) 
2 (10.0)
0 
0 
0 
3 (15.0) 
Hypophosphataemia 
0 
2 (6.7) 
2 (6.7) 
1 (3.3) 
0 
5 (16.7)
0 
4 (20.0)
2 (10.0)
0 
0 
6 (30.0) 
Urinary tract infection 
0 
5 (16.7)
0 
0 
0 
5 (16.7)
0 
1 (5.0) 
0 
0 
0 
1 (5.0) 
Fatigue 
1 (3.3) 
2 (6.7) 
1 (3.3) 
0 
0 
4 (13.3)
3 (15.0) 
4 (20.0)
0 
0 
0 
7 (35.0) 
Hypomagnesaemia 
4 (13.3) 
0 
0 
0 
0 
4 (13.3)
7 (35.0) 
0 
0 
0 
0 
7 (35.0) 
Musculoskeletal chest pain 
0 
1 (3.3) 
0 
0 
0 
1 (3.3) 
1 (5.0) 
4 (20.0)
0 
0 
0 
5 (25.0) 
Back pain 
0  
3 (10.0) 
0 
0 
0 
3 (10.0)
0 
3 (15.0)
1 (5.0) 
0 
0 
4 (20.0) 
a. >15% in Part 1 SC cohorts and/or Part 1.1 SC Priming Cohorts 
b. CRS grading based on modified ASTCT criteria (Lee, 2019)22; all AEs according to NCI CTCAE v4.03. 
Cut-off date : 04 Feb 2021. 


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PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 34 
SC dose administration resulted in a lower dose normalized Cmax relative to IV 
administration.  Elranatamab maximum serum concentrations within 24 hours after the first 
dose (ie, Cmax-24h) were shown to be associated with all Grade and Grade ≥2 CRS.  The 
24-hour timepoint coincides with onset of CRS symptoms in the majority of participants.  
Exposure to total elranatamab increased with dose in an approximately dose-proportional 
manner.  SC dose administration resulted in a prolonged absorption phase with median time 
to reach Cmax (Tmax) ranging from 3 to 7 days.  Based on the available SC data, the model-
predicted SC bioavailability is approximately 65% (95% CI: 61%, 68%).   
Preliminary immunogenicity data available from 50 ADA-evaluable participants suggests 
low (14%) overall incidence of ADAs against elranatamab.  The overall incidence of ADA 
appeared comparable between the IV (18.2%) and SC (10.7%) routes.  Also, there appears to 
be no impact of the presence of ADA on the PK profiles by visual inspection and population 
PK analysis. 
Preliminary population PK analysis based on data from 53 participants from IV and SC 
cohorts suggests that body weight (range: 42 to 120 kg) does not appear to be a clinically 
meaningful covariate on elranatamab exposure.  This may support the use of fixed dosing 
approach for further clinical development.  Age, sex, and race were not clinically meaningful 
covariates on elranatamab exposure. 
2.3. Benefit/Risk Assessment 
Based on the clinical data available to date, the conduct of the trial with the proposed single 
agent elranatamab doses and regimens is considered justifiable. 
The clinical safety data available to date, in participants with relapsed or refractory MM, has 
suggested an acceptable safety profile of elranatamab in SC administration.  The safety 
profile of elranatamab is acceptable and manageable.  There were no DLTs observed in the 
SC dosing cohort across the dose range from 80 to 1000 μg/kg.  In addition, measures 
including guidelines for treatment interruption and permanent discontinuation in case of 
toxicities, guidelines for steroid treatment, have been implemented.  Furthermore, 
encouraging clinical activity of elranatamab has been observed in Study C1071001. 
These data currently observed in the ongoing Phase 1 trial C1071001, support the hypothesis 
that elranatamab may represent an important therapeutic approach in participants with 
relapsed or refractory MM.  Thus, the projected benefit/risk of C1071001 is favorable for 
investigation in this participant population. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of elranatamab may be found in the elranatamab IB, which is the single 
reference safety document (SRSD) for this study. 
 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 35 
2.3.1. Risk Assessment 
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Study Intervention(s) 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. Phase 1 results to date 
indicate that only Grade 1 and 2 CRS were observed 
with both IV and SC administration. No Grade ≥3 
CRS events have been reported (see Table 1). 
 
Participants will be hospitalized for at least 3 days after the C0D1 
dose and C1D1 dose for safety surveillance.  (see Schedule of 
Activities).  
The priming regimen is expected to mitigate 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 Section 10.13.  
Dose modification/discontinuation in the setting of Grade ≥2 AEs 
(including CRS) is described in Section 6.6.3. 
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 Section6.5.2). 
ICANS 
A known toxicity of therapeutics that function by 
activation of immune effector cells.  
Phase 1 safety results suggest ICANS is infrequent 
and Grade ≤2. 
Participants will be hospitalized for at least 3 days after the C0D1 
dose and C1D1 dose for safety surveillance.  (see Schedule of 
Activities).  
The priming regimen is expected to mitigate rate, duration, and 
severity of ICANS (see Section 4.3). 
Regular neurologic examinations will be performed by the 
investigator or designee (Section 8.2.1). 
Guidance for monitoring, grading, and management of ICANS per 
ASTCT criteria and guidelines is included in Section 10.13. 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 36 
Peripheral neuropathy  
In the Phase 1 study (C1071001), Grade 3 peripheral 
neuropathy has been observed with elranatamab. 
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 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 (Section 6.5) 
Participants should be closely monitored for signs and symptoms of 
neuropathy following infections or following the administration of 
any vaccine.  Work-up recommendations for new or worsening 
peripheral neuropathy (Grade ≥2) is described in Section 6.5.2. 
Dose modification/discontinuation for peripheral neuropathy is 
described in Section 6.6.3.  
Study Procedures 
Bone marrow aspirate and 
biopsy 
 
 
The risks associated with bone marrow aspiration and 
biopsy include pain or discomfort during the biopsy, 
including slight, stinging pain when a local anesthetic 
is injected by needle to numb the area, pressure and 
dull pain where the biopsy needle is inserted, 
discomfort from lying still for an extended time, and 
soreness at the biopsy site. Other risks can include 
bleeding, swelling, scarring, bruising, nerve damage 
and infection, which can be life-threatening or fatal in 
rare cases. 
To reduce these risks, the site of the biopsy will be numbed and sterile 
techniques will be used. 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 37 
2.3.2. Benefit Assessment 
Elranatamab is a bispecific monoclonal antibody against BCMA and CD3 and has 
demonstrated potent single agent anti-tumor activities in both preclinical studies as well as in 
the clinical study of C1071001. 
2.3.3. Overall Benefit/Risk Conclusion 
Taking into account the measures taken to minimize risk to participants participating in this 
study, the potential risks identified in association with elranatamab are justified by the 
anticipated benefits that may be afforded to participants with relapsed or refractory MM. 
3. OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary:  
Primary:  
 
To assess the safety and tolerability at the RP2D with 
a priming dose approach of single-agent elranatamab 
administered to Japanese participants 
 
First cycle including a priming dose (4 weeks) Dose 
Limiting Toxicities (DLTs) 
Secondary:  
Secondary:
 
To evaluate the overall safety profile 
 
AEs as characterized by type, frequency, severity (as 
graded by NCI CTCAE version 5.0), timing, 
seriousness, and relationship to study therapy.  
Severity of CRS and ICANS will be graded 
according to ASTCT grading criteria 
 
Laboratory abnormalities as characterized by type, 
frequency, severity (as graded by NCI CTCAE 
version 5.0), and timing 
 
To evaluate the single-dose and multiple-dose PK of 
elranatamab 
 
PK parameters of elranatamab: C0D1 dose, C1D1 
dose and C2D1 dose maximum concentration 
(Cmax), area under the concentration versus time 
curve from time zero to the last quantifiable time 
point prior to the next dose (AUClast) and if data 
permit, apparent clearance (CL/F), apparent volume 
of distribution during terminal phase (Vz/F), and 
terminal elimination (t1/2) 
 
Pre-dose trough concentrations after multiple doses 
of elranatamab 
 
To evaluate the immunogenicity of elranatamab 
 
Incidence and titers of ADA and NAb against 
elranatamab 
 
To evaluate preliminary anti-tumor activity 
 
ORR based on the IMWG response criteria for MM 
 
Time to event endpoints: TTR, DOR, PFS and OS, 
as assessed by IMWG criteria for response 
 
MRD after treatment with elranatamab using IMWG 
MRD criteria 
 
To characterize the impact of elranatamab on 
systemic soluble immune factors 
 
Pre- and post-dose quantification of soluble 
cytokines in serum 


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4.3.3. Dose Limiting Toxicity Definition 
A participant is classified as DLT-evaluable if he/she experiences a DLT (irrespective of 
whether they received all of the planned doses of investigational product and study 
intervention and scheduled safety assessments during the DLT window) or if he/she 
otherwise in the absence of a DLT receives all of the planned doses of investigational 
product and study intervention and has received scheduled safety assessments during the 
DLT window.  If a participant fails to meet these criteria, he/she may be replaced.   
The DLT observation period will include a priming dose and the first cycle (throughout 
Cycle 0 to Cycle 1, 4 weeks in total) of treatment in each participant.   
Significant adverse events considered to be related to the study intervention or treatment 
under investigation that occur after the DLT observation period will be reviewed in context 
of all safety data available.  That review may result in re-evaluation of the dosing level or 
regimen. 
Severity of AEs except for CRS and ICANS will be graded according to CTCAE version 5.0.  
CRS and ICANS will be graded according to ASTCT grading criteria (see Section 10.13).  
Any of the following AEs occurring in Cycle 0 and Cycle 1 will be classified as DLTs: 
Hematological: 
 Grade 4 neutropenia lasting >7 days. 
 Febrile neutropenia (defined as an absolute neutrophil count [ANC] <1000/mm3 with 
a single temperature of >38.3C [101F], or a sustained temperature of 38C 
[100.4F] for more than one hour).  If fever is determined to be a symptom of CRS 
confirmed by clinical course and cytokine levels and resolves in a manner consistent 
with CRS, this would no longer be considered a DLT, and the participant may resume 
treatment. 
 Grade 3 neutropenia with infection.  
 Grade 4 thrombocytopenia (unless the study entry baseline count was ≥25,000 and 
<50,000 to take into account bone marrow suppression due to MM, in this case Grade 
4 thrombocytopenia needs to be accompanied by ≥ Grade 2 bleeding to be a DLT).  
For participants who experience a platelet count <10,000/mm3, this is considered a 
DLT irrespective of other factors.  
 Grade 3 thrombocytopenia with  Grade 2 bleeding. 
Non-hematological: 
 Grade 4 Adverse Events (AEs). 


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 Grade 3 AE lasting 5 days despite optimal supportive care, with the exception of AE 
attributed to a CRS event (ie, Grade 3 transaminitis). 
 Grade 3 CRS, except those CRS that have i) not been maximally treated (ie, lack of 
administration of standard of care treatment per the institution’s, Investigator’s, or 
treating physician’s guidelines for the management of CRS) or ii) improved to 
≤ Grade 1 within 48 hours. 
 Grade 4 CRS. 
 Confirmed drug-induced liver injury (DILI) meeting Hy’s law criteria outlined in 
Section 10.6. 
 Grade 4 laboratory abnormalities deemed clinically significant by the investigator 
shall be reported as Grade 4 AE.  
Clinically important or persistent toxicities (eg, toxicities leading to dose interruption for ≥7 
days including skipping planned dose during the DLT observation window) that are not 
included in the above criteria may also be considered a DLT following review by the 
investigators and the Sponsor.  All DLTs need to represent a clinically significant shift from 
baseline. 
The following AEs will not be adjudicated as DLTs: 
 Isolated Grade 3 laboratory abnormalities that are not associated with clinical 
sequelae and are corrected with supplementation/appropriate management within 
72 hours of their onset or deemed not clinically insignificant by the investigator. 
 Grade 3 injection site reactions (ISR), allergic reaction or anaphylaxis will not be 
considered as DLTs but may be a reason for study discontinuation and will be 
reviewed with the sponsor’s medical monitor. 
4.3.4. Maximum Tolerated Dose Definition 
MTD estimation is not planned for this study.  However, if DLT is observed in ≥2 of the 
initial 4 participants or ≥2 of the 6 participants at the 1000 µg/kg dose level with a priming 
dose of 600 µg/kg SC, this dose level will be determined to be above MTD for the Japanese 
population. 
4.3.5. Recommended Phase 2 Dose Definition  
The target DLT rate is 25%.  If no DLT is observed in the initial 4 participants or one DLT is 
observed in 6 participants, it will be concluded that the RP2D defined in the study C1071001 
in non-Japanese population with a priming dose is tolerable in the Japanese population.  If 
DLT is observed in ≥2 of the initial 4 participants or ≥2 of the 6 participants, a lower dose 
cohort may be explored, if deemed necessary. 


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4.4. End of Study Definition 
A participant is considered to have completed the study if he/she has completed all phases of 
the study, including the last visit. 
The end of the study is defined as the date of the last visit of the last participant in the study. 
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: 
1. Females and/or male participants age 20 years. 
 Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female 
(Section 10.4.2) participants.   
2. Participants with relapsed or refractory MM, as defined by the international myeloma 
working group (IMWG) criteria 2014 (see Section 10.9) 
3. Participants who have measurable disease as defined by one or more of the 
abnormalities listed below: 
a. Serum myeloma (M)-protein ≥0.5 g/dL (5 g/L).   
b. Urine M-protein ≥200 mg/24 h. 
c. Serum free light chain (FLC)  >100 mg/L (10 mg/dL) with abnormal 
kappa:lambda ratio. 
4. Participants must have progressed on or been intolerant of at least 3 prior therapies.  
The prior therapy includes proteasome inhibitor, IMID drug and anti-CD38 antibody, 
either in combination or as a single agent.  Participants who are determined to be 
inappropriate for those standard therapies by the investigator may be eligible. 
5. ECOG PS 0, 1 or 2.  PS 3 is permitted if PS is due solely to bone pain. 
6. Adequate Bone Marrow Function, including: 


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 
ANC 1,000/mm3 or 1.0 x 109/L; 
 
Platelets 25,000/mm3 or 25 x 109/L (transfusion support is permitted if 
completed prior to planned start of dosing); 
 
Hemoglobin 8.0 g/dL (transfusion support is permitted if completed prior to 
planned start of dosing). 
7. Adequate Renal Function, including: 
 
Estimated creatinine clearance (CrCl) 30 mL/min as calculated using the 
method standard for the institution.  (If an estimated CrCl is believed to be 
inaccurate for a participant, 24-hour urine collection with actual assessment of 
CrCl is allowed);  
 
Serum creatinine 2.5 mg/dL;  
8. Adequate Liver Function, including: 
 
Total serum bilirubin 2.0 mg/dL, except in participants with Gilbert Syndrome 
who must have a total bilirubin less than 3.0 mg/dL;  
 
AST and ALT 2.5 x ULN; 5.0 x ULN if there is liver involvement by the 
tumor;  
 
Alkaline phosphatase 2.5 x ULN (5 x ULN in case of bone metastasis).  
9. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 
except for AEs not constituting a safety risk by investigator judgment. 
10. Participants who are willing and able to comply with all scheduled visits, treatment 
plan, laboratory tests, lifestyle considerations, and other study procedures.  
11. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the informed 
consent document (ICD) and in this protocol. 
5.2. Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Participants with POEMS syndrome 
2. Participants with 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. 
3. Major surgery within 4 weeks prior to study entry.  


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4. Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry.   
5. Radiation therapy within 2 weeks prior to study entry (bone lesions requiring radiation 
may be treated with limited [ie, 25% of bone marrow in field] radiation therapy during 
this period) (see Section 10.8 Bone Marrow Reserve in Adults).   
6. History of active autoimmune disorders (including but not limited to: Crohn’s disease, 
rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave’s disease) and 
other conditions that compromise or impair the immune system. 
7. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency 
Disease). 
8. History of CTCAE Grade 3 immune-mediated adverse event (including hepatitis, 
pancreatitis, colitis, pneumonitis, carditis, and CRS) that was considered related to prior 
immune-modulatory therapy (exceptions: immune-related adverse events secondary to 
checkpoint inhibitors- that have been appropriately managed or --resolved such as 
hypophysitis and hypothyroidism). 
9. Ongoing Grade ≥2 peripheral sensory or motor neuropathy. 
10. Participant with history of GBS or GBS variants, history of any Grade ≥3 peripheral 
motor polyneuropathy, or history of any grade peripheral sensory or motor neuropathy 
with prior BCMA-directed therapy. 
11. Stem cell transplant within 12 weeks prior to enrollment or active graft versus host 
disease (GVHD) with other than Grade 1 skin involvement, or GVHD requiring 
immunosuppressive treatment. 
12. Requirement for systemic immune suppressive medication [eg, 10 mg of prednisone or 
equivalent (1.5 mg of dexamethasone)]. 
13. Participant known to be refractory to platelet or red blood cell transfusions.   
14. Current requirement for chronic blood product support. 
15. Participants with active, uncontrolled bacterial, fungal, or viral infection, including HBV, 
HCV, known HIV or AIDS related illness and SARS-CoV2.  In equivocal cases, 
participants whose viral load is negative, may be eligible after discussion with the 
sponsor’s medical monitor.  HIV seropositive participants who are healthy and low-risk 
for AIDS-related outcomes could be considered eligible.  Eligibility criteria for 
HIV-positive participants should be evaluated and discussed with sponsor’s medical 
monitor, and will be based on current and past CD4 and T-cell counts, history (if any) of 
AIDS-defining conditions (eg, opportunistic infections), and status of HIV treatment. 
Also the potential for drug-drug interactions will be taken into consideration.  Active 
infections must be resolved at least 14 days prior to enrollment. 


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16. Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect 
participant safety or interpretation of study results (eg, baseline QTc interval >470 msec 
unless a cardiac rhythm device/pacemaker is placed and eligibility is approved by the 
sponsor’s medical monitor, complete left bundle branch block (LBBB), signs of an acute 
or indeterminate-age myocardial infarction, ST-T interval changes suggestive of active 
myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or 
tachyarrhythmias).  If the baseline uncorrected QT interval is >470 msec, this interval 
should be rate-corrected using the Fridericia method and the resulting QTcF should be 
used for decision making and reporting.  If QTc exceeds 470 msec, or QRS exceeds 
120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or 
QRS values should be used to determine the participant’s eligibility.  
Computer-interpreted ECGs should be overread by a physician experienced in reading 
ECGs before excluding participants.  Cases must be discussed in detail with sponsor’s 
medical monitor to judge eligibility. 
17. Any of the following in the previous 6 months: myocardial infarction, long QT 
syndrome, Torsade de Pointes, arrhythmias (including sustained ventricular 
tachyarrhythmia and ventricular fibrillation), serious conduction system abnormalities 
(eg, left anterior hemiblock), unstable angina, coronary/peripheral artery bypass graft, 
symptomatic congestive heart failure (CHF), New York Heart Association class III or IV, 
cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, 
and/or other clinical significant episode of thrombo embolic disease.  Ongoing cardiac 
dysrhythmias of NCI CTCAE ≥ Grade 2, atrial fibrillation of any grade.  If a participant 
has a cardiac rhythm device/pacemaker placed and QTcF >470 msec, the participant can 
be considered eligible.  Participants with cardiac rhythm device/pacemaker must be 
discussed in detail with sponsor’s medical monitor to judge eligibility. 
18. Hypertension that cannot be controlled by medications (eg, >150/100 mmHg). 
19. Participation in other studies involving investigational drug(s) within 4 weeks prior to 
study entry.  Participant may be included if 5 times elimination half-life of drug has 
passed. 
20. Known or suspected hypersensitivity to component of elranatamab, murine and bovine 
products.  
21. Live attenuated vaccine within 4 weeks of the first dose of study intervention 
22. Other medical or psychiatric condition 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.  
23. 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. 


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5.3. Lifestyle Considerations 
5.3.1. Contraception 
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected an appropriate method of contraception for the individual 
participant and his or her partner(s) from the permitted list of contraception methods (see 
Appendix 4) and will confirm that the participant has been instructed in its consistent and 
correct use.  At time points indicated in the schedule of activities (SoA), the investigator or 
designee will inform the participant of the need to use highly effective contraception 
consistently and correctly and document the conversation and the participant’s affirmation in 
the participant’s chart (participants need to affirm their consistent and correct use of at least 1 
of the selected methods of contraception).  In addition, the investigator or designee will 
instruct the participant to call immediately if the selected contraception method is 
discontinued or if pregnancy is known or suspected in the participant or partner. 
5.4. Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently enrolled in the study.  A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants to meet the CONSORT 
publishing requirements and to respond to queries from regulatory authorities.  Minimal 
information includes demography, screen failure details, eligibility criteria, and any SAE. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened if the participant do not meet a specific modifiable factor (eg, lab abnormality).   
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 describe specific investigational 
product. 


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6.1. Study Intervention(s) Administered 
Intervention Name 
Elranatamab Solution for Injection
Type 
Biologic 
Dose Formulation 
solution for injection
Unit Dose Strength(s) 
40 mg/mL 
Dosage Level(s) 
600 µg/kg and 1000 µg/kg
Route of Administration 
SC 
Use 
Experimental
IMP or NIMP 
IMP 
Sourcing 
Provided centrally by the sponsor 
 
Refer to the Product Specific IP manual.
Packaging and Labeling 
Study intervention will be provided in 1vial/carton.  Each vial and carton will be labeled as 
required per country requirement in an open-label manner.
[Current/Former 
Name(s) or Alias(es)] 
N/A 
 
Elranatamab 40 mg/mL solution for injection is presented as a sterile solution for SC 
administration.  Each vial of elranatamab aqueous buffered solution, is sealed with a coated 
stopper and an overseal, and is labeled according to local regulatory requirements. 
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, the number of injections may 
increase to accommodate this difference in volume to ensure the correct final dose is 
delivered. 
Study drug should be administered to the abdomen (with preference given to the lower 
quadrants when possible).  Refer to Section 10.14 for details on administration of multiple 
injections to the abdomen.  Study staff should refer to the investigational product (IP) manual 
for specific instructions on the handling and preparation of study drug. 
The first dose of study intervention will be 600 µg/kg, which will serve as a priming dose 
and will be administered 7 days prior to Day 1 of the first cycle (C0D1).  In a treatment 
cycle, 1000 µg/kg will be administered in weekly schedule.  Each cycle will be 3 weeks in 
duration, and each participant will be treated 3 times during each cycle, unless dose delays or 
interruptions occur (a minimum of 6 days should be maintained between doses).  On C0D1 
and C1D1, elranatamab will be administered on an inpatient basis.  On all other days, 
elranatamab will be administered on an outpatient basis. 
Details for preparation of elranatamab SC injection are provided in the current elranatamab 
IP manual.  All participants should be weighed within 72 hours prior to dosing for every 
cycle to ensure they did not experience either a weight loss or gain >10% from the prior 
weight used to calculate the amount of elranatamab required for dose preparation.  The 
decision to recalculate elranatamab dose based on the weight obtained at each cycle can be in 
accordance with institutional practice; however, if the participant experienced either a weight 
loss or gain >10% compared to the weight used to calculate the prior dose, the amount of 


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elranatamab required for preparation and administration for the current cycle must be 
recalculated using this most recent weight obtained.   
Each participant may receive elranatamab until disease progression, unacceptable toxicity, 
withdrawal from treatment, participant no longer willing to participate in trial, investigator 
decision, or study termination.  If a participant has received treatment with Q1W elranatamab 
for at least 6 months, and disease assessments have remained stable over at least 2 months, 
consideration may be given to increasing dose intervals from weekly to every 2 weeks after 
consultation with sponsor’s medical monitor.  If the participant subsequently begins to have 
increase of disease burden, dose intervals should return to weekly dosing. 
6.2. Preparation/Handling/Storage/Accountability 
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.  
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. 
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. 
Any storage conditions stated in the SRSD will be superseded by the storage conditions 
stated on the label. 
Study interventions should be stored in their original containers. 
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. 
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 


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authorized to take place at the investigator site, the investigator must ensure that the materials 
are destroyed in compliance with applicable environmental regulations, institutional policy, 
and any special instructions provided by Pfizer. 
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IP manual.  
6.2.1. Preparation and Dispensing 
See the IP manual for instructions on how to prepare the study intervention for 
administration.  Study intervention should be prepared and dispensed by an appropriately 
qualified and experienced member of the study staff (eg, physician, nurse, physician’s 
assistant, nurse practitioner, pharmacy assistant/technician, or pharmacist) as allowed by 
local, state, and institutional guidance.  A second staff member will verify the dispensing. 
Only qualified personnel who are familiar with procedures that minimize undue exposure to 
themselves and to the environment should undertake the preparation, handling, and safe 
disposal of biologic agents. 
6.3. Measures to Minimize Bias: Randomization and Blinding 
6.3.1. Allocation to Study Intervention 
Participants will be enrolled to the study after participants have given their written informed 
consent and have completed the necessary baseline assessments.  The site staff will 
fax/e-mail a complete Registration Form to the designated sponsor study team member or 
designee.  The sponsor will assign a participant identification (ID) number and supply this 
number to the site.  The participant ID number will be used on all study-related 
documentation at the site. 
No participant will receive study intervention until the investigator or designee has received 
the following information in writing from the sponsor: 
 Confirmation of the participant’s enrolment; 
 Specification of the dose level for that participant and;  
 Permission to proceed with dosing the participant. 
Study intervention will be injected at the study visits summarized in the SoA. 
6.4. Study Intervention Compliance 
When participants are dosed at the site, they will receive study intervention directly from the 
investigator or designee, under medical supervision.  The date and time of each dose 
administered in the clinic will be recorded in the source documents and recorded in the case 
report form (CRF).  The dose of study intervention and study participant ID will be 
confirmed at the time of dosing by a member of the study site staff other than the person 
administering the study intervention.  


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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. 
6.5. Concomitant Therapy 
Concomitant treatment considered necessary for the participant’s well-being may be given at 
discretion of the treating physician.   
All concomitant treatments, blood products, as well as nondrug interventions 
(eg, paracentesis) received by participants from screening until the end of treatment visit will 
be recorded on the CRF. 
All COVID-19 vaccines are permitted and should be recorded as concomitant medications 
(standard AE collection and reporting processes should be followed).  For participants in 
screening, the timing of vaccine dosing relative to the dosing of study drug on planned C0D1 
is at the discretion of the investigator although it may be best to avoid the 7 days prior to 
C0D1 (priming dose) and consider the potential for vaccine-related adverse events, if 
applicable.  For patients under the study treatment, the timing of vaccine dosing relative to 
the dosing of study drug is at the discretion of the investigator, although it may be best to 
avoid the DLT observation period (inclusive of Cycle 0 and Cycle 1; 28 days) and especially 
within 48 hours of C0D1 or C1D1 and to administer the vaccine during scheduled dosing 
holidays, if applicable. 
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 bispecific antibodies.  
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 including a 
priming dose.  If the use of warfarin is clinically necessary, caution and additional INR 
monitoring are 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. 
6.5.1. Other Anti-tumor/Anti-cancer or Experimental Drugs 
No additional anti-tumor treatment will be permitted while participants are receiving study 
treatment.  Additionally, the concurrent use of select vitamins or herbal supplements is not 


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permitted.  Palliative radiotherapy on study 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 that the need for palliative radiotherapy is not indicative of disease 
progression.  In view of the current lack of data about the interaction of elranatamab with 
radiotherapy, elranatamab treatment should be interrupted during palliative radiotherapy, 
stopping 7 days before and resuming treatment after 7 days. 
6.5.2. Supportive Care 
Palliative and supportive care for disease related symptoms may be administered at the 
investigator’s discretion and according to the specific supportive care product Prescribing 
Information or the current ASCO guidelines.  
Allopurinol/rasburicase may be administered as needed for tumor lysis prophylaxis or 
treatment.  
Supportive Care for Cytokine Release Syndrome:  
Symptoms associated with CRS vary greatly and may be difficult to distinguish from other 
conditions.  The more common symptoms include fever, nausea, headache, tachycardia, 
hypotension, rash and shortness of breath.  The severity of symptoms can be mild to life-
threatening and thus there should be a high suspicion for CRS if these symptoms occur.  If 
CRS is suspected, cytokines will be analyzed at central laboratories to determine if cytokine 
elevation consistent with CRS is observed (see Section 8.2.5).  The severity of CRS will be 
assessed according to the modified grading described by Lee et al (2019).22  A suggested 
treatment algorithm for the management of CRS is also provided in Section 10.13; however, 
if local standard of care is a different regimen this should be utilized.  
For the priming dose (C0D1) and first full dose (C1D1), 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 label are permissible.  
Similar premedications for doses at other time points may be given at the discretion of the 
investigator. 
The pre-treatment medication will not be supplied by Pfizer. 
Supportive Care for Injection Site Reactions (ISR) 
ISR is a type of hypersensitivity reaction that may be immediate, although it usually appears 
within 24-48 hours after injection.  ISR, by definition, includes the following erythema, 


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pruritus, pain, inflammation, rash, induration, itching and edema at the injection site.  To 
evaluate ISRs, site tolerability assessments will be performed per the SoA. 
Immune Effector Cell-Associated Neurotoxicity Syndrome ICANS: 
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.22  It has been observed following 
administration of some CAR-Ts and bispecific antibodies and can occur independently of 
CRS.  The severity of ICANS should be graded according to the ASTCT consensus criteria,22 
and management guidelines are provided in the Section 10.13.23,24  
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.25  Recently, peripheral 
neuropathy has been described following administration of BCMA-directed bispecific T-cell 
engagers.26   
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), nerve conduction velocity 
(NCV)/electromyographies (EMGs), and lumbar puncture to assess cerebrospinal fluid 
(CSF).  In consultation with the 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. 
Tumor Lysis Syndrome (TLS) 
Tumor lysis is a group of metabolic complications that can occur after treatment of cancer.  
Tumor lysis syndrome (TLS) occurs when tumor cells release their contents into the 
bloodstream, either spontaneously or in response to therapy, leading to the characteristic 
findings of hyperuricemia, hyperkalemia, hypophosphatemia, and hypocalcemia.  These 
electrolyte and metabolic disturbances can progress to clinical toxic effects, including renal 
insufficiency, cardiac arrhythmias, seizures, and death due to multi-organ failure.  The 


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incidence and severity of the TLS depend on the cancer mass, the potential for lysis of tumor 
cells, the characteristics of the participant, and supportive care. 
Optimal management of TLS should involve preservation of renal function.  Management 
should also include prevention of dysrhythmias and neuromuscular irritability.  All 
participants who are at risk for TLS should receive intravenous hydration to rapidly improve 
renal perfusion and glomerular filtration and to minimize acidosis.  Reducing the level of uric 
acid, with the use of allopurinol and particularly with the use of rasburicase, can preserve or 
improve renal function and reduce serum phosphorus levels as a secondary beneficial effect.  
Hyperkalemia remains the most dangerous component of TLS because it can cause sudden 
death due to cardiac dysrhythmia.  Participants should limit potassium and phosphorus intake 
during the risk period for TLS.  Frequent measurement of potassium levels (every 4 to 
6 hours), continuous cardiac monitoring, and the administration of oral sodium polystyrene 
sulfonate are recommended in participants with TLS and acute kidney injury.  Hypocalcemia 
can also lead to life-threatening dysrhythmias and neuromuscular irritability; controlling the 
serum phosphorus level may prevent hypocalcemia.  Symptomatic hypocalcemia should be 
treated with calcium at the lowest dose required to relieve symptoms.  Hypocalcemia not 
accompanied by signs or symptoms does not require treatment.  
6.5.3. Hematopoietic Growth Factors 
Primary prophylactic use of colony stimulating factors is not permitted during the first 28 
days from Cycle 0 Day 1, but they may be used to treat treatment emergent neutropenia as 
indicated by the current ASCO guidelines27 and Japan guidelines28.  During the screening 
window (ie, 28 days prior to Day 1), Granulocyte colony stimulating factors are not 
permitted to qualify a participant with low white blood cell (WBC) counts.  
6.5.4. Anti-Diarrheal, Anti-Emetic Therapy  
Primary prophylaxis is at the investigator’s discretion.  The choice of the prophylactic drug 
as well as the duration of treatment is up to the investigator with sponsor’s medical monitor 
approval assuming there is no known or expected drug-drug interaction and assuming the 
drug is not included in the Concomitant Therapy section. 
6.5.5. Anti-Inflammatory Therapy 
Anti-inflammatory or narcotic analgesic may be offered as needed assuming there is no 
known or expected drug-drug interaction and assuming the drug is not included in the 
Concomitant Therapy section.  
6.5.6. Corticosteroids  
Chronic systemic corticosteroid use (prednisone >10 mg/day or equivalents) for palliative or 
supportive purposes is not permitted.  However, systemic corticosteroid use at a low dose for 
a short duration (eg, 5 mg q.d. of prednisone, for 2 weeks) as symptomatic treatment on 
individual basis and upon discussion with the sponsor’s medical monitor.  Acute emergency 
administration, topical applications, inhaled sprays, eye drops, or local injections of 
corticosteroids are allowed.  


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6.5.7. Surgery  
Caution is advised on theoretical grounds for any surgical procedures during the study.  The 
appropriate interval of time between surgery and elranatamab required to minimize the risk 
of impaired wound healing and bleeding has not been determined.  Stopping elranatamab is 
recommended at least 7 days prior to surgery.  Postoperatively, the decision to reinitiate 
elranatamab treatment should be based on a clinical assessment of satisfactory wound healing 
and recovery from surgery. 
6.5.8. Transfusion 
Primary prophylactic use of transfusion support for anemia is allowed to treat anemia. 
Primary prophylactic use of transfusion support for thrombocytopenia is allowed during 
screening if the transfusion is completed prior to planned study treatment start.  Primary 
prophylactic use of transfusion support for thrombocytopenia is allowed to treat 
thrombocytopenia. 
6.5.9. Rescue Medicine 
There is no rescue therapy to reverse the AEs observed with elranatamab; standard medical 
supportive care must be provided to manage the AEs.  
6.6. Dose Modification 
Every effort should be made to administer study intervention on the planned dose and 
schedule.  In the event of significant toxicity, dosing may be delayed and/or reduced as 
described below.  In the event of multiple toxicities, dose modification should be based on 
the worst toxicity observed.  Participants are to be instructed to notify investigators at the 
first occurrence of any adverse symptom. 
Dose modifications may occur in one of three ways: 
 Within a cycle: dosing interruption until adequate recovery and dose reduction, if 
required, during a given treatment cycle;  
 Between cycles: next cycle administration may be delayed due to persisting toxicity 
when a new cycle is due to start; 
 In the next cycle: dose reduction may be required in a subsequent cycle based on 
toxicity experienced in the previous cycle.  
6.6.1. Dosing Interruptions 
With respect to study intervention, participants experiencing the following adverse events 
should have their treatment interrupted.  Participants experiencing Grade 3 or 4 potentially 
treatment related toxicity or intolerable Grade 2 toxicity despite supportive care. 


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Appropriate follow-up assessments should be done until adequate recovery occurs as 
assessed by the investigator.  Criteria required before treatment can resume are described in 
Section 6.6.2. 
Doses may be held as needed until toxicity resolution.  Depending on when the adverse event 
resolved, a treatment interruption may lead to the participant missing all subsequent planned 
doses within that same cycle or even to delay the initiation of the subsequent cycle.  
If the adverse event that led to the treatment interruption recovers within the same cycle, then 
re-dosing in that cycle is allowed.  Doses omitted for toxicity are not replaced within the 
same cycle.  The need for a dose reduction at the time of treatment resumption should be 
based on the criteria defined in Section 6.6.3, unless expressly agreed otherwise following 
discussion between the investigator and the sponsor’s medical monitor.  
In the event of a treatment interruption for reasons other than treatment-related toxicity 
(eg, elective surgery) lasting >3 weeks, treatment resumption will be decided in consultation 
with the sponsor’s medical monitor. 
6.6.2. Dose Delays 
Re-treatment following treatment interruption for treatment-related toxicity or at the start of 
any new cycle may not occur until all of the following parameters have been met: 
 ANC 1,000/mm3  
 Platelets count 25,000/mm3  
 Nonhematologic toxicities have returned to baseline or Grade 1 severity (or, at the 
investigator’s discretion, Grade 2 if not considered a safety risk for the participant). 
 For any dosing day (start of cycle or during a cycle), no ongoing CRS or ICANS 
 Recovery of treatment-emergent peripheral neuropathy to Grade ≤1 severity. 
If a treatment delay results from worsening of hematologic or biochemical parameters, the 
frequency of relevant blood tests should be increased as clinically indicated. 
If these conditions are met within 3 weeks of treatment interruption, elranatamab may be 
resumed.  Refer to the Dose Reductions section for adverse events requiring dose reduction 
at the time of treatment resumption.  
If participants require discontinuation of elranatamab for more than 42 days at any time 
during the study, then study treatment should be permanently discontinued, unless the 
investigator’s benefit/risk assessment suggests otherwise after discussion with the Sponsor’s 
medical monitor.   
If a treatment interruption continues beyond Day 21 of the current cycle, then the day when 
treatment is restarted will be counted as Day 1 of the next cycle. 


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6.6.3. Dose Reductions 
Following dosing interruption or cycle delay due to toxicity, the elranatamab dose may need 
to be reduced when treatment is resumed. 
No dose reductions are planned for patients experiencing toxicities other than those listed as 
DLTs.  No specific dose adjustments are recommended for Grade 1/2 treatment-related 
toxicity except for peripheral neuropathy.  However, investigators should always manage 
their participants according to their medical judgment based on the particular clinical 
circumstances. 
Participants experiencing recurrent and intolerable Grade 2 toxicity may resume dosing at the 
next lower dose level once recovery to Grade 1 or baseline is achieved. 
Dose reduction of elranatamab by 1 and, if needed, 2 dose levels will be allowed depending 
on the type and severity of toxicity encountered.  Participants requiring more than 2 dose 
reductions will be discontinued from the treatment and entered into the follow-up phase, 
unless otherwise agreed between the investigator and the sponsor’s medical monitor.  All 
dose modifications/adjustments must be clearly documented in the participant’s source notes 
and CRF.  
Once a dose has been reduced for a given participant, all subsequent cycles should be 
administered at that dose level, unless further dose reduction is required.  Intraparticipant 
dose re-escalation is not allowed. 
Table 2. 
Available Dose Levels  
Dose Level 
Study Intervention A 
+1 
1000 µg/kg
0 
600 µg/kg
-1 
360 µg/kg*
*Dose de-escalation below 360 µg/kg is not allowed.   
 
Participants experiencing a DLT may resume dosing at the next lower dose level (if 
applicable) once adequate recovery is achieved, and in the opinion of the investigator and the 
sponsor’s medical monitor, the participant is benefiting from therapy.  Participants 
experiencing a DLT of prolonged myelosuppression (>42 days) may not resume treatment 
even if adequate recovery is achieved.   
Recommended dose reductions for study intervention are described in Table 3. 


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Table 3. 
Dose Modifications for Study Intervention-Related Toxicity and for 
Sensory or Motor Peripheral Neuropathy 
Toxicity 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Nonhematologic 
(excluding 
peripheral 
neuropathy)  
Continue at the 
same dose 
level. 
Continue at the same 
dose level. 
Withhold dose until toxicity 
is Grade 1, or has returned 
to baseline, then reduce the 
dose by 1 level.*
Permanently 
discontinue.* 
Peripheral 
sensory or motor 
neuropathy (all 
causality) 
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**. 
If Grade ≥2 
neuropathy reoccurs, 
permanently 
discontinue 
elranatamab.
Permanently discontinue 
elranatamab. 
Permanently 
discontinue 
elranatamab 
Hematologic*** 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.****  If toxicity 
reoccurs, dosing may be 
reduced by 1 dose level.  If 
toxicity reoccurs after a 
maximum of 2 dose level 
reductions, participant may 
be permanently 
discontinued from 
treatment. 
For platelets, withhold dose 
if toxicity ≤25,000mm3 and 
re-start when platelets have 
returned to ≥25,000mm3 or 
baseline. 
Withhold dose 
until toxicity is 
Grade 2, or has 
returned to 
baseline, then 
reduce the dose by 
1 level and resume 
treatment.***  If 
toxicity reoccurs 
despite dose 
reduction, dosing 
may be reduced by 
1 more dose level.  
If toxicity 
reoccurs, 
participant may be 
permanently 
discontinued from 
treatment. 
* Nausea, vomiting, or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy to require dose 
modification. 
** Consider additional diagnostic work-up (see Section 6.5.2). 
*** For Grade 3 or 4 lymphopenia not associated with clinical events (eg, opportunistic infection), elranatamab 
treatment may continue without dose reduction and interruption. 
**** Cycle will not be extended to cover for the missing doses. 
In case of ongoing CRS or ICANS of any grade on any dosing day, dosing will be held until resolution.   


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6.7. Intervention After the End of the Study 
No study treatment will be provided to study participants at the end of the study. 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1. Discontinuation of Study Intervention 
In rare instances, it may be necessary for a participant to permanently discontinue study 
intervention (definitive discontinuation).  Reasons for definitive discontinuation of study 
intervention may include the following: 
 Objective disease progression; 
 Global deterioration of health status requiring discontinuation; 
 Unacceptable toxicity; 
 Pregnancy or begins breastfeeding; 
 Significant protocol violation; 
 Lost to follow-up; 
 Participant refused further treatment; 
 Study terminated by sponsor; 
 Death; 
Note that discontinuation of study intervention does not represent withdrawal from the study.  
If study intervention is definitively discontinued, the participant will remain in the study to 
be evaluated for survival.  See the SoA for data to be collected at the time of discontinuation 
of study intervention and follow-up for any further evaluations that need to be completed. 
In the event of discontinuation of study intervention, it must be documented on the 
appropriate CRF/in the medical records whether the participant is discontinuing further 
receipt of study intervention or also from study procedures, posttreatment study follow-up, 
and/or future collection of additional information. 
Follow-Up Visit: 
At least 28 calendar days, and no more than 35 calendar days after discontinuation of study 
intervention, participants will return to undergo safety assessments, review of concomitant 
treatments and contraception check (see Schedule of Activities 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 


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clinical judgment of the investigator, that no further improvement is expected (see also 
Section 8.3.1 for AE reporting period).   
Survival follow-up:  
Following discontinuation of study treatment (unless participants are lost to follow-up, 
consent is withdrawn, or study is discontinued by the sponsor), survival status will be 
collected at visit or by telephone every 3 months after the follow-up visit until death, or at 
least 12 months after first treatment of the last participant, whichever comes first.  
Subsequent anti-cancer therapies and relevant transplant information will also be collected.  
Any standard of care (SOC) disease assessments obtained between EOT and subsequent anti-
cancer therapy will be collected.  Information of AEs and contraception check will also be 
collected until the end of active AE reporting period as defined in Section 8.3.1, and 
contraception check period in Section 10.4. 
ECG Changes 
A participant who meets either bulleted criteria based on the average of triplicate ECG 
readings will be withdrawn from the study intervention.  If the mean QTcF intervals rise 
above 500 msec, during the monitoring for the QTcF prolongation,  
 the QTcF interval has still not decreased to ≤480 msec after 2 weeks. 
  at any time a participant has a QTcF interval >515 msec, or 
 becomes symptomatic 
If a clinically significant finding is identified (including, but not limited to, changes from 
baseline in QTcF after enrollment), the investigator or qualified designee will determine if 
the participant can continue in the study and if any change in participant management is 
needed.  This review of the ECG printed at the time of collection must be documented.  Any 
new clinically relevant finding should be reported as an AE. 
7.1.1. Request to Continue Study Intervention 
If the investigator feels the participant is still deriving benefit from treatment, following 
discussion with the sponsor the participant may have an option to continue dosing at the 
same dose or one dose lower, as long as the criteria below are met, until such benefit no 
longer exists. 
Criteria that must be met to ensure that participants are not exposed to unreasonable risks by 
continued use of the investigational agent in spite of progression of disease.  Such criteria 
may include the following: 
 Absence of symptoms and signs indicating clinically significant progression of 
disease. 


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 No decline in ECOG PS. 
 Absence of symptomatic rapid disease progression requiring urgent medical 
intervention (eg, symptomatic pleural effusion, spinal cord compression). 
At the time of progression of disease, obtain the re-consent of participants using a written 
ICD that details all approved therapy, and potential clinical benefit, that the participant may 
be foregoing in order to continue receiving the investigational product. 
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 may include: 
 Completed study follow-up; 
 Study terminated by sponsor; 
 Lost to follow-up; 
 Refused further follow-up; 
 Death. 
The early discontinuation visit applies only to participants who are enrolled and then are 
prematurely withdrawn from the study.  Participants should be questioned regarding their 
reason for withdrawal.   
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly. 
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations should be performed and no 
additional data should be collected.  The sponsor may retain and continue to use any data 
collected before such withdrawal of consent. 
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 
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 


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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 Schedule of Activities.  Protocol 
waivers or exemptions are not allowed. 
Safety issues should be discussed with the sponsor immediately upon occurrence or 
awareness to determine whether the participant should continue or discontinue study 
intervention. 
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct. 
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria.  The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 


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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 
well-being of the participant.  When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible.  The study team must be informed of these incidents in a timely manner. 
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study. 
8.1. Efficacy Assessments 
8.1.1. Disease Response Assessment 
Anti-cancer assessments and response will be assessed according to the International 
Myeloma Working Group (IMWG) response criteria for MM (See Section 10.10).29  
Disease assessment will be assessed at baseline, during treatment as specified in the schedule 
of activities, whenever disease progression is suspected (eg, symptomatic deterioration), and 
at the time of withdrawal from treatment. 
If imaging is used in disease assessment, the same imaging technique used to characterize 
each identified and reported lesion at baseline will be employed in post-baseline disease 
assessments. 
All participants’ files and radiologic images and pathology samples must be available for 
source verification. 
8.1.1.1. Laboratory Evaluation of Disease Response 
Laboratory tests for disease response will be used to explore early signals of anti-cancer 
activity (see Section 10.10).29,30  These laboratory tests will be completed per SoA, including 
assessments at suspected CR, whenever disease progression is suspected (eg, symptomatic 
deterioration), and at withdrawal from treatment if not done in the previous 4 weeks.  
Assessments will include:  
 Serum protein electrophoresis (SPEP) for the measurement of serum M-proteins.  
 Serum immunofixation electrophoresis (SIFE) for definitive identification of specific 
M-proteins (including immunoglobulin [Ig]G, IgA, IgM, and two light chains kappa 


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and lambda).  SIFE will only be completed at baseline, when electrophoresis shows 
no measurable protein, at suspected CR/sCR, and at suspected progression (clinical or 
biochemical). 
 24 hr urine protein electrophoresis (UPEP) for the measurement of urine M-proteins.   
 24 hr urine immunofixation electrophoresis (UIFE) for definitive identification of 
specific M-proteins (including IgG, IgA, IgM, and two light chains kappa and 
lambda).  UIFE will only be completed at baseline, when electrophoresis shows no 
measurable protein, at suspected CR, and at suspected progression (clinical or 
biochemical). 
 Involved and uninvolved serum free light chain analysis (FLC) 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 should be recorded.  If 
participants were treated with daratumumab less than 114 days prior to planned 
treatment day, daratumumab will interfere with SPEP, UPEP, SIFE and UIFE assays.  
Therefore, for these participants, FLC assay should be completed at screening, C0D1, 
and all subsequent disease assessments.  Serum and urine M-spike if measurable at 
baseline in these participants should also be followed at the same timepoints as FLC 
with the most representative marker of disease status used for determination IMWG 
assessment.  
 Beta-2 microglobulin.  This will only be collected on the first day of treatment. 
All samples will be collected prior to investigational product administration on days whereby 
investigational product is to be administered.  In participants with two M-protein bands at the 
start of therapy, 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.  When a 
complete response (CR), or a clinical or biochemical progression is suspected, SPEP, serum 
SIFE, UPEP, UIFE and FLC tests will be repeated within 1 to 4 weeks.  
Note that if a participant had measurable serum or urine M-spike at baseline, unless the band 
is due to daratumumab or measurement of M-spike is confounded by the presence of 
daratumumab or other therapeutic mAb, progression cannot be defined by increases in serum 
FLC alone.  Serum FLC levels should only be used for response assessment when both the 
serum and urine M-component levels are deemed not measurable or uninterpretable.  
Furthermore, careful attention should be given to new positive immunofixation results 
appearing in participants who have achieved a CR, when the isotype is different.  This may 
represent oligoclonal immune reconstitution and should not be confused with relapse; these 
bands typically disappear over time. 
8.1.1.2. Bone Marrow Plasma Cell Evaluation and Bone Marrow Sample Collection 
Bone marrow evaluation of plasma cells in bone marrow aspirate and/or bone marrow 
biopsies will be performed to follow disease response.  


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Bone marrow aspirates will also be evaluated centrally for minimal residual disease (MRD, 
see Section 10.11) by high-throughput sequencing using next generation sequencing (NGS) if 
there is evidence of CR.  Results from central NGS assay may not be utilized if assay 
validation does not meet local policies and regulations.  In this case, local validated assays 
may be utilized. 
8.1.1.3. Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed 
Tomography (CT) Imaging 
Fluorodeoxyglucose-PET/CT (18F-FDG-PET/CT) imaging will be used to explore early 
signals of anti-cancer activity.  FDG-PET/CT is a functional imaging method in which the 
uptake of 18F-FDG by cells reflects the tissue uptake of glucose, thus revealing specific 
types of tissue metabolism.  In MM, functional imaging on hybrid scanners (combination of 
PET and CT imaging) rather than on PET scanners alone are required.  The association of 
abnormal FDG uptake provided by PET imaging and the assessment of bone structure 
provided by CT imaging leads to an optimal evaluation of disease. 
Imaging studies will be collected per SoA at screening, at suspected CR, when disease 
progression is suspected (eg, symptomatic deterioration), when clinically indicated and at 
end of treatment visit (if not done in the previous 4 weeks).  The screening PET/CT will be 
used to determine evaluable index lesions for each participant.  Tumor background ratios 
(TBRs) and development of new sites of abnormality will be recorded.  
If imaging is used in disease assessment, the same imaging technique used to characterize 
each identified and reported lesion at baseline will be employed in post-baseline disease 
assessments.  Any soft tissue plasmacytoma documented at baseline must undergo serial 
monitoring; otherwise, the participant will be classified as unevaluable.  For participants with 
only skin involvement, skin lesions should be measured with a ruler at timepoints specified 
in Schedule of Activities.  Plasmacytoma that has been irradiated will not be suitable for 
response assessment; however, it must be monitored for progressive disease. 
Radiographic studies are not required to satisfy response and MRD requirements, except if 
CR or imaging MRD-negative status is suspected (see Section 10.11).  
All participants’ files and radiologic images and pathology samples must be available for 
source verification and for potential peer review.  
Radiographic assessments obtained per the patient’s standard of care prior to enrollment into 
the study 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 treatment, (2) the same technique/modality 
can be used to follow identified lesions throughout the trial for a given participant, and (3) 
appropriate documentation indicating that these radiographic tumor assessments were 
performed as standard of care is available in the participant’s source notes. 


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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. 
Safety assessments will include collection of AEs, SAEs, vital signs and physical 
examination, ECG (12-lead), laboratory assessments, including pregnancy tests, Echo or 
multigated acquisition scan (MUGA) and verification of concomitant treatments. 
8.2.1. Physical Examinations 
Participants will have a physical examination to include weight, vital signs, assessment of 
ECOG PS and height; height will be measured at Screening only. 
A complete physical examination will include, at a minimum, assessments of the 
cardiovascular, respiratory, gastrointestinal, and neurological systems.  
A brief physical examination will include, at a minimum, assessments of the skin, lungs, 
cardiovascular system, abdomen (liver and spleen) and neurological system.  
Neurological examinations include assessment of mental state, motor function, sensory 
function, gait, deep tendon reflexes, cranial nerve function, station and coordination. 
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. 
Investigators should pay special attention to clinical signs related to previous serious 
illnesses. 
8.2.2. Vital Signs 
Vital signs will be measured with the participant in the sitting position after 5 minutes of rest 
and will include temperature, systolic and diastolic blood pressure, and pulse rate. 
Vital signs should be monitored at least every 4 hours (±15 minutes) during the first 48 hours 
after first dose of study intervention (C0D1) and 24 hours after second dose of study 
intervention (C1D1) (see Section 10.13). 
8.2.3. Electrocardiograms 
Standard 12-lead ECGs utilizing limb leads (with a 10-second rhythm strip) should be 
collected at times specified in the SoA section of this protocol using an ECG machine that 
automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS 
complex.  Alternative lead placement methodology using torso leads (eg, Mason-Likar) is not 
recommended given the potential risk of discrepancies with ECGs acquired using standard 
limb lead placement.  All scheduled ECGs should be performed after the participant has 
rested quietly for at least 10 minutes in a supine position.  


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At each time point (see Schedule of Activities), 3 consecutive ECGs will be performed at 
approximately 2 minutes apart to determine the mean QTc interval.  To ensure safety of the 
participants, a qualified individual at the investigator site will make comparisons to baseline 
measurements.  Additional ECG monitoring will occur if a) the mean value from the 
triplicate measurements for any postdose QTcF interval is increased by 60 msec from the 
baseline and is >450 msec; or b) an absolute QTcF value is 500 msec for any scheduled 
ECG.  If either of these conditions occurs, then a single ECG measurement must be repeated 
at least hourly until QTc values from 2 successive ECGs fall below the threshold value that 
triggered the repeat measurement.  In addition, if verified QTc values continue to exceed the 
criteria above, immediate correction for reversible causes including electrolyte abnormalities, 
hypoxia and concomitant medications for drugs with the potential to prolong the QTcF 
interval should be performed. 
If the QTc interval reverts to less than the threshold criteria listed above, and in the judgment 
of the investigator(s) and sponsor, it is determined that the cause(s) of QTc prolongation is 
something other than study intervention, treatment may be continued with regular ECG 
monitoring.  If in that timeframe the QTcF intervals rise above the threshold values, the study 
intervention will be held until the QTc interval decreases to below the threshold values.  
Participants will then restart the study intervention at the next lowest dose level.  If the QTc 
interval has still not decreased to 480 msec after 2 weeks, or if at any time a participant has a 
QTcF interval >515 msec or becomes symptomatic, the participant will be removed from the 
study.  Additional triplicate ECGs may be performed as clinically indicated. 
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 QTc 
value is prolonged, as defined above, repeat measurements may not be necessary if a 
qualified medical provider’s interpretation determines that the QTc values are in the 
acceptable range. 
Symptom of CRS including nausea, vomiting and diaphoresis may interfere with the accurate 
assessment of QTc.  When CRS symptoms that indicate heightened autonomic tone are 
observed, ECG should be skipped until the symptoms are resolved. 
If a participant experiences a cardiac or neurologic AE (specifically syncope, dizziness, 
seizures, or stroke), an ECG (triplicate) should be obtained at the time of the event.  
ECG values of potential clinical concern are listed in Appendix 7. 
8.2.4. Echocardiogram (Echo) or Multigated Acquisition Scan (MUGA) 
Echo or MUGA will be evaluated in participants with previous history of cardiac events.  For 
these participants, an Echo or MUGA will be performed at screening, when clinically 
indicated, and at the end of treatment visit.  The following parameters will be evaluated: 
ventricular function (including left ventricular ejection fraction [LVEF], end systolic volume 
[ESV] and end diastolic volume [EDV]), qualitative evaluation of chamber size, and wall 
motion.  A Doppler examination will be completed and should include an assessment of 


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mitral valve, atria, right ventricle, tricuspid valve, aortic valve, pulmonic valve, great vessels, 
and pericardium. 
8.2.5. 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 
DILI. 
Participants with positive HBsAb and positive HBcAb are allowed to participate in the study 
if they have negative HBV DNA test at screening but HB viral load should be monitored for 
re-activation every 12 weeks. 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 elranatamab, 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.31  
8.2.6. Pregnancy Testing  
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least 
25 mIU/mL.  Pregnancy tests will be performed in woman of childbearing potential 
(WOCBP) at the times listed in the SoA.  Following a negative pregnancy test result at 
screening, appropriate contraception must be commenced and a second negative pregnancy 
test result will be required at the baseline visit prior to the participant’s receiving the study 
treatment.  Pregnancy tests will also be done whenever 1 menstrual cycle is missed during 
the active treatment period (or when potential pregnancy is otherwise suspected) and at the 
end of the study.  Pregnancy tests may also be repeated if requested by IRBs/ECs or if 


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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. 
8.2.7. Local Site Injection Tolerability Assessment 
Assessments of the injection sites in the abdominal fat fold to monitor local tolerability to 
elranatamab SC injections will be performed for 1 to 4 hours following study drug 
administration in Cycle 0 and Cycle 1, as per the SoA.  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.  Refer to Section 10.14 for more details. 
Site tolerability assessments should continue at regularly scheduled visits if injection site 
pain or injection site reaction (ISR) characteristics continue to persist.  The assessments 
should continue until the symptoms resolve.  The injection sites will be assessed for 
erythema, induration, ecchymosis, injection site pain, injection site pruritus, or other 
observed characteristics after study drug dosing.  Any observed abnormality at the injection 
site will be judged by the investigator to determine whether a corresponding AE should be 
reported.  When appropriate, at the discretion of the investigator, a participant with an ISR 
may be referred for a dermatological consultation and skin biopsy may be obtained for future 
examination of the ISR.  The dermatology consultation is expected to take place at the 
dermatologist’s practice location, or may occur within the same institution where this study is 
conducted. 
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/legally authorized representative will be questioned about the occurrence of 
AEs in a nonleading manner.  In addition, the investigator may be requested by Pfizer Safety 
to obtain specific follow-up information in an expedited fashion. 
8.3.1. Time Period and Frequency for Collecting AE and SAE Information 
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before the participant’s participation in the study (ie, before undergoing 
any study-related procedure and/or receiving study intervention), through and including a 


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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.  
Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator and Pfizer concurs with that assessment. 
For participants who are screen failures, the active collection period ends when screen failure 
status is determined. 
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn. 
If a participant definitively discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the CT SAE Report Form. 
Investigators are not obligated to actively seek AEs or SAEs after the participant has 
concluded study participation.  However, if the investigator learns of any SAE, including a 
death, at any time after a participant has completed the study, and he/she considers the event 
to be reasonably related to the study intervention, the investigator must promptly report the 
SAE to Pfizer using the CT SAE Report Form. 
8.3.1.1. Reporting SAEs to Pfizer Safety 
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the CT SAE Report Form immediately upon 
awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 3.  The investigator will submit any updated SAE data to the sponsor within 
24 hours of it being available. 
If a participant begins a new anticancer therapy, SAEs occurring during the above-indicated 
active collection period must still be reported to Pfizer Safety irrespective of any intervening 
treatment.  Note that a switch to a commercially available version of the study intervention is 
considered as a new anticancer therapy for purposes of SAE reporting. 
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF 
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF.  
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant. 


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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. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary. 
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements. 


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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 ingestion, inhalation, or skin 
contact. 
 A male family member or healthcare provider who has been exposed to the study 
intervention by ingestion, inhalation, or skin contact then exposes his female 
partner prior to or around the time of conception. 
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred.  The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy).  
 If EDP occurs in a participant or a participant’s partner, the investigator must report 
this information to Pfizer Safety on the CT SAE Report Form and an EDP 
Supplemental Form, regardless of whether an SAE has occurred.  Details of the 
pregnancy will be collected after the start of study intervention and until pregnancy 
completion (or until pregnancy termination).  
 If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the CT SAE Report Form and EDP Supplemental 
Form.  Since the exposure information does not pertain to the participant enrolled in 
the study, the information is not recorded on a CRF; however, a copy of the 
completed CT SAE Report Form is maintained in the investigator site file. 
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome.  The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 


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follow-up to the initial EDP Supplemental Form.  In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported). 
Abnormal pregnancy outcomes are considered SAEs.  If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a live-born baby, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death), the investigator should follow the procedures 
for reporting SAEs.  Additional information about pregnancy outcomes that are reported to 
Pfizer Safety as SAEs follows:  
 Spontaneous abortion including miscarriage and missed abortion; 
 Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the study intervention.  
Additional information regarding the EDP may be requested by the sponsor. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays).  In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner.  The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner. 
8.3.5.2. Exposure During Breastfeeding 
An exposure during breastfeeding occurs if: 
 A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention. 
 A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure).  An example of environmental 
exposure during breastfeeding is a female family member or healthcare provider who 
reports that she is breastfeeding after having been exposed to the study intervention 
by inhalation or skin contact.   
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 


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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.22  See 
Section 10.13. 
For the priming dose and first full dose, premedication for CRS is required (see Section 
6.5.2). 
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 


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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.  
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 
Section 10.13.All adverse events of special interest (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 according to SAE reporting procedur described in Section 10.3.4. 
8.3.8.1. Lack of Efficacy 
Not applicable because the study intervention has not approved for the treatment of MM and 
MM is life-threatening disease. 
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. 
Safety Event 
Recorded on the CRF 
Reported on the CT SAE Report 
Form to Pfizer Safety Within 24 
Hours of Awareness 
Medication errors  All (regardless of whether 
associated with an AE) 
Only if associated with an SAE 
 
Medication errors include: 
 Medication errors involving participant exposure to the study intervention; 
 Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant. 
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page. 
In the event of a medication dosing error, the sponsor should be notified within 24 hours. 
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 


PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 76 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF.   
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE. 
8.4. Treatment of Overdose 
For this study, any dose of elranatamab at each scheduled dosing greater than the assigned 
dose level will be considered an overdose. 
Pfizer does not recommend specific treatment for an overdose. 
In the event of an overdose, the investigator should: 
1. Contact the medical monitor within 24 hours. 
2. Closely monitor the participant for any AEs/SAEs and laboratory abnormalities for at 
least 5 half-lives or 28 calendar days after the overdose of elranatamab (whichever is 
longer). 
3. Document the quantity of the excess dose as well as the duration of the overdose in the 
CRF. 
4. Overdose is reportable to Safety only when associated with an SAE. 
5. Obtain a blood sample for PK analysis within 2 weeks from the date of the last dose of 
study intervention if requested by the medical monitor (determined on a case-by-case 
basis). 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant.  
8.5. Pharmacokinetics  
Blood samples for the analysis of elranatamab concentrations will be collected into 
appropriately labeled tubes at the times specified in the SoA of the protocol.  If CRS is 
suspected, and if a PK sample is not already scheduled to be taken (eg, from Cycle 3 
onwards), a PK sample should also be taken.  For each analysis, approximately 5 mL of 
blood samples will be collected to provide approximately 2 mL serum.  The PK sampling 
schedule may be modified based on emerging PK data. 
In addition to samples collected at the scheduled times, an additional blood sample for 
elranatamab should be collected from participants experiencing unexpected and/or serious 
AEs and the date and time of blood sample collection and of last dosing prior to PK 
collection should be documented in the CRF.  Where noted in the SoA, blood samples for 
elranatamab concentrations will be collected at approximately the same time as other 
assessments such as pharmacodynamic samples whenever possible. 


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PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 81 
initial 4 participants.  Thus, maximum 6 evaluable participants may be enrolled in this study.  
The actual sample size may be smaller, depending on the underlying dose toxicity profile. 
Although the sample size is not based on any statistical considerations, the study would have 
>55% chance to declare the RP2D determined in C1071001 study with a priming dose as it 
has exceeded the MTD for Japanese participants if the true DLT rate for Japanese 
participants is over 30%.  Especially, the study would have 74.6% and 87.5% chance if the 
true DLT rate is 40% and 50%, respectively.  It is determined that the RP2D with a priming 
dose exceeds the MTD in the Japanese participants if ≥2 DLTs are observed in this study. 
Table 5. 
Detection Probablity of Over MTD 
Total 
Sample 
Size 
Number of DLTs Observed 
True DLT Rate 
Initial 4 
Participants 
Additional 
2 
Participants
Total 
0.20 
0.25 
0.30 
0.40 
0.50 
4 
0 
NA 
0
40.96%
31.64%
24.01% 
12.96% 
6.25%
6 
1 
0 
1
26.21%
23.73%
20.17% 
12.44% 
6.25%
6 
≥1 
≥2
14.75%
18.46%
20.99% 
22.12% 
18.75%
4 
≥2 
NA 
≥2
18.08%
26.17%
34.83% 
52.48% 
68.75%
Detection Probability of Over MTD 
32.83%
44.63%
55.82% 
74.60% 
87.50%
NA: Not Applicable
 
9.3. Analysis Sets 
9.3.1. Full Analysis Set 
The full analysis set includes all enrolled participants. 
9.3.2. Safety Analysis Set 
The safety analysis set includes all enrolled participants who receive at least 1 dose of study 
intervention.  Unless otherwise specified the safety analysis set will be the default analysis 
set used for all analyses. 
9.3.3. Per Protocol Analysis Set (evaluable for RP2D) 
The per protocol analysis set includes all enrolled participants who had at least 1 dose of 
study treatment and either experienced DLT or do not have major treatment deviations 
during the DLT observation period. 
9.3.4. PK Analysis Sets 
The PK parameter analysis population is defined as all enrolled participants treated who do 
not have protocol deviations influencing PK assessment, and have sufficient information to 
estimate at least 1 of the PK parameters of interest. 
The PK concentration population is defined as all enrolled participants who are treated and 
have at least 1 analyte concentration. 


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PF-06863135 (Elranatamab) 
Protocol C1071002 
Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
Page 83 
9.4.2.2. Laboratory Test Abnormalities 
The number and percentage of participants who experienced laboratory test abnormalities 
will be summarized according to worst toxicity grade (CTCAE version 5.0) observed for 
each laboratory assay.  The analyses will summarize laboratory tests both on the entire study 
period and by cycle (Cycle 0, Cycle 1 and Cycles beyond 1).  Shift tables will be provided to 
examine the distribution of laboratory toxicities. 
For laboratory tests without CTCAE grade definitions, results will be categorized as normal, 
abnormal, or not done. 
9.4.2.3. Best Overall Response 
Disease response will be presented in the form of patient data listings that include, but are not 
limited to starting dose, disease response at each visit, and best overall response.  In addition, 
progression date, death date, date of the first response and the last disease assessment date, 
and the date of the last contact will be listed. 
Best overall response (BOR) will be assessed based on reported overall responses at different 
evaluation time points using IMWG response criteria. 
 Complete Response (CR) will encompass stringent Complete Response (sCR) and CR. 
 Overall Response (OR) will encompass sCR, CR, very good partial response (VGPR), 
and partial response (PR) . 
 Clinical Benefit (CB) will encompass sCR, CR, VGPR, PR, and minimal response (MR) . 
A summary table of BOR will also be provided. 
9.4.2.4. Progression Free Survival 
Progression free survival (PFS) is the time from the first date of the study intervention to the 
date of the first documentation of progression, or death due to any cause.  Progression is 
defined as the appearance of local, regional or distant disease of the same type after CR or 
progression of pre-existing lesions.  It does not include second primary malignancies of 
unrelated types.  A data listing of PFS will be provided.  A summary table may be provided 
as appropriate. 
9.4.2.5. Overall Survival 
Overall survival (OS) is the time from the first date of the study intervention to the date of 
death due to any cause.  A data listing of OS will be provided.  A summary table may be 
provided as appropriate. 
9.4.2.6. Time to Response 
Time to response (TTR) is defined for participants with confirmed objective response (as 
defined above in overall response) as the time from the first date of the study intervention to 


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the date of the first documentation of objective tumor response.  A data listing of TTR will be 
provided.  A summary table may be provided as appropriate. 
9.4.2.7. Duration of Response 
Duration of Response (DOR) is defined for participants with confirmed objective response 
(as defined above in overall response) as the time from the first documentation of objective 
tumor response to the first documentation of objective tumor progression or to death due to 
any cause, whichever occurs first.  A data listing of DOR will be provided.  A summary table 
may be provided as appropriate. 
9.4.2.8. Elranatamab Pharmacokinetic Analysis 
The concentrations of elranatamab will be summarized by descriptive statistics (n, mean, 
standard deviation, coefficient of variation (CV%), median, minimum maximum, geometric 
mean, and geometric CV%) by cycle, and nominal time.  Individual participant and median 
profiles of the concentration-time data will be plotted by cycle using nominal times.  Median 
profiles will be presented on both linear-linear and log-linear scales. 
Individual concentration-time data of elranatamab following the Cycle 0 Day 1 dose, Cycle 1 
Day 1 dose and Cycle 2 Day 1 dose will be analyzed separately using non-compartmental 
analysis to estimate the PK parameters.  The PK parameters estimated will include Cmax, time 
to maximum concentration (Tmax), and concentration versus time curve (AUClast).  If data 
permit or if considered appropriate, minimum concentration (Cmin), terminal elimination 
half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution during terminal 
phase (Vz/F) will be also estimated for Cycle 0 Day 1, Cycle 1 Day 1 and Cycle 2 Day 1.  
Actual sample collection times will be used for the parameter calculations.  The PK 
parameters will be summarized descriptively by cycle. 
9.4.2.9. Analysis of Immunogenicity Data  
For the immunogenicity data, the percentage of participants with 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 participants with positive ADA or NAb, the magnitude (titer), 
time of onset, and duration of ADA or NAb response will also be described, if data permit.  
The potential impact of immunogenicity on PK and clinical response including 
pharmacodynamic markers, safety/tolerability and efficacy of ADA will be explored, if 
warranted by the data. 
9.4.3. Other Safety Analyses 
All safety analyses will be performed on the safety population. 
Summaries and analyses of safety parameters will include all participants in the safety 
analysis set. 
AEs, ECGs, BP, pulse rate, continuous cardiac monitoring, and safety laboratory data will be 
reviewed and summarized on an ongoing basis during the study to evaluate the safety of 


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participants.  Any clinical laboratory, ECG, BP, and pulse rate abnormalities of potential 
clinical concern will be described.  Safety data will be presented in tabular and/or graphical 
format and summarized descriptively, where appropriate. 
Medical history and physical examination and neurological examination information, as 
applicable, collected during the course of the study will be considered source data and will 
not be required to be reported, unless otherwise noted.  However, any untoward findings 
identified on physical and/or neurological examinations conducted during the active 
collection period will be captured as AEs, if those findings meet the definition of an AE.  
Data collected at screening that are used for inclusion/exclusion criteria, such as laboratory 
data, ECGs, and vital signs, will be considered source data, and will not be required to be 
reported, unless otherwise noted.  Demographic data collected at screening will be reported. 
9.4.3.1. Electrocardiogram Analyses 
The analysis of ECG results will be based on participants in the safety analysis set with 
baseline and on treatment ECG data. 
ECG measurements (an average of the triplicate measurements) will be used for the 
statistical analysis and all data presentations.  Any data obtained from ECGs repeated for 
safety reasons after the nominal time points will not be averaged along with the preceding 
triplicates.  Interval measurements from repeated ECGs will be included in the outlier 
analysis (categorical analysis) as individual values obtained at unscheduled time points. 
QT intervals will be corrected for HR (QTcF) using Fridericia’s correction.  Data will be 
summarized and listed for QT, HR, RR, PR, QRS, QTcF, and by dose.  Individual QT (all 
evaluated corrections) intervals will be listed by time and dose.  Descriptive statistics (n, 
mean, median, standard deviation, minimum, and maximum) will be used to summarize the 
absolute corrected QT interval and changes from baseline in corrected QT after treatment by 
dose and time point.Details of additional analysis (if any) will be specified in SAP. 
Changes from baseline for the ECG parameters QT interval, HR, QTcF interval, PR interval, 
and QRS complex will be summarized by time and dose. 
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 
In addition, the number of participants with uncorrected QT values >500 msec will be 
summarized. 
If more than 1 ECG is collected at a nominal time after dose administration (for example, 
triplicate ECGs), the mean of the replicate measurements will be used to represent a single 


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Final Protocol Amendment 2, 10 June 2021 
 
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations 
10.1.1. Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with the following: 
 Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines; 
 Applicable ICH GCP guidelines; 
 Applicable laws and regulations, including applicable privacy laws. 
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor 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. 
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 
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. 


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10.1.2. Financial Disclosure 
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities.  Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study. 
10.1.3. Informed Consent Process 
The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions regarding the 
study.  The participant or his/her legally authorized representative should be given sufficient 
time and opportunity to ask questions and to decide whether or not to participate in the trial. 
Participants must be informed that their participation is voluntary.  Participants or their 
legally authorized representative 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 or his or her legally authorized 
representative is fully informed about the nature and objectives of the study, the sharing of 
data related to the study, and possible risks associated with participation, including the risks 
associated with the processing of the participant’s personal data.  
The participant 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 or his or her legally 
authorized representative 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. 
Participants must be reconsented to the most current version of the ICD(s) during their 
participation in the study. 
A copy of the ICD(s) must be provided to the participant or the participant’s legally 
authorized representative. 
Participants who are rescreened are required to sign a new ICD. 


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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. 
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, 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. 


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www.clinicaltrials.gov 
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in participants) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted.  These results are 
submitted for posting in accordance with the format and timelines set forth by US law. 
EudraCT 
Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies in 
accordance with the format and timelines set forth by EU requirements.   
www.pfizer.com 
Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used 
to identify individual participants have been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are 
posted to www.clinicaltrials.gov. 
Documents within marketing authorization packages/submissions 
Pfizer complies with the European Union Policy 0070, the proactive publication of clinical 
data to the EMA website.  Clinical data, under Phase 1 of this policy, includes clinical 
overviews, clinical summaries, CSRs, and appendices containing the protocol and protocol 
amendments, sample CRFs, and statistical methods.  Clinical data, under Phase 2 of this 
policy, includes the publishing of individual participant data.  Policy 0070 applies to new 
marketing authorization applications submitted via the centralized procedure since 
01 January 2015 and applications for line extensions and for new indications submitted via 
the centralized procedure since 01 July 2015. 
Data Sharing 
Pfizer provides researchers secure access to patient-level data or full CSRs for the purposes 
of “bona-fide scientific research” that contributes to the scientific understanding of the 
disease, target, or compound class.  Pfizer will make available data from these trials 
24 months after study completion.  Patient-level data will be anonymized in accordance with 
applicable privacy laws and regulations.  CSRs will have personally identifiable information 
redacted. 
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 


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Final Protocol Amendment 2, 10 June 2021 
 
PFIZER CONFIDENTIAL 
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responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF. 
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. 
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password protected or secured in a locked room to 
prevent access by unauthorized third parties. 
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data 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 (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 on-site monitoring), are provided in the 
monitoring plan. 
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data. 
Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements. 
Records and documents, including signed 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 


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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 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 on which the clinical study will be open for recruitment of 
participants. 
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date. 
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.  Study sites will be closed upon 
study completion.  A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time upon notification to the sponsor 
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants. 
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to: 
 Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor's procedures, or 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 


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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 
The results of this study may be published or presented at scientific meetings by the 
investigator after publication of the overall study results or 1 year after the end of the study 
(or study termination), whichever comes first.   
The investigator agrees to refer to the primary publication in any subsequent publications 
such as secondary manuscripts, and submits all manuscripts or abstracts to the sponsor 30 
days before submission.  This allows the sponsor 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- or Pfizer 
intervention-related information necessary for the appropriate scientific presentation or 
understanding of the study results. 
For all publications relating to the study, the investigator will comply with recognized ethical 
standards concerning publications and authorship, including those established by the 
International Committee of Medical Journal Editors. 
The sponsor will comply with the requirements for publication of the overall study results 
covering all investigator sites.  In accordance with standard editorial and ethical practice, the 
sponsor will support publication of multicenter studies only in their entirety and not as 
individual site data. In this case, a coordinating investigator will be designated by mutual 
agreement. 
Authorship of publications for the overall study results will be determined by mutual 
agreement and in line with International Committee of Medical Journal Editors authorship 
requirements.   
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 Qualified Medical Personnel 
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the supporting study documentation. 
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, participants are provided with a contact card at the time of informed 
consent.  The contact card contains, at a minimum, protocol and study intervention 
identifiers, participant numbers, contact information for the investigator site, and contact 
details for a contact center in the event that the investigator site staff cannot be reached to 


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PFIZER CONFIDENTIAL 
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provide advice on a medical question or problem originating from another healthcare 
professional not involved in the participant’s participation in the study.  The contact number 
can also be used by investigator staff if they are seeking advice on medical questions or 
problems; however, it should be used only in the event that the established communication 
pathways between the investigator site and the study team are not available.  It is therefore 
intended to augment, but not replace, the established communication pathways between the 
investigator site and the study team for advice on medical questions or problems that may 
arise during the study.  The contact number is not intended for use by the participant directly, 
and if a participant calls that number, he or she will be directed back to the investigator site. 


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10.2. Appendix 2: Clinical Laboratory Tests 
The following safety laboratory tests will be performed at times defined in the SoA section of 
this protocol.  Additional laboratory results may be reported on these samples as a result of 
the method of analysis or the type of analyzer used by the clinical laboratory, or as derived 
from calculated values.  These additional tests would not require additional collection of 
blood.  Unscheduled clinical laboratory measurements may be obtained at any time during 
the study to assess any perceived safety issues. 
Table 6. 
Safety Laboratory Tests 
Hematology 
Chemistry 
Serology
Coagulation
Urinalysis 
Pregnancy 
Test 
Ad hoc 
Central 
Lab 
Cytokine 
Analysis†
Hemoglobin 
ALT 
HBV 
PT
Urine 
dipstick for 
urine protein: 
If positive, 
microscopy 
(Reflex 
Testing) 
For female 
participants 
of 
childbearing 
potential, 
serum. 
IL-6, 
IL-10, 
IL- 2, 
sIL2R, 
IL-12, 
IL-4, IL-5, 
IL-10, 
IL-13, 
IL-17, 
IL-1b, 
IL-8, IFNγ, 
and TNF-α
Platelets 
AST 
HCV 
PTT/aPTT 
WBC 
bicarbonate 
 
Absolute or % 
Neutrophils 
CRP 
 
 
Alk Phos 
Absolute or % 
Lymphocytes 
Sodium 
 
 
Potassium 
Absolute or % 
Monocytes 
Magnesium 
 
 
Chloride 
Absolute or % 
Eosinophils 
Total calcium 
 
 
Urine 
dipstick for 
urine blood: 
If positive, 
collect a 
microscopy 
(Reflex 
Testing) 
Total 
bilirubin* 
Absolute or % 
Basophils 
 
 
 
Optional 
Ad hoc 
Local Lab 
Cytokine 
Analysis† 
Total Protein 
 
BUN 
 
 
 
 
Creatinine 
 
 
 
 
Uric Acid 
 
 
 
IL-6
IL-1
 
Glucose 
(nonfasted) 
 
IL-10
 
 
 
 
 
TNF
 
LDH 
 
Other 
cytokines 
 
Albumin 
 
 
Phosphorus or 
Phosphate 
 
 
 
 
 
 
 
* For potential Hy's Law cases, in addition to repeating AST and ALT, laboratory tests should include albumin, 
creatine kinase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, PT/INR, alkaline 
phosphatase, total bile acids and acetaminophen drug and/or protein adduct levels.  
† Cytokines for central lab evaluation will be collected if CRS is suspected.  Local lab evaluation of cytokine is 
only required if the site require this information for participant management. 
Investigators must document their review of each laboratory safety report.  


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10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting 
10.3.1. Definition of AE 
AE Definition 
 An AE is any untoward medical occurrence in a patient or clinical study 
participant, temporally associated with the use of study intervention, whether or 
not considered related to the study intervention. 
 NOTE: An AE can therefore be any unfavorable and unintended sign (including 
an abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention. 
 
Events Meeting the AE Definition 
 Any abnormal laboratory test results (hematology, clinical chemistry, or 
urinalysis) or other safety assessments (eg, ECG, radiological scans, vital sign 
measurements), including those that worsen from baseline, considered clinically 
significant in the medical and scientific judgment of the investigator.  Any 
abnormal laboratory test results that meet any of the conditions below must be 
recorded as an AE: 
 Is associated with accompanying symptoms; 
 Requires additional diagnostic testing or medical/surgical intervention; 
 Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy. 
 Exacerbation of a chronic or intermittent preexisting condition including either 
an increase in frequency and/or intensity of the condition. 
 New conditions detected or diagnosed after study intervention administration 
even though it may have been present before the start of the study. 
 Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
 Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication.  Overdose per se will not be reported 
as an AE/SAE unless it is an intentional overdose taken with possible 
suicidal/self-harming intent.  Such overdoses should be reported regardless of 
sequelae. 


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Events NOT Meeting the AE Definition 
 Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by 
the investigator to be more severe than expected for the participant’s condition. 
 The disease/disorder being studied or expected progression, signs, or symptoms 
of the disease/disorder being studied, unless more severe than expected for the 
participant’s condition. 
 Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
 Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
 Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) 
present or detected at the start of the study that do not worsen. 
 Worsening of signs and symptoms of the malignancy under study should be 
recorded as AEs in the appropriate section of the CRF.  Disease progression 
assessed by measurement of malignant lesions on radiographs or other methods 
should not be reported as AEs. 
10.3.2. Definition of SAE 
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, death 
due to progression of disease). 
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. 
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 


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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). 
 
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 


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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 on the CT SAE Report Form to Pfizer Safety.  
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 CT SAE Report Form for reporting of SAE information is not 
the same as the AE page of the CRF.  When the same data are collected, the forms must 
be completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE 
Report Form for reporting of SAE information. 
Safety Event 
Recorded on the CRF 
Reported on the CT SAE 
Report Form to Pfizer Safety 
Within 24 Hours of Awareness
SAE 
All
All
Nonserious AE 
All
None
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding, 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. 
 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 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 


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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 make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories:  
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 (see 
Section 10.13). 
 
Assessment of Causality 
 The investigator is obligated to assess the relationship between study 
intervention and each occurrence of each AE/SAE. 
 A “reasonable possibility” of a relationship conveys that there are facts, 
evidence, and/or arguments to suggest a causal relationship, rather than a 
relationship cannot be ruled out. 
 The investigator will use clinical judgment to determine the relationship. 
 Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration, will be considered and investigated. 


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 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 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. 
 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. 


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10.3.4. Reporting of SAEs 
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool 
 The primary mechanism for reporting an SAE to Pfizer Safety will be the 
electronic data collection tool. 
 If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to report the event within 24 hours. 
 The site will enter the SAE data into the electronic system as soon as the data 
become available. 
 After the study is completed at a given site, the electronic data collection tool 
will be taken off-line to prevent the entry of new data or changes to existing data.
 If a site receives a report of a new SAE from a study participant or receives 
updated data on a previously reported SAE after the electronic data collection 
tool has been taken off-line, then the site can report this information on a paper 
SAE form (see next section) or to Pfizer Safety by telephone. 
 
SAE Reporting to Pfizer Safety via CT SAE Report Form 
 Facsimile transmission of the CT SAE Report Form is the preferred method to 
transmit this information to Pfizer Safety. 
 In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the CT SAE Report Form sent by overnight mail or 
courier service. 
 Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Report Form pages within the designated 
reporting time frames. 
 


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10.4. Appendix 4: Contraceptive Guidance  
10.4.1. Male Participant Reproductive Inclusion Criteria 
Male participants are eligible to participate if they agree to the following requirements during 
the intervention period and for at least 90 days after the last dose of study intervention, which 
corresponds to the time needed to eliminate reproductive safety risk of the study 
intervention(s):  
 Refrain from donating sperm. 
PLUS either: 
 Be abstinent from heterosexual intercourse with a female of childbearing potential as 
their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and 
agree to remain abstinent.  
 
OR 
 Must agree to use a male condom when engaging in any activity that allows for 
passage of ejaculate to another person. 
 In addition to male condom use, a highly effective method of contraception may be 
considered in WOCBP partners of male participants (refer to the list of highly 
effective methods below in Section 10.4.4). 
10.4.2. Female Participant Reproductive Inclusion Criteria 
A female participant is eligible to participate if she is not pregnant or breastfeeding (women 
who are currently breastfeeding and intend to interrupt breastfeeding are excluded from 
participating), 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 90 days 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.   


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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. Premenopausal female with 1 of the following: 
 Documented hysterectomy; 
 Documented bilateral salpingectomy; 
 Documented bilateral oophorectomy. 
For individuals with permanent infertility due to an alternate medical cause other than 
the above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion 
should be applied to determining study entry. 
Note: Documentation for any of the above categories can come from the site 
personnel’s review of the participant’s medical records, medical examination, or 
medical history interview.  The method of documentation should be recorded in the 
participant’s medical record for the study. 
2. Postmenopausal female. 
 A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause.  In addition, a 
 High FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years old and not using hormonal 
contraception or HRT.  When there is a high FSH level, it should be confirmed 
that there is no other medical cause. 
 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. 


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1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation (not approved in Japan). 
2. Intrauterine device. 
3. Intrauterine hormone-releasing system. 
4. Bilateral tubal occlusion. 
5. Vasectomized partner. 
 Vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the woman of childbearing potential and the 
absence of sperm has been confirmed.  If not, an additional highly effective 
method of contraception should be used.  The spermatogenesis cycle is 
approximately 90 days. 
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation. 
 Oral; 
 Intravaginal (not approved in Japan); 
 Transdermal (not approved in Japan); 
7. Progestogen-only hormone contraception associated with inhibition of ovulation. 
 Oral (not approved in Japan); 
 Injectable (not approved in Japan). 
8. Sexual abstinence. 
 Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention.  The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the study and the preferred and usual 
lifestyle of the participant. 
In addition, one of the following effective barrier methods must also be used when 
option 6 or 7 are chosen above: 
 Male or female condom with or without spermicide; 
 Cervical cap, diaphragm, or sponge with spermicide (all not approved in Japan); 


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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.   
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 >120 msec). 
 New-onset right bundle branch block (QRS >120 msec). 
 Symptomatic bradycardia. 
 Asystole: 
 In awake, symptom-free participants 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 participants with atrial fibrillation and bradycardia 
with 1 or more pauses of at least 5 seconds or longer.  
 Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate 
>120 bpm. 
 Sustained supraventricular tachycardia (rate >120 bpm) (“sustained” = short 
duration with relevant symptoms or lasting >1 minute). 


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 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. 
 Sustained ventricular tachyarrhythmias (>30 seconds’ duration). 
 Second- or third-degree AV block requiring pacemaker placement. 
 Asystolic pauses requiring pacemaker placement. 
 Atrial flutter or fibrillation with rapid ventricular response requiring 
cardioversion. 
 Ventricular fibrillation/flutter. 
 At the discretion of the investigator, any arrhythmia classified as an adverse 
experience. 
 


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10.8. Appendix 8: Bone Marrow Reserve in Adults 
Adapted from R.E. ELLIS: The Distribution of Active Bone Marrow in the Adult, Phy. Med. 
Biol.  5, 255-258, 1961 
Marrow Distribution of the Adult 
SITE 
MARROW 
wt. (g) 
FRACTION 
RED 
MARROW 
AGE 40 
RED 
MARROW 
wt. (g) 
AGE 40 
% TOTAL 
RED MARROW 
 
CRANIUM 
Head : 
136.6
 
AND 
 
Cranium 
165.8
0.75
124.3
13.1 
13.1 
MANDIBLE 
 
Mandible 
16.4
0.75
12.3
 
 
Upper Limb Girdle : 
86.7
 
HUMERI, 
SCAPULAE, 
 
2 Humerus,  
 
head & neck
26.5 
0.75 
20.0 
8.3 
8.3 
CLAVICLES 
 
2 Scapulae  
67.4
0.75
50.5
 
 
 
2 Clavicles 
21.6
0.75
16.2
 
 
Sternum 
39.0
0.6
23.4
2.3 
 
Ribs :  
82.6
 
 
 
1 pair 
10.2
All 0.4
4.1
 
 
 
2  
12.6
5.0
 
 
 
3 
16.0
6.4
 
STERNUM 
 
4 
18.6
7.4
 
AND 
 
5 
23.8
9.5
7.9 
10.2 
RIBS 
 
6 
23.6
9.4
 
 
 
7 
25.0
10.0
 
 
 
8 
24.0
9.6
 
 
 
9 
21.2
8.5
 
 
 
10 
16.0
6.4
 
 
 
11 
11.2
4.5
 
 
 
12 
4.6
1.8
 
 
Sacrum  
194.0
0.75
145.6
13.9 
PELVIC 
BONES 
2 os coxae 
310.6 
0.75 
233.0 
22.3 
36.2 
FEMUR 
2 Femoral head  
and neck 
53.0 
0.75 
40.0 
 
3.8 
 


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Marrow Distribution of the Adult (cont’d) 
SITE 
MARROW 
wt. (g) 
FRACTION RED 
MARROW 
AGE 40 
RED 
MARROW 
wt. (g) 
AGE 40 
% TOTAL 
RED MARROW 
 
Vertebrae 
(Cervical): 
 
 
35.8 
 
 
 
1 
6.6
All 0.75
5.0
 
 
2 
8.4
6.3
 
 
3 
5.4
4.1
3.4 
 
4 
5.7
4.3
 
 
5 
5.8
4.4
 
 
6 
7.0
5.3
 
 
7 
8.5
6.4
 
 
Vertebrae 
(Thoracic): 
 
 
147.9 
 
 
 
1 pair 
10.8
All 0.75
8.1
 
 
2 
11.7
8.8
 
 
3 
11.4
8.5
 
 
4 
12.2
9.1
 
VERTEBRAE 
5 
13.4
10.1
14.1 
28.4 
 
6 
15.3
11.5
 
 
7 
16.1
12.1
 
 
8 
18.5
13.9
 
 
9 
19.7
14.8
 
 
10 
21.2
15.9
 
 
11 
21.7
16.3
 
 
12 
25.0
18.8
 
 
Vertebrae 
(Lumbar) : 
 
 
114.1 
 
 
 
1 pair 
27.8
All 0.75
20.8
 
 
2 
29.1
21.8
10.9 
 
3 
31.8
23.8
 
 
4 
32.1
24.1
 
 
5 
31.4
23.6
 
TOTAL 
 
1497.7 
 
1045.7 
100.0 
100.0 
 
 


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10.9. Appendix 9: International Myeloma Working Group (IMWG) Multiple Myeloma 
Diagnosis Criteria 
Clonal bone marrow plasma cells 10% or biopsy-proven bony or extramedullary 
plasmacytoma* and any one or more of the following myeloma defining events: 
1. Evidence of end organ damage that can be attributed to the underlying plasma cell 
proliferative disorder, specifically: 
a. 
Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper 
limit of normal or >2.75 mmol/L (>11 mg/dL). 
b. 
Renal insufficiency: creatinine clearance <40 mL per min† or serum creatinine 
>177 µmol/L (>2 mg/dL). 
c. 
Anemia: hemoglobin value of >20 g/L below the lower limit of normal, or a 
hemoglobin value <100 g/L. 
d. 
Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or 
PET-CT.‡ 
2. Any one or more of the following biomarkers of malignancy: 
a. Clonal bone marrow plasma cell percentage* 60%. 
b. 
Involved: uninvolved serum free light chain ratio§ 100.  
c. 
>1 focal lesions on MRI studies.¶ 
PET-CT=18F-fluorodeoxyglucose PET with CT.  
* Clonality should be established by showing κ/-light-chain restriction on flow cytometry, 
immunohistochemistry, or immunofluorescence.  Bone marrow plasma cell percentage should preferably be 
estimated from a core biopsy specimen; in case of a disparity between the aspirate and core biopsy, the 
highest value should be used. 
† Measured or estimated by validated equations.  
‡ If bone marrow has less than 10% clonal plasma cells, more than one bone lesion is required to distinguish 
from solitary plasmacytoma with minimal marrow involvement.  
§ These values are based on the serum freelite assay (The Binding Site Group, Birmingham, UK).  The involved 
free light chain must be 100 mg/L.   
¶ Each focal lesion must be 5 mm or more in size. 
Relapse is defined as progression of disease after an initial response to previous treatment, 
more than six months after cessation of treatment. 
Refractory is defined as resistance to treatment due to lack of response or progression of 
disease during treatment or within six months after cessation of treatment. 


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10.10. Appendix 10: International Myeloma Working Group (IMWG) Response 
Criteria for Multiple Myeloma 
All response categories require two consecutive assessments made any time before starting 
any new therapy. Participants must have measurable disease at enrolment (study entry). 
Measurable disease is defined as: 
 Serum M-protein ≥ 0.5 g/dL (5 g/L);  
 Urine M-protein ≥ 200 mg/24 h; 
 Serum FLC assay: involved FLC level ≥ 100 mg/L (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 lower or lowest level of response. Participants will continue in 
the last confirmed response category until there is confirmation of progression or 
improvement to a higher response status; participants cannot move to a lower response 
category. 
Response 
IMWG Criteria* 
Stringent 
Complete 
Response (sCR) 
 
Complete response as defined below plus normal FLC ratio and absence of clonal 
cells in bone marrow biopsy by immunohistochemistry (κ/ λ ratio ≤ 4:1 or ≥ 1:2 
for κ and λ patients, respectively, after counting ≥100 plasma cells).1 
 
In patients whereby the only measurable disease is by serum FLC levels, sCR is 
defined as normal FLC ratio of 0.26 to 1.65 plus absence of clonal cells in bone 
marrow as defined above. 
Complete 
Response (CR) 
 
Negative immunofixation on the serum and urine and disappearance of any soft 
tissue plasmacytomas and <5% plasma cells in bone marrow aspirates.2 
 
In patients whereby the only measurable disease is by serum FLC levels, CR is 
defined as normal FLC ratio of 0.26 to 1.65 plus criteria listed above. 
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. 
 
In patients whereby the only measurable disease is by serum FLC levels, VGPR 
is defined as a ≥90% decrease in the difference between involved (tumor) and 
uninvolved (non-tumor) serum FLC levels. 
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 FLC levels is required in place of 
the M-protein criteria. 


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 
If serum and urine M-protein are unmeasurable, and serum-free light assay is also 
unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, 
provided baseline bone marrow plasma-cell percentage was ≥30%. 
 
In addition to these criteria, if present at baseline, a ≥ 50% reduction in the size 
(SPD)3 of soft tissue plasmacytomas is also required. 
Minimal Response 
(MR) 
≥ 25% but ≤ 49% reduction of serum M-protein and reduction in 24-h urine M-
protein by 50–89%. In addition to the above listed criteria, if present at baseline, a 
50% reduction in the size (SPD)3 of soft tissue plasmacytomas is also required. 
No Change/Stable 
Disease (SD) 
Not meeting criteria for CR, VGPR, PR, MR or progressive disease. 
Progressive 
Disease (PD) 
 
Increase of ≥ 25% from lowest response value in any one or more of the 
following: 
o 
Serum M-protein (absolute increase must be ≥ 0.5 g/dL); 
o 
Serum M-protein increase ≥1 g/dL, if the lowest M component was ≥ 5 g/dL;
o 
Urine M-protein (absolute increase must be ≥ 200 mg/24 h; 
o 
In patients without measurable serum and urine M-protein levels, the 
difference between involved and uninvolved FLC levels (absolute increase 
must be >10 mg/dL); 
o 
In patients without measurable serum and urine M-protein levels and without 
measurable involved FLC levels, bone marrow plasma-cell percentage 
irrespective of baseline status (absolute increase must be ≥10%); 
o 
Appearance of a new lesion(s), ≥ 50% increase from nadir in SPD3 of >1 
lesion, or ≥ 50% increase in the longest diameter of a previous lesion >1 cm 
in short axis.  
o 
≥50% increase in circulating plasma cells (minimum of 200 cells per μL) if 
this is the only measure of disease 
Clinical Relapse 
Clinical relapse requires one or more of the following criteria: 
 
Direct indicators of increasing disease and/or end organ dysfunction (CRAB 
features) related to the underlying clonal plasma-cell proliferative disorder; 
 
Development of new soft tissue plasmacytomas or bone lesions (osteoporotic 
fractures do not constitute progression); 
 
Definite increase in the size of existing plasmacytomas or bone lesions. A 
definite increase is defined as a 50% (and ≥1 cm) increase as measured serially 
by the SPD3 of the measurable lesion; 
 
Hypercalcemia (>11 mg/dL); 
 
Decrease in hemoglobin of ≥2 g/dL not related to therapy or other non-myeloma-
related conditions; 
 
Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and 
attributable to myeloma; 
 
Hyperviscosity related to serum paraprotein. 


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* All response categories require two consecutive assessments made at any time before classification as 
relapse or disease progression and/or the institution of any new therapy.  To confirm response or 
progressive disease, two discrete samples are required, and testing cannot be based upon the splitting of a 
single sample.  In the IMWG criteria, CR patients must also meet the criteria for progressive disease shown 
here to be classified as progressive disease for the purposes of calculating time to progression and 
progression free survival.  The definitions of relapse, clinical relapse and relapse from CR are not to be 
used in calculation of time to progression or progression free survival.  Patients will be considered to have 
progressive disease if they meet the criteria for progression by a variable that was not considered 
measurable at baseline; however, for patients who had a measurable serum or urine M-spike at baseline, 
progression cannot be defined by increases in serum FLC alone. 
1 Presence/absence of clonal cells on immunohistochemistry is based upon the κ/ λ /L ratio.  An abnormal κ/ 
λ ratio by immunohistochemistry 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. 
2 Confirmation with repeat bone marrow biopsy is not required.  Careful attention should be given to new 
positive immunofixation results appearing in patients who have achieved a complete response, when the 
isotype is different.  This probably represents oligoclonal immune reconstitution and should not be 
confused with relapse; these bands typically disappear over time. 
3 Plasmacytoma measurements should be taken from the CT portion of the PET/CT, or dedicated CT scans 
where applicable.  Measurement of tumor size will be determined by the SPD. 
 
 


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10.11. Appendix 11: IMWG MINIMAL RESIDUAL DISEASE (MRD) Criteria 
MRD tests should be initiated only at the time of suspected complete response.  Confirmation 
with two consecutive assessments is not required.  
Response 
IMWG Criteria 
Sustained 
MRD-Negative1 
MRD negativity in the marrow (NGF or NGS, or both) and by imaging as defined 
below, confirmed minimum of 1 year apart.  Subsequent evaluations can be used to 
further specify the duration of negativity (eg, MRD-negative at 5 years). 
Flow 
MRD-negative2 
Absence of phenotypically aberrant clonal plasma cells by NGF on bone marrow 
aspirates using the EuroFlow standard operation procedure for MRD detection in 
multiple myeloma (or validated equivalent method) with a minimum sensitivity of 1 
in 105 nucleated cells or higher. 
Sequencing 
MRD-negative  
Absence of clonal plasma cells by NGS on bone marrow aspirate in which presence 
of a clone is defined as less than two identical sequencing reads obtained after DNA 
sequencing of bone marrow aspirates using the LymphoSIGHT platform (or 
validated equivalent method) with a minimum sensitivity of 1 in 105 nucleated cells 
or higher. 
Imaging-negative 
MRD-negative 
MRD negativity as defined by NGF or NGS plus disappearance of every area of 
increased tracer uptake found at baseline or a preceding PET/CT or decrease to less 
mediastinal blood pool SUV or decrease to less than that of surrounding normal 
tissue.  
CT = computed tomography; IMWG=International Myeloma Working Group; MRD = minimal residual 
disease; NGF = next-generation flow cytometry; NGS = next generation sequencing; PET = positron emission 
tomography; SUV = standardized uptake value. 
Footnotes 
1. Sustained MRD negativity, when reported, should also annotate the method used (eg, sustained sequencing 
MRD- negative). 
2. Bone marrow multiparametric flow cytometry should follow NGF guidelines.  The reference NGF method 
is an eight-color two-tube approach, which has been extensively validated.  The two-tube approach 
improves reliability, consistency, and sensitivity because of the acquisition of a greater number of cells.  
The complete eight-color method should use a lyophilized mixture of antibodies.  5 million cells should be 
assessed.  The method employed should have a sensitivity of detection of at least 1 in 105 plasma cells. 


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10.12. Appendix 12: ECOG Performance Status* 
 
 
10.13. Appendix 13. CRS and ICANS Mitigation and Management 
Participants are required to be hospitalized and monitored for CRS/ICANS for at least 3 days 
(72 hours) beginning on C0D1 and C1D1.  For the priming dose (C0D1) and first full dose 
(C1D1), premedication for CRS is required (see Section 6.5.2) 
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 (see Section 10.2) as long as the sampling does not interfere with the 
medical treatment of the participant. 
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.   
ASTCT CSR criteria22 (Table 7) should be used only for the purposes of grading of CRS on 
the adverse event case report form (CRF) and management guidelines will follow ASTCT 
CRS grading.  These treatment guidelines23 may be modified as needed by the responsible 
investigators according to the best practices at their institute. 
 


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Table 7. 
ASTCT CRS Revised Grading System22 
CRS parameter 
Fever* 
With Hypotension 
And/or† Hypoxia 
Grade 1 
Temp. ≥38°C 
None
None
Grade 2 
Temp. ≥38°C 
Not requiring vasopressors 
Requiring low-flow‡ nasal 
cannula, low-flow‡ facemask or 
blow-by 
Grade 3 
Temp. ≥38°C 
Requiring a vasopressor with or 
without vasopressin 
Requiring high-flow‡ nasal 
cannula, high-flow‡ facemask, 
nonrebreather mask, or Venturi 
mask
Grade 4 
Temp. ≥38°C 
Requiring multiple vasopressors 
(excluding vasopressin) 
Requiring positive pressure (eg, 
CPAP, BiPAP, intubation and 
mechanical ventilation)
Organ toxicities associated with CRS may be graded according to CTCAE v5.0 and do not influence CRS 
grading. 
* Fever is defined as temperature ≥38°C and not attributable to any other cause.  In patients who have CRS then 
receive antipyretic or anticytokine 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. 
† CRS grade is determined by the more severe event: hypotension or hypoxia not attributable to any other 
cause.  For example, a patient with temperature of 39.5°C, hypotension requiring 1 vasopressor, and hypoxia 
requiring low-flow nasal cannula is classified as grade 3 CRS. 
‡ Low-flow nasal cannula 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 is defined as oxygen delivered at >6 L/min.   
CRS management guidelines23,24  
ASTCT Grade 1 CRS: 
 Monitor vital signs for worsening of condition. 
Fever 
 Acetaminophen/paracetamol and hypothermia blanket for the treatment of fever.  
 Non-steroidal anti-inflammatory drugs (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 tocilizumab1 8 mg/kg IV or siltuximab2 11 mg/kg IV for persistent 
(lasting >3 days) and refractory fever.  
ASTCT Grade 2 CRS: 
 Monitor vital signs every 4 hours for worsening of condition. 
Fever 
 Manage as in Grade 1 CRS.  
Hypotension 
 IV fluid bolus of 500-1000 ml of normal saline. Can give second IV fluid bolus if 
systolic blood pressure 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 hrs if needed.  
 If hypotension persists after 2 fluid boluses and anti-IL-6 therapy, start 
vasopressors, consider transfer to intensive care unit (ICU), obtain 
echocardiogram (ECHO), and initiate other methods of hemodynamic 
monitoring.  
 In patients at high-risk (bulky disease, older age 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. 
ASTCT Grade 3 CRS: 
 Monitor patient (including continuous ECG monitoring) in an ICU and obtain ECHO 
if not done already. 
 
1 Tocilizumab is not approved in Japan for the treatment of CRS other than the events associated with 
chimeric antigen receptor T-cell (CAR-T) therapy. 
2 Siltuximab is not approved in Japan. 


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Fever 
 Manage as in Grade 1 CRS.  
Hypotension 
 IV boluses, as needed, as recommended for Grade 2 CRS.  
 Tocilizumab and siltuximab as recommended for Grade 2 CRS if not 
administered previously.  
 Vasopressors as needed.  
 Dexamethasone 10 mg IV every 6 hrs; if refractory, increase to 20 mg IV every 
6 hrs. 
Hypoxia 
 Supplemental oxygen including high-flow oxygen delivery.  
 Tocilizumab or siltuximab plus corticosteroids and supportive care, as described 
above. 
ASTCT Grade 4 CRS: 
 Monitor patient (including continuous ECG monitoring) in an ICU and obtain ECHO 
if not done already. 
Fever 
 Manage as in Grade 1 CRS. 
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. 


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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 delirium, encephalopathy, aphasia, lethargy, difficulty 
concentrating, agitation, tremor, seizures, and cerebral edema.22  If ICANS is observed in 
relation to -elranatamab, the ASTCT criteria, its grading and management will be 
followed.23,24  These treatment guidelines may be modified as needed by the responsible 
investigators according to the best practices at their institute. 
Table 8. 
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 9. 
ASTCT ICANS Grading 
Neurotoxicity 
Domain 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
ICE score* 
7-9 
3-6 
0-2 
0 (unarousable and unable 
to perform ICE)
Depressed level of 
consciousness† 
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 
focal or generalized 
that resolves rapidly 
or non-convulsive 
seizures on EEG 
that resolve with 
intervention
Life-threatening prolonged 
seizure (>5 min); or 
repetitive clinical or 
electrical seizures without 
return to baseline in 
between 
Motor findings‡ 
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 neuroimaging⁂ 
Diffuse cerebral edema on 
neuroimaging; decerebrate 
or decorticate or 
decorticate posturing; or 
cranial nerve VI (abducens 
nerve) palsy; or 
papilledema; or Cushing’s 
triad 
ICANS grade is determined by the most severe event (ICE score, level of consciousness, seizure, motor 
findings, raised intracranial pressure[ICP]/cerebral edema) not attributable to any other cause; for example, a 
patient with an ICE score of 3 who has a generalized seizure is classified as grade 3 ICANS. 


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* A patient with an ICE score of 0 may be classified as grade 3 ICANS if awake with global aphasia, but a 
patient with an ICE score of 0 may be classified as grade 4 ICANS if unarousable. 
† Depressed level of consciousness should be attributable to no other cause (eg, no sedating medication). 
‡ Tremors and myoclonus associated with immune effector cell therapies may be graded according to CTCAE 
v5.0, but they do not influence ICANS grading. 
⁂ Intracranial hemorrhage with or without associated edema is not considered a neurotoxicity feature and is 
excluded from ICANS grading.  It may be graded according to CTCAE v5.0. 
ICANS management guidelines23,24  
ASTCT ICANS Grade 1: 
 Vigilant supportive care; aspiration precautions; intravenous (IV) hydration. 
 Withhold oral intake of food, medicines, and fluids, and assess swallowing. 
 Convert all oral medications and/or nutrition to IV if swallowing is impaired. 
 Avoid medications that cause central nervous system depression. 
 Neurology consultation. 
 Evaluate elevated intracranial pressure (ICP), if suspected, with fundoscopic exam for 
papilledema and lumbar puncture for cerebrospinal fluid opening pressure. 
 MRI of the brain with and without contrast; CT scan of the brain can be performed if 
MRI of the brain is not feasible. 
 Daily 30 min electroencephalogram (EEG) until toxicity symptoms resolve; if no 
seizures are detected on EEG, continue levetiracetam 750 mg every 12 hrs. 
 Consider anti-IL-6 therapy with tocilizumab 8 mg/kg (maximum 800 mg) IV or 
siltuximab 11 mg/kg IV, if there is concurrent CRS. 
ASTCT 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 hrs or methylprednisolone 1 mg/kg IV every 12 hrs 
if refractory to anti-IL-6 therapy, or for ICANS without concurrent CRS. 
 Consider transferring patient to intensive care unit (ICU) if ICANS associated with 
grade ≥2 CRS. 


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ASTCT 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 intravenously (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 intensive care unit (ICU) and treat with 
phenobarbital loading dose of 60 mg IV.  
 Maintenance doses after resolution of non-convulsive status epilepticus are as 
follows: lorazepam 0.5 mg IV every 8 hrs for three doses; levetiracetam 1,000 
mg IV every 12 hrs; phenobarbital 30 mg IV every 12 hrs.  
 Lacosamide may also be considered for treatment of seizures should the seizures 
persist but should not be used in patients 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 treatment at a loading dose of 15 mg/kg IV.  
 Maintenance doses after resolution of convulsive status epilepticus are: 
lorazepam 0.5 mg IV every 8 hrs for three doses; levetiracetam 1,000 mg IV 
every 12 hrs; phenobarbital 1–3 mg/kg IV every 12 hrs.  
 Lacosamide may also be considered for treatment of seizures should the seizures 
persist but should not be used in patients with concurrent CRS in order to avoid 
arrhythmias and hypotension.  


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 Continuous electroencephalogram 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. 
ASTCT 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 methylprednisolone IV 1 g/day 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 hrs for 2 days, 125 mg every 
12 hrs for 2 days, and 60 mg every 12 hrs for 2 days. 
 For seizures, treat as described for grade 3 ICANS. 
 MRI of the spine should be obtained for focal motor weakness. 
 To manage elevated ICP: 
 Elevate head end of the patient'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 to lower.  
 Hyperosmolar therapy with either mannitol (20 g/dL solution) or hypertonic 
saline (3% or 23.4%, as detailed below):  
 Mannitol: initial dose 0.5–1 g/kg; maintenance at 0.25–1 g/kg every 6 hrs while 
monitoring metabolic profile and serum osmolality every 6 hrs, and withhold 
mannitol if serum osmolality is ≥320 mOsm/kg, or the osmolality gap is ≥40.  
 Hypertonic saline: initial 250 mL of 3% hypertonic saline; maintenance at 50–75 
mL/h while monitoring electrolytes every 4 hrs, and withhold infusion if serum 
Na levels reach ≥155 mEq/L.  


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 For patients with imminent herniation: initial 30 mL of 23.4% hypertonic saline; 
repeat after 15 min, if needed.  
 Consider neurosurgery consultation for ventriculoperitoneal shunt in patients with 
cerebral edema and IV anesthetics for burst-suppression pattern on EEG. 
 Metabolic profiling every 6 hrs 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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10.14. Appendix 14: Subcutaneous Injection Site Locations 
 
Injection site locations include a maximum of 8 unique administration sites distributed across 
4 abdominal quadrants with a possibility of up to 2 injection locations per quadrant.  
Location 1 is proximal to the umbilicus and Location 2 is distal to the umbilicus. 
Administer the required number of injections in the following order: 
1. Lower Left Quadrant Location 1; 
2. Lower Right Quadrant Location 1; 
3. Lower Left Quadrant Location 2; 
4. Lower Right Quadrant Location 2; 
5. Upper Right Quadrant Location 1; 
6. Upper Left Quadrant Location 1; 
7. Upper Right Quadrant Location 2; 
8. Upper Left Quadrant Location 2. 
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 ISR in the participant’s source records 
and study CRF.  Complete one CRF per injection. 


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10.15. Appendix 15: 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 globally 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).  
10.15.1. Eligibility 
While SARS-CoV2 testing is not mandated for this study, local clinical practice standards for 
testing should be followed.  A patient should be excluded if he/she has a positive test result 
for SARS-CoV2 infection, is known to have asymptomatic infection, or is suspected of 
having SARS-CoV2.  Patients with active infections are excluded from study participation as 
per exclusions criteria in this protocol.  When the infection resolves, the patient may be 
considered for re-screening. 
10.15.2. 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 (e.g., audio, video, video-conferencing 
software) remotely, allowing the participant and the investigator to communicate on aspects 
of clinical care, including medical advice, reminders, education, and safety monitoring.  The 
following assessments must be performed during a telehealth visit:  
 Review and record study intervention(s), including compliance and missed doses. 
 Review and record any AEs and SAEs since the last contact.  Refer to Section 8.3. 
 Review and record any new concomitant medications or changes in concomitant 
medications since the last contact.  
 Review and record contraceptive method and results of pregnancy testing.   Confirm 
that the participant is adhering to the contraception method(s) required in the 
protocol.  Refer to Seciton 10.4 and Section 10.15.3.1 of this appendix regarding 
contraceptive guidance.  
Study participants must be reminded to promptly notify site staff about any change in their 
health status.  


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10.15.3. Alternative Facilities for Safety Assessments   
10.15.3.1. Laboratory Testing 
If a study participant is unable to visit the site for protocol-specified safety laboratory 
evaluations, testing may be conducted at a local laboratory if permitted by local regulations.  
The local laboratory may be a standalone institution or within a hospital.  The following 
safety laboratory evaluations may be performed at a local laboratory:  
 Hematology 
 Blood chemistry 
 Coagulation 
 Urinalysis 
 Pregnancy test 
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 IU/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.  
10.15.3.2. 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.  
10.15.4. 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 elranatamab for participants who 
have active [confirmed (positive by regulatory authority-approved test) or presumed (test 
pending/clinical suspicion)] SARS-CoV2 infection:  


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 For symptomatic participants with active SARS-CoV2 infection, elranatamab 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.  Notify the study team when treatment is restarted.  
 Continue to consider potential drug-drug interactions as described in Section 6.5 for 
any concomitant medication administered for treatment of SARS-CoV2 infection.  
10.15.5. Home Health Visits 
A home health care service will be utilized to facilitate scheduled visits per the Schedule of 
Activities.  Home health visits include a healthcare provider conducting an in-person study 
visit at the participant’s location, rather than an in-person study visit at the site.  The 
following may be performed during a home health visit: 
 Physical examination 
 Vital signs 
 ECOG PS 
10.15.6. Adverse Events and Serious Adverse Events 
If a participant has COVID-19 during the study, this should be reported as an AE or 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 study medical monitor.  


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10.16. Appendix 16: Condition to be discharged 
When a participant is discharged from the hospital during the DLT evaluation period, the 
following conditions (tests, medical examination, etc.) should be performed on the day of the 
scheduled discharge by the investigators, and the propriety of discharge should be 
determined.  The tests/medical examinations which are needed to confirm the participant’s 
status will be conducted per clinical practice in the study site as appropriate. 
• There is no current clinically significant adverse or side effects, including CRS, or 
medical reasons that requires monitoring in a hospital setting. 
• If a clinically significant adverse or side effect has occurred or continues to be present, the 
investigator has determined that the event is manageable by appropriate treatment or 
prophylaxis in an out of the hospital setting.  
• Overall physical condition is stable and acceptable.  
• In case of emergency, the participant may return to the clinical study site or other medical 
institution. If participants go to a medical institution other than the clinical study site, the 
clinical study site asks that the participants contact the study site contact information and 
study investigator and the doctor at the medical institution will communicate to discuss 
appropriate treatments.  A study site keeps flamework to ready for emergency situations 
that is available even during nights and holidays, and the sponsor will ensure that the 
selected study site will thoroughly follow all participants according to study procedures.  
 


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10.17. Appendix 17: Abbreviations 
The following is a list of abbreviations that may be used in the protocol.   
Abbreviation 
Term 
ADA 
antidrug antibodies
ADC 
antibody-drug conjugate
AE 
adverse event
AIDS 
acquired immunodeficiency syndrome
ALL 
acute lymphoblastic leukemia
ALT 
alanine aminotransferase
ANC 
absolute neutrophil count
APC 
antigen presenting cell
aPTT 
activated partial thromboplastin time
ASCO 
American Society of Clinical Oncology
AST 
aspartate aminotransferase
ASCT 
autologous stem cell transplant
ASTCT 
American Society for Transplantation and Cellular Therapy
AUC 
area under the curve
BCMA 
B-cell maturation antigen
BiPAP 
biphasic positive airway pressure
BM 
bone marrow
BP 
blood pressure
bpm 
beats per minute
BUN 
blood urea nitrogen
C1D1 
cycle 1 day 1
CAR-T 
chimeric antigen receptor T-cell
CB 
clinical benefit
CD 
cluster of differentiation
CFR 
Code of Federal Regulations
CHF 
congestive heart failure
CIOMS 
Council for International Organizations of Medical Sciences
CK 
creatine kinase
CL 
clearance
Cmax 
maximum observed concentration
CONSORT 
Consolidated Standards of Reporting Trials
COVID-19 
Coronavirus disease 2019
CPAP 
Continuous Positive Airway Pressure
CR 
complete response
CRAB 
C = calcium (elevated), R = renal failure, A = anemia, B = bone 
lesions 
CrCl 
creatinine clearance
CRF 
case report form
CRO 
contract research organization
CRP 
c-reactive protein


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Abbreviation 
Term 
CRS 
cytokine release syndrome
CSF 
cerebrospinal fluid
CSR 
clinical study report
CT 
clinical trial
CT 
computed tomography
CTCAE 
Common Terminology Criteria for Adverse Events 
DILI 
drug-induced liver injury
DLI 
donor lymphocyte infusion
DLT 
dose-limiting toxicity
DMC 
data monitoring committee
DNA 
deoxyribonucleic acid
DOR 
duration of response
EC 
effective concentration
EC 
ethics committee
ECG 
electrocardiogram
ECHO 
echocardiogram
ECOG 
Eastern Cooperative Oncology Group
eCRF 
electronic case report form
EDP 
exposure during pregnancy
EDV 
end diastolic volume
EEG 
electroencephalogram
EMA 
European Medicines Agency
EMG 
electromyography
EOT 
end of treatment
ESV 
end systolic volume
EU 
European Union
EudraCT 
European Clinical Trials Database
Fc 
fragment crystallizable
FDA 
Food and Drug Administration (United States) 
FDG 
fluorodeoxyglucose
FLC 
free light chain
FSH 
follicle-stimulating hormone
GBS 
Guillain Barré Syndrome
GCP 
Good Clinical Practice
GGT 
gamma-glutamyl transferase
GVHD 
graft versus host disease
HBV 
hepatitis B virus
HBsAg 
hepatitis B surface antigen
HBcAb 
hepatitis B core antibody
HCV 
hepatitis C virus
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
human immunodeficiency virus
HRT 
hormone replacement therapy


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Abbreviation 
Term 
IB 
investigator’s brochure
ICANS 
immune effector cell-associated neurotoxicity
ICD 
informed consent document
ICE 
Immune Effector Cell-Associated Encephalopathy 
ICH 
International Council for Harmonisation
ICU 
intensive care unit
ICP 
intracranial pressure
ID 
identification
IFN 
interferon
Ig 
immunoglobulin
IHC 
immunohistochemistry
IL 
interleukin
IMID 
immunomodulatory drug
IMP 
investigational medicinal product
IND 
investigational new drug
INR 
international normalized ratio
IP manual 
investigational product manual
IPAL 
Investigational Product Accountability Log
IRB 
institutional review board
ISR 
injection site reaction
IV 
intravenous
IMWG 
International Myeloma Working Group
LBBB 
left bundle branch block
LDH 
lactate dehydrogenase
LFT 
liver function test
LVEF 
left ventricular ejection fraction
MedDRA 
Medical Dictionary for Regulatory Activities
MHC 
major histocompatibility complex
MGUS 
monoclonal gammopathy of undetermined clinical significance
MM 
multiple myeloma
MR 
minimal response
MRD 
minimal residual disease
MRI 
magnetic resonance imaging
MTD 
maximum tolerated dose
MUGA 
multigated acquisition scan
N/A 
not applicable
NAb 
neutralizing antibodies
NCI 
National Cancer Institute
NCV 
nerve conduction velocity
NGF 
next generation flow cytometry
NGS 
next generation sequencing
NIMP 
non-investigational medicinal product
NOAEL 
no-observed-adverse-effect level


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Abbreviation 
Term 
NSAID 
non-steroidal anti-inflammatory drug
NSG 
NOD scid gamma
OR 
overall response
ORR 
objective response rate
OS 
overall survival
PD 
pharmacodynamic(s)
PD 
progressive disease
PET 
positron emission tomography
PFS 
progression free survival
PI 
proteasome inhibitor
PK 
pharmacokinetic(s)
POEMS 
polyneuropathy, organomegaly, endocrinopathy, myeloma protein, 
and skin changes
PR 
partial response
PS 
performance status
PT 
prothrombin time
PTT 
partial thromboplastin time
PVC 
premature ventricular contraction/complex
Q1W 
once weekly
Q2W 
every other week
QTc 
corrected QT
QTcB 
corrected QT (Bazett method)
QTcF 
corrected QT (Fridericia method)
RNA 
ribonucleic acid
RP2D 
recommended Phase 2 dose
SAE 
serious adverse event
SAP 
statistical analysis plan
SARS-CoV2 
severe acute respiratory syndrome coronavirus 2 
SC 
subcutaneous
sCR 
stringent complete response
SD 
stable disease
SIFE 
serum immunofixation electrophoresis
SPEP 
serum protein electrophoresis
SoA 
schedule of activities
SOC 
standard of care
SOP 
standard operating procedure
SPD 
sum of products of the maximal perpendicular diameters 
SRSD 
single reference safety document
SUSAR 
suspected unexpected serious adverse reaction 
SUV 
tandardized uptake value
SWOG 
Southwest Oncology Group
t1/2 
terminal elimination half-life
TBili 
total bilirubin


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Abbreviation 
Term 
TBR 
tumor background ratio
TEAE 
treatment-emergent adverse event
TLS 
tumor lysis syndrome
Tmax 
time to maximum concentration
TNF 
tumor necrosis factor
TTR 
time to response
UIFE 
24 hr urine immunofixation electrophoresis
ULN 
upper limit of normal
UPEP 
24 hr urine protein electrophoresis
US 
United States
VGPR 
very good partial response
Vss 
volume of distribution 
Vz 
volume of distribution during terminal phase
WBC 
white blood cell
WOCBP 
woman of childbearing potential
 


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11. REFERENCES 
1. 
Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: 
sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 
2015;136:E359-86. 
2. 
Cancer Registry and Statistics. Cancer Information Service, National Cancer Center, 
Japan (Ministry of Health, Labour and Welfare, National Cancer Registry), (Vital 
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September 2020. 
3. 
Palumbo A, Anderson K: Multiple myeloma. N Engl J Med. 2011;364:1046-60. 
4. 
Anderson KC, Alsina M, Atanackovic D, et al. NCCN Guidelines Insights: Multiple 
Myeloma, Version 3.2016. J Natl Compr Canc Netw. 2016;14:389-400. 
5. 
Gay F, Magarotto V, Crippa C, et al. Bortezomib induction, reduced-intensity 
transplantation, and lenalidomide consolidation-maintenance for myeloma: updated 
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6. 
Dhakal B, Vesole DH, Hari PN. Allogeneic stem cell transplantation for multiple 
myeloma: is there a future? Bone Marrow Transplant. 2016;51:492-500. 
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Durie BG, Hoering A, Rajkumar SV, et al. Bortezomib, Lenalidomide and 
Dexamethasone vs. Lenalidomide and Dexamethasone in patients (Pts) with previously 
untreated multiple myeloma without an intent for immediate autologous stem cell 
transplant (ASCT). Results of the randomized phase III trial SWOG S0777. Presented at 
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8. 
Jimenez-Zepeda VH, Reece DE, Trudel S, et al. Early relapse after single auto-SCT for 
multiple myelosma is a major predictor of survival in the era of novel agents. Bone 
Marrow Transplant. 2015;50:204-8. 
9. 
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;4:64-9. 
10. Kumar SK, Therneau TM, Gertz MA, et al. Clinical course of patients with relapsed 
multiple myeloma. Mayo Clin Proc. 2004;79:867-74. 
11. Sonneveld P, Broijl A. Treatment of relapsed and refractory multiple myeloma. 
Haematologica. 2016;101:995. 
12. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple 
myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter 
international myeloma working group study. Leukemia. 2012;26:149-57. 


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13. Topp MS, Gokbuget N, Stein AS, et al. Safety and activity of blinatumomab for adult 
patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a 
multicentre, single-arm, phase 2 study. Lancet Oncol, 2015;16:57-66. 
14. Lee L, Bounds D, Paterson J, et al. Evaluation of B cell maturation antigen as a target 
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2016;174:911-22. 
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long-lived bone marrow plasma cells. J Exp Med. 2004;199:91-8. 
18. Ramadoss NS, Schulman AD, Choi SH, et al. An anti-B cell maturation antigen 
bispecific antibody for multiple myeloma. J Am Chem Soc. 2015;137:5288-91. 
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anti-BCMA bi-specific T-cell engager, in relapsed and/or refractory multiple myeloma 
(RRMM). J Clin Oncol. 2016;34 (15 suppl; abstr TPS8067). 
21. Siler H. Panowski, Tracy C Kuo, Yi Zhang, et al. Preclinical Efficacy and Safety 
Comparison of CD3 Bispecific and ADC Modalities Targeting BCMA for the 
Treatment of Multiple Myeloma. Mol Cancer Ther. 2019;18:2008-20.  
22. 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. 2019;25:625-38. 
23. Neelapu SS, Tummala S, Kebriaei P, et al. Chimeric antigen receptor T-cell therapy – 
assessment and management of toxicities. Nat Rev Clin Oncol. 2018;15:47-62. 
24. Neelapu SS. Managing the toxicities of CAR T-cell therapy. Hematol Oncol. 2019;37 
Suppl 1:48-52. 
25. Richardson PG, Delforge M, Beksac M, et al. Management of treatment-emergent 
peripheral neuropathy in multiple myeloma. Leukemia. 2012;26(4):595-608. 


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26. 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. 2020;38(8):775-83. 
27. 2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: An 
Evidence-Based Clinical Practice Guideline. JCO. 2006;24:3187-205. 
28. Japan Society of Clinical Oncology. Available from: http://jsco-
cpg.jp/guideline/30.html. Accessed 3 August 2020. 
29. 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:e328-46. 
30. Dispenzieri A, Kyle R, Merlini G et al. International Myeloma Working Group 
guidelines for serum-free light chain analysis in multiple myeloma and related 
disorders. Leukemia. 2009;23:215-24. 
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https://www.jsh.or.jp/medical/guidelines/jsh_guidlines/hepatitis_b.html. Accessed 26 
November 2020. 
 

SAP_001.pdf: 
Protocol C1071002 (Elranatamab) Statistical Analysis Plan
PFIZER CONFIDENTIAL 
Page 1
Protocol C1071002
A Phase I, Open Label Study to Evaluate the Safety and Pharmacokinetic of 
Elranatamab (PF-06863135), a B-Cell Maturation Antigen (BCMA)—CD3 Bispecific 
Antibody, As a Single Agent in Japanese Participants with Relapsed/Refractory 
Advanced Multiple Myeloma
Statistical Analysis Plan
(SAP)
Version:
5
Date:
28 Apr 2022


Protocol C1071002 (Elranatamab) Statistical Analysis Plan
PFIZER CONFIDENTIAL 
Page 2
TABLE OF CONTENTS
TABLE OF CONTENTS.......................................................................................................... 2
LIST OF TABLES.................................................................................................................... 4
LIST OF FIGURES .................................................................................................................. 4
APPENDICES .......................................................................................................................... 5
1. VERSION HISTORY........................................................................................................... 6
2. INTRODUCTION ................................................................................................................ 9
2.1. Study Objectives, Endpoints, and Estimands......................................................... 10
2.1.1. Study Objectives........................................................................................ 10
2.1.2. Primary Estimand ...................................................................................... 10
2.1.3. Secondary Estimand .................................................................................. 10
2.2. Study Design .......................................................................................................... 11
2.2.1. Sample Size Determination ....................................................................... 12
3. ENDPOINTS AND BASELINE VARIABLES: DEFINITIONS AND 
CONVENTIONS ............................................................................................................... 13
3.1. Primary Endpoint ................................................................................................... 13
3.1.1. DLT............................................................................................................ 13
3.2. Secondary Endpoints.............................................................................................. 14
3.2.1. Adverse Events .......................................................................................... 14
3.2.2. Laboratory Test Abnormalities.................................................................. 14
3.2.3. Best Overall Response............................................................................... 15
3.2.4. Progression Free Survival.......................................................................... 15
3.2.5. Overall Survival......................................................................................... 16
3.2.6. Time to Response ...................................................................................... 16
3.2.7. Duration of Response ................................................................................ 16
3.2.8. PK .............................................................................................................. 16
3.2.9. Immunogenicity Data ................................................................................ 17
3.2.10. Minimal Residual Disease ....................................................................... 17
3.4. Baseline Variables.................................................................................................. 18
3.5. Safety Endpoints..................................................................................................... 18
CCI


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4. ANALYSIS SETS (POPULATIONS FOR ANALYSIS).................................................. 18
4.1. Safety Analysis Set................................................................................................. 18
4.2. Per Protocol Analysis Set (evaluable for RP2D).................................................... 18
4.3. PK Analysis Sets .................................................................................................... 18
4.3.1. PK Parameter Analysis Population............................................................ 18
4.3.2. PK Concentration Population .................................................................... 19
4.5. Immunogenicity Analysis Set ................................................................................ 19
5. GENERAL METHODOLOGY AND CONVENTIONS................................................... 19
5.1. Hypotheses and Decision Rules ............................................................................. 19
5.1.1. Confirmation of the RP2D with the Priming Dose.................................... 19
5.2. General Methods .................................................................................................... 19
5.2.1. Analyses for Binary Endpoints.................................................................. 19
5.2.2. Analyses for Continuous Endpoints .......................................................... 19
5.2.3. Analyses for Categorical Endpoints .......................................................... 19
5.2.4. Analyses for Time-to-Event Endpoints ..................................................... 19
5.3. Methods to Manage Missing Data.......................................................................... 20
5.3.1. PK .............................................................................................................. 20
6. ANALYSES AND SUMMARIES ..................................................................................... 20
6.1. Primary Endpoint ................................................................................................... 20
6.1.1. DLT............................................................................................................ 20
6.2. Secondary Endpoints.............................................................................................. 21
6.2.1. AE.............................................................................................................. 21
6.2.2. Laboratory Test Abnormalities.................................................................. 23
6.2.3. BOR ........................................................................................................... 24
6.2.4. PFS............................................................................................................. 24
6.2.5. OS .............................................................................................................. 24
6.2.6. TTR............................................................................................................ 25
6.2.7. DOR........................................................................................................... 25
6.2.8. PK Analyses............................................................................................... 25
6.2.9. Analysis of Immunogenicity Data............................................................. 27
6.2.10. MRD ........................................................................................................ 27
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6.4. Baseline and Other Summaries and Analyses........................................................ 27
6.4.1. Baseline Summaries................................................................................... 27
6.4.2. Study Conduct and Participant Disposition............................................... 28
6.4.3. Study Treatment Exposure ........................................................................ 28
6.4.4. Concomitant Medications and Nondrug Treatments................................. 29
6.4.5. Prior Anticancer Therapy .......................................................................... 30
6.4.6. Subsequent Anticancer Therapy................................................................ 31
6.5. Safety Summaries and Analyses ............................................................................ 31
6.5.1. Vital Signs ................................................................................................. 31
6.5.2. Electrocardiograms.................................................................................... 31
6.5.3. Other Safety Data ...................................................................................... 32
7. INTERIM ANALYSES...................................................................................................... 32
8. APPENDICES .................................................................................................................... 33
LIST OF TABLES
Table 1.
Summary of Changes................................................................................. 6
Table 2.
Operating Characteristics of C1071002 Study Design............................ 12
Table 3. 
Definition of PK Parameters.................................................................... 16
Table 4.
AESI ........................................................................................................ 21
Table 5.
oAECI...................................................................................................... 22
Table 6.
PK Parameters to be Summarized Descriptively..................................... 26
Table 7.
Safety QTcF Assessment......................................................................... 31
Table 8.
IMWG Response Criteria for MM .......................................................... 33
Table 9.
IMWG MRD Criteria .............................................................................. 36
LIST OF FIGURES
Figure 1.
Schema..................................................................................................... 12
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APPENDICES
Appendix 1. IMWG Response Criteria for MM..................................................................... 33
Appendix 2. IMWG MRD Criteria......................................................................................... 36
Appendix 3. List of Abbreviations.......................................................................................... 37


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1. VERSION HISTORY
This statistical analysis plan (SAP) for Study C1071002 is based on the protocol dated 
10JUN2021.
Table 1.
Summary of Changes
Version/
Date
Associated
Protocol 
Amendment
Rationale
Specific Changes
1
22 Dec 2020
Amendment 1
03 Dec 2020
N/A
N/A
2
14 Apr 2021
Amendment 1
03 Dec 2020

Reviewed the 
content to be 
analyzed.

Physical examination was deleted from 
Section 3.4 because physical examination was 
not reported on the CRF.

Additional summaries of TEAEs were described
in Section 6.2.1.

Section 6.5.3 in version 1 was deleted because 
physical examination was not reported on the 
CRF.

Ad-hoc analyses for a regulatory submission 
was added in Section 7.
3
09 Jul 2021
Amendment 2
10 Jun 2021

Reviewed the 
analysis for 
regulatory 
submission

The definition of treatment-emergent adverse 
event was changed to align with the protocol 
amendment 2.

Section 4.1 “Full Analysis Set” in version 2 was 
deleted and the full analysis set will be no longer 
used in the C1071002 study.  The DLT 
confirmation meeting was held on 11 Jun 2021.  
The followings were confirmed in the meeting: 
1) all 4 enrolled patients were DLT-evaluable, 
ie, received at least 1 study intervention and 
completed the DLT observation period without 
any DLTs and major protocol deviations, and 2) 
an additional enrollment was not necessary.  
This means that all patients were included in 
both the full analysis set and the safety analysis 
set.  Therefore, the full analysis set was identical 
to the safety analysis set. The full analysis set 
was removed to avoid redundant analyses and to 
reduce the number of TLFs.

Additional summaries related to CRS and 
ICANS were described in Section 6.2.1.

The analysis set for the all efficacy analyses was 
changed from the full analysis set to the safety 
analysis set.


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4
14 Dec 2021
Amendment 2
10 Jun 2021
•
Aligned with 
protocol 
amendment 2
•
Added some 
safety analyses
•
Reviewed the 
summary of 
treatment 
exposure
•
Section 3.2.10 for a new secondary endpoint
was inserted.
•
The minimal residual disease (MRD) was 
moved from Section 3.3.1 to Section 3.2.10 
because the MRD was changed to a secondary 
endpoint.
•
Clustered cytopenia was defined in 
Section 6.2.1.
•
Section 6.2.1.1 where the summary of AESI was 
described was inserted.
•
Peripheral neuropathy was added into AESI in 
Section 6.2.1.1.
•
Some analyses for AESI were added in 
Section 6.2.1.1.
•
Section 6.2.1.2 where the summary of oAECI 
was described was inserted.
•
The definition of oAECI was presented in 
Section 6.2.1.2.
•
Analyses for oAECI were described in 
Section 6.2.1.2.
•
Section 6.2.1.3 where the summary of deaths 
was described was inserted.
•
Analyses for deaths was presented in 
Section 6.2.1.3.
•
eDISH plot was added in Section 6.2.2.
 
•
A box and whisker plot were removed from 
summaries of PK concentration in 
Section 6.2.8.1.
•
PK plot for assessing he relationship were added 
in Section 6.2.8.2.
•
Section 6.2.10 where the summary of MRD was 
described was inserted.
•
Analyses for MRD was presented in 
Section 6.2.10.
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
Some items of disease characteristics were 
added in Section 6.4.1.

Summaries of study treatment exposure were 
changed to align with the C1071003 study in 
Section 6.4.3.

Some of additional safety analyses were 
removed from Section 6.5.3 due to no longer 
concern about them.

IMWG MRD Criteria was added in Appendix.

Administrative and typographical modifications 
were made.
5
28 Apr 2022
Amendment 2
10 Jan 2021

Reviewed the 
analysis for 
regulatory 
submission

The end of observation period for TEAEs was
changed in Section 3.2.1.

The term was changed from cumulative 
complete response to complete response in 
Section 3.2.3.

The time point of confirmed objective response 
for participants with extramedullary disease at 
baseline was specified in Section 3.2.6.

Time to very good partial response and time to 
complete response were defined in 
Section 3.2.6.

PK parameter at C2D1 was removed from 
Section 3.2.8 due to insufficient PK sampling 
point.

AUClast was removed because AUCwas 
calculated instead of AUClast in Section 3.2.8.

The threshold of 10-6 was used only if available 
in Section 3.2.10.

The sentences about coding system for CRS and 
ICANS was moved from Section 6.2.1.1 to 
Section 6.2.1.

Some terms for Lymphopenia cluster term were 
added in Section 6.2.1. 

The definition of peripheral neuropathy was 
made clear in Section 6.2.1.1.

An overview of treatment-related AESI was 
removed in Section 6.2.1.1 because AESI, 


Protocol C1071002 (Elranatamab) Statistical Analysis Plan
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especially CRS/ICANS, are reported as 
treatment-related and an overview of all 
causality AESI is sufficient to investigate AESI.

Injection site reactions and Secondary
malignancies were added as oAECI in 
Section 6.2.1.2.

Death within 28 days of the first dose of study 
intervention was added in Section 6.2.1.3.

As there were no participants who have no 
adequate baseline disease assessment, the related 
sentence was removed in Section 6.2.4.

Summary of duration of follow-up time was 
added in Section 6.2.4, Section 6.2.5 and 
Section 6.2.7.

Summary of time to very good partial response 
and time to complete response were added in 
Section 6.2.6.

Time points deriving PK parameter was clarified 
in Section 6.2.8.1.

Some PK parameters were removed due to 
insufficient PK sampling point in 
Section 6.2.8.2.

The subset for summary of MRD negativity rate 
was added in Section 6.2.10.

Summary of prior anticancer therapy was newly 
added in Section 6.4.5.

Summary of subsequent anticancer therapy was
newly added in Section 6.4.6.

Administrative and typographical modifications 
were made.
2. INTRODUCTION
This SAP provides the detailed methodology for summary and statistical analyses of the data 
collected in Study C1071002.  This document may modify the plans outlined in the protocol; 
however, any major modifications of the primary endpoint definition or its analysis will also 
be reflected in a protocol amendment.


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2.1. Study Objectives, Endpoints, and Estimands
2.1.1. Study Objectives
A primary objective of this study is to assess the safety and tolerability at the recommended 
phase 2 dose (RP2D) with a priming dose approach of single-agent elranatamab administered 
to Japanese participants.
Secondary objectives are:
•
To evaluate the overall safety profile,
•
To evaluate the single-dose and multiple-dose pharmacokinetics (PK) of elranatamab,
•
To evaluate the immunogenicity of elranatamab,
•
To evaluate preliminary anti-tumor activity, and
•
To characterize the impact of elranatamab on systemic soluble immune factors.
 
2.1.2. Primary Estimand
Dose-limiting toxicity (DLT) rate estimated based on data from DLT-evaluable participants 
during the DLT observation period is the primary estimand of this study.
•
Variable: Occurrence of DLTs.  DLTs are defined in Section 3.1.1.1.
•
Analysis population: DLT-evaluable participants defined as participants who have at least 
1 dose of study intervention in the first cycle including a priming dose (4 weeks), and 
either experiences a DLT (irrespective of whether they received all of the planned doses 
of study intervention and scheduled safety assessments during the DLT observation 
period) or receives all of the planned doses of study intervention without experiencing 
any DLTs and has received scheduled safety assessments during the DLT observation 
period.  Participants without DLTs who withdraw from study treatment and fails to meet 
these criteria above are not evaluable for DLT.  All participants deemed non-evaluable 
for DLT will be replaced.
•
Population-level summary measure: DLT rate defined as the number of DLT-evaluable 
participants with DLTs in the DLT observation period divided by the number of 
DLT-evaluable participants in the DLT observation period.
2.1.3. Secondary Estimand
Incidence of treatment-emergent adverse events (TEAEs) estimated in the analysis 
population during the TEAE-evaluation period, defined as the time from the first dosing date
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to 90 days post last dosing date or a day before start date of a new anticancer therapy, 
whichever occurs first, is the secondary estimand for this study.
•
Variable: Occurrence of TEAEs.  TEAEs are defined in Section 3.2.1.
•
Analysis population: Safety analysis set defined as participants who receive at least one 
dose of study intervention without regard to tolerability or duration of treatment.
•
Population-level summary measure: Incidence of TEAEs defined as the number of 
participants with TEAEs in the TEAE-evaluation period divided by the number of 
participants in the safety analysis set. TEAEs will be summarized by type, frequency, 
severity (as graded by National Cancer Institute [NCI] Common Terminology Criteria for 
Adverse Events [CTCAE] version 5.0), timing, seriousness and causality.
2.2. Study Design
This is a phase 1, open-label, multi-center study to evaluate the safety and PK of elranatamab
in Japanese adult participants with relapsed or refractory multiple myeloma (MM) who have 
received at least 3 prior therapies, including immunomodulatory drug (IMID), proteasome 
inhibitor (PI) and anti-cluster of differentiation 38 (CD38) antibody.  Approximately 4–
6 participants are expected to be enrolled overall in this study, and the RP2D (1000 μg/kg) 
which was declared in Study C1071001 with a priming dose (600 μg/kg) will be 
administered to each participant.
Treatment with study intervention will continue until either disease progression, withdrawal 
from treatment, or unacceptable toxicity occurs, whichever occurs first.
The proposed doses, schedule(s), and PK time points may be reconsidered and amended 
during the study based on the emerging safety and PK data.
 
  
 
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Figure 1.
Schema
2.2.1. Sample Size Determination
The total number of participants will depend on the absence/presence of DLT in the initial 
4 participants and the number of participants evaluable for DLT.  Additional 2 participants 
will be enrolled to verify the toxicity in Japanese population if at least one DLT is observed 
in the initial 4 participants.  Thus, maximum of 6 evaluable participants may be enrolled in 
this study.
The target DLT rate is 25%.  Although the sample size is not based on any statistical 
considerations, the study would have 55.82% chance to declare the RP2D determined in 
Study C1071001 with a priming dose exceeded the maximum tolerated dose (MTD) for 
Japanese participants if the true DLT rate for Japanese participants is 30%.  Additionally, this 
probability increases to 74.6% and 87.5% if the true DLT rate is 40% and 50%, respectively.  
It is determined that the RP2D with a priming dose exceeds the MTD in the Japanese 
participants if ≥2 DLTs are observed in this study.  These probabilities are calculated based 
on a binomial probability.
Table 2.
Operating Characteristics of C1071002 Study Design
Scenario
Total
Sample
Size
Number of DLTs Observed
True DLT Rate in Japanese Participants
Initial 4 
Participants
Additional 2 
Participants
Total
0.20
0.25
0.30
0.40
0.50
1
4
0
NA
0
40.96%
31.64%
24.01%
12.96%
6.25%
2
6
1
0
1
26.21%
23.73%
20.17%
12.44%
6.25%
3
6
≥1
≥2
14.75%
18.46%
20.99%
22.12%
18.75%
4
4
≥2
NA
≥2
18.08%
26.17%
34.83%
52.48%
68.75%
Probability C1071001 RP2D is Confirmed in Japanese 
Participants (Scenarios 1 + 2)
67.17%
55.37%
44.18%
25.40%
12.50%
Probability C1071001 RP2D Exceeds MTD in Japanese 
Participants (Scenarios 3 + 4)
32.83%
44.63%
55.82%
74.60%
87.50%
NA: Not Applicable


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3. ENDPOINTS AND BASELINE VARIABLES: DEFINITIONS AND 
CONVENTIONS
3.1. Primary Endpoint
3.1.1. DLT
The DLTs observed during the DLT observation period are the primary endpoint of this 
study.  This endpoint will be used to confirm the tolerability of the RP2D, which includes a 
priming dose, that was determined in Study C1071001.  If the proportion of evaluable 
participants in this study experiencing a DLT is less than or equal to 30%, the tolerability of 
the RP2D with the priming dose in Japanese population will be confirmed.
3.1.1.1. Definition of DLT
Cycle 0 consists of 7 days. Cycle 0 Day 1 (C0D1) is 7 days prior to Cycle 1 Day 1 (C1D1). 
Each cycle except for Cycle 0 consists of 3 weeks.  Any of the following TEAEs occurring in 
Cycle 0 and Cycle 1 (total 4 weeks) will be classified as DLTs:
Hematological:

Grade 4 neutropenia lasting >7 days.

Febrile neutropenia (defined as an absolute neutrophil count [ANC] <1,000/mm3 with a 
single temperature of >38.3°C, or a sustained temperature of ≥38°C for more than one 
hour).  If fever is determined to be a symptom of cytokine release syndrome (CRS)
confirmed by clinical course and cytokine levels and resolves in a manner consistent with 
CRS, this would no longer be considered a DLT, and the participant may resume 
treatment.

Grade ≥3 neutropenia with infection.

Grade 4 thrombocytopenia (unless the study entry baseline count was ≥25,000/mm3 and 
<50,000/mm3 to take into account bone marrow suppression due to MM, in this case 
Grade 4 thrombocytopenia needs to be accompanied by ≥Grade 2 bleeding to be a DLT).  
For participants who experience a platelet count <10,000/mm3, this is considered a DLT 
irrespective of other factors.

Grade 3 thrombocytopenia with ≥Grade 2 bleeding.
Non hematological:

Grade 4 adverse events (AEs).

Grade 3 AE lasting ≥5 days despite optimal supportive care, with the exception of AE 
attributed to a CRS event (ie, Grade 3 transaminitis).

Grade 3 CRS, except those CRS that have i) not been maximally treated (ie, lack of 
administration of standard of care treatment per the institution’s, investigator’s, or 


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treating physician’s guidelines for the management of CRS) or ii) improved to ≤Grade 1 
within 48 hours.

Grade 4 CRS.

Confirmed drug induced liver injury (DILI) meeting Hy’s law criteria outlined in 
Section 10.6 of Study C1071002 protocol.

Grade 4 laboratory abnormalities deemed clinically significant by the investigator shall 
be reported as Grade 4 AE.
Clinically important or persistent toxicities (eg, toxicities leading to dose interruption for
≥7 days including skipping planned dose during the DLT observation period) that are not 
included in the above criteria may also be considered a DLT following review by the 
investigators and the sponsor.  All DLTs need to represent a clinically significant shift from 
baseline.
The following AEs will not be adjudicated as DLTs:

Isolated Grade 3 laboratory abnormalities that are not associated with clinical sequelae 
and are corrected with supplementation/appropriate management within 72 hours of their 
onset or deemed not clinically insignificant by the investigator.

Grade 3 injection site reactions (ISR), allergic reaction or anaphylaxis will not be 
considered as DLTs but may be a reason for study discontinuation and will be reviewed 
with the sponsor’s medical monitor.
3.2. Secondary Endpoints
3.2.1. Adverse Events
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.  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.
A TEAE is defined as an AE that first occurred from the first dose of the study intervention 
until 90 days after the last dose or the day before starting a new anticancer therapy, 
whichever occurs first.  TEAEs will be assessed mainly in this study.
3.2.2. Laboratory Test Abnormalities
The following laboratory parameters will be assessed:

Hematology: hemoglobin, platelets, white blood cell (WBC), neutrophils, lymphocytes, 
monocytes, eosinophils, and basophils,


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•
Chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), 
bicarbonate, c-reactive protein (CRP), alkaline phosphatase (ALP), sodium, potassium, 
magnesium, chloride, total calcium, total bilirubin, total protein, blood urea nitrogen 
(BUN), creatinine, uric acid, glucose (nonfasted), lactate dehydrogenase (LDH), albumin, 
and phosphorus or phosphate,
•
Serology: hepatitis B virus (HBV), and hepatitis C virus (HCV),
•
Coagulation: prothrombin time (PT), and partial thromboplastin time (PTT)/activated 
PTT (aPTT),
•
Urinalysis: urine protein, and urine blood,
•
Pregnancy test: serum for female participants of childbearing potential,
•
Ad hoc central lab cytokine analysis: interleukin (IL)-6, IL-10, IL-2, soluble IL-2 
receptor (sIL-2R), IL-12, IL-4, IL-5, IL-13, IL-17, IL-1b, IL-8, interferon (IFN)-γ, and 
tumor necrosis factor (TNF)-α,
•
Optional ad hoc local lab cytokine analysis: IL-6, IL-1β, IL-10, TNF-α, and other 
cytokines.
For potential Hy's Law cases, the following laboratory tests will be reported: albumin, 
creatine kinase, total bilirubin, direct and indirect bilirubin, gamma glutamyl transferase, 
PT-international normalized ratio (PT/INR), ALP, total bile acids, and acetaminophen drug 
and/or protein adduct levels.
Cytokines for central lab evaluation will be collected if CRS is suspected.  Local lab 
evaluation of cytokine is only required if the site require this information for participant 
management.
3.2.3. Best Overall Response
Best overall response (BOR) will be assessed based on reported overall responses at different 
evaluation time points using International Myeloma Working Group 
IMWG) response 
criteria.
•
Complete Response (CR) will encompass stringent Complete Response (sCR) and CR.
•
Objective Response (OR) will encompass sCR, CR, very good partial response (VGPR) 
and partial response (PR).
•
Clinical Benefit (CB) will encompass sCR, CR, VGPR, PR and minimal response (MR).
3.2.4. Progression Free Survival
Progression free survival (PFS) is the time from the first date of the study intervention to the 
date of the first documentation of confirmed progression, or death due to any cause, 


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whichever occurs first.  Progression is defined per the IMWG response criteria for 
progressive disease (PD).  It does not include second primary malignancies of unrelated 
types.
3.2.5. Overall Survival
Overall survival (OS) is the time from the first date of the study intervention to the date of 
death due to any cause.
3.2.6. Time to Response
Time to response (TTR) is defined for participants with confirmed objective response (sCR, 
CR, VGPR and PR) as the time from the first date of the study intervention to the date of the 
first documentation of objective tumor response. For participants with extramedullary disease
at baseline, MR or better cannot be confirmed until a post-baseline extramedullary disease
assessment is performed, and the date of confirmed response cannot be prior to the initial 
extramedullary disease assessment date.
Time to VGPR (TTVGPR) and time to CR (TTCR) are also defined similar to TTR but for 
participants with BOR of VGPR or better and sCR/CR, respectively.
3.2.7. Duration of Response
Duration of Response (DOR) is defined for participants with confirmed objective response 
(sCR, CR, VGPR and PR) as the time from the first documentation of objective tumor 
response to the first documentation of confirmed PD per the IMWG response criteria or to 
death due to any cause, whichever occurs first.
3.2.8. PK
Drug concentrations of elranatamab will be measured using validated methods.
The PK parameters estimated for C0D1 and C1D1 will be derived from the 
concentration-time data as described in Table 3 using standard noncompartmental methods.
Actual sample collection times will be used for the parameter calculations.  In the case that 
actual PK sampling times are not available, nominal PK sampling time will be used in the 
derivation of PK parameters.
Table 3.
Definition of PK Parameters
Parameter
Definition
Method of Determination
AUC
Area under the concentration-time 
profile from time zero to the time 
, the dosing interval (= 1 week)
Linear/Log trapezoidal method
AUCinfa)
Area under the concentration-time 
profile from time zero 
extrapolated to infinite time
AUClast + (Clast*/kel),
where Clast* is the predicted serum concentration 
at the last quantifiable time point estimated from 
the log-linear regression analysis and kel is a 
terminal phase rate constant.
Cmin b)
Lowest concentration observed 
during the dosing interval
Observed directly from data


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Parameter
Definition
Method of Determination
Cmax
Maximum observed concentration
over the dosing interval
Observed directly from data
Tmax
Time for Cmax
Observed directly from data as time of first 
occurrence
t½ a)
Terminal elimination half-life
Loge(2)/kel,
where kel is the terminal phase rate constant 
calculated by a linear regression of the log-
linear concentration-time curve.  Only those 
data points judged to describe the terminal log-
linear decline will be used in the regression.
CL/F a)
Apparent clearance
Dose/AUCinf following a single dose and 
Dose/AUCτ following multiple dosing
Vz/F a)
Apparent volume of distribution
during terminal phase
Dose/(AUCinf*kel) following a single dose and 
Dose/(AUCτ*kel) following multiple dosing
a) if data permit
b) PK parameters are calculated for C1D1 only
3.2.9. Immunogenicity Data
For the immunogenicity data, the percentage of subjects with positive antidrug antibodies 
(ADA) of elranatamab will be further characterized in terms of antibody specificity.  Samples 
may also be analyzed for the presence of neutralizing antibodies (NAb).
3.2.10. Minimal Residual Disease
Minimal residual disease (MRD) negativity rate is defined as the proportion of participants 
with negative MRD per IMWG sequencing criteria by bone marrow aspirate (BMA) from the 
first date of the study intervention until the first documentation of confirmed PD, death or 
start of a new anticancer therapy, whichever occurs first.
MRD negativity will be defined by two thresholds, 10-5 and 10-6 if applicable.
 
 
 
 
 
 
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3.4. Baseline Variables
Baseline will be defined as the last non-missing assessment prior to the first date of study 
intervention. An assessment on C0D1 is assumed to be pre-dose of study intervention unless 
otherwise specified.
The following variables will be collected during screening period.
•
Demographics (gender, age and race)
•
Myeloma history
•
Medical history
3.5. Safety Endpoints
In addition to safety endpoints described in Section 3.2.1 and Section 3.2.2, 
electrocardiograms (ECGs), temperature, blood pressure (BP), pulse rate and continuous 
cardiac monitoring will also be reviewed on an ongoing basis during the study to evaluate the 
safety of participants.
4. ANALYSIS SETS (POPULATIONS FOR ANALYSIS)
Data for all participants will be assessed to determine if participants meet the criteria for 
inclusion in each analysis population prior to releasing the database and classifications will 
be documented per standard operating procedures.
4.1. Safety Analysis Set
A safety analysis set (SAS) will include all enrolled participants who receive at least 1 dose 
of study intervention.  The SAS will be the default analysis set used for all safety analyses 
unless otherwise specified.
4.2. Per Protocol Analysis Set (evaluable for RP2D)
The per protocol analysis set (PPS) will include all enrolled participants who had at least 
1 dose of study intervention and either experienced DLT or do not have major treatment 
deviations during the DLT observation period.  Replaced participants will be excluded from 
the PPS.  The PPS will be the default analysis set used for DLT evaluation.
4.3. PK Analysis Sets
4.3.1. PK Parameter Analysis Population
The PK parameter analysis population is defined as all enrolled participants treated who do 
not have protocol deviations influencing PK assessment, and have sufficient information to 
estimate at least 1 of the PK parameters of interest.
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4.3.2. PK Concentration Population
The PK concentration population is defined as all enrolled participants who are treated and 
have at least 1 analyte concentration.
 
4.5. Immunogenicity Analysis Set
The immunogenicity analysis set includes all enrolled participants who receive at least 1 dose 
of study intervention and have at least 1 sample tested for ADA.
5. GENERAL METHODOLOGY AND CONVENTIONS
5.1. Hypotheses and Decision Rules
There are no statistical hypotheses in this study so that no formal statistical testing will be 
performed.
5.1.1. Confirmation of the RP2D with the Priming Dose
If there is either no DLT in the initial 4 participants or one DLT in 6 participants, the RP2D 
with the priming dose will be confirmed.  If DLT observed in ≥2 of the initial 4 participants 
or ≥2 of 6 participants, a lower dose level may be explored, if deemed necessary.
5.2. General Methods
5.2.1. Analyses for Binary Endpoints
Binary data will be summarized using the frequency table (the number of patients, frequency 
and percentage). A Clopper-Pearson confidence interval (CI) of estimated proportion will 
also be presented as needed.
5.2.2. Analyses for Continuous Endpoints
Continuous data will be summarized descriptively (the number of patients, mean, standard 
deviation, minimum, median and maximum) unless otherwise specified.
5.2.3. Analyses for Categorical Endpoints
Categorical data will be summarized using the frequency table (the number of patients, 
frequency and percentage). A Clopper-Pearson CI of estimated proportion will also be 
presented as needed.
5.2.4. Analyses for Time-to-Event Endpoints
Time-to-event data will be summarized using a data listing and/or be presented graphically 
such as a swimmer plot due to a small sample size.  Time-to-event data may be summarized 
using the Kaplan-Meier method and estimated survival curves may be displayed graphically 
when appropriate.  A censoring rule for each endpoint is described in Section 6.
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5.3. Methods to Manage Missing Data
Missing safety data will be handled according to Pfizer standards.  Other missing data except 
for PK will be excluded from the tabular summaries.
5.3.1. PK
5.3.1.1. Concentrations Below the Limit of Quantification
In all data presentations (except listings), concentrations below the limit of quantification 
(BLQ) will be set to zero.  In listings BLQ values will be reported as “<LLQ”, where LLQ 
will be replaced with the value for the lower limit of quantification.
5.3.1.2. Deviations, Missing Concentrations and Anomalous Values
In summary tables and plots of the median values at each time point, statistics will be 
calculated having set concentrations to missing if 1 of the following cases is true:
1. A concentration has been collected as ND (i.e. not done) or NS (i.e. no sample),
2. A deviation in sampling time is of sufficient concern or a concentration has been flagged 
anomalous by the pharmacokineticist.
Note that summary statistics will not be presented at a particular time point if more than 50% 
of the data are missing.
5.3.1.3. PK Parameters
Actual PK sampling times will be used in the derivation of PK parameters.
If a PK parameter cannot be derived from a participant’s concentration data, the parameter 
will be coded as NC (ie, not calculated). Note that NC values will not be generated beyond 
the day that a participant discontinues.
In summary tables, statistics will be calculated by setting NC values to missing; and statistics 
will be presented for a particular dose with ≥3 evaluable measurements.
6. ANALYSES AND SUMMARIES
6.1. Primary Endpoint
6.1.1. DLT
The PPS will be used to assess DLTs.
The number and percentage of participants with DLTs will be presented.  AEs constituting 
DLTs will be listed including DLT start/end date (both actual and study day), cycle, severity, 
outcome, action taken and causality.  Also refer to Section 3.1.1.


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6.2. Secondary Endpoints
6.2.1. AE
The SAS will be used for all summaries of AEs.
AEs (except CRS and immune effector cell-associated neurotoxicity [ICANS]) will be 
graded by the investigator according to the CTCAE version 5.0.  CRS and ICANS  will be 
graded by the investigator according to the American Society for Transplantation and 
Cellular Therapy (ASTCT) criteria. All AEs will be coded using the Medical Dictionary for 
Regulatory Activities (MedDRA).
The focus of AE summaries will be on TEAEs.  The number and percentage of participants 
who experienced any TEAEs (all causality and treatment-related), TEAEs leading to death 
(all causality and treatment-related), TEAEs leading to permanent discontinuation (all 
causality), TEAEs leading to dose interruption (all causality), TEAEs leading to dose 
reduction (all causality), TEAEs leading to dose interruption or reduction (all causality) and
serious AEs (SAEs) (all causality and treatment-related) will be summarized according to 
worst toxicity grades.  The summaries will present TEAEs both on the entire study period 
and by cycle (Cycle 0, Cycle 1 and cycles beyond 1).  For all the AE summaries by system 
organ class (SOC) and preferred term (PT), or PT only, the following cytopenias will be 
clustered.  Each participant will be counted only once within each SOC and clustered terms.  
However, the number of total events will be based on the individual PTs.

Thrombocytopenia (PT = Thrombocytopenia, Platelet count decreased)

Anaemia (PT = Anaemia, Haemoglobin decreased, Red blood cell count decreased, 
Haematocrit decreased, Normochromic anaemia, Normocytic anaemia, Normochromic 
normocytic anaemia)

Neutropenia (PT = Neutropenia, Neutrophil count decreased, Neutrophil percentage 
decreased, Cyclic neutropenia, Agranulocytosis, Granulocytopenia, Granulocyte count 
decreased)

Leukopenia (PT = Leukopenia, White blood cell count decreased)

Lymphopenia (PT = Lymphopenia, Lymphocyte count decreased, Lymphocyte 
percentage decreased, CD4 lymphocytes decreased, CD4 lymphocyte percentage 
decreased, CD8 lymphocytes decreased, CD8 lymphocyte percentage decreased)
6.2.1.1. Adverse Events of Special Interest
Adverse events of special interest (AESI) include CRS, ICANS and peripheral neuropathy.
Table 4.
AESI
AESI
Definition
CRS
PT coded as “Cytokine release syndrome” and collected on the AE CRF page


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Table 4.
AESI
AESI
Definition
ICANS
PT coded as “Immune effector cell-associated neurotoxicity syndrome” and 
collected on the AE CRF page
Peripheral Neuropathy
Peripheral neuropathy standardized MedDRA queries (SMQ) (narrow and 
broad excluding PTs included in the Guillain-Barre syndrome SMQ (narrow)) 
and Guillain-Barre syndrome SMQ (narrow)
All the analyses will be performed for each individual AESI separately.  The number and 
percentage of participants who experienced any AESI (all causality), AESI leading to 
permanent discontinuation (all causality), AESI leading to dose interruption (all causality), 
AESI leading to dose reduction (all causality), AESI leading to dose interruption or reduction 
(all causality) and serious AESI (all causality) will be summarized according to worst 
toxicity grades.  Further, had >1 AESI (for CRS and ICANS only; all causality) and 
peripheral neuropathy with outcome as resolved (all causality) will also summarized.  If there 
are >1 AESI with different grades, it will be considered as one event.  In addition, time to 
onset of the AESI and time to resolution of the AESI will be separately summarized with 
descriptive statistics by each AESI.  For CRS and ICANS, time relative to dose (ie, after the 
first dose, after the second dose, after >2 doses) will be summarized descriptively.
A summary of CRS and ICANS as collected from “CRS AE”, “ICANS” and “ICE” CRFs 
will be provided.  The most severe symptom will be summarized if participants have multiple 
occurrences of AESI symptoms.  In addition, the number and percent of participants with 
CRS or ICANS who received tocilizumab/steroids (from Concomitant Medications CRF) 
will be summarized.  A listing of CRS and ICANS with supportive information will also be 
provided.
For peripheral neuropathy, peripheral neuropathy TEAEs by PT and maximum severity grade 
(all-causality and treatment-related), and medical history for participants with peripheral 
neuropathy will be provided.
6.2.1.2. Other Adverse Events of Clinical Interest
Other adverse events of clinical interest (oAECI) include infections and cytopenias.
Table 5.
oAECI
oAECI
Definition
Infection
SOC coded as “Infections and infestations”


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Table 5.
oAECI
oAECI
Definition
Cytopenias
PTs coded as either of the following terms: “Cytopenia", "Bicytopenia”, 
“Pancytopenia”, “Full blood count decreased”, “Bone marrow failure”, 
“Myelosuppression”, “Red blood cell count decreased”, “Haematocrit 
decreased”, “Haemoglobin decreased”, “Anaemia”, “Normochromic anaemia”, 
“Normocytic anaemia”, “Normochromic normocytic anaemia”, “Leukopenia”, 
“Agranulocytosis”, “Granulocytopenia”, “Granulocyte count decreased”, 
“White blood cell count decreased”, “Neutropenia”, “Neutrophil count 
decreased”, “Neutrophil percentage decreased”, “Band neutrophil count 
decreased”, “Band neutrophil percentage decreased”, “Cyclic neutropenia”, 
“Metamyelocyte count decreased”, “Lymphopenia”, “Lymphocyte count 
decreased”, “Lymphocyte percentage decreased”, “Thrombocytopenia”, 
“Platelet count decreased”, “Platelet production decreased”
Injection site reactions
HLT coded as “Injection site reactions”
Secondary 
malignancies
SOC coded as “Neoplasms benign, malignant and unspecified (incl cysts and 
polyps)”
All the analyses will be performed by each individual oAECI separately.  For cytopenias, the 
individual PTs (ie, not clustered terms) will be reported in the summary.
The number and percentage of participants who experienced any oAECI (all causality and 
treatment-related), oAECI leading to permanent discontinuation (all causality), oAECI
leading to dose interruption (all causality), oAECI leading to dose reduction (all causality),
oAECI leading to dose interruption or reduction (all causality) and serious oAECI (all 
causality and treatment-related) will be summarized according to worst toxicity grades.  In 
addition, time to onset of the oAECI and time to resolution of the oAECI will be separately 
summarized with descriptive statistics by each oAECI.
6.2.1.3. Deaths
The number and percentage of participants who died at any time, who died within 28 days of 
the first dose of study intervention and who died within 90 days after the last dose of study 
intervention as well as the primary reason for death will be tabulated.
Date and cause of death will be provided in individual participant data listing together with
selected dosing information.
In addition, deaths due to COVID-19 may be presented in a separate listing if there is
significant impact of COVID-19.
6.2.2. Laboratory Test Abnormalities
The SAS will be used to evaluate laboratory tests.
The number and percentage of participants who experienced laboratory test abnormalities 
will be summarized according to worst toxicity grade observed for each laboratory assay.  
The analyses will summarize laboratory tests both on the entire study period and by cycle 


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(Cycle 0, Cycle 1 and cycles beyond 1).  Shift tables will be provided to examine the 
distribution of laboratory toxicities.
For laboratory tests without CTCAE grade definitions, results will be categorized as normal, 
abnormal, or not done.
An evaluation of drug-induced serious hepatotoxicity (eDISH) plot showing the following 
laboratory test items will be created:
•
Peak serum ALT vs peak total bilirubin
•
Peak serum AST vs peak total bilirubin
 
6.2.3. BOR
The SAS will be used for BOR.
Response rate of CR, OR and CB will be calculated along with two-sided 95% CIs.  Disease 
response will be presented in the form of patient data listings that include, but are not limited 
to disease response at each visit and best overall response.  In addition, progression date, 
death date, date of the first response, the last disease assessment date and the date of the last 
contact will be listed.  A swimmer plot will also be generated.
6.2.4. PFS
The SAS will be used for PFS.
PFS will be censored on the date of the last adequate disease assessment for participants who 
do not have an event, 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 first date of the study 
intervention unless death occurs on or before the time of the second planned disease 
assessment in which case the death will be considered an event.
A data listing of PFS will be provided.  A swimmer plot will be generated.  Although a 
summary table is not planned to be generated due to a small sample size, it may be provided 
using the Kaplan-Meier method as appropriate.
In addition, duration of follow-up time will be summarized with simple descriptive statistics 
as well as with the reverse Kaplan-Meier method.
6.2.5. OS
The SAS will be used for OS.
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OS for participants not known to have died are censored on the date of the last known alive.
A data listing of OS will be provided.  A swimmer plot will be generated.  Although a 
summary table is not planned to be generated due to a small sample size, it may be provided 
using the Kaplan-Meier method as appropriate.
In addition, duration of follow-up time will be summarized with simple descriptive statistics 
as well as with the reverse Kaplan-Meier method.
6.2.6. TTR
The SAS will be used for TTR, TTVGPR and TTCR.  In TTR summary, participants whose 
BOR are PD, stable disease (SD), MR or deaths will be excluded. Similarly, participants 
whose BOR are PD, SD, MR, PR or deaths will be excluded from the summary of TTVGPR, 
and participants whose BOR are other than sCR/CR will be excluded from the summary of 
TTCR.
A data listings of TTR, TTVGPR and TTCR will be provided.
6.2.7. DOR
The SAS will be used for DOR.  In DOR summary, participants whose BOR are PD, clinical 
relapse, SD or MR will be excluded.
DOR will be censored on the date of the last adequate disease assessment for participants 
who do not have an event, 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.
A data listing of DOR will be provided.  A swimmer plot will be generated.  Although a 
summary table is not planned to be generated due to a small sample size, it may be provided 
using the Kaplan-Meier method as appropriate.
In addition, duration of follow-up time will be summarized with simple descriptive statistics.
6.2.8. PK Analyses
6.2.8.1. PK Concentrations
The PK concentration population will be used to summarize PK concentrations.
The concentrations of elranatamab will be summarized by descriptive statistics (as described 
in Table 6) by cycle and nominal time.  Individual participant and median profiles of the 
concentration time data will be plotted by cycle using nominal times for only Cycle 0 and 
Cycle 1.  Median profiles will be presented on both linear-linear and log-linear scales.


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In addition, plot (linear and log scale) of the predose concentrations by cycle and day within 
cycle will be provided for each dose, on the same plot, in order to assess the attainment of 
steady-state.
For summary statistics and median plots by sampling time, the nominal PK sampling time 
will be used.  For individual subject plots by time, the actual PK sampling time will be used.
6.2.8.2. PK Parameters
The PK parameter analysis population will be used to summarize PK parameters.
The PK parameters will be summarized descriptively by cycle and will include the set of 
summary statistics as specified in the table below:
Table 6.
PK Parameters to be Summarized Descriptively
Parameter
Summary statistics
AUCinf, AUC, Cmin,
Cmax, CL/F, and Vz/F
N, arithmetic mean, median, coefficient of variation (CV%), 
standard deviation, minimum, maximum, geometric mean, 
geometric CV%
t½
N, arithmetic mean, median, CV%, standard deviation, minimum, 
maximum
Tmax
N, median, minimum, maximum
Presentations for elranatamab concentrations will include:

A listing of all concentrations sorted by participant ID, cycle and nominal time post-dose. 
The concentration listing will also include the actual times.  Deviations from the nominal 
time will be given in a separate listing.

A summary of concentrations by each nominal time post-dose, cycle where the set of 
statistics will include n, mean, median, standard deviation, CV%, minimum, maximum, 
geometric mean, and geometric CV% and the number of concentrations above the lower 
limit of quantification.

Median concentrations against nominal time post-dose by cycle, with all cycles presented 
on the same plot.  Two plots will be generated, so that the concentrations can be 
presented on linear and logarithmic scales.

Individual concentration time plots by participant (on both linear and semi-log scales) 
against actual time post-dose.

For summary statistics and median plots by sampling time, the nominal PK sampling 
time will be used.  For individual participant plots by time, the actual PK sampling time 
will be used
To assess the relationship between the PK parameters and dose, Cmax and AUCwill be 
plotted across cycles on linear scale, and will include individual participants values and the 
geometric means. Geometric means will have a different symbol than the individual values.


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6.2.9. Analysis of Immunogenicity Data
The immunogenicity analysis set will be used to assess immunogenicity data.
For the immunogenicity data, the percentage of participants with ADA will be summarized.  
Listings and summary tabulations of the ADA data at baseline and post-baseline will be 
generated.  Any data related to NAb will be similarly summarized.  For participants with 
positive ADA or NAb, the magnitude (titer), time of onset, and duration of ADA or NAb 
response will also be described, if data permit.  The potential impact of immunogenicity on 
PK and clinical response including PD markers, safety/tolerability and efficacy of ADA will 
be explored, if warranted by the data.
6.2.10. MRD
The SAS will be used for MRD unless otherwise specified.
The MRD negativity rate will be calculated along with the 2-sided 95% CI as follows:
•
MRD negative with confirmed sCR/CR,
•
MRD negative based on the subset who achieved confirmed sCR/CR,
•
MRD negative based on the subset who achieved confirmed sCR/CR among evaluable 
participants who have at least one MRD assessment.
 
 
 
 
 
 
6.4. Baseline and Other Summaries and Analyses
6.4.1. Baseline Summaries
The SAS and PPS will be used to summarize baseline characteristics, separately.  In case 
these 2 analysis sets are completely the same set, summaries using the PPS may be omitted.
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Baseline characteristics such as demographics, prior line of therapy, medical history, disease 
characteristics (baseline relapse or refractory, baseline cytogenetic risk, IMWG MM 
Diagnosis Criteria, baseline bone marrow plasma cells, ECOG performance status, 
extramedullary disease, type of measurable disease at baseline, current disease stage by 
Revised Multiple Myeloma International Staging System (R-ISS), renal function and liver 
function) will be tabulated and listed.  Further, the following baseline disease characteristics 
will be summarized by descriptive statistics:

Time since first diagnosis (months), defined as (date of the first dose of study 
intervention - date of the first diagnosis) / 30.4375;

Time since onset of current episode, defined as (date of the first dose of study 
intervention - date of the onset of current episode) / 30.4375.
6.4.2. Study Conduct and Participant Disposition
The total number of enrolled participants, the number of participants who 
completed/discontinued the treatment/study and the reason for any premature discontinuation 
from the treatment/study will be presented. In addition, the number of participants in each 
analysis set also be provided.
6.4.3. Study Treatment Exposure
The SAS will be used to summarize participant exposure to study intervention.
The following will be summarized:

Duration of treatment (weeks),

Number of cycles started per participant,

Number (%) of participants starting a cycle,

Total cumulative dose (mg),

Overall dose intensity (mg/week),

Overall relative dose (%), and

Overall relative dose intensity (%).
The duration of treatment will be calculated as follows:
Duration of treatment (weeks) = ((last non-zero dose date) - (first dose date) + 1) / 7.
The total cumulative dose will be calculated as the sum of the actual doses (mg) that the 
participant received during the study.


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The overall dose intensity will be calculated as follows:
Overall dose intensity (mg/week) = (total cumulative dose) / Ceiling(((last zero/non-
zero dose date) - (first dose date) + 1) / 7).
In the expression above, “Ceiling” denotes a ceiling function.
The total planned dose is defined as follows:
Total planned dose (mg) =
0.6 × (baseline body weight) +
Sum(Ceiling(((last zero/non-zero QW dose date in a QW interval) - (first QW dose 
date in the same interval) + 1) / 7) × (body weight used to calculate an actual 
dose)) +
Sum(Ceiling(((last zero/non-zero Q2W dose date in a Q2W interval) - (first Q2W 
dose date in the same interval) + 1) / 14) × (body weight used to calculate an actual 
dose)).
In the expression above, “Sum” denotes a summation.  If a participant experiences either a 
weight loss or gain >10% compared to weight used to calculate a prior dose within a 
QW/Q2W interval, the interval will be split based on weight used to calculate actual doses.  
If a participant never receives a Q2W dosing, the third term in the right-hand side of 
expression will put zero.  If a patient continues the study, the latest date of either the last QW 
dose date or the last Q2W dose date will be replaced by the data cutoff date.
The overall relative dose will be calculated as follows:
Overall relative dose (%) = (total cumulative dose) / (total planned dose) × 100.
The planned duration of treatment is calculated as follows:
Planned duration of treatment (weeks) = ((date of permanent treatment discontinuation 
or data cutoff date, whichever occurs first) - (first dose date) + 1) / 7.
The overall planned dose intensity (mg/week) will be calculated as follows:
Overall planned dose intensity (mg/week) = (total planned dose) / Ceiling(planned 
duration of treatment).
Last of all, the overall relative dose intensity will be calculated as follows:
Overall relative dose intensity (%) = (overall dose intensity) / (overall planned dose 
intensity) × 100.
6.4.4. Concomitant Medications and Nondrug Treatments
The SAS will be used to summarize concomitant medications and non-drug treatments.


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Summary of concomitant medications will include the frequency and percentage of 
participants by Anatomical Therapeutic Chemical (ATC) Classification level 2 and preferred 
term. In case any specific medication does not have ATC classification level 2 coded term, it 
will be summarized under “Unavailable ATC classification” category.
Summary of non-drug treatments will include the frequency and percentage of patients by 
MedDRA preferred term.
6.4.5. Prior Anticancer Therapy
The SAS will be used to summarize prior anticancer therapy.
Prior anticancer drugs will be coded in the WHO Drug coding dictionary and will be 
summarized by PT.  A participant will be counted only once within a given PT, even if he or 
she received the same medication at different times.
The number and percentage of participants in each of the following anticancer therapy 
categories will be tabulated:

Number of prior anticancer therapy lines (descriptive statistics, as well as broken down in 
categories by the number of prior lines),

Prior IMiDs and type,

Prior PI and type,

Prior anti-CD38 mAb and type,

Participants who are triple-class exposed,

Participants who are triple-class refractory,

Participants who are penta-drug exposed,

Participants who are penta-drug refractory,

Participants with prior stem cell transplant and type, and

Prior BCMA-targeted therapy.
Prior anticancer drug therapy will be summarized as follows based on the number and 
percentage of participants:

Best overall response on the last prior anticancer therapy line received, and

Reason for stopping the last prior therapy.


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6.4.6. Subsequent Anticancer Therapy
The SAS will be used to summarize subsequent anticancer therapy.
Subsequent anticancer drug treatment will be coded in the WHO Drug coding dictionary and 
will be summarized by PT.
Number and percentage of participants with any anticancer therapy after discontinuation of 
study intervention will be tabulated overall and by type of therapy.
6.5. Safety Summaries and Analyses
6.5.1. Vital Signs
Vital signs (temperature (axillary), BP and pulse rate) and body weight will be presented by 
data listing.
6.5.2. Electrocardiograms
The analysis of ECG results will be based on participants in the SAS with baseline and on 
treatment ECG data.
ECG measurements (an average of the triplicate measurements) will be used for the 
statistical analysis and all data presentations.  Any data obtained from ECGs repeated for 
safety reasons after the nominal time points will not be averaged along with the preceding 
triplicates.  Interval measurements from repeated ECGs will be included in the outlier 
analysis (categorical analysis) as individual values obtained at unscheduled time points.
QT intervals will be corrected for HR using Fridericia’s correction (QTcF).  Data will be 
summarized and listed for QT, HR, RR, PR, QRS, QTcF.  Individual QT (all evaluated 
corrections) intervals will be listed by time.
The number and percentage of participants with maximum postdose QTcF values and 
maximum increases from baseline in the following categories will be tabulated:
Table 7.
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
In addition, the number and percentage of participants with uncorrected QT values 
>500 msec will be summarized.
If more than 1 ECG is collected at a nominal time after dose administration (for example, 
triplicate ECGs), the mean of the replicate measurements will be used to represent a single 
observation at that time point.  If any of the 3 individual ECG tracings has a QTcF value 
>500 msec, but the mean of the triplicates is not >500 msec, the data from the participant’s 
individual tracing will be described in a safety section of the CSR in order to place the 
>500 msec value in appropriate clinical context.  However, values from individual tracings 


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within triplicate measurements that are >500 msec will not be included in the categorical 
analysis unless the average from the triplicate measurements is also >500 msec.  Changes 
from baseline will be defined as the change between the postdose QTcF value and the 
average of the time matched baseline triplicate values on Day 1, or the average of the predose 
triplicate values on Day 1.
In addition, an attempt will be made to explore and characterize the relationship between 
plasma concentration and QT interval length using a PK/PD modeling approach.  If a PK/PD
relationship is found, the impact of participant factors (covariates) on the relationship will be 
examined.
6.5.3. Other Safety Data
The SAS will be used to summarize any additional safety data.
Serum/urine pregnancy test results will be presented in the listings.
7. INTERIM ANALYSES
No formal interim analysis will be conducted for this study.  As this is an open-label study, 
the sponsor may conduct reviews of the data during the course of the study for the purpose of 
safety assessment.  Further, ad-hoc analyses may be performed due to a regulatory 
submission outside Japan.


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8. APPENDICES
Appendix 1. IMWG Response Criteria for MM
All response categories require two consecutive assessments made any time before starting 
any new therapy.  Participants must have measurable disease at enrolment (study entry).
Measurable disease is defined as:

Serum M-protein ≥0.5 g/dL (5 g/L); 

Urine M-protein ≥200 mg/24 h;

Serum free light chain (FLC) assay: involved FLC level ≥100 mg/L (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 lower or lowest level of response. Participants will continue in 
the last confirmed response category until there is confirmation of progression or 
improvement to a higher response status; participants cannot move to a lower response 
category.
Table 8.
IMWG Response Criteria for MM
Response
IMWG Criteria a
Stringent 
Complete 
Response (sCR)

Complete response as defined below plus normal FLC ratio and absence of 
clonal cells in bone marrow biopsy by immunohistochemistry (κ/ratio ≤4:1 or 
≥1:2 for κ and patients, respectively, after counting ≥100 plasma cells). b

In patients whereby the only measurable disease is by serum FLC levels, sCR is 
defined as normal FLC ratio of 0.26 to 1.65 plus absence of clonal cells in bone 
marrow as defined above.
Complete 
Response (CR)

Negative immunofixation on the serum and urine and disappearance of any soft 
tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. c

In patients whereby the only measurable disease is by serum FLC levels, CR is 
defined as normal FLC ratio of 0.26 to 1.65 plus criteria listed above.
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.

In patients whereby the only measurable disease is by serum FLC levels, VGPR 
is defined as a ≥90% decrease in the difference between involved (tumor) and 
uninvolved (non-tumor) serum FLC levels.


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Table 8.
IMWG Response Criteria for MM
Response
IMWG Criteria a
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 FLC levels is required in place of 
the M-protein criteria.

If serum and urine M-protein are unmeasurable, and serum-free light assay is 
also unmeasurable, ≥50% reduction in plasma cells is required in place of 
M-protein, provided baseline bone marrow plasma-cell percentage was ≥30%.

In addition to these criteria, if present at baseline, a ≥50% reduction in the size 
(SPD) d of soft tissue plasmacytomas is also required.
Minimal Response 
(MR)

≥25% but ≤49% reduction of serum M-protein and reduction in 24-h urine 
M-protein by 50%–89%. In addition to the above listed criteria, if present at 
baseline, a 50% reduction in the size (SPD) d of soft tissue plasmacytomas is 
also required.
No Change/Stable 
Disease (SD)

Not meeting criteria for CR, VGPR, PR, MR or progressive disease.
Progressive 
Disease (PD)

Increase of ≥25% from lowest response value in any one or more of the 
following:

Serum M-protein (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 (absolute increase must be ≥200 mg/24 h;

In patients without measurable serum and urine M-protein levels, the 
difference between involved and uninvolved FLC levels (absolute increase 
must be >10 mg/dL);

In patients without measurable serum and urine M-protein levels and 
without measurable involved 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 d of 
>1 lesion, or ≥50% increase in the longest diameter of a previous lesion 
>1 cm in short axis. 

≥50% increase in circulating plasma cells (minimum of 200 cells per µL) if 
this is the only measure of disease
Clinical Relapse
Clinical relapse requires one or more of the following criteria:

Direct indicators of increasing disease and/or end organ dysfunction (CRAB 
features) related to the underlying clonal plasma-cell proliferative disorder;

Development of new soft tissue plasmacytomas or bone lesions (osteoporotic 
fractures do not constitute progression);

Definite increase in the size of existing plasmacytomas or bone lesions. A 
definite increase is defined as a 50% (and ≥1 cm) increase as measured serially 
by the SPD d of the measurable lesion;

Hypercalcemia (>11 mg/dL);

Decrease in hemoglobin of ≥2 g/dL not related to therapy or other 
non-myeloma-related conditions;

Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and 
attributable to myeloma;

Hyperviscosity related to serum paraprotein.


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Table 8.
IMWG Response Criteria for MM
Response
IMWG Criteria a
a.
All response categories require two consecutive assessments made at any time before classification as 
relapse or disease progression and/or the institution of any new therapy.  To confirm response or PD, 
two discrete samples are required, and testing cannot be based upon the splitting of a single sample.  
In the IMWG criteria, CR patients must also meet the criteria for PD shown here to be classified as PD
for the purposes of calculating time to progression and progression free survival.  The definitions of 
relapse, clinical relapse and relapse from CR are not to be used in calculation of time to progression or 
progression free survival.  Patients 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 patients who 
had a measurable serum or urine M-spike at baseline, progression cannot be defined by increases in 
serum FLC alone.
b. Presence/absence of clonal cells on immunohistochemistry is based upon the κ//L ratio.  An 
abnormal κ/ratio by immunohistochemistry requires a minimum of 100 plasma cells for analysis.  
An abnormal ratio reflecting presence of an abnormal clone is κ/of >4:1 or <1:2.
c.
Confirmation with repeat bone marrow biopsy is not required.  Careful attention should be given to 
new positive immunofixation results appearing in patients who have achieved a complete response, 
when the isotype is different.  This probably represents oligoclonal immune reconstitution and should 
not be confused with relapse; these bands typically disappear over time.
d. Plasmacytoma measurements should be taken from the CT portion of the PET/CT, or dedicated CT 
scans where applicable.  Measurement of tumor size will be determined by the SPD.


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Appendix 2. IMWG MRD Criteria
MRD tests should be initiated only at the time of suspected complete response.  Confirmation 
with two consecutive assessments is not required.
Table 9.
IMWG MRD Criteria
Response
IMWG Criteria
Sustained MRD-negative1
MRD negativity in the marrow (NGF or NGS, or both) and by 
imaging as defined below, confirmed minimum of 1 year apart.  
Subsequent evaluations can be used to further specify the duration of 
negativity (eg, MRD negative at 5 years).
Flow MRD-negative2
Absence of phenotypically aberrant clonal plasma cells by NGF on 
bone marrow aspirates using the EuroFlow standard operation 
procedure for MRD detection in multiple myeloma (or validated 
equivalent method) with a minimum sensitivity of 1 in 105 nucleated 
cells or higher.
Sequencing MRD-negative
Absence of clonal plasma cells by NGS on bone marrow aspirate in 
which presence of a clone is defined as less than two identical 
sequencing reads obtained after DNA sequencing of bone marrow 
aspirates using the LymphoSIGHT platform (or validated equivalent 
method) with a minimum sensitivity of 1 in 105 nucleated cells or 
higher.
Imaging negative MRD-negative
MRD negativity as defined by NGF or NGS plus disappearance of 
every area of increased tracer uptake found at baseline or a preceding 
PET/CT or decrease to less mediastinal blood pool SUV or decrease 
to less than that of surrounding normal tissue.
CT = computed tomography; IMWG = International Myeloma Working Group; MRD = minimal residual 
disease; NGF = next generation flow cytometry; NGS = next generation sequencing; PET = positron 
emission tomography; SUV = standardized uptake value.
1.
Sustained MRD negativity, when reported, should also annotate the method used (eg, sustained 
sequencing MRD-negative).
2.
Bone marrow multiparametric flow cytometry should follow NGF guidelines.  The reference NGF 
method is an eight color two tube approach, which has been extensively validated.  The two tube 
approach improves reliability, consistency, and sensitivity because of the acquisition of a greater 
number of cells.  The complete eight color method should use a lyophilized mixture of antibodies.  
Five million cells should be assessed.  The method employed should have a sensitivity of detection of 
at least 1 in 105 plasma cells.


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Appendix 3. List of Abbreviations
Abbreviation
Term
ADA
antidrug antibodies
AE
adverse event
ALP
alkaline phosphatase
ALT
alanine aminotransferase
ANC
absolute neutrophil count
aPTT
activated partial thromboplastin time
AST
aspartate aminotransferase
ASTCT
American Society for Transplantation and Cellular Therapy
ATC
Anatomical Therapeutic Chemical
AUClast
concentration versus time curve
BCMA
B-cell maturation antigen
BMA
bone marrow aspirate
BLQ
below the limit of quantification
BOR
best overall response
BP
blood pressure
BUN
blood urea nitrogen
C0D1
Cycle 0 Day 1
C1D1
Cycle 1 Day 1
C2D1
Cycle 2 Day 1
CB
clinical benefit
CD38
cluster of differentiation 38
CI
confidence interval
CL/F
apparent clearance
Cmax
maximum concentration
Cmin
minimum concentration
CR
complete response
CRP
c-reactive protein
CRS
cytokine release syndrome
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
CV%
coefficient of variation
DILI
drug induced liver injury
DLT
dose-limiting toxicity
DOR
duration of response


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Abbreviation
Term
ECG
Electrocardiogram
eDISH
evaluation of drug-induced serious hepatotoxicity
FLC
free light chain
HBV
hepatitis B virus
HCV
hepatitis C virus
ICANS
immune effector cell-associated neurotoxicity
IFN
interferon
IL
interleukin
IMID
immunomodulatory drug
IMWG
International Myeloma Working Group
ISR
injection site reactions
LDH
lactate dehydrogenase
LLQ
lower limit of quantification
MedDRA
Medical Dictionary for Regulatory Activities
MM
multiple myeloma
MR
minimal response
MRD
minimal residual disease
MTD
maximum tolerated dose
NAb
neutralizing antibodies
NC
not calculated
NCI
National Cancer Institute
ND
not done
NGS
next-generation sequencing
NS
no sample
oAECI
other adverse events of clinical interest
OR
overall response
OS
overall survival
PD
pharmacodynamics
PD
progressive disease
PFS
progression free survival
PI
proteasome inhibitor
PK
pharmacokinetics
PPS
per protocol analysis set
PR
partial response
PT
preferred term
PT
prothrombin time


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Abbreviation
Term
PT/INR
prothrombin time-international normalized ratio
PTT
partial thromboplastin time
QTcF
corrected QT (Fridericia method)
R-ISS
Revised Multiple Myeloma International Staging System
RP2D
recommended phase 2 dose
SAE
serious adverse event
SAP
statistical analysis plan
SAS
safety analysis set
sCR
stringent complete response
SD
stable disease
sIL-2R
soluble interleukin-2 receptor
SMQ
standardized MedDRA queries
SOC
system organ class
t½
terminal elimination half life
TEAE
treatment-emergent adverse event
Tmax
time to maximum concentration
TNF
tumor necrosis factor
TTR
time to response
TTCR
time to complete response
TTVGPR
time to very good partial response
VGPR
very good partial response
Vz/F
apparent volume of distribution during terminal phase
WBC
white blood cell