Clinical trial NCT04892446
Conditions: Multiple Myeloma
Sponsor: Gilead Sciences
Start date: 2021-11-09; Completion date: 2024-04-25
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab, in combination with other anticancer therapies in participants with relapsed/refractory multiple myeloma.

Detailed description:

Arms: arm 1: Participants with relapsed/refractory multiple myeloma (MM) who have had 3 or more prior therapies including an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) will receive magrolimab as per protocol and daratumumab 1800 mg subcutaneously (SC) or 16 milligrams per kilogram (mg/kg) intravenously (IV) on Days 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and Days 1 and 15 (every 2 weeks) until Cycle 6 (total of 8 doses) followed by Day 1 (every 4 weeks) for subsequent cycles. (Cycle 1=35 days, All other Cycles=28 days). arm 2: Participants with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and pomalidomide 4 mg on Days 1 to 21 (daily) of Cycle 1, Days 1 to 21 (daily) of Cycle 2 and onward and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and onward. (Cycle 1=35 days, All other Cycles=28 days). arm 3: Participants with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and carfilzomib 20 mg/m\^2 on Days 8, 15, 22 of Cycle 1, Days 1, 8, 15 of Cycle 2 and onward (if the carfilzomib starting dose of 20 mg/m\^2 is tolerated after Cycle 1, Day 8, the dose will be escalated to 70 mg/m\^2 on Cycle 1, Day 15 and thereafter) and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days). arm 4: Bortezomib + Dexamethasone may be initiated based on the preliminary safety and efficacy of the Carfilzomib + Dexamethasone cohort.

Participants with relapsed/refractory multiple myeloma who have had 1 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and carfilzomib 1.3 mg/m\^2 on Days 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and onward (Maximum of 8 cycles in those who have previously received bortezomib) and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, and 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days).
Interventions: intervention 1: Magrolimab intervention 2: Daratumumab intervention 3: Pomalidomide intervention 4: Dexamethasone intervention 5: Bortezomib intervention 6: Carfilzomib
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered either SC or IV intervention 3: Administered orally intervention 4: Administered orally intervention 5: Administered either SC or IV intervention 6: Administered IV

Protocol documents:
Prot_000.pdf: 
CLINICAL STUDY PROTOCOL
Study Title:
A Phase 2 Multi-Arm Study of Magrolimab Combinations in 
Patients With Relapsed/Refractory Multiple Myeloma 
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
118300
2021-001798-21
NCT04892446
Indication:
Multiple Myeloma
Protocol ID:
GS-US-558-5915
Contact Information:
The medical monitor name and contact information will be 
provided on the Key Study Team Contact List.
Protocol 
Version/Date:
Original:
22 December 2020
Amendment 1:
18 March 2021
Amendment 2:
05 May 2021
Amendment 3:
12 October 2021
Amendment 4:
31 March 2022
Amendment 5:
31 May 2022
Amendment 6:
02 November 2023
This study will be conducted under United States Food and Drug Administration investigational 
new drug (IND) regulations (21 Code of Federal Regulations Part 312); however, sites located in 
the European Economic Area, United Kingdom, and Switzerland are not included under the IND 
and are considered non-IND sites.
CONFIDENTIALITY STATEMENT
The information contained in this document, particularly unpublished data, is the property or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable 
institutional review board or independent ethics committee. The information is only to be used 
by you in connection with authorized clinical studies of the investigational drug described in 
the protocol. You will not disclose any of the information to others without written 
authorization from Gilead Sciences, Inc., except to the extent necessary to obtain informed 
consent from those persons to whom the drug may be administered.
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TABLE OF CONTENTS
TABLE OF CONTENTS ..........................................................................................................................2
LIST OF IN-TEXT TABLES....................................................................................................................6
LIST OF IN-TEXT FIGURES ..................................................................................................................6
PROTOCOL SYNOPSIS..........................................................................................................................7
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS...............................................21
1.
INTRODUCTION ..........................................................................................................................25
1.1.
Background........................................................................................................................25
1.2.
Magrolimab........................................................................................................................26
1.2.1.
General Information ............................................................................................26
1.2.2.
Nonclinical Pharmacology and Toxicology ........................................................27
1.2.3.
Clinical Background for Magrolimab .................................................................29
1.3.
Information About Agents Used in Combination With Magrolimab................................32
1.3.1.
Daratumumab ......................................................................................................32
1.3.2.
Pomalidomide and Dexamethasone ....................................................................34
1.3.3.
Carfilzomib and Dexamethasone ........................................................................35
1.3.4.
Bortezomib and Dexamethasone.........................................................................37
1.4.
Rationale for This Study....................................................................................................37
1.4.1.
Magrolimab in Combination With Daratumumab ..............................................38
1.4.2.
Magrolimab in Combination With Pomalidomide and Dexamethasone.............39
1.4.3.
Magrolimab in Combination with Proteasome Inhibitors 
(Carfilzomib/Dexamethasone and Bortezomib/Dexamethasone) .......................40
1.5.
Rationale for Dose Selection of Magrolimab ....................................................................40
1.5.1.
Rationale for Daratumumab, Dexamethasone, Pomalidomide, Carfilzomib, and 
Bortezomib Dose Selection .................................................................................41
1.6.
Risk/Benefit Assessment for the Study..............................................................................42
1.7.
Compliance ........................................................................................................................42
2.
OBJECTIVES AND ENDPOINTS................................................................................................43
3.
STUDY DESIGN ...........................................................................................................................44
3.1.
Study Design......................................................................................................................44
3.1.1.
Safety Run-in Cohorts .........................................................................................45
3.1.2.
Dose-expansion Cohorts......................................................................................48
3.1.3.
Treatment-Related Toxicity Monitoring .............................................................48
3.2.
Study Treatments ...............................................................................................................48
3.3.
Duration of Treatment........................................................................................................48
3.4.
Discontinuation Criteria.....................................................................................................48
3.5.
Discontinuation From Study Criteria/End of Study...........................................................49
3.6.
Poststudy Care ...................................................................................................................50
3.7.
Source Data........................................................................................................................50
3.8.
Pharmacokinetics/Biomarker Testing................................................................................50
3.8.1.
Biomarker Samples to Address the Study Objectives.........................................50
4.
PATIENT POPULATION..............................................................................................................52
4.1.
Number of Patients and Patient Selection..........................................................................52
4.1.1.
Patient Replacement ............................................................................................52
4.2.
Inclusion Criteria ...............................................................................................................52
4.3.
Exclusion Criteria ..............................................................................................................55
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5.
INVESTIGATIONAL MEDICINAL PRODUCTS.......................................................................58
5.1.
Enrollment..........................................................................................................................58
5.2.
Description and Handling ..................................................................................................58
5.2.1.
Magrolimab .........................................................................................................58
5.2.2.
Daratumumab ......................................................................................................59
5.2.3.
Pomalidomide......................................................................................................59
5.2.4.
Carfilzomib..........................................................................................................60
5.2.5.
Bortezomib ..........................................................................................................60
5.2.6.
Dexamethasone....................................................................................................61
5.3.
Dosage and Administration................................................................................................61
5.3.1.
Magrolimab .........................................................................................................61
5.3.2.
Daratumumab ......................................................................................................64
5.3.3.
Pomalidomide and Dexamethasone ....................................................................65
5.3.4.
Carfilzomib and Dexamethasone ........................................................................66
5.3.5.
Bortezomib and Dexamethasone.........................................................................67
5.4.
Dose Modification and Delays...........................................................................................69
5.4.1.
Magrolimab .........................................................................................................69
5.4.2.
Daratumumab ......................................................................................................71
5.4.3.
Pomalidomide......................................................................................................72
5.4.4.
Carfilzomib..........................................................................................................74
5.4.5.
Bortezomib ..........................................................................................................76
5.4.6.
Dexamethasone....................................................................................................77
5.5.
Prior and Concomitant Medications ..................................................................................78
5.5.1.
Prohibited Prior Medications...............................................................................78
5.5.2.
Prohibited Concomitant Medications..................................................................79
5.5.3.
Permitted and Required Concomitant Medications.............................................79
5.6.
Accountability for Study Drug(s) ......................................................................................81
5.6.1.
Study Drug(s) Return or Disposal .......................................................................81
6.
STUDY PROCEDURES ................................................................................................................82
6.1.
Patient Enrollment and Treatment Assignment.................................................................82
6.2.
Pretreatment Assessments..................................................................................................82
6.2.1.
Screening Laboratory Assessments.....................................................................84
6.2.2.
Type and Screen and Direct Antiglobulin Test ...................................................85
6.3.
Treatment Assessments......................................................................................................85
6.4.
Safety Assessments............................................................................................................85
6.4.1.
Adverse Events....................................................................................................85
6.4.2.
Laboratory Assessments......................................................................................85
6.4.3.
Vital Signs ...........................................................................................................86
6.4.4.
Physical Examination ..........................................................................................86
6.4.5.
Pregnancy Test ....................................................................................................87
6.4.6.
Performance Status..............................................................................................87
6.4.7.
12-lead Electrocardiogram ..................................................................................87
6.4.8.
Echocardiogram...................................................................................................87
6.4.9.
Prior and Concomitant Medications....................................................................88
6.4.10.
Peripheral Blood Smear Assessment...................................................................88
6.5.
Efficacy Assessments.........................................................................................................88
6.5.1.
Laboratory Assessments for Multiple Myeloma – Serum Protein 
Electrophoresis, Urine Protein Electrophoresis, Serum Free Light Chain, Serum 
Immunofixation, and Urine Immunofixation ......................................................88
6.5.2.
Tumor Response and Multiple Myeloma Disease Assessment...........................89
6.5.3.
Progressive Disease Assessment .........................................................................91
6.5.4.
Bone Marrow Assessments .................................................................................91


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6.5.5.
Minimal Residual Disease...................................................................................92
6.5.6.
Skeletal Survey....................................................................................................92
6.5.7.
Extramedullary Plasmacytoma Assessment........................................................93
6.6.
Patient-Reported Outcome Assessments ...........................................................................94
6.6.1.
FACT-MM Questionnaire...................................................................................94
6.7.
Pharmacokinetic Assessments ...........................................................................................94
6.8.
Immunogenicity.................................................................................................................94
6.9.
Pharmacodynamic and Biomarker Assessments ...............................................................95
6.9.1.
Analyses of Peripheral Blood..............................................................................95
6.9.2.
Cancer Mutation Profiles and Mutation Burden .................................................95
6.9.3.
Changes in Immune Effector Cell Composition .................................................95
6.9.4.
Changes in Immune Effector Cell Signaling Molecules .....................................96
6.9.5.
Expression of Prophagocytic and Antiphagocytic Signals by Cancer Cells .......96
6.10.
Posttreatment Assessments................................................................................................96
6.11.
End of Study ......................................................................................................................96
6.12.
Poststudy Care ...................................................................................................................97
6.13.
Sample Storage ..................................................................................................................97
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT ..........................................................98
7.1.
Definitions of Adverse Events and Serious Adverse Events.............................................98
7.1.1.
Adverse Events....................................................................................................98
7.1.2.
Serious Adverse Events.......................................................................................98
7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations Reports .......99
7.2.
Assessment of Adverse Events and Serious Adverse Events..........................................100
7.2.1.
Assessment of Causality for Study Drugs and Procedures ...............................100
7.2.2.
Assessment of Severity......................................................................................101
7.3.
Investigator Reporting Requirements and Instructions....................................................101
7.3.1.
Requirements for Collection Prior to Study Drug Initiation .............................101
7.3.2.
Adverse Events..................................................................................................101
7.3.3.
Serious Adverse Events.....................................................................................101
7.3.4.
Study Drug Special Situations Reports .............................................................102
7.3.5.
Concomitant Therapy Reports...........................................................................102
7.4.
Reporting Process for Serious Adverse Events and Special Situation Reports...............103
7.4.1.
Serious Adverse Event Reporting Process ........................................................103
7.4.2.
Special Situations Reporting Process ................................................................103
7.5.
Gilead Reporting Requirements.......................................................................................105
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events 
or Serious Adverse Events...............................................................................................105
7.7.
Abnormal Liver Function Tests.......................................................................................106
7.8.
Toxicity Management......................................................................................................106
7.8.1.
Magrolimab .......................................................................................................106
7.8.2.
Daratumumab ....................................................................................................112
7.8.3.
Pomalidomide....................................................................................................113
7.8.4.
Carfilzomib........................................................................................................113
7.8.5.
Bortezomib ........................................................................................................113
7.8.6.
Dexamethasone..................................................................................................113
8.
STATISTICAL CONSIDERATIONS .........................................................................................114
8.1.
Analysis Objectives and Endpoints .................................................................................114
8.1.1.
Study Objectives................................................................................................114
8.1.2.
Primary Endpoints.............................................................................................114
8.1.3.
Secondary Endpoints for Dose-expansion Cohorts...........................................114
8.2.
Planned Analyses.............................................................................................................115
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8.3.
Analysis Conventions ......................................................................................................115
8.3.1.
Analysis Sets .....................................................................................................115
8.3.2.
Data Handling Conventions ..............................................................................116
8.4.
Demographic and Baseline Characteristics Analysis ......................................................117
8.5.
Efficacy Analysis.............................................................................................................117
8.5.1.
Primary Analysis ...............................................................................................117
8.5.2.
Secondary Analyses...........................................................................................117
8.6.
Safety Analysis ................................................................................................................117
8.6.1.
Extent of Exposure ............................................................................................117
8.6.2.
Adverse Events..................................................................................................118
8.6.3.
Laboratory Evaluations .....................................................................................118
8.6.4.
Other Safety Evaluations...................................................................................118
8.7.
Pharmacokinetic Analysis................................................................................................118
8.8.
Immunogenicity Analysis................................................................................................119
8.9.
Sample Size......................................................................................................................119
9.
RESPONSIBILITIES ...................................................................................................................120
9.1.
Investigator Responsibilities............................................................................................120
9.1.1.
Good Clinical Practice.......................................................................................120
9.1.2.
Financial Disclosure ..........................................................................................120
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval............................................................................................................120
9.1.4.
Informed Consent ..............................................................................................120
9.1.5.
Confidentiality...................................................................................................121
9.1.6.
Case Report Forms ............................................................................................121
9.1.7.
Study Files and Retention of Records ...............................................................122
9.1.8.
Investigator Inspections.....................................................................................123
9.1.9.
Protocol Compliance .........................................................................................123
9.2.
Sponsor Responsibilities..................................................................................................123
9.2.1.
Protocol Modifications ......................................................................................123
9.2.2.
Study Report and Publications ..........................................................................123
9.3.
Joint Investigator/Sponsor Responsibilities.....................................................................124
9.3.1.
Payment Reporting ............................................................................................124
9.3.2.
Access to Information for Monitoring...............................................................124
9.3.3.
Access to Information for Auditing or Inspections ...........................................124
9.3.4.
Study Discontinuation .......................................................................................124
10.
REFERENCES .............................................................................................................................125
11.
APPENDICES ..............................................................................................................................131
Appendix 1.
Investigator Signature Page...............................................................................132
Appendix 2.
Schedules of Assessments .................................................................................133
Appendix 3.
Pandemic Risk Assessment and Mitigation Plan ..............................................141
Appendix 4.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements............................................................................145
Appendix 5.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities...................................................................................................156
Appendix 6.
Disease Response Criteria Based on International Myeloma Working Group 
(IMWG) 2016 Criteria .....................................................................................157
Appendix 7.
Eastern Cooperative Oncology Group Performance Status ..............................161
Appendix 8.
Cockcroft-Gault Method for Estimating Creatinine Clearance.........................162
Appendix 9.
FACT-MM (Version 4) {Facit.org 2009}.........................................................163
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Appendix 10.
Myeloma Frailty Score Calculator ....................................................................166
Appendix 11.
Amendment History ..........................................................................................167
LIST OF IN-TEXT TABLES
Table 1.
Objectives and Endpoints for the Safety Run-in Cohorts ...................................43
Table 2.
Objectives and Endpoints for the Dose-expansion Cohorts................................43
Table 3.
Stopping Boundary Due to Toxicity for Each Cohort.........................................48
Table 4.
Magrolimab Dose De-escalation and Schedule (All Safety Run-in Cohorts).....62
Table 5.
Magrolimab Dose Level and Schedule (All Dose-expansion Cohorts) ..............62
Table 6.
Dose Level and Schedule for Daratumumab in Combination With Magrolimab
............................................................................................................................64
Table 7.
Dose Level and Schedule for Pomalidomide and Dexamethasone in 
Combination With Magrolimab.........................................................................66
Table 8.
Dose Level and Schedule for Carfilzomib and Dexamethasone in Combination 
With Magrolimab...............................................................................................67
Table 9.
Dose Level and Schedule for Bortezomib and Dexamethasone in Combination 
With Magrolimab...............................................................................................68
Table 10.
Magrolimab Dosing Guidance for Planned Surgical Procedures on Study ........70
Table 11.
Repriming Guidelines..........................................................................................70
Table 12.
Management of Daratumumab-related Dosing Delays .......................................71
Table 13.
Pomalidomide Dose Modifications .....................................................................73
Table 14.
Pomalidomide Dose Reduction Levels ...............................................................73
Table 15.
Carfilzomib Dose Modifications .........................................................................75
Table 16.
Carfilzomib Dose Reduction Levels ...................................................................76
Table 17.
Bortezomib Dose Modifications..........................................................................76
Table 18.
Bortezomib Dose Reduction Levels....................................................................77
Table 19.
Dose Reductions for Low-Dose Dexamethasone-related Toxicities...................77
Table 20.
Low-Dose Dexamethasone Dose Reduction Levels ...........................................78
Table 21.
Prohibited Prior Medications...............................................................................78
Table 22.
Laboratory Analyte Listing (to be Performed at Screening)...............................84
Table 23.
Laboratory Analyte Listing (to be Performed During Treatment) ......................86
Table 24.
Management of Infusion-Related Reactions .....................................................109
Table 25.
Pneumonitis Management Algorithm................................................................111
LIST OF IN-TEXT FIGURES
Figure 1.
Effect of Magrolimab on Anemia and Mitigation with a Priming/Maintenance 
Dosing Regimen.................................................................................................31
Figure 2.
In Vitro Assessment of Synergy in MM Cell Lines............................................39
Figure 3.
In Vitro Assessment of Bortezomib Combined With CD47-targeted Antibodies
............................................................................................................................40
Figure 4.
Study Schema ......................................................................................................45


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Study Title: 
A Phase 2 Multi-Arm Study of Magrolimab Combinations in 
Patients With Relapsed/Refractory Multiple Myeloma
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
118300
2021-001798-21
NCT04892446
Study Centers 
Planned:
Approximately 50 centers globally
Objectives and 
Endpoints:
Safety Run-in Cohorts
Primary Objective
Primary Endpoint
•
To evaluate the safety and 
tolerability of magrolimab in 
combination with other anticancer 
therapies and to determine the 
recommended Phase 2 dose 
(RP2D) of magrolimab for the 
following combinations in patients 
with relapsed/refractory multiple 
myeloma (MM):

Magrolimab in combination 
with daratumumab

Magrolimab in combination 
with pomalidomide and 
dexamethasone

Magrolimab in combination 
with carfilzomib and 
dexamethasone

Magrolimab in combination 
with bortezomib and 
dexamethasone
•
The incidence of dose-limiting 
toxicities (DLTs), adverse 
events (AEs), and laboratory 
abnormalities according to the 
National Cancer Institute 
(NCI) Common Terminology 
Criteria for Adverse Events 
(CTCAE) Version 5.0


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Dose-expansion Cohorts
Primary Objective
Primary Endpoint
•
To evaluate the efficacy of 
magrolimab in combination with 
other anticancer therapies in 
patients with relapsed/refractory 
MM as determined by objective 
response rate (ORR)
•
ORR, defined as the 
percentage of patients who 
achieve stringent complete 
response (sCR), complete 
response (CR), very good 
partial response (VGPR), or 
partial response (PR)a
Secondary Objectives
Secondary Endpoints
•
To evaluate the safety and 
tolerability of magrolimab in 
combination with other anticancer 
therapies
•
The incidence of AEs and 
laboratory abnormalities 
according to the NCI CTCAE 
Version 5.0
•
To investigate other parameters of 
efficacy including the duration of 
response
•
Duration of response (DOR)a
•
To evaluate the pharmacokinetics 
(PK) and immunogenicity of 
magrolimab in combination with 
other anticancer therapies in 
patients with relapsed/refractory 
MM
•
Magrolimab concentration 
versus time
•
Measurements of antidrug 
antibody (ADA) against 
magrolimab
a
Response assessments will be performed per the International Myeloma Working 
Group (IMWG) 2016 criteria.
Study Design:
Number of 
Patients Planned:
Approximately 153 patients will be enrolled in the study, with up 
to 27 in each safety run-in cohorts (up to 9 patients at each of the 
3 possible dose levels; total up to 81 patients) and approximately 
72 patients in the dose-expansion cohorts.
Target 
Population:
Patients with relapsed/refractory MM.
Duration of 
Treatment:
The length of Cycle 1 will be 35 days; all subsequent cycles will 
be 28 days. All patients will continue on study treatment until they 
meet study treatment discontinuation criteria.
Diagnosis and 
Main Eligibility 
Criteria:
Inclusion Criteria: All patients must meet all the following 
inclusion criteria to be eligible for participation in this study:
1) Patient has been previously diagnosed with MM based on the 
International Myeloma Working Group (IMWG) 2016 criteria 
and currently requires treatment.


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2) Patients must have measurable disease as defined by 1 or more 
of the following:
a) Serum monoclonal protein (M-protein) ≥ 0.5 g/dL 
(≥ 5 g/L)
b) Urine M-protein ≥ 200 mg/24 h
c) Serum free light chain (SFLC) assay: involved SFLC level 
≥ 10 mg/dL (100 mg/L) with abnormal SFLC ratio
3) Patient has provided informed consent
4) Patient is willing and able to comply with clinic visits and 
procedures outlined in the study protocol.
5) Male or female ≥ 18 years of age
6) Eastern Cooperative Oncology Group (ECOG) performance 
status ≤ 2
7) Life expectancy ≥ 3 months
8) Absolute neutrophil count ≥ 1000 cells/μL (1.0  109/L); 
granulocyte colony-stimulating factor is not permitted within 
1 week of screening to meet eligibility criteria.
9) Platelet count ≥ 75,000 cells/μL (75  109/L); platelet 
transfusion is not permitted within 1 week of screening to meet 
eligibility criteria.
10) Hemoglobin must be ≥ 9 g/dL prior to initial dose of study 
treatment. NOTE: Transfusions are allowed to meet 
hemoglobin eligibility.
11) Criterion removed.
12) Adequate liver function as demonstrated by the following:
a) Aspartate aminotransferase ≤ 3.0  upper limit of normal 
(ULN)
b) Alanine aminotransferase ≤ 3.0  ULN
c) Total bilirubin ≤ 1.5  ULN (or ≤ 3.0  ULN and primarily 
unconjugated if patient has a documented history of 
Gilbert’s syndrome or genetic equivalent).
13) International normalized ratio (INR) ≤ 1.2; patients receiving 
anticoagulation treatment may be allowed to participate if INR 
is within the therapeutic range prior to alternate assignment.
14) Patients must have adequate renal function as demonstrated by 
a creatinine clearance ≥ 30 mL/min calculated by the 
Cockcroft-Gault formula or measured by 24 hours urine 
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15) Corrected serum calcium ≤ 2.9 mmol/L (11.5 mg/dL); 
measures to reduce calcium to acceptable levels, such as a 
short course of steroids, bisphosphonates, hydration, or 
calcitonin are acceptable.
16) Pretreatment blood cross-match completed.
17) Male and female patients of childbearing potential who engage 
in heterosexual intercourse must agree to use 
protocol-specified method(s) of contraception.
18) Patients must be willing to consent to mandatory pretreatment 
and on-treatment bone marrow biopsies (trephines).
Magrolimab in Combination with Daratumumab: In addition to 
fulfilling the inclusion criteria for all patients, patients who are 
assigned to receive magrolimab in combination with daratumumab 
should fulfill the following:
19) Patients must have received at least 3 previous lines of therapy 
for MM including an immunomodulatory drug (IMiD) such as 
lenalidomide and a proteasome inhibitor (PI) such as 
bortezomib.
20) Patients must have not had prior anti-CD38 antibody therapy 
for at least 6 months prior to enrollment.
21) No prior history of discontinuation of daratumumab due to 
toxicity
Magrolimab in Combination with Pomalidomide and 
Dexamethasone: In addition to fulfilling the inclusion criteria for 
all patients, patients who are assigned to receive magrolimab in 
combination with pomalidomide and dexamethasone should fulfill 
the following:
22) Patients must have received at least 3 previous lines of therapy 
for MM including an IMiD such as lenalidomide and a PI such 
as bortezomib.
23) Prior treatment with pomalidomide is allowed if the patient 
achieved at least a PR to the most recent pomalidomide 
therapy and will have had at least a 6-month treatment-free 
interval from the last dose of pomalidomide until first study 
treatment.
24) No prior history of discontinuation of pomalidomide due to 
toxicity
25) No contraindication to dexamethasone


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Magrolimab in Combination with Carfilzomib and 
Dexamethasone: In addition to fulfilling the inclusion criteria for 
all patients, patients who are assigned to receive magrolimab in 
combination with carfilzomib and dexamethasone should fulfill 
the following:
26) Patient must have received at least 3 previous lines of therapy 
for MM including an IMiD such as lenalidomide and a PI such 
as bortezomib.
27) Prior treatment with a PI, including carfilzomib, is allowed if 
the patient achieved at least a PR to the most recent prior PI 
therapy, and will have had at least a 6-month PI treatment-free 
interval from the last dose until first study treatment.
28) No prior history of discontinuation of carfilzomib due to 
toxicity.
29) No contraindication to dexamethasone
Magrolimab in Combination with Bortezomib and 
Dexamethasone:
In addition to fulfilling the inclusion criteria for all patients, 
patients who are assigned to receive magrolimab in combination 
with bortezomib and dexamethasone should fulfill the following:
30) Patient must have received at least 1 previous line of therapy 
for MM.
31) Prior treatment with a PI, including bortezomib, is allowed if 
the patient achieved at least a PR to the most recent prior PI 
therapy, and will have had at least a 6-month PI treatment-free 
interval from the last dose until first study treatment.
32) No prior history of discontinuation of bortezomib due to 
toxicity.
33) No contraindication to dexamethasone.
Exclusion Criteria: Patients who meet any of the following 
exclusion criteria are not eligible to be enrolled in this study:
1) Patients with known amyloidosis including myeloma 
complicated by amyloidosis
2) Multiple myeloma of immunoglobulin M subtype
3) Patients with Waldenstrom’s macroglobulinemia
4) Patients with myelodysplastic syndrome
5) Plasma cell leukemia (defined as either 20% of peripheral 
blood white blood cell count comprised of 


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plasma/CD138-positive cells) or circulating plasma cells 
≥ 2 × 109/L
6) Patients with solitary bone or extramedullary plasmacytoma as 
the only evidence of plasma cell dyscrasia
7) POEMS syndrome (plasma cell dyscrasia with 
polyneuropathy, organomegaly, endocrinopathy, M-protein, 
and skin changes)
8) Glucocorticoid therapy (prednisone > 40 mg/day or 
equivalent) within 14 days prior to enrollment; corticosteroid 
therapy for hypercalcemia is allowed
9) Chemotherapy with approved or investigational anticancer 
therapeutics within 28 days prior to enrollment
10) Focal radiation therapy within 7 days prior to enrollment; 
radiation therapy to an extended field involving a significant 
volume of bone marrow within 21 days prior to enrollment (ie, 
prior radiation must have been to less than 30% of the bone 
marrow)
11) Immunotherapy within 28 days prior to enrollment
12) Major surgery (excluding procedures to stabilize the vertebrae) 
within 28 days prior to enrollment
13) Positive serum pregnancy test (Appendix 4)
14) Breastfeeding female
15) Known hypersensitivity to any of the study drugs, the 
metabolites, or formulation excipient
16) Prior treatment with CD47 or signal regulatory protein alpha 
(SIRPα)-targeting agents
17) Current participation in another interventional trial
18) Autologous stem cell transplant (SCT) < 100 days prior to 
enrollment
19) Considered eligible to receive autologous or allogeneic SCT at 
the time of enrollment
20) Allogeneic SCT for the treatment of MM within 6 months of 
enrollment or active graft-versus-host disease requiring 
immunosuppression
21) Significant neuropathy (Grade 3 to 4, or Grade 2 with pain) 
within 14 days prior to enrollment
22) Known inherited or acquired bleeding disorders


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23) Known cirrhosis.
24) Clinical suspicion or documentation of central nervous system 
(CNS) disease.
25) Significant disease or medical conditions, as assessed by the 
investigator and sponsor, that would substantially increase the 
risk-benefit ratio of participating in the study; this includes, 
but is not limited to, acute myocardial infarction within the last 
6 months, unstable angina, uncontrolled diabetes mellitus, 
significant active infections, congestive heart failure, or 
NYHA Class III or IV heart failure.
26) Acute active infection requiring systemic antibiotics, antiviral 
(except antiviral therapy directed against reactivation) or 
antifungal agents within 14 days prior to enrollment.
27) Second malignancy, except treated basal cell or localized 
squamous skin carcinomas, localized prostate cancer, or other 
malignancies for which patients are not on active anticancer 
therapies and have had no evidence of active malignancy for at 
least 1 year; other exceptions may be considered with sponsor 
approval. Previous hormonal therapy with luteinizing 
hormone-releasing hormone agonists for prostate cancer and 
treatment with bisphosphonates and receptor activator of 
nuclear factor kappa-B ligand (RANKL) inhibitors are not 
criteria for exclusion.
28) Known active or chronic hepatitis B or C infection or HIV 
infection in medical history.
29) Active hepatitis B virus (HBV) and/or active hepatitis C virus 
(HCV), and/or HIV following testing at screening:
a) Patients who test positive for hepatitis B surface antigen 
(HBsAg). Patients who test positive for hepatitis B core 
antibody (anti-HBc) will require HBV DNA by 
quantitative polymerase chain reaction (PCR) for 
confirmation of active disease.
b) Patients who test positive for HCV antibody. Patients who 
test positive for HCV antibody will require HCV RNA by 
quantitative PCR for confirmation of active disease.
c) Patients who test positive for HIV.
30) Patients who received any live vaccine within 4 weeks prior to 
initiation of study treatments. 
Study Procedures/
Frequency:
Screening will commence with obtaining the patient’s signed 
informed consent and will occur up to 30 days prior to the first 


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dosing of study drug. Screening procedures include medical 
history review; complete physical examination; vital signs; 
12-lead electrocardiogram (ECG) and echocardiogram 
(ECHO)/multigated acquisition (MUGA) scan; ECOG 
Performance Status, blood collection for chemistry, for complete 
blood count with differential, platelets, reticulocytes, SFLC 
analysis, blood phenotyping or genotyping for minor antigens, 
serum protein electrophoresis (SPEP), serum pregnancy test, urine 
collection for urine analysis and 24-hour urine protein 
electrophoresis (UPEP), peripheral blood smear, bone marrow 
aspirate/biopsy, skeletal survey, computed tomography (CT) (with 
or without positron emission tomography [PET]) or magnetic 
resonance imaging (MRI) assessment for extramedullary soft 
tissue plasmacytoma, Functional Assessment of Cancer 
Therapy-Multiple Myeloma (FACT-MM) questionnaire (not 
collected after Protocol Amendment 6), myeloma frailty score 
calculation (patients ≥ 65 years of age), prior/concomitant 
medication review, and recording of any serious adverse events 
(SAEs) and all AEs related to protocol-mandated procedures after 
signed informed consent.
Eligible patients will return to the study site within 30 days after 
screening for completion of baseline/Day 1 assessments and 
enrollment into applicable treatment cohort, magrolimab + 
daratumumab; magrolimab + pomalidomide + dexamethasone; 
magrolimab + carfilzomib + dexamethasone; or magrolimab + 
bortezomib + dexamethasone. The length of Cycle 1 will be 
35 days; all subsequent cycles will be 28 days. On-treatment 
assessments include clinical laboratory evaluations, PK, antidrug 
antibody evaluations, bone marrow aspirate/biopsy assessments, 
bone lesion assessments, response assessments, FACT-MM 
questionnaire (not collected after Protocol Amendment 6), vital 
signs, and monitoring for AEs and concomitant medications.
Patients may continue treatment unless they meet study treatment 
discontinuation criteria. 


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Test Product, Dose, 
and Mode of 
Administration:
Magrolimab Dose De-escalation and Schedule (All Safety 
Run-in Cohorts)
Dose 
Level
Magrolimab Dosing
Starting 
Dose
30 mg/kg
•
Cycle 1: 1 mg/kg IV on Day 1, 30 mg/kg on Days 8, 15, 
22, 29
•
Cycle 2: 30 mg/kg IV every week on Days 1, 8, 15, 22
•
Cycle 3 and onward: 30 mg/kg IV on Days 1, 15
Level −1
20 mg/kg
•
Cycle 1: 1 mg/kg IV on Day 1, 20 mg/kg on Days 8, 15, 
22, 29
•
Cycle 2: 20 mg/kg IV every week on Days 1, 8, 15, 22
•
Cycle 3 and onward: 20 mg/kg IV on Days 1, 15
Level −2
15 mg/kg
•
Cycle 1: 1 mg/kg IV on Day 1, 15 mg/kg on Days 8, 15, 
22, 29
•
Cycle 2: 15 mg/kg IV every week on Days 1, 8, 15, 22
•
Cycle 3 and onward: 15 mg/kg IV on Days 1, 15
IV = intravenous
Magrolimab Dose Level and Schedule (All Dose-Expansion 
Cohorts)
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles are 
28 Days)
RP2Da
Cycle 1
Cycle 2
Cycle 3+
30 mg/kg
1 mg/kg IV Day 1 
(priming dose)
and
30 mg/kg IV Days 8, 
15, 22, 29
30 mg/kg IV
Days 1, 8, 15, 22
30 mg/kg IV
Days 1, 15
20 mg/kg
1 mg/kg IV Day 1 
(priming dose)
and
20 mg/kg IV Days 8, 
15, 22, 29
20 mg/kg IV
Days 1, 8, 15, 22
20 mg/kg IV
Days 1, 15
15 mg/kg
1 mg/kg IV Day 1 
(priming dose)
and
15 mg/kg IV Days 8, 
15, 22, 29
15 mg/kg IV
Days 1, 8, 15, 22
15 mg/kg IV
Days 1, 15
IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in the safety run-in cohorts.


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Dose Level and Schedule for Daratumumab in Combination 
with Magrolimab
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles 
are 28 Days)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Daratumumab
16 mg/kg IV
or
1800 mg SC
Days 8, 15, 
22, 29
Days 1, 8, 15, 
22
Days 1 and 15 
(every 2 weeks) until 
Cycle 6 (total of 
8 doses) followed by 
Day 1 (every 
4 weeks) for 
subsequent cycles
IV = intravenous; SC = subcutaneous
Dose Level and Schedule for Pomalidomide and 
Dexamethasone in Combination with Magrolimab
Dose Schedule (Cycle 1 is 35 Days; All Other 
Cycles are 28 Days)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Pomalidomide
4 mg PO
Days 1 to 21 
(daily)
Days 1 to 21 
(daily)
Days 1 to 21 
(daily)
Dexamethasone
40 mg POa
Days 1, 8, 
15, 22, 29
Days 1, 8, 15, 22
Days 1, 8, 15, 22
PO = orally
a
Dexamethasone starting dose is 20 mg in patients more than 75 years of age.
Dose Level and Schedule for Carfilzomib and Dexamethasone 
in Combination with Magrolimab
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles 
are 28 Days)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Carfilzomib
20/70 mg/m2 IVa
Days 8 
(20 mg/m2), 15 
(70 mg/m2), 22 
(70 mg/m2)
Days 1, 8, 15b 
Days 1, 8 15b
Dexamethasone
40 mg PO or IVc
Days 8, 15, 22, 
and 29
Days 1, 8, 15, 
and 22
Days 1, 8, 15, and 
22 until Cycle 9 
and Days 1, 8, 
and 15 from 
Cycle 10 onward
IV = intravenous; PO = orally
a
The recommended starting dose of carfilzomib is 20 mg/m2 on Cycle 1, Day 8. If 
tolerated, escalate the dose to 70 mg/m2 on Cycle 1, Day 15 and thereafter.
b
From Cycle 2 onwards, carfilzomib will be given on Days 1, 8 and 15. 
Dexamethasone starting dose is 20 mg in patients more than 75 years of age.


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Dose Level and Schedule for Bortezomib and Dexamethasone 
in Combination with Magrolimab
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles 
are 28 Days)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Bortezomib
1.3 mg/m2 SC or 
IVa
Days 8, 15, 22, 
29
Days 1, 8, 15, 22
Days 1, 8 15, 
22b
Dexamethasone
40 mg POc
Days 1, 8, 15, 
22, 29
Days 1, 8, 15, 22
Days 1, 8, 15, 
22d
IV = intravenous; PO = orally; SC = subcutaneous
a
SC is preferred over IV, where feasible.
b
Maximum of 8 cycles in those who have previously received bortezomib.
c
Dexamethasone starting dose is 20 mg in patients more than 75 years of age.
d
Days 1, 8, 15, and 22 from Cycles 3 to 9 and then Days 1, 8, and 15 from Cycle 10 
onward.
Reference Therapy, 
Dose, and Mode of 
Administration:
Not applicable
Criteria for 
Evaluation:
Safety:
Safety will be assessed by evaluating occurrence of DLTs in 
patients in the safety run-in cohorts, the incidence of AEs, clinical 
laboratory test findings, physical examination, 12-lead 
electrocardiogram, ECOG performance status, and vital signs 
measurements. AEs will be graded using the NCI CTCAE Version 
5.0.
Efficacy:
Response assessment will be performed by the investigator 
according to the IMWG 2016 criteria. Efficacy will be evaluated 
by ORR, DOR, and time to response (TTR).
Objective response rate is defined as the percentage of patients 
who achieve sCR, CR, VGPR, or PR.
Pharmacokinetics:
Serum magrolimab concentration will be assessed before the first 
dose and at specified time points after start of treatment. 
Immunogenicity:
Immunogenicity assessments will be conducted before the first 
dose and at specified time points after start of treatment to detect 
and measure antidrug antibodies against magrolimab.


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Statistical Methods:
Analysis Data Sets:
Full Analysis Set: The primary analysis set for efficacy analysis is 
the Full Analysis Set (FAS). The FAS includes all enrolled 
patients who received at least 1 dose of study treatment with 
treatment group designated according to the planned treatment 
assigned at enrollment.
Safety Analysis Set: The analysis set for safety analyses is the 
Safety Analysis Set. It includes all patients who received at least 
1 dose of study treatment with treatment group designated 
according to the actual treatment received. This analysis set will 
be used in the analyses of safety endpoints as well as study 
treatment administration. All data collected during treatment up to 
70 days after treatment discontinuation will be included in the 
safety summaries.
DLT-Evaluable Analysis Set: The DLT-Evaluable Analysis Set 
includes all patients in the Safety Analysis Set who are enrolled in 
the safety run-in cohorts and fulfill either of the following criteria:
•
Experienced a DLT after initiation of the first infusion of 
magrolimab during the DLT assessment period
•
Completed DLT assessment period and received at least 
3 infusions of magrolimab and the following cohort-specific 
criteria:
Magrolimab in combination with daratumumab cohort: 
Completed at least 2 doses of daratumumab
Magrolimab in combination with pomalidomide and 
dexamethasone cohort: Completed at least 10 doses of 
pomalidomide and 2 doses of dexamethasone
Magrolimab in combination with carfilzomib and 
dexamethasone cohort: Completed at least 2 doses of 
carfilzomib and 2 doses of dexamethasone
Magrolimab in combination with bortezomib and 
dexamethasone cohort: Completed at least 2 doses of 
bortezomib and 2 doses of dexamethasone
PK Analysis Set: The PK Analysis Set includes all enrolled 
patients who received at least 1 dose of magrolimab and have at 
least 1 measurable posttreatment serum concentration of 
magrolimab.
Immunogenicity Analysis Set: The Immunogenicity Analysis Set 
includes all enrolled patients who received at least 1 dose of 
magrolimab and have at least 1 evaluable anti-magrolimab 
antibody test result.


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Biomarker Analysis Set: The Biomarker Analysis Set includes 
all enrolled patients who received at least 1 dose of magrolimab 
and have the evaluable baseline and on-study measurements to 
provide interpretable results for the specific parameters of interest.
All Enrolled Set: The All Enrolled Analysis Set includes all 
patients who received a study patient identification number in the 
study after screening. This will be the primary analysis set for 
analyses of patient demographic and baseline characteristics, 
enrollment, and disposition.
Planned Analyses:
Efficacy analysis: Efficacy analysis will be based on the Full 
Analysis Set. For the primary efficacy endpoint ORR, the point 
estimate and the corresponding 2-sided exact 95% CI based on 
Clopper-Pearson method will be provided for each cohort. 
Objective response rate will also be tested against the historical 
control rate of 25% using 1-group Chi-square test for each cohort 
separately.
The medians, first quartile (Q1), and third quartile (Q3) of DOR 
will be estimated using the Kaplan-Meier (KM) method along 
with the corresponding 95% CIs. KM curves will be provided. For 
DOR, the analysis will include only patients who achieve an 
objective response.
Safety analysis: All safety data collected on or after the date that 
any drug in a study treatment regimen was first administered up to 
the date of the last dose of any drug in a study treatment regimen 
plus 70 days will be summarized by treatment cohort based on the 
Safety Analysis Set. Dose limiting toxicities will be summarized 
based on the DLT-Evaluable Set for safety run-in cohorts. Data for 
the pretreatment will be included in data listings. For categorical 
safety data, including incidence of AEs and categorizations of 
laboratory data, the number and percentage of patients will be 
summarized. For continuous safety data, including laboratory data, 
the number of patients, mean, standard deviation, minimum, 
quartiles, median, and maximum will be summarized.
PK analysis: The PK Analysis Set will be used for summaries of 
PK concentration of magrolimab versus time. Due to the sparse 
nature of PK collection, PK parameters will not be calculated. 
Summary statistics will be presented for magrolimab serum 
concentrations at each scheduled time point. Descriptive graphical 
plots of individual serum concentration versus time profiles and 
mean concentration versus time profiles will be generated.


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Immunogenicity analysis: Immunogenicity will be assessed using 
a 3-tier-screen, confnmato1y , and titer - approach on study 
samples using a validated immunoassay. The rate and magnitude 
of anti-magrolimab antibody incidence, prevalence, persistence, 
and transience will be summarized for the Immunogenicity 
Analysis Set. 
Sample Size Calculation: 
For each of the dose-expansion cohorts, a sample size of 30 
(24 expansion patients together with the 6 patients from the safety 
nm-in coho1i), provides 86.1 % power for a I-group Chi-square 
test at a I-sided alpha of 0.1 to detect ORR of:::: 45% for the 
combination treatment compared with a historical control ORR of 
25%. 
The historical control ORR of25% is based on outcomes from the 
MAMMOTH study; the subset of patients treated with any 
daratumumab-containing regimen, including daratumumab in 
combination with an IMiD or PI, following at least 1 prior 
treatment. 
This study will be conducted in accordance with the guidelines of Good Clinical Practice, 
including archiving of essential documents. 
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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
ABO
any of the 4 blood groups A, B, AB, and O composing the ABO system
ADA
antidrug antibody
ADCP
antibody-dependent cellular phagocytosis
AE
adverse event
ALT
alanine aminotransferase
AML
acute myeloid leukemia
ANC
absolute neutrophil count
anti-HBc
hepatitis B core antibody
ASCO
American Society of Clinical Oncology
AST
aspartate aminotransferase
CD38
cluster of differentiation 38
CD47
cluster of differentiation 47
CDC
complement-dependent cytotoxicity
CI
confidence interval
CMV
cytomegalovirus
CNS
central nervous system
CR
complete response
CRF
case report form
CRP
C-reactive protein
CSR
clinical study report
CT
computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
CTCL
cutaneous T-cell lymphoma
CYP
cytochrome P450
DAT
direct antiglobulin test
DC
dendritic cell
DEX
dexamethasone
DKd
daratumumab and dexamethasone
DLBCL
diffuse large B-cell lymphoma
DLT
dose-limiting toxicity
DNA
deoxyribonucleic acid
DOR
duration of response
DVd
daratumumab/bortezomib/dexamethasone
ECG
electrocardiogram
ECHO
echocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDC
electronic data capture


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ELISA
enzyme-linked immunosorbent assay
EOT
end of treatment
EU
European Union
FACT-MM
Functional Assessment of Cancer Therapy-Multiple Myeloma
FAS
Full Analysis Set
Fc
crystallizable fragment
FcR
Fc receptor
FDA
Food and Drug Administration
FL
follicular lymphoma
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
G-CSF
granulocyte colony-stimulating factor
Gilead
Gilead Sciences
GLP
Good Laboratory Practice
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
HCV
hepatitis C virus
HIV
human immunodeficiency virus
HR
hazard ratio
IB
investigator’s brochure
ICF
informed consent form
ICH
International Council for Harmonisation (of Technical Requirements for 
Pharmaceuticals for Human Use)
IEC
independent ethics committee
IFE
immunofixation electrophoresis
Ig
immunoglobulin
IgG4
immunoglobulin G4
IL
interleukin
IMiD
immunomodulatory drug
IMWG
International Myeloma Working Group
INR
international normalized ratio
IRB
institutional review board
IRR
infusion-related reaction
IUD
intrauterine device
IV
intravenous(ly)
IXRS
interactive voice/web response system
KD
dissociation constant
Kd
Kyprolis and dexamethasone
KM
Kaplan-Meier
KRd
Kyprolis with lenalidomide and dexamethasone


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mAb
monoclonal antibody
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary for Regulatory Activities
MGUS
monoclonal gammopathy of undetermined significance
MM
multiple myeloma
MOA
mechanism of action
M-protein
monoclonal protein
MR
minimal response
MRD
minimal residual disease
MRI
magnetic resonance imaging
mRNA
messenger RNA
MTD
maximum tolerated dose
MUGA
multigated acquisition (scan)
NCCN
National Comprehensive Cancer Network
NCI
National Cancer Institute
NGS
next-generation sequencing
NHL
non-Hodgkin lymphoma
NK
natural killer
NYHA
New York Heart Association
ORR
objective response rate
OS
overall survival
PBMC
peripheral blood mononuclear cell
PCR
polymerase chain reaction
PD
progressive disease
PET
positron emission tomography
PFS
progression-free survival
PI
proteasome inhibitor
PK
pharmacokinetic(s)
PO
orally
POM
pomalidomide alone
POM-DEX
pomalidomide + dexamethasone
PR
partial response
PRO
patient-reported outcome
PS
Patient Safety
PT
prothrombin time
Q1
first quartile
Q3
third quartile
QOL
quality of life
RANKL
receptor activator of nuclear factor kappa-B ligand
RBC
red blood cell


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Rd
lenalidomide and dexamethasone alone
REMS
risk evaluation and mitigation strategy
Rh
Rhesus factor
RNA
ribonucleic acid
RP2D
recommended Phase 2 dose
SAE
serious adverse event
SC
subcutaneous(ly)
sCR
stringent complete response
SCT
stem cell transplant
SD
stable disease
SFLC
serum free light chain
SIFE
serum immunofixation
SIRPα
signal regulatory protein alpha
SmPC
summary of product characteristics
SOP
standard operating procedure
SPEP
serum protein electrophoresis
SRT
Safety Review Team
SSR
special situation report
SUSAR
suspected unexpected serious adverse reaction
TNF
tumor necrosis factor
TTR
time to response
UIFE
urine immunofixation
ULN
upper limit of normal
UPEP
urine protein electrophoresis
US
United States
USPI
United States prescribing information
Vd
bortezomib and dexamethasone
VGPR
very good partial response
VMP
bortezomib-melphalan-prednisone
VMPT
bortezomib-melphalan-prednisone-thalidomide
WBC
white blood cell
w/v
weight-to-volume
WGS
whole genome sequencing


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1.
INTRODUCTION
1.1.
Background
Multiple myeloma (MM) is a clonal plasma cell disorder that accounts for 1% of all cancers 
and approximately 10% of hematological malignancies. Each year over 32,000 cases are 
diagnosed in the United States (US) and almost 13,000 patients die of the disease {Rajkumar 
2020}. Despite the availability of proteasome inhibitors (PIs), immunomodulatory agents, 
and monoclonal antibodies (mAbs) for MM, most patients will relapse and develop 
refractory disease. Treatment of patients with relapsed/refractory MM remains challenging 
despite numerous therapeutic advances. Patients with disease refractory to 
immunomodulatory drugs, PIs, and anti-CD38 mAbs have a poor prognosis, with newer 
combination therapies such as selinexor plus dexamethasone resulting in 26% of patients 
achieving an objective response (median progression-free survival [PFS] of 3.7 months and 
median overall survival (OS) of 8.6 months) {Chari 2019}. Recently, the DREAMM-2 study 
reported an objective response rate (ORR) of up to 34% in relapsed/refractory patients 
treated with belantamab mafodotin who had disease progression after 3 or more lines of 
therapy and were refractory to immunomodulatory drugs and PIs, and refractory or intolerant 
(or both) to an anti-CD38 mAb {Lonial 2020}. Therefore, effective novel therapies with 
acceptable safety profiles are needed to increase the response rates in later lines as well as to 
enhance the depth and durability of response.
CD47 is a key molecule mediating cancer cell evasion of innate immune surveillance. CD47 
expression is a well-characterized mechanism by which cancer cells, including cancer stem 
cells, overcome phagocytosis due to intrinsic expression of prophagocytic “eat me” signals 
{Jaiswal 2009, Majeti 2009}. The progression from normal cell to cancer cell involves 
changes in genes and gene expression that trigger programmed cell death and programmed 
cell removal {Chao 2012}. Many of the steps in cancer progression subvert the multiple 
mechanisms of programmed cell death, and the expression of the dominant antiphagocytic 
signal, CD47, may represent an important checkpoint {Chao 2012}. In mouse xenograft 
models, CD47-blocking mAbs inhibit human xenograft tumor growth and metastasis by 
enabling the phagocytosis and elimination of cancer cells from various hematologic 
malignancies and solid tumors {Chao 2011a, Chao 2010a, Chao 2011b, Edris 2012, Kim 
2012, Majeti 2009, Willingham 2012}. Binding of CD47 expressed by cancer cells to signal 
regulatory protein alpha (SIRPα) expressed on phagocytes leads to inhibition of tumor cell 
phagocytosis. Thus, blockade of the CD47 SIRPα-signaling pathway by an anti-CD47 
antibody leads to phagocytosis and elimination of tumor cells. Selective targeting of tumor 
cells by an anti-CD47 antibody is due to the presence of prophagocytic signals expressed 
mainly on tumor cells and not on normal cell counterparts {Chao 2010b}.


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There is growing body of evidence that suggests that the overexpression of CD47 contributes 
to the pathogenesis of MM. A study of 37 MM patient samples demonstrated that myeloma 
cells express higher levels of CD47 by flow cytometry compared with patient-matched 
normal bone marrow cells {Kim 2012}. Herein, blocking CD47 with B6H12 antibodies 
increased phagocytosis of myeloma cells in vitro. In mice engrafted MM models, the 
anti-CD47 antibody B6H12 inhibited the growth of myeloma cells and led to significant 
tumor regression and eradication, with a response rate of 72% versus 19% in the control 
group at 6 weeks. An analysis of patient samples with MM (n = 171 patients) and 
monoclonal gammopathy of undetermined significance (MGUS) (n = 18 patients) showed 
that CD47 messenger RNA (mRNA) levels increased with progression from MGUS to MM. 
A very recent study has reported that MM cells had remarkably higher CD47 expression than 
other cell populations in the bone marrow and that blocking of CD47 using an anti-CD47 
antibody induced immediate activation of macrophages and eliminated MM cells in the 
3D-tissue engineered bone marrow model, as early as 4 hours after exposure {Sun 2020}. 
Taken together, these findings indicate that CD47 is specifically expressed on MM and can 
be used as a potential therapeutic target.
Magrolimab (GS-4721, formerly Hu5F9-G4 or 5F9) is a recombinant humanized anti-CD47 
mAb of the immunoglobulin G4 (IgG4) kappa isotype. There is extensive nonclinical and 
clinical experience with magrolimab across a range of hematological malignancies and in 
solid tumors, which is summarized below and in the investigator’s brochure (IB). This 
Phase 2 multi-arm study will investigate the efficacy, safety, and pharmacokinetics (PK) of 
magrolimab administered intravenously (IV) in combination with other anticancer therapies 
to patients with relapsed/refractory MM.
1.2.
Magrolimab
1.2.1.
General Information
Magrolimab is a humanized anti-CD47 mAb that blocks the interaction of CD47 with its 
receptor and enables phagocytosis of human cancer cells {Liu 2015}. The activity of 
magrolimab is primarily dependent on blocking CD47 binding to SIRPα and not on the 
recruitment of crystallizable fragment (Fc)-dependent effector functions, although the 
presence of the IgG4 Fc domain is required for its full activity. For this reason, magrolimab 
was engineered with a human IgG4 isotype that is relatively inefficient at recruiting 
Fc-dependent effector functions that might enhance toxic effects on normal CD47-expressing 
cells {Liu 2015}. Nonclinical studies using xenograft cancer models provide compelling 
evidence that magrolimab triggers phagocytosis and elimination of cancer cells from human 
solid tumors and hematologic malignancies. Based on this mechanism of action (MOA) and 
its potent nonclinical activity, magrolimab is being developed as a novel therapeutic 
candidate for solid tumors and hematologic malignancies.


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The magrolimab clinical development program represents a novel strategy for the treatment 
of cancer and is the first therapeutic agent to target the CD47-SIRPα axis. Extensive 
nonclinical studies have demonstrated activity against both human solid tumors (breast, 
ovarian, pancreas, colon, leiomyosarcoma, bladder, prostate, and others) and hematologic 
malignancies (acute myeloid leukemia [AML], acute lymphoblastic leukemia, non-Hodgkin 
lymphoma [NHL], myeloma, myelodysplastic syndromes [MDS], and others).
For further information on GS-4721 (magrolimab), refer to the current IB.
1.2.2.
Nonclinical Pharmacology and Toxicology
1.2.2.1.
Pharmacology
In vitro studies of magrolimab activity included protein and cell-based assays using cancer 
cell lines. Magrolimab showed high binding affinity to monomeric and bivalent human CD47 
antigen with a dissociation constant (KD) of 8 × 10−9 and 8 × 10−12 M, respectively. 
Magrolimab bound to cynomolgus monkey and human CD47 with high affinity of KD = 10 
and 8.0 pM, respectively, but did not bind to mouse CD47. No complement-dependent 
cytotoxicity (CDC) activity of magrolimab was observed in AML cells, and no 
antibody-dependent cellular cytotoxicity activity of magrolimab was observed in Raji and 
HL60 cells. Magrolimab-induced macrophage-mediated phagocytosis in rat myeloma and 
HL60 cells and did not induce apoptosis in AML cells. Nonclinical experiments in MM cell 
lines demonstrated that magrolimab inhibits the myeloma cell growth and proliferation both 
alone and in combination with other agents. (Figure 2).
Expression of CD47 was observed on human peripheral blood cells, and magrolimab did not 
trigger phagocytosis by human macrophages of normal red blood cells (RBCs) or normal 
human bone marrow cells in vitro but was a potent inducer of phagocytosis of 
CD47-expressing AML cells in vitro. Treatment of AML cells with hydroxyurea had no 
effect on magrolimab-induced phagocytosis, nor did treatment trigger magrolimab-induced 
phagocytosis of normal bone marrow cells. In contrast, the combination of magrolimab and 
avelumab effectively enhanced phagocytosis of ovarian cancer cells by human macrophages 
compared with magrolimab or avelumab alone. Moreover, the combination of magrolimab 
with cytotoxic agent azacitidine at a clinically relevant concentration enhanced phagocytosis 
of HL60 cells in vitro when compared with magrolimab or azacitidine alone.
Nonclinical in vivo pharmacology studies using xenograft cancer models provide compelling 
evidence that magrolimab triggers phagocytosis and elimination of cancer cells from multiple 
human solid tumors and hematological malignancies. Overall, magrolimab in combination 
with azacitidine, trastuzumab, rituximab, cetuximab, and panitumumab demonstrated 
additive effect on eliminating cancer cells, resulting in a long-term remission and increased 
survival of animals.


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Receptor occupancy assays showed that optimal antitumor activity (phagocytosis) in 
HL60 cells and primary human AML cells could be achieved without full CD47 receptor 
occupancy. The safety pharmacology evaluations as part of Good Laboratory Practice (GLP) 
8-week toxicology study demonstrated no magrolimab-related effects on central nervous 
system (CNS), cardiovascular, or respiratory function in cynomolgus monkey.
1.2.2.2.
Toxicology
In in vitro studies, magrolimab was not hemolytic and there was no evidence of adverse 
elevations of proinflammatory cytokines.
In the pivotal 8-week repeat-dose toxicology study, magrolimab was administered to 
cynomolgus monkeys via a 1-hour IV infusion as a priming dose of 5 mg/kg in Week 1 
(Day 1), followed by twice-weekly maintenance doses for 7 consecutive weeks at doses 
ranging from 5 to 100 mg/kg.
Treatment-related findings were limited to changes in hematology and clinical chemistry 
parameters and erythroid cell morphology.
Hematology changes included decreases in red cell mass associated with decreases in mean 
corpuscular volume and haptoglobin; increases in mean corpuscular hemoglobin 
concentration, reticulocytes, and red cell distribution width; red cell morphology changes 
including spherocytes (microcytes), eccentrocytes, atypical erythrocyte fragments consistent 
with erythrocyte injury, erythrocyte clumping, and large platelets; and changes associated 
with increased erythropoiesis consisting of anisocytosis, polychromatophilic macrocytes, and 
increased total bilirubin.
Changes in blood cell morphology were consistent with previous studies and considered to 
be associated with accelerated RBC destruction/clearance and increased erythropoiesis.
Additional clinical chemistry changes were observed at the highest dose only (100 mg/kg), 
which included a slight decrease in albumin, a slight increase in globulin, and a 
corresponding decrease in albumin:globulin ratio. There was partial to complete recovery for 
all treatment-related changes, with the exception of increased spleen weights in males and 
females at 50 and 100 mg/kg at recovery necropsy, which had no macroscopic or 
microscopic correlate. Based on these results, the highest-non-severely-toxic-dose for this 
study was considered to be 100 mg/kg, the highest dose evaluated.
Reproductive and developmental toxicology studies have not been conducted, but all the 
available data (literature, data from knockout mice and limited clinical data) suggests no role 
for CD47 on embryo-fetal development.


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1.2.3.
Clinical Background for Magrolimab
1.2.3.1.
Summary of Clinical Pharmacology
Clinical PK data have been collected in all ongoing studies of magrolimab conducted to date. 
Pharmacokinetic data have been analyzed in Phase 1 study (SCI-CD47-001) in patients with 
solid tumor. In this study, patients were treated with weekly magrolimab doses ranged from 
0.1 to 45 mg/kg, with increasing serum concentrations associated with increasing dose. 
Nonlinear PK consistent with target-mediated clearance was observed over this dose range. 
However, at maintenance doses of 10 mg/kg and above, target-mediated clearance was 
saturated within the dosing regimen, and trough levels associated with magrolimab efficacy 
in nonclinical studies were achieved. Nine of 88 (10%) evaluable patients tested positive for 
antidrug antibody (ADA) against magrolimab at any time point including baseline; ADA 
positivity had no impact on PK or clinical safety in these patients.
In the Phase 1 AML study (SCI-CD47-002), similar to the solid tumor Phase 1 study, 
nonlinear PK consistent with target-mediated clearance was observed. Three of 20 
(15%) evaluable patients tested positive for ADA against magrolimab at any time point 
including baseline; ADA positivity had no impact on PK. Antidrug antibody positivity in 
either study was not associated with increased adverse events (AEs).
Preliminary PK data of magrolimab from other ongoing studies (5F9003, 5F9004, and 
5F9005) of magrolimab indicates similar PK properties across all tumor populations and in 
the presence of coadministered drugs. Across all studies, 46 of 430 (11%) patients tested 
positive for ADA against magrolimab at any time point including baseline. Antidrug 
antibody positivity was not associated with changes in PK or AE profile.
A preliminary population PK analysis of combined magrolimab PK data indicated that results 
for magrolimab population PK were typical of other nonlinear antibodies. No clinically 
significant covariates of PK variability were identified.
1.2.3.2.
Summary of Clinical Safety
Magrolimab is administered as an IV infusion and it is currently being studied in 6 clinical 
studies. Two completed single-agent Phase 1 studies include Study SCI-CD47-001 in 
patients with advanced solid tumors and lymphomas, and Study SCI-CD47-002 in patients 
with relapsed/refractory AML, along with Phase 1b partnered studies in AML as well as 
urothelial carcinoma. Four combination studies include the following: Study 5F9003, a 
Phase 1b/2 study of magrolimab with rituximab in patients with relapsed/refractory NHL; 
Study 5F9004, a Phase 1b/2 study of magrolimab with cetuximab in solid tumor and 
colorectal cancer patients; Study 5F9005, a Phase 1b study of magrolimab with azacitidine in 
AML and MDS patients; and Study 5F9006, a Phase 1b study of magrolimab with avelumab 
in solid tumor and ovarian cancer patients. As of July 2020, over 500 patients have been 
treated with magrolimab. Overall, the safety profile has been acceptable with magrolimab as 
monotherapy or in combination, with no maximum tolerated dose (MTD) reached in any 
study with dosing up to 45 mg/kg. Two anticipated adverse reactions included on-target 


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anemia and infusion-related reactions (IRRs), which are expected with mAbs. Importantly, 
on-target anemia due to CD47 blockade-mediated RBC clearance was mitigated with a 
priming/maintenance dose strategy. The average hemoglobin declines with the first (priming) 
dose was between approximately 0.4 to 1.5 g/dL across indications, with many patients 
improving their hemoglobin on therapy back to baseline with a decrease in RBC transfusion 
requirements for those patients who were transfusion-dependent at baseline.
Magrolimab has been evaluated as a monotherapy or in combination in multiple solid tumor 
types. In the Phase 1 Study SCI-CD47-001 of magrolimab monotherapy, 88 patients with 
advanced solid tumors were treated with magrolimab doses up to 45 mg/kg. No MTD was 
reached. As per the 2020 IB, across 548 patients treated with magrolimab, which includes 
both solid tumors and hematologic malignancies, fatigue, anemia, and headache were the 
3 most frequently reported AEs (43.0%, 40.8%, and 36.4% of patients, respectively). Patients 
experienced mostly Grade 1 and 2 fatigue (2.8% of patients reported severe fatigue).
Anemia is the most common treatment-related AE, reported in 35.4% of patients. 
Approximately 13% of all patients experienced anemia Grade 1 or 2, and 22% severe 
anemia. Notably many of those patients with severe anemia occurred in patients with AML 
and MDS, who have severe anemia at baseline. Anemia was typically manifested as a decline 
in hemoglobin observed within the first 2 weeks of treatment. The initial decrease in 
hemoglobin after the first dose is on average 0.5 to 2 g/dL. In patients with solid tumors, the 
fall in hemoglobin was followed by a compensatory reticulocytosis, with many patients 
experiencing a gradual return to baseline despite continued dosing. The changes in 
hemoglobin and reticulocytes described with magrolimab treatment are fairly consistent 
across tumor types and is shown in Figure 1. Hyperbilirubinemia (predominately 
unconjugated) is indicative of extravascular hemolysis consistent with phagocytic removal of 
RBCs arising from the blockade of CD47 signaling. Administration of a low priming dose of 
magrolimab mitigated on-target anemia, an effect that is mostly observed after the first dose.


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Figure 1.
Effect of Magrolimab on Anemia and Mitigation with a 
Priming/Maintenance Dosing Regimen
The RBC profile of a solid tumor patient treated with magrolimab monotherapy is shown {Sikic 2019}.
Infusion-related reactions are also a commonly observed AE with magrolimab. In total, 29% 
of patients reported at least 1 IRR. Most common signs/symptoms of IRRs related to 
magrolimab included chills, pyrexia, back pain, headache, nausea, vomiting, dyspnea, 
anemia, and blood bilirubin increase. These IRRs were generally observed during the initial 
2 doses of magrolimab. Current recommendations for premedication and IRR management 
are described in Sections 5.3.1 and 7.8.1.2. Lastly, hemagglutination (RBC agglutination) as 
observed on the peripheral smear is a common treatment effect and was reported as a 
treatment-related AE in 11.8% of all patients.
Transient hemagglutination is observed after the initial priming or first maintenance dose of 
drug, however, it is less common thereafter, and it has not been consistently correlated with 
any clinical sequelae.
In summary, 568 patients (346 solid tumor/lymphoma patients and 222 AML/MDS patients) 
have been treated with magrolimab as monotherapy or in combination. Based on this 
aggregate safety data, magrolimab has an acceptable safety profile both as monotherapy and 
in combination with other agents (rituximab, gemcitabine, oxaliplatin, cetuximab, avelumab, 
or azacitidine) across multiple advanced solid tumor and hematological malignancies. Refer 
to the magrolimab IB for further details.
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1.2.3.3.
Summary of Clinical Efficacy
In Study 5F9005, 10 relapsed/refractory patients (4 MDS and 6 AML) received magrolimab 
monotherapy and 68 treatment-naive patients (39 MDS and 29 AML) were enrolled in the 
magrolimab plus azacitidine cohort. As of May 2020, for patients treated with magrolimab 
plus azacitidine, 58 untreated MDS/AML patients were evaluable for efficacy. In the AML 
cohort, 16/25 (64%) patients achieved an objective response, including 56% with complete 
response (CR) or CR with incomplete blood count recovery. In the MDS cohort, 30/33 (91%) 
achieved an objective response, including 45% with a CR + partial response (PR). 
Additionally, 26% of all responders were minimal residual disease (MRD)-negative, as 
determined by flow cytometry. Patients are continuing to be enrolled in the magrolimab plus 
azacitidine combination cohorts. In summary, magrolimab plus azacitidine induced a high 
rate of objective responses in newly diagnosed AML and MDS patients.
In Study SCI-CD47-001, magrolimab was investigated as a monotherapy in 66 solid tumor 
and lymphoma patients, including 2 patients with refractory diffuse large B-cell lymphoma 
(DLBCL), 16 patients with ovarian or fallopian tube cancers, and 10 patients with cutaneous 
T-cell lymphoma (CTCL). No objective responses were observed, although some mixed 
responses and stable disease (SD) were noted. Study 5F9003 investigated magrolimab plus 
rituximab in patients with DLBCL and follicular lymphoma (FL) and revealed an ORR of 
45%, with 19% achieving a best response of CR. An ongoing Phase 1b/2 study (5F9004) is 
combining magrolimab with cetuximab in solid tumor and advanced colorectal cancer 
including both wild-type and mutant-KRAS patients, although efficacy results are not yet 
available.
For further clinical efficacy and safety information of magrolimab in other indications, please 
refer to the magrolimab IB.
1.3.
Information About Agents Used in Combination With Magrolimab
Where available and allowed by the local regulations, for each of the combination agents 
(daratumumab, pomalidomide, carfilzomib, bortezomib or dexamethasone), an appropriate 
approved generic or a biosimilar may be used.
1.3.1.
Daratumumab
1.3.1.1.
Description of Daratumumab
Daratumumab (DARZALEX®, DARZALEX FASRPO®) is a first-in-class human 
monoclonal IgG1k antibody directed against the CD38 antigen with a direct on-tumor and 
immunomodulatory MOA {DARZALEX 2020, DARZALEX FASPRO 2020, Overdijk 
2016}. CD38 is a transmembrane glycoprotein expressed on the surface of hematopoietic 
cells, including MM and other cell types and tissues, and has multiple functions, such as 
receptor mediated adhesion, signaling, and modulation of cyclase and hydrolase activity. 
Daratumumab binds to CD38 and inhibits the growth of CD38 expressing tumor cells by 
inducing apoptosis directly through Fc mediated cross linking as well as by 


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immune-mediated tumor cell lysis through CDC, antibody-dependent cell-mediated 
cytotoxicity and antibody-dependent cellular phagocytosis (ADCP). Daratumumab is 
approved both as a monotherapy and in combination with various regimens for the treatment 
of relapsed/refractory MM; selected daratumumab-based regimens are approved for newly 
diagnosed MM patients. Daratumumab is available as both IV and subcutaneous (SC) 
formulations {DARZALEX 2020, DARZALEX FASPRO 2020}.
1.3.1.2.
Clinical Data for Daratumumab
Daratumumab has been extensively studied in MM, both as a single agent and in 
combination with various regimens. In relapsed/refractory MM patients, daratumumab is 
indicated: a) in combination with lenalidomide and dexamethasone in patients who are 
ineligible for autologous stem cell transplant (SCT) and in those patients who have received 
at least 1 prior therapy; b) in combination with bortezomib (VELCADE®) and 
dexamethasone in patients who have received at least 1 prior therapy, plus alongside 
melphalan and prednisone or thalidomide depending on eligibility for autologous SCT; c) in 
combination with carfilzomib and dexamethasone in patients who have received 1 to 3 prior 
lines of therapy d) in combination with pomalidomide (POMALYST®) and dexamethasone 
in patients who have received at least 2 prior therapies including lenalidomide and a PI; and 
e) as monotherapy in patients who have received at least 3 prior lines of therapy including a 
PI and an immunomodulatory agent or who are double-refractory to a PI and an 
immunomodulatory agent {DARZALEX 2020, DARZALEX FASPRO 2020}.
Daratumumab monotherapy was evaluated in the SIRIUS study in patients with 
relapsed/refractory MM who had received at least 3 prior lines of therapy including a PI and 
an immunomodulatory drug (IMiD) or who were double-refractory to a PI and an IMiD. 
Daratumumab achieved an ORR of 29.2% (stringent complete response [sCR] 2.8%, very 
good partial response [VGPR] 9.4% and PR 17%). The CASTOR study demonstrated an 
improvement in PFS in the DVd (daratumumab/bortezomib/dexamethasone) combination as 
compared with the Vd (bortezomib/dexamethasone) arm; the median PFS had not been 
reached in the DVd arm and was 7.2 months in the Vd arm (hazard ratio [HR] 
[95% CI]: 0.39 [0.28, 0.53]; P < 0.0001), representing a 61% reduction in the risk of disease 
progression or death for patients treated with DVd versus Vd. Similarly, daratumumab in 
combination with pomalidomide and dexamethasone, achieved an ORR of 59.2% (sCR 
7.8%, CR 5.8%, VGPR 28.2%, and PR 17.5%) in the EQUULEUS study, a single-arm study 
that enrolled a cohort of 103 patients who had been heavily pretreated (median number of 
4 therapies; all previously treated with a PI and an IMiD) {DARZALEX 2020, DARZALEX 
FASPRO 2020}.
The most frequently reported adverse reactions (incidence ≥ 20%) reported in daratumumab 
studies were infusion reactions, neutropenia, thrombocytopenia, fatigue, asthenia, nausea, 
diarrhea, constipation, decreased appetite, vomiting, muscle spasms, arthralgia, back pain, 
pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory 
neuropathy, bronchitis, pneumonia, and upper respiratory tract infection {DARZALEX 2020, 
DARZALEX FASPRO 2020}.


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1.3.2.
Pomalidomide and Dexamethasone
1.3.2.1.
Description of Pomalidomide
Pomalidomide is an analog of thalidomide with potent immunomodulatory, antiangiogenic, 
and antineoplastic properties. Cellular activities of pomalidomide are mediated through its 
target cereblon, a component of the cullin ring E3 ubiquitin ligase enzyme complex. In vitro, 
in the presence of drug, substrate proteins (including Aiolos and Ikaros) are targeted for 
ubiquitination and subsequent degradation leading to direct cytotoxic and 
immunomodulatory effects. In in vitro cellular assays, pomalidomide inhibited proliferation 
and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited 
the proliferation of lenalidomide-resistant MM cell lines and synergized with dexamethasone 
in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell 
apoptosis. Pomalidomide enhanced T cell and natural killer (NK) cell–mediated immunity 
and inhibited production of proinflammatory cytokines (eg, tumor necrosis factor [TNF]-α 
and interleukin [IL]-6) by monocytes {POMALYST 2020}.
1.3.2.2.
Description of Dexamethasone
Dexamethasone is widely commercially available. Details regarding the description, supply, 
and storage instructions for dexamethasone are found in the reference US prescribing 
information (USPI), summary of product characteristics (SmPC), or applicable local or 
regional label. Sites are advised to refer to the prescribing information for information that is 
specific to the brand or formulation of the drug product in use.
1.3.2.3.
Clinical Data for Pomalidomide and Dexamethasone
The US Food and Drug Administration (FDA) granted accelerated approval for 
pomalidomide on the basis of the Phase 2 study (MM-002), which randomized patients with 
relapsed/refractory disease after at least 2 prior regimens (including lenalidomide and 
bortezomib) and who had progressed within 60 days of their last therapy to receive either 
pomalidomide alone (POM) (4 mg/day on Days 1 to 21 of a 28-day cycle; n = 108) or in 
combination with 40 mg/week dexamethasone (POM-DEX) (n = 113) {POMALYST 2020}. 
Patients in both arms were comparably refractory to lenalidomide (79%), bortezomib (71%), 
or both (62%), and 95% had greater than 2 prior therapy regimens. With a median follow-up 
of 14.2 months, the median PFS was 4.2 versus 2.7 months (HR = 0.68, P = 0.003), 
respectively, for the POM-DEX arm compared with the POM arm. The ORR (PR or better) 
was 33% versus 18% (P = 0.013), median response duration was 8.3 versus 10.7 months, and 
median OS was 16.5 versus 13.6 months, respectively for the POM-DEX arm compared with 
the POM arm. The most common hematologic Grade 3/4 AEs were neutropenia (41% vs 
48%), anemia (22% vs 24%), and thrombocytopenia (19% vs 22%). The most common 
nonhematologic AE was pneumonia (22% vs 15%) and fatigue (14% vs 11%) in the 
POM-DEX arm compared with the POM arm, respectively. The frequency of febrile 
neutropenia was low (3% vs 5%), as was the incidence of deep vein thrombosis (2% vs 3%). 
There were no Grade 3 or 4 events of peripheral neuropathy reported.


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NIMBUS is a multicenter, open-label, randomized Phase 3 study where relapsed/refractory 
MM patients who failed at least 2 previous treatments of bortezomib and lenalidomide were 
randomized to either pomalidomide + low-dose dexamethasone (POM-DEX) or high-dose 
dexamethasone (DEX) alone. The primary endpoint was PFS. A total of 302 patients 
received POM plus low-dose DEX and 153 patients received high-dose DEX alone. After a 
median follow-up of 10 months, median PFS with POM-DEX was 4 months versus 2 months 
with high-dose DEX alone (HR = 0.48; P < 0.0001) {Miguel 2013}. The most common 
Grade 3/4 hematological AEs in the POM-DEX versus high-dose DEX alone groups were 
neutropenia (48% vs 16%), anemia (33% vs 37%), and thrombocytopenia (22% vs 26%); and 
Grade 3/4 nonhematological AEs included pneumonia (13% vs 8%), bone pain (7% vs 5%), 
and fatigue (5% vs 6%). Treatment-related AEs leading to death were 4% in the POM-DEX 
group and 5% in the high-dose DEX alone group.
The STRATUS study also assessed safety and efficacy of POM plus low-dose DEX in 
relapsed/refractory MM. A total of 682 patients who failed treatment with bortezomib and 
lenalidomide (80% to both) with adequate prior alkylator therapy were enrolled, with safety 
as the primary endpoint and secondary endpoints including ORR, duration of response 
(DOR), PFS, and OS. Median number of prior regimens was 5. Median follow-up was 
17 months, and median DOR was 5 months. The most frequent Grade 3/4 hematologic AEs 
included neutropenia (50%), anemia (33%), and thrombocytopenia (24%), and the most 
frequent Grade 3/4 nonhematologic AEs were pneumonia (11%) and fatigue (6%). The ORR 
was 33%, and the median DOR was 7 months. Median PFS and OS were 5 months and 
12 months, respectively {Dimopoulos 2016}. This study further supports that POM plus 
low-dose DEX in relapsed/refractory MM patients offers clinically meaningful benefit and is 
generally well tolerated.
1.3.3.
Carfilzomib and Dexamethasone
1.3.3.1.
Description of Carfilzomib
Carfilzomib is a tetrapeptide epoxyketone PI that irreversibly binds to the N-terminal 
threonine-containing active sites of the 20S proteasome, the proteolytic core particle within 
the 26S proteasome. The 26S proteasome is a large protein complex that degrades 
ubiquitinated proteins. The ubiquitin-proteasome pathway plays an essential role in 
regulating the intracellular concentration of specific proteins, thereby maintaining 
homeostasis within cells. Inhibition of the 26S proteasome prevents this targeted proteolysis, 
which can affect multiple signaling cascades within the cell. This disruption of normal 
homeostatic mechanisms can lead to cell death.
1.3.3.2.
Clinical Data for Carfilzomib and Dexamethasone
Carfilzomib was initially approved in 2012 under the FDA’s accelerated approval program 
for the treatment of patients with MM who have received at least 2 prior therapies, including 
bortezomib and an IMiD based on the initial Phase 2 Study PX-171-003-A1 in the US.


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ASPIRE was a randomized, open-label, multicenter study which evaluated the combination 
of Kyprolis with lenalidomide and dexamethasone (KRd) versus lenalidomide and 
dexamethasone alone (Rd) in patients with relapsed/refractory MM who had received 1 to 
3 lines of therapy. The 792 patients in ASPIRE were randomized 1:1 to the KRd or Rd arm. 
Patients in the KRd arm demonstrated improved median PFS compared with those in the Rd 
arm (26.3 months vs 17.6 months HR = 0.69, P = 0.0001) A statistically significant 
advantage in median OS was also observed in patients in the KRd arm compared with 
patients in the Rd arm.
ENDEAVOR was a randomized, open-label, multicenter study of Kyprolis and 
dexamethasone (Kd) versus bortezomib and dexamethasone (Vd) in patients with 
relapsed/refractory MM who had received 1 to 3 lines of therapy. A total of 929 patients 
were enrolled and randomized (464 in the Kd arm; 465 in the Vd arm). Randomization was 
stratified by prior PI therapy (yes versus no), prior lines of therapy (1 versus 2 or 3), current 
International Staging System stage (1 versus 2 or 3), and planned route of bortezomib 
administration. Notably, in both arms of the study, > 50% of the patients had previously been 
treated with bortezomib. The study demonstrated a median PFS of 18.7 months in the Kd 
arm versus 9.4 months in the Vd arm (HR = 0.53, P < 0.0001). Similarly, OS was superior in 
the Kd arm compared with the Vd arm (47.6 months vs 40 months; HR = 0.79, P = 0.01).
Following these approvals, carfilzomib in combination with either lenalidomide and 
dexamethasone or dexamethasone alone is indicated for treatment of relapsed/refractory 
MM. The efficacy of carfilzomib in combination with daratumumab and dexamethasone 
(DKd) was evaluated in 2 open-label clinical studies (CANDOR and EQUULEUS). 
CANDOR was a randomized, open-label, multicenter study which evaluated the combination 
of carfilzomib 20/56 mg/m2 twice weekly with IV daratumumab and dexamethasone (DKd) 
versus carfilzomib 20/56 mg/m2 twice weekly and dexamethasone (Kd) in patients with 
relapsed/refractory MM who had received 1 to 3 prior lines of therapy. EQUULEUS was an 
open-label, multicohort study which evaluated the combination of carfilzomib with IV 
daratumumab and dexamethasone in patients with relapsed/refractory MM who had received 
1 to 3 prior lines of therapy. Carfilzomib was administered IV over 30 minutes once weekly 
at a dose of 20 mg/m2 on Cycle 1 Day 1 and escalated to a dose of 70 mg/m2 on Cycle 1, 
Days 8 and 15; and on Days 1, 8, and 15 of each 28-day cycle. Based on the results of these 
2 studies, carfilzomib was approved for the treatment of adult patients with 
relapsed/refractory MM who have received 1 to 3 lines of therapy in combination with 
daratumumab and dexamethasone. In the current study, 20/70 mg/m2 dosing regimen of 
carfilzomib, as was used in the EQUULEUS study, will be utilized.
Based on the results of ASPIRE and ENDEAVOR, carfilzomib was approved in the US and 
globally in combination with either lenalidomide and dexamethasone or dexamethasone 
alone for treatment of relapsed/refractory MM.
Subsequently, the efficacy of carfilzomib in combination with daratumumab and 
dexamethasone was evaluated in 2 open-label clinical studies (CANDOR and EQUULEUS). 
Based on the results of these 2 studies, carfilzomib was approved for the treatment of adult 
patients with relapsed/refractory MM who have received 1 to 3 lines of therapy in 
combination with daratumumab and dexamethasone.


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1.3.4.
Bortezomib and Dexamethasone
1.3.4.1.
Description of Bortezomib
Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome 
in mammalian cells {VELCADE 2019}. Experiments have demonstrated that bortezomib is 
cytotoxic to a variety of cancer cell types in vitro. Bortezomib causes a delay in tumor 
growth in vivo in nonclinical tumor models, including MM. See Section 1.3.2.2 for a 
description of dexamethasone.
1.3.4.2.
Clinical Data for Bortezomib and Dexamethasone
Bortezomib was approved for the treatment of relapsed/refractory MM based on the results 
of a Phase 3 study (APEX Trial) comparing bortezomib with high-dose dexamethasone as 
salvage therapy {Richardson 2005, Richardson 2007}. The addition of dexamethasone to 
bortezomib therapy was shown to add benefit in the Phase 2 SUMMIT Trial {Richardson 
2006}. In the recent update of the National Comprehensive Cancer Network (NCCN) 
Clinical Practice Guidelines in Oncology for MM, single-agent bortezomib and bortezomib 
plus dexamethasone are Category 1 and Category 2A recommendations for MM salvage 
therapy, respectively. Considering the clinical evidence on the effect of bortezomib and more 
recent data on bortezomib combined with dexamethasone, a treatment regimen of bortezomib 
combined with low-dose dexamethasone is consistent with the current standard of care in this 
previously treated MM patient population.
1.4.
Rationale for This Study
Multiple myeloma remains incurable. Despite the availability of PIs, immunomodulatory 
agents, and mAbs for MM, most patients will relapse and develop refractory disease. 
Strategies directed at improving both the duration and depth of response as well as new 
treatment options directed at alternative mechanisms are urgently needed for patients with 
MM. Strong nonclinical rationale exists for the combination of magrolimab with other 
antimyeloma therapies. There is growing body of evidence to suggest that the overexpression 
of CD47 contributes to the pathogenesis of MM. A very recent study has reported that MM 
cells had remarkably higher CD47 expression than other cell populations in the bone marrow. 
Furthermore, blocking of CD47 using an anti-CD47 antibody induced immediate activation 
of macrophages and eliminated MM cells in the 3D-tissue engineered bone marrow model, as 
early as 4 hours after exposure {Sun 2020}. Several early phase studies are currently 
investigating CD47-targeted therapies for the treatment of MM. Magrolimab, a recombinant 
humanized anti-CD47 mAb, is currently being studied across many hematological 
malignancies.


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Recent studies have indicated that multiple drug combinations are superior over single- or 
double-agent combinations in treating MM. The addition of new drugs to available regimens 
could induce a higher rate of initial CRs, which then improves PFS and OS. Contingent on 
the premise that the combined agents have nonoverlapping and synergistic MOAs, the 
immediate and effective targeting of the tumors with multiple agents appears to be a 
successful strategy in improving the clinical outcome of MM therapy. Such a strategy is 
consistent with the emerging concept that the genetic signature of MM, and consequently the 
patient’s susceptibility to a specific agent, will be highly heterogeneous, which may lead to 
drug resistance. Furthermore, nonclinical evidence suggests these drug combinations all have 
the potential for achieving synergy as discussed in Sections 1.4.1, 1.4.2, and 1.4.3.
The current study will investigate the combination of magrolimab with other standard of care 
options used in this setting as the backbones. The study will enroll patients who have 
previously been treated with at least 3 prior lines of therapy (except for the 
bortezomib/dexamethasone/magrolimab cohort), including a PI and an IMiD. Although not 
explicitly specified, these patients are also likely to have been treated with daratumumab. For 
patients who have been treated with all 3 of the main classes of therapy (PI, IMiD, and an 
anti-CD38), the options are limited; options are even more limited for those who are 
refractory to 1 or more classes of drugs. Given the limited treatment options for this patient 
population, the nonoverlapping MOA for these therapies justifies the selection of the 
combinations chosen in this study. Carfilzomib has been chosen as the preferred PI given its 
superiority over bortezomib in patients with relapsed/refractory MM based on the 
ENDEAVOR study (Section 1.3.3.2). The cohort investigating the 
bortezomib/dexamethasone/magrolimab combination will only be initiated at the sponsor’s 
discretion based on the preliminary safety and efficacy results of the 
carfilzomib/dexamethasone/magrolimab combination in patients who have received at least 
1 previous line of therapy. In this earlier line of patients, use of bortezomib is justified once 
the proof-of-concept for the PI class has been generated with carfilzomib.
1.4.1.
Magrolimab in Combination With Daratumumab
Nonclinical experiments with MM cell lines, purified MM cells, and mononuclear cell 
suspensions have demonstrated that daratumumab triggers the lysis of MM cells by a variety 
of mechanisms. Binding of the antibody to CD38 positions the Fc receptor (FcR) in a way 
that optimizes interaction with complement resulting in strong complement-dependent lysis 
{de Weers 2011}. Antibody-dependent lysis with daratumumab has been demonstrated in 
complement free cell suspensions of MM cells and cell lines with peripheral blood 
mononuclear cells (PBMCs) enriched for NK cells using both normal and patient PBMCs. 
Other MOA, including apoptosis triggered by FcR-crosslinking and ADCP, have been 
demonstrated with daratumumab. In ADCP, effector cells (such as monocytes and 
macrophages) bind to the Fc tail of the CD38 antibody via their FcγR, leading to 
opsonization of the target (ie, tumor) cell. ADCP mediated by macrophages has been 
described as a fast and efficient MOA of daratumumab {Overdijk 2015}. We hypothesize 
that the daratumumab-induced ADCP can be further enhanced by magrolimab, based on in 
vitro evidence for synergy between the 2 agents (Figure 2, unpublished data). The highly 


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significant activity of daratumumab in MM, both in newly diagnosed and relapsed/refractory 
patients, together with novel nonoverlapping MOA with regard to magrolimab, predict 
tolerability and efficacy for combination therapy with magrolimab + daratumumab in 
treatment of patients with relapsed/refractory MM.
Figure 2.
In Vitro Assessment of Synergy in MM Cell Lines
1.4.2.
Magrolimab in Combination With Pomalidomide and Dexamethasone
Pomalidomide induces antiproliferative and proapoptotic effects on MM cells {Hideshima 
2000, Li 2011}, and modulation of bone marrow microenvironment to inhibit the binding of 
MM cells to bone marrow stromal cells that mediate the production of growth factors and 
angiogenic molecules, including vascular endothelial growth factor {Mark 2014}. In 
addition, pomalidomide improves cellular immunity via the activation of immune effector 
cells, such as dendritic cells (DCs), NK cells, and T cells {Richardson 2013} and the 
reduction of immune inhibitory cells, such as regulatory T cells, on tumor microenvironment 
{Gorgun 2010, Li 2007}. Importantly, in a nonclinical study, pomalidomide displayed 
significant therapeutic activity against CNS lymphoma with a major impact on the tumor 
microenvironment with an increase in M1 macrophages and NK cells {Rychak 2016}. In a 
murine myeloma model, POM-DEX in combination with tumor-antigen loaded DCs resulted 
in decreased tumor growth, prolonged survival, induced NK cell, and T lymphocytes 
responses associated with strong antimyeloma activities against myeloma cells and increased 
numbers of effector cells, including M1 macrophages {Vo 2018}. Based on these 
observations, we hypothesize that the addition of magrolimab will enhance the efficacy of the 
POM-DEX combination.
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1.4.3.
Magrolimab in Combination with Proteasome Inhibitors 
(Carfilzomib/Dexamethasone and Bortezomib/Dexamethasone)
CD47 ligation with magrolimab induces cell death in a caspase-independent manner; 
therefore, its effects may be complementary to cytotoxic agents that induce 
caspase-dependent apoptosis, including carfilzomib and bortezomib. This is supported by the 
observation that myeloma cells prewashed with PIs are more susceptible to cell death 
induced by CD47-targeted antibodies compared with either agent given alone (Figure 3, 
unpublished data). This combinatory effect has been observed with magrolimab as well as 
other anti-CD47 antibodies when combined with either carfilzomib or bortezomib {Linderoth 
2017, Richards 2019}.
Figure 3.
In Vitro Assessment of Bortezomib Combined With 
CD47-targeted Antibodies
Ab = antibody; MM = multiple myeloma; PBS = phosphate-buffered saline
1.5.
Rationale for Dose Selection of Magrolimab
The rationale for the magrolimab dose proposed in this study originates from safety, efficacy, 
and PK/pharmacodynamic data, and modeling and simulation analyses based on data 
obtained from all ongoing and completed clinical studies with magrolimab in patients with 
solid tumors, NHL, and AML/MDS.
In the first-in-human study of magrolimab (SCI-CD47-001) in patients with solid tumors and 
lymphomas, after an initial priming dose of 1 mg/kg on the first day, magrolimab was tested 
as a monotherapy at weekly doses of up to 45 mg/kg. The use of an initial 1 mg/kg priming 
dose was integrated into the dosing regimen to mitigate the on-target anemia induced by 
CD47 blockade. An initial priming dose leads to elimination of aged RBCs that are sensitive 
to CD47 blockade and triggers reticulocytosis of young RBCs that are not affected by CD47 
blockade {Chen 2018}. Utilizing a priming dose leads to an initial, transient, and mild 
anemia that generally normalizes back to baseline over several weeks, even in the presence 
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of repeated therapeutic doses of magrolimab {Advani 2018, Liu 2015, Sikic 2019}. The 
maximum weekly dose of 45 mg/kg has an acceptable safety profile, and no MTD was 
identified in this study. In Studies SCI-CD47-002 and 5F9005 in patients with AML/MDS, 
magrolimab was administered as a monotherapy at doses of up to 30 mg/kg twice weekly 
(60 mg/kg per week cumulative) and in combination with azacitidine at doses of up to 
30 mg/kg once weekly in higher-risk MDS patients and up to 60 mg/kg every 4 weeks in 
lower-risk MDS patients. In these studies, no significant dose-limiting toxicity (DLT) was 
observed, and magrolimab had an acceptable safety profile over the tested dose range up to a 
maximum of 30 mg/kg twice a week. In studies 5F9004 (solid tumor and colorectal cancer 
patients) and 5F9006 (solid tumor and ovarian cancer patients), magrolimab, in combination 
with cetuximab and avelumab, respectively, was found to have an acceptable safety profile at 
doses up to 45 mg/kg every week followed by every other week. Taken together, the 
proposed dosing regimen of magrolimab in this study is expected to have an acceptable 
safety profile based on the entirety of safety data in multiple oncology populations, both as a 
monotherapy and in combination with other antimyeloma therapies.
1.5.1.
Rationale for Daratumumab, Dexamethasone, Pomalidomide, 
Carfilzomib, and Bortezomib Dose Selection
Given the lack of dose-related toxicities with magrolimab, the approved doses and the dosing 
regimens were chosen for daratumumab, pomalidomide (with dexamethasone), and 
carfilzomib (with dexamethasone). The bortezomib dosing regimen has been modified from a 
5-week cycle to a 4-week cycle to align with the magrolimab dosing regimen and to improve 
patient convenience, which results in a reduced rest period between cycles compared with 
what is in the approved label (6 days versus 13 days) {POMALYST 2020, VELCADE 
2019}. The most common side effect of bortezomib therapy is peripheral neuropathy. In an 
effort to manage this toxicity, a weekly regimen has been chosen rather than a biweekly 
regimen, which may result in less neurotoxicity. A study comparing the 2 regimens, 
bortezomib-melphalan-prednisone (VMP) versus 
bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide 
maintenance (VMPT), as up-front therapy for patients > 65 years of age, showed that the 
weekly infusion of bortezomib significantly reduced the incidence of Grade 3 to 4 peripheral 
neuropathy (18% in the biweekly vs 9% in the weekly schedule for the VMPT arm, and 12% 
in the biweekly vs 3% in the weekly schedule for the VMP arm) without adversely 
influencing the outcome {Palumbo 2008}. Furthermore, the once-weekly schedule of 
bortezomib resulted in a reduced discontinuation rate and prolonged the time on therapy. 
Patients will be closely monitored for the development of any dose-related toxicities, in 
particular, peripheral neuropathy, through regular neurological assessments, and toxicities 
will be managed with the dose modifications described in Section 7.8.


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1.6.
Risk/Benefit Assessment for the Study
This study will enroll previously treated patients with relapsed/refractory MM. In each arm, 
patients will be treated with agents that are considered standard of care in this setting in 
addition to magrolimab. All these agents, daratumumab, pomalidomide, carfilzomib, 
bortezomib, and dexamethasone, have been extensively used for the treatment of MM 
patients and have been approved by the US FDA and European Medicines Agency; their 
safety profiles have been well characterized. There are guidelines stipulated in the protocol for 
dose reductions, delays and/or discontinuation of these agents in line with their approved 
labels. Magrolimab has been investigated in several hematological malignancies and solid 
tumors. The safety profile has been well documented from these studies and the MTD has not 
been reached. Although there are no dose-dependent toxicities expected with magrolimab, 
dose de-escalation option has been included in the protocol as a precautionary measure. No 
drug-drug interactions between magrolimab and any of the selected combination agents are 
expected.
During a pandemic, additional potential risks to patients may include adequate study drug 
availability, interruptions to the study visit schedule, and adherence to protocol-specified 
safety monitoring or laboratory assessments. Refer to Appendix 3 for further details on the 
risks and risk mitigation strategy.
In summary, based on strong scientific rationale, nonclinical and emerging clinical data, and 
the risk mitigation measures being implemented for the pandemic, the evaluation of 
magrolimab in combination with agents that are considered standard of care is anticipated to 
have an acceptable risk-benefit ratio for patients with MM enrolled in this study.
1.7.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.


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2.
OBJECTIVES AND ENDPOINTS
Table 1.
Objectives and Endpoints for the Safety Run-in Cohorts
Primary Objective
Primary Endpoint
•
To evaluate the safety and tolerability of 
magrolimab in combination with other anticancer 
therapies and to determine the recommended Phase 
2 dose (RP2D) of magrolimab for the following 
combinations in patients with relapsed/refractory 
MM:

Magrolimab in combination with 
daratumumab

Magrolimab in combination with 
pomalidomide and dexamethasone

Magrolimab in combination with carfilzomib 
and dexamethasone

Magrolimab in combination with bortezomib 
and dexamethasone
•
The incidence of dose-limiting toxicities 
(DLTs), AEs and laboratory abnormalities 
according to the National Cancer Institute 
(NCI) Common Terminology Criteria for 
Adverse Events (CTCAE) Version 5.0 
(Appendix 5)
Table 2.
Objectives and Endpoints for the Dose-expansion Cohorts
Primary Objective
Primary Endpoint
•
To evaluate the efficacy of magrolimab in 
combination with other anticancer therapies in 
patients with relapsed/refractory MM as 
determined by ORR
•
ORR, defined as the percentage of patients 
who achieve sCR, CR, VGPR, or PRa
Secondary Objectives
Secondary Endpoints
•
To evaluate the safety and tolerability of 
magrolimab in combination with other anticancer 
therapies
•
The incidence of AEs and laboratory 
abnormalities according to the NCI CTCAE 
Version 5.0
•
To investigate other parameters of efficacy 
including duration of response
•
DORa
•
To evaluate the PK and immunogenicity of 
magrolimab in combination with other anticancer 
therapies in patients with relapsed/refractory MM
•
Magrolimab concentration versus time
•
Measurements of ADA against magrolimab
CCI


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3.
STUDY DESIGN
3.1.
Study Design
This is a Phase 2, open-label, multicenter, multiarm study evaluating magrolimab in 
combination with anticancer therapies for patients with relapsed/refractory MM. This study 
will include safety run-in cohorts (Section 3.1.1) for the following combination therapies:
•
Magrolimab in combination with daratumumab
•
Magrolimab in combination with pomalidomide and dexamethasone
•
Magrolimab in combination with carfilzomib and dexamethasone
•
Magrolimab in combination with bortezomib and dexamethasone – this cohort will only 
be initiated at the sponsor's discretion based upon the preliminary safety and efficacy 
results from the carfilzomib/dexamethasone combination cohort.
After completion of the safety run-in cohorts, dose-expansion cohorts using the same 
combination therapies will occur as described in Section 3.1.2.
Patient participation will include screening, treatment, and follow-up. Screening will occur 
up to 30 days before the first dose of study treatment, during which time the patient’s 
eligibility and baseline characteristics will be determined.
The study schema is presented in Figure 4.


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Figure 4.
Study Schema
IMiD = immunomodulatory drug; PI = proteasome inhibitor; RP2D = recommended Phase 2 dose
3.1.1.
Safety Run-in Cohorts
All safety run-in cohorts may progress concurrently. The DLT assessment period will be the 
first cycle (35 days). Patients are considered evaluable for assessment of a DLT if either of 
the following criteria are met in the DLT assessment period:
•
The patient experienced a DLT at any time after initiation of the first dose of any study 
drug
•
Completed DLT assessment period and received at least 3 infusions of magrolimab and 
the following cohort-specific criteria:
Magrolimab in combination with daratumumab cohort: Completed at least 2 doses of 
daratumumab
Magrolimab in combination with pomalidomide and dexamethasone cohort: 
Completed at least 10 doses of pomalidomide and 2 doses of dexamethasone
Magrolimab in combination with carfilzomib and dexamethasone cohort: Completed 
at least 2 doses of carfilzomib and 2 doses of dexamethasone
Magrolimab in combination with bortezomib and dexamethasone cohort: Completed 
at least 2 doses of bortezomib and 2 doses of dexamethasone
Patients who are not evaluable for DLT assessment will be replaced.
Patients with relapsed 
/refractory multiple myeloma 
who have had 3 or more prior 
therapies including an IMiD 
and a PI 
Safety Run-in 
n=6 to 9 (up to 3 dose levels) 
Magrolimab + Daratumumab 
Safety Run-in 
n=6 to 9 ( up to 3 dose levels) 
Magrolimab + Pomalidomide + 
Dexamethasone 
Safety Run-in 
n=6 to 9 (up to 3 dose levels) 
Magrolimab + Carfilzomib + 
Dexamethasone 
Safety evaluation 
and RP2D 
Safety evaluation 
and RP2D 
Safety evaluation 
and RP2D 
Dose Expansion 
n=24 
Magrolimab + Daratumumab 
Dose Expansion 
n=24 
Magrolimab + Pomalidomide + 
Dexamethasone 
Dose Expansion 
n=24 
Magrolimab + Carfilzomib + 
Dexamethasone 
Bortezomib + Dexamethasone may be initiated based on the preliminary safety and efficacy of the 
Carfilzomib + Dexamethasone cohort. If initiated, bortezomib cohort only requires I prior line of therapy 
Safety Run-in 
n=6 to 9 (up to 3 dose levels) 
Magrolimab + Bortezomib + 
Dexamethasone 
Safety evaluation 
and RP2D 
Dose Expansion 
n=24 
Magrolimab + Bortezomib + 
Dexamethasone 


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The first patient in each safety run-in cohort will be treated for 3 days prior to enrolling 
additional patients.
In general, no dose-dependent toxicities have been observed with magrolimab, in contrast to 
the other chemotherapies. To preserve the efficacious doses of the partner drugs, dose 
de-escalation will take place for magrolimab. The starting magrolimab dose (30 mg), Dose 
Level −1 (20 mg), and Dose Level −2 (15 mg) are described in Section 5.3.1. Dosing of 
magrolimab and drugs to be given in combination with magrolimab are described in 
Section 3.2.
For each of the safety run-in cohorts, a 6 + 3 de-escalation algorithm will be implemented. 
Six patients will be enrolled in each of the safety run-in cohorts. Dose de-escalation decisions 
will be made after the first 6 patients in each cohort have completed the Cycle 1 DLT 
evaluation period and the Safety Review Team (SRT) has reviewed safety and clinical data 
for the first cycle as follows:
•
If no more than 1 patient experienced a DLT in Cycle 1, enrollment into the dose-
expansion cohort will begin at this dose level.
•
If 2 patients experienced DLTs, 3 additional patients will be enrolled into the cohort at 
the same dose level. If no additional DLTs occur in these 3 patients, the dose level will be 
deemed safe by the SRT. If 1 or more DLTs occur in these 3 patients, a lower-dose 
cohort will be evaluated using the same 6 + 3 de-escalation algorithm to define the 
recommended dose for the combination regimens.
•
If more than 2 patients experienced DLTs, another 6 patients will be enrolled at a lower 
dose and evaluated in the same manner to define the recommended dose for the 
combination regimens.
DLT Definition
All toxicities will be graded according to the NCI CTCAE Version 5.0 (Appendix 5). A DLT 
is defined as any Grade 3 or higher hematologic toxicity or Grade 3 or higher 
nonhematologic toxicity, that has worsened in severity from pretreatment baseline during the 
DLT assessment period and, in the opinion of the investigator, the AE is at least possibly 
related to magrolimab.
The following are exceptions to the DLT definition and are NOT considered a DLT:
•
Grade 3 anemia; however, Grade 3 hemolytic anemia that is medically significant, 
requiring hospitalization or prolongation of existing hospitalization, disabling, or limiting 
self-care activities of daily life is considered a DLT.
•
Grade 3 neutropenia that resolves to Grade 2 or pretreatment baseline with supportive 
care (including growth factors) within 14 days.


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•
Grade 3 indirect/unconjugated hyperbilirubinemia that resolves to ≤ Grade 2 with 
supportive care within 1 week and is not associated with other clinically significant 
consequences.
•
Isolated Grade 3 electrolyte abnormalities that resolve to ≤ Grade 2 with supportive care 
within 1 week and are not associated with other clinically significant consequences.
•
Grade 3 elevation in alanine aminotransferase (ALT), aspartate aminotransferase (AST), 
or alkaline phosphatase that resolves to ≤ Grade 2 with supportive care within 1 week and 
is not associated with other clinically significant consequences.
•
Grade 3 nausea, vomiting, or diarrhea that resolves to ≤ Grade 2 with supportive care 
within 72 hours.
•
Grade 3 fatigue that resolves to ≤ Grade 2 within 1 week on study.
•
Grade 3 magrolimab infusion reactions in the absence of an optimal pretreatment 
regimen, which is defined as acetaminophen or a comparable nonsteroidal 
anti-inflammatory agent, plus an antihistamine and corticosteroids.
•
Grade 3 tumor lysis syndrome or electrolyte disturbances (hyperkalemia, 
hypophosphatemia, hyperuricemia) that resolves to ≤ Grade 2 or baseline within 
72 hours.
•
Grade 3 hypomagnesemia, that resolves to ≤ Grade 2 within 1 week.
•
Grade 3 or 4 lymphopenia or leukopenia not associated with other clinically significant 
consequences.
The RP2D will be determined by Gilead in discussion with SRT based on all relevant clinical 
and PK data from all patients treated in the safety run-in cohorts.
Safety Review Team
An SRT will be established to assess safety of patients in various cohorts.
The SRT will include at least 1 investigator, a Gilead Safety Physician, and the Gilead 
medical monitor. Others may be invited to participate as members of the SRT if additional 
expertise is desired (ie, representatives from Patient Safety [PS], Clinical Operations, 
Biostatistics, Clinical Pharmacology, and Biomarker Sciences, as applicable). The medical 
monitor serves as the chair of the SRT. An SRT charter (or similar document) will be agreed 
on by all SRT members prior to the first SRT meeting. The data reviewed at the SRT meeting 
to make dose de-escalation decisions will be defined in the SRT charter (or similar 
document). The quality control checks performed on the data reviewed and used for making 
dose de-escalation decisions will be described in the SRT charter (or similar document).


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3.1.2.
Dose-expansion Cohorts
Once any of the safety run-in cohorts have been completed and an RP2D is established for 
that combination, a dose-expansion cohort using the dose level and schedule specified in 
Table 5 may be initiated. Each dose-expansion cohort may enroll up to 24 patients. Patients 
may be enrolled simultaneously into the dose-expansion cohorts without an observation 
period between patients.
3.1.3.
Treatment-Related Toxicity Monitoring
The treatment-related toxicity will be monitored at a preset frequency with the stopping 
boundary listed in Table 3 after the first 10 patients are treated at the dose level for the 
dose-expansion phase and thereafter when the safety data from every set of 10 patients from 
the first 3 cycles become available. The frequency of the SRT review is outlined in the SRT 
charter. This is a Pocock-type boundary {Ivanova 2005, Ivanova 2006} with 80% probability 
of crossing the boundary when > 25% of patients in the study experience Grade 4 or higher 
treatment-related AEs or treatment-related deaths occur among > 15% of patients.
Table 3.
Stopping Boundary Due to Toxicity for Each Cohort
N = 10
N = 20
N = 30
Grade 4/5 treatment-related TEAEs
≥ 3
≥ 6
≥ 8
Treatment-related deaths
≥ 2
≥ 3
≥ 5
TEAE = treatment-emergent adverse event
3.2.
Study Treatments
Details of on-study treatments administered in this study are described in Section 5. Refer to 
Section 5.3 for details on planned doses to be administered, timing of doses and any required 
pre- or postmedication and prophylaxis, Section 5.4 for instructions with regards to dose 
modifications and delays, and Section 5.5 for information about prior and concomitant 
medications.
3.3.
Duration of Treatment
The length of Cycle 1 will be 35 days; all subsequent cycles will be 28 days. All patients will 
continue on-study treatment until they meet study treatment discontinuation criteria 
(Section 3.4).
3.4.
Discontinuation Criteria
Reasons for discontinuation of study treatment may include, but are not limited to, the 
following:
•
Disease progression
•
Unacceptable toxicity


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•
Loss of clinical benefit
•
Clinically significant change in the patient’s status that precludes further treatment 
(eg, death, pregnancy or other AEs)
•
Patient request, with or without a stated reason
•
Patient noncompliance
•
Discontinuation of the study at the request of Gilead, a regulatory agency, or an 
institutional review board (IRB) or independent ethics committee (IEC)
•
Investigator or treating physician decision in the absence of any of the above
Although disease progression is considered a sufficient reason for discontinuing a patient 
from study treatment the investigator is advised to continue to treat the patient until the 
confirmation of disease progression through a subsequent response assessment, or until the 
investigator considers the study treatment to be no longer clinically beneficial to the patient, 
or the change of disease state renders the patient unacceptable for further treatment in the 
judgment of the investigator. All patients must be followed through completion of all study 
treatment. Refer to Section 6.5.3 for progressive disease (PD) assessments.
Patients who discontinue study treatment are to return for an end of treatment (EOT) visit for 
evaluation of safety within 7 days of their last dose or the decision to end study treatment, 
whichever is later. In addition, patients are to have a safety follow-up telephone call 70 days 
(± 7 days) after their last dose of study treatment. When a serious adverse event (SAE) or 
treatment-related AE is reported during the telephone call, the patient should come to the 
clinic for physical examination and blood tests, if clinically needed. Follow-up for ongoing 
SAEs or treatment-related AEs after the safety follow-up visit/call will stop if a patient 
begins another anticancer therapy.
The assessments to be performed at each of the posttreatment visits are listed in 
Appendix Table 3.
3.5.
Discontinuation From Study Criteria/End of Study
All Patients: The end of the entire study for all patients is defined as the date on which the 
last patient remaining on study completes the last study visit/call or when the sponsor decides 
to end the study. The sponsor reserves the right to terminate the study at any time for any 
reason (including safety).
Individual Patients: Patients are considered to have completed study participation altogether 
when they are no longer followed for safety.
Criteria for early discontinuation from study treatment are described in Section 3.4.


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3.6.
Poststudy Care
Upon withdrawal from study treatment, patients will receive the care upon which they and 
their physicians agree. Patients will be followed for AEs until the end of the study, as 
specified in Appendix Table 3.
3.7.
Source Data
The source data for this study will be obtained from original records (eg, clinic notes, 
hospital records, patient charts), patient-reported outcome (PRO) assessments, central 
laboratory, local laboratory, specialty laboratory (for PK, ADA, and/or pharmacodynamic 
data) and/or additional biomarker testing, and interactive web/voice response system (IXRS).
The patient identification numbers captured by the IXRS are considered source data.
3.8.
Pharmacokinetics/Biomarker Testing
3.8.1.
Biomarker Samples to Address the Study Objectives
Peripheral blood and tumor biopsy samples will be collected from all patients who have 
provided consent to participate in this study. They may be used to evaluate the association of 
systemic and/or tissue-based biomarkers with study drug response, including efficacy and/or 
AEs, disease progression, dosage selection, and to better understand the biology of the cancer 
indications studied, as well as the efficacy and MOA for magrolimab combinations. Because 
biomarker science is a rapidly evolving area of investigation, and AEs in particular are 
difficult to predict, it may not be possible to specify prospectively all tests that may be done 
on the specimens provided. The specific analyses will include, but may not be limited to, the 
biomarkers and assays described below. The testing outlined below is based upon the current 
state of scientific knowledge. It may be modified during or after the end of the study to 
remove tests no longer indicated and/or to add new tests based upon new state of the art 
knowledge.
Blood, bone marrow, and buccal samples will be collected to measure biomarkers which may 
include but will not be limited to the presence of or changes to immune cell populations, 
secreted protein factors, the expression of cell surface markers on either tumor cells or cells 
of the tumor microenvironment, and genetic mutations in tumor cells or subclones of tumor 
cells at the time points listed in the schedule of assessments (Appendix 2).


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Blood and tumor samples will also be used for genomic research. These samples will be used 
to identify or validate genetic markers that may increase om knowledge and understanding of 
the biology of the study disease and related diseases, and to study the association of genetic 
markers with disease pathogenesis, progression and/or treatment outcomes, including 
efficacy, AEs, and the processes of drng absorption and disposition. These specimens may 
also be used to develop biomarker or diagnostic assays and establish the perfo1mance 
characteristics of these assays. Genomics research may include sequencing of genetic 
material derived from both cancer cells and n01mal cells. Sequencing of genetic material 
derived from cancer cells will be used to better understand the MOA of magrolimab 
combinations in this patient population, and potentially to identify subsets of patients who are 
likely to benefit. Sequencing of genetic material derived from nonnal cells will be used to 
define differences in sequence that are cancer specific. 
Samples collected for biomarker assessments will be destroyed no later than 15 years after 
the end of study or per country requirements. 
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4.
PATIENT POPULATION
4.1.
Number of Patients and Patient Selection
Approximately 153 patients will be enrolled in the study, with up to 27 in each of the safety 
run-in cohorts (up to 9 patients at each of the 3 possible dose levels; total up to 81 patients) 
and approximately 72 patients in the dose-expansion cohorts.
4.1.1.
Patient Replacement
Patients may be replaced during the safety run-in period of the study, if not evaluable for 
DLT assessment as described in Section 3.1.1.
4.2.
Inclusion Criteria
All patients must meet all of the following inclusion criteria to be eligible for participation in 
this study:
1) Patient has been previously diagnosed with MM based on the International Myeloma 
Working Group (IMWG) 2016 criteria (Appendix 6) and currently requires treatment.
2) Patients must have measurable disease as defined by 1 or more of the following:
a) Serum monoclonal protein (M-protein) ≥ 0.5 g/dL (≥ 5 g/L)
b) Urine M-protein ≥ 200 mg/24 h
c) Serum free light chain (SFLC) assay: involved SFLC level ≥ 10 mg/dL (100 mg/L) 
with abnormal SFLC ratio
3) Patient has provided informed consent.
4) Patient is willing and able to comply with clinic visits and procedure outlined in the study 
protocol.
5) Male or female ≥ 18 years of age
6) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix 7)
7) Life expectancy ≥ 3 months
8) Absolute neutrophil count (ANC) ≥ 1000 cells/μL (1.0  109/L); granulocyte 
colony-stimulating factor (G-CSF) is not permitted within 1 week of screening to meet 
eligibility criteria.


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9) Platelet count ≥ 75,000 cells/μL (75  109/L); platelet transfusion is not permitted within 
1 week of screening to meet eligibility criteria.
10) Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment. NOTE: 
Transfusions are allowed to meet hemoglobin eligibility (Section 7.8.1.1).
11) Criterion removed.
12) Adequate liver function as demonstrated by the following:
a) AST ≤ 3.0  upper limit of normal (ULN)
b) ALT ≤ 3.0  ULN
c) Total bilirubin ≤ 1.5  ULN (or ≤ 3.0  ULN and primarily unconjugated if patient 
has a documented history of Gilbert’s syndrome or genetic equivalent).
13) International normalized ratio (INR) ≤ 1.2; patients receiving anticoagulation treatment 
may be allowed to participate if INR is within the therapeutic range prior to alternate 
assignment.
14) Patients must have adequate renal function as demonstrated by a creatinine 
clearance ≥ 30 mL/min calculated by the Cockcroft-Gault formula (Appendix 8) or 
measured by 24 hours urine collection.
15) Corrected serum calcium ≤ 2.9 mmol/L (11.5 mg/dL); measures to reduce calcium to 
acceptable levels, such as a short course of steroids, bisphosphonates, hydration, or 
calcitonin are acceptable.
16) Pretreatment blood cross-match completed (Section 7.8.1.1).
17) Male and female patients of childbearing potential who engage in heterosexual 
intercourse must agree to use protocol-specified method(s) of contraception 
(Appendix 4).
18) Patients must be willing to consent to mandatory pretreatment and on-treatment bone 
marrow biopsies (trephines).
Magrolimab in Combination With Daratumumab:
In addition to fulfilling the inclusion criteria for all patients, patients who are assigned to 
receive magrolimab in combination with daratumumab should fulfill the following:
19) Patient must have received at least 3 previous lines of therapy for MM including an IMiD 
such as lenalidomide and a PI such as bortezomib.


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20) Patients must have not had prior anti-CD38 antibody therapy for at least 6 months prior 
to enrollment.
21) No prior history of discontinuation of daratumumab due to toxicity
Magrolimab in Combination With Pomalidomide and Dexamethasone:
In addition to fulfilling the inclusion criteria for all patients, patients who are assigned to 
receive magrolimab in combination with pomalidomide and dexamethasone should fulfill the 
following:
22) Patient must have received at least 3 previous lines of therapy for MM including an IMiD 
such as lenalidomide and a PI such as bortezomib.
23) Prior treatment with pomalidomide is allowed if the patient achieved at least a PR to the 
most recent pomalidomide therapy and will have had at least a 6-month treatment-free 
interval from the last dose of pomalidomide until first study treatment.
24) No prior history of discontinuation of pomalidomide due to toxicity
25) No contraindication to dexamethasone
Magrolimab in Combination With Carfilzomib and Dexamethasone:
In addition to fulfilling the inclusion criteria for all patients, patients who are assigned to 
receive magrolimab in combination with carfilzomib and dexamethasone should fulfill the 
following:
26) Patient must have received at least 3 previous lines of therapy for MM including an IMiD 
such as lenalidomide and a PI such as bortezomib.
27) Prior treatment with a PI, including carfilzomib, is allowed if the patient achieved at least 
a PR to the most recent prior PI therapy, and will have had at least a 6-month PI 
treatment-free interval from the last dose until first study treatment.
28) No prior history of discontinuation of carfilzomib due to toxicity.
29) No contraindication to dexamethasone
Magrolimab in Combination With Bortezomib and Dexamethasone:
In addition to fulfilling the inclusion criteria for all patients, patients who are assigned to 
receive magrolimab in combination with bortezomib and dexamethasone should fulfill the 
following:
30) Patient must have received at least 1 previous line of therapy.


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31) Prior treatment with a PI, including bortezomib, is allowed if the patient achieved at least 
a PR to the most recent prior PI therapy, and will have had at least a 6 month PI treatment 
free interval from the last dose until first study treatment.
32) No prior history of discontinuation of bortezomib due to toxicity.
33) No contraindication to dexamethasone.
4.3.
Exclusion Criteria
Patients who meet any of the following exclusion criteria are not eligible to be enrolled in 
this study:
1) Patients with known amyloidosis including myeloma complicated by amyloidosis
2) Multiple myeloma of immunoglobulin M subtype
3) Patients with Waldenstrom’s macroglobulinemia
4) Patients with MDS
5) Plasma cell leukemia (defined as either 20% of peripheral blood white blood cell (WBC) 
count comprised of plasma/CD138-positive cells) or circulating plasma cells ≥ 2 × 109/L
6) Patients with solitary bone or extramedullary plasmacytoma as the only evidence of 
plasma cell dyscrasia
7) POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, 
endocrinopathy, M-protein, and skin changes)
8) Glucocorticoid therapy (prednisone > 40 mg/day or equivalent) within 14 days prior to 
enrollment; corticosteroid therapy for hypercalcemia is allowed
9) Chemotherapy with approved or investigational anticancer therapeutics within 28 days 
prior to enrollment
10) Focal radiation therapy within 7 days prior to enrollment; radiation therapy to an 
extended field involving a significant volume of bone marrow within 21 days prior to 
enrollment (ie, prior radiation must have been to less than 30% of the bone marrow)
11) Immunotherapy within 28 days prior to enrollment
12) Major surgery (excluding procedures to stabilize the vertebrae) within 28 days prior to 
enrollment
13) Positive serum pregnancy test (Appendix 4)
14) Breastfeeding female


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15) Known hypersensitivity to any of the study drugs, the metabolites, or formulation 
excipient
16) Prior treatment with CD47 or SIRPα-targeting agents.
17) Current participation in another interventional clinical study
18) Autologous stem cell transplant < 100 days prior to enrollment
19) Considered eligible to receive autologous or allogeneic SCT at the time of enrollment
20) Allogeneic SCT for the treatment of MM within 6 months of enrollment or active 
graft-versus-host disease requiring immunosuppression
21) Significant neuropathy (Grade 3 to 4, or Grade 2 with pain) within 14 days prior to 
enrollment
22) Known inherited or acquired bleeding disorders
23) Known cirrhosis
24) Clinical suspicion or documentation of CNS disease
25) Significant disease or medical conditions, as assessed by the investigator and sponsor, 
that would substantially increase the risk-benefit ratio of participating in the study. This 
includes, but is not limited to, acute myocardial infarction within the last 6 months, 
unstable angina, uncontrolled diabetes mellitus, significant active infections, congestive 
heart failure, or NYHA Class III or IV heart failure.
26) Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy 
directed against reactivation) or antifungal agents within 14 days prior to enrollment
27) Second malignancy, except treated basal cell or localized squamous skin carcinomas, 
localized prostate cancer, or other malignancies for which patients are not on active 
anticancer therapies and have had no evidence of active malignancy for at least 1 year. 
Other exceptions may be considered with sponsor approval. Previous hormonal therapy 
with luteinizing hormone-releasing hormone agonists for prostate cancer and treatment 
with bisphosphonates and receptor activator of nuclear factor kappa-B ligand (RANKL) 
inhibitors are not criteria for exclusion.
28) Known active or chronic hepatitis B or C infection or HIV infection in medical history
29) Active hepatitis B virus (HBV) and/or active hepatitis C virus (HCV), and/or HIV 
infection following testing at screening:


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d) Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test 
positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by 
quantitative polymerase chain reaction (PCR) for confirmation of active disease.
e) Patients who test positive for HCV antibody. Patients who test positive for HCV 
antibody will require HCV RNA by quantitative PCR for confirmation of active 
disease.
f)
Patients who test positive for HIV
30) Patients who received any live vaccine within 4 weeks prior to initiation of study 
treatments.


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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Enrollment
Patients who meet eligibility criteria will be enrolled into individual safety run-in cohorts for 
the specific combination treatment.
An IXRS will be employed to manage the conduct of the study. During the safety run-in 
and/or dose expansion, the IXRS will be used to maintain a central log documenting 
enrollment, to manage dose modifications, to assess current inventories of products procured 
by the sponsor, to initiate any necessary resupply of products procured by the sponsor, and to 
document discontinuation of study drug and study participation. This is an open-label study 
in both the safety run-in and the dose-expansion cohorts of the study.
5.2.
Description and Handling
5.2.1.
Magrolimab
Formulation
Magrolimab is formulated as a sterile, clear to slightly opalescent, colorless to slightly 
yellow, preservative-free liquid intended for IV administration, containing 10 mM sodium 
acetate, 5% (weight-to-volume [w/v]) sorbitol, 0.01% (w/v) polysorbate 20 at pH of 5.0. 
Each vial is manufactured to ensure a deliverable volume of 10 mL containing 200 mg of 
magrolimab at a concentration of 20 mg/mL.
Packaging and Labeling
Magrolimab is supplied in single-use, 10 mL glass vials with coated elastomeric stoppers and 
aluminum crimp overseals with a flip-off cap.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, European Union (EU) Guideline to 
Good Manufacturing Practice – Annex 13 (Investigational Medicinal Products), and/or other 
local regulations.
Storage and Handling
Magrolimab should be stored at 2 to 8 °C (36 to 46 °F). Magrolimab should not be frozen. 
Protect from light during storage. Do not shake. Storage conditions are specified on the label. 
Until dispensed to the patients, study drugs should be stored in a securely locked area, 
accessible only to authorized site personnel.
To ensure the stability and proper identification, study drug(s) should not be stored in a 
container other than the container in which they were supplied.


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Consideration should be given to handling, preparation, and disposal through measures that 
minimize drug contact with the body. Appropriate precautions should be followed to avoid 
direct eye contact or exposure when handling.
5.2.2.
Daratumumab
Formulation
Daratumumab is commercially sourced. Information regarding the formulation can be found 
in the current prescribing information from the reference USPI, SmPC, or applicable local or 
regional label.
Packaging and Labeling
Commercially available daratumumab will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good 
Manufacturing Practice - Annex 13 (Investigational Medicinal Products), and/or other local 
regulations.
Storage and Handling
Commercial product of daratumumab will be used for the study. Further information 
regarding storage and handling are available in the reference USPI, SmPC, or applicable 
local or regional label for commercial products.
5.2.3.
Pomalidomide
Formulation
Pomalidomide is commercially sourced. Information regarding the formulation can be found 
in the current prescribing information from the reference USPI, SmPC, or applicable local or 
regional label.
Packaging and Labeling
Commercially available pomalidomide will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good 
Manufacturing Practice – Annex 13 (Investigational Medicinal Products), and/or other local 
regulations.


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Storage and Handling
Commercial product of pomalidomide will be used for the study. Further information 
regarding storage and handling are available in the reference USPI, SmPC, or applicable 
local or regional label for commercial products.
5.2.4.
Carfilzomib
Formulation
Carfilzomib is commercially sourced. Information regarding the formulation can be found in 
the current prescribing information from the reference USPI, SmPC, or applicable local or 
regional label.
Packaging and Labeling
Commercially available carfilzomib will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good 
Manufacturing Practice – Annex 13 (Investigational Medicinal Products), and/or other local 
regulations.
Storage and Handling
Commercial product of carfilzomib will be used for the study. Further information regarding 
storage and handling are available in the reference USPI, SmPC, or applicable local or 
regional label for commercial products.
5.2.5.
Bortezomib
Formulation
Bortezomib is commercially sourced. Information regarding the formulation can be found in 
the current prescribing information from the reference USPI, SmPC, or applicable local or 
regional label.
Packaging and Labeling
Commercially available bortezomib will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good 
Manufacturing Practice - Annex 13 (Investigational Medicinal Products), and/or other local 
regulations.


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Storage and Handling
Commercial product of bortezomib will be used for the study. Further information regarding 
storage and handling are available in the reference USPI, SmPC, or applicable local or 
regional label for commercial products.
5.2.6.
Dexamethasone
Formulation
Dexamethasone is commercially sourced. Information regarding the formulation can be 
found in the current prescribing information from the reference USPI, SmPC, or applicable 
local or regional label.
Packaging and Labeling
Commercially available dexamethasone will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good 
Manufacturing Practice – Annex 13 (Investigational Medicinal Products), and/or other local 
regulations.
Storage and Handling
Commercial product of dexamethasone will be used for the study. Further information 
regarding storage and handling are available in the reference USPI, SmPC, or applicable 
local or regional label for commercial products.
5.3.
Dosage and Administration
5.3.1.
Magrolimab
The planned dosage and administration schedule for magrolimab in the safety run-in cohorts 
and dose-expansion cohorts are described in Table 4 and Table 5, respectively.


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Table 4.
Magrolimab Dose De-escalation and Schedule (All Safety Run-in 
Cohorts)
Dose Level
Magrolimab Dosing
Starting Dose
30 mg/kg
•
Cycle 1: 1 mg/kg IV on Day 1, 30 mg/kg on Days 8, 15, 22, 29
•
Cycle 2: 30 mg/kg IV every week on Days 1, 8, 15, 22
•
Cycle 3 and onward: 30 mg/kg IV on Days 1, 15
Level −1
20 mg/kg
•
Cycle 1: 1 mg/kg IV on Day 1, 20 mg/kg on Days 8, 15, 22, 29
•
Cycle 2: 20 mg/kg IV every week on Days 1, 8, 15, 22
•
Cycle 3 and onward: 20 mg/kg IV on Days 1, 15
Level −2
15 mg/kg
•
Cycle 1: 1 mg/kg IV on Day 1, 15 mg/kg on Days 8, 15, 22, 29
•
Cycle 2: 15 mg/kg IV every week on Days 1, 8, 15, 22
•
Cycle 3 and onward: 15 mg/kg IV on Days 1, 15
IV = intravenous
Table 5.
Magrolimab Dose Level and Schedule (All Dose-expansion 
Cohorts)
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles are 28 Days)
RP2Da
Cycle 1
Cycle 2
Cycle 3+
30 mg/kg
1 mg/kg IV Day 1 (priming dose)
and
30 mg/kg IV Days 8, 15, 22, 29
30 mg/kg IV
Days 1, 8, 15, 22
30 mg/kg IV
Days 1, 15
20 mg/kg
1 mg/kg IV Day 1 (priming dose)
and
20 mg/kg IV Days 8, 15, 22, 29
20 mg/kg IV
Days 1, 8, 15, 22
20 mg/kg IV
Days 1, 15
15 mg/kg
1 mg/kg IV Day 1 (priming dose)
and
15 mg/kg IV Days 8, 15, 22, 29
15 mg/kg IV
Days 1, 8, 15, 22
15 mg/kg IV
Days 1, 15
IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in the safety run-in cohorts.
Instructions for Magrolimab Administration
Magrolimab should be administered as outlined in the Pharmacy Manual for the study. The 
dose of magrolimab will be calculated based on actual weight enrollment (using weight 
obtained either at screening or on Day 1) and will remain constant throughout the study, 
unless there is a > 10% change in weight from baseline. Modifications to the study drug 
doses administered should be made for a > 10% change in body weight and according to 
local and regional prescribing standards. Dose modifications for changes in body weight 
≤ 10% may be made according to local institutional guidelines.


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Magrolimab will be administered by IV infusion. The duration of each magrolimab infusion 
will be 3 hours (± 30 minutes) for the first 5 doses during Cycle 1 of treatment. From Cycle 2 
onward, magrolimab infusions will be 2 hours (± 30 minutes). The reduced infusion time to 
2 hours is utilized based on prior data demonstrating majority CD47 receptor occupancy on 
peripheral blood cells, thus mitigating anticipated RBC toxicities from magrolimab. When 
magrolimab is given in combination with daratumumab, carfilzomib, or bortezomib on the 
same day, magrolimab will be administered at least 1 hour after the completion of the other 
agent.
Magrolimab dosing days may only be adjusted by a maximum of ± 3 days in order to 
accommodate the administration of other medicines.
Magrolimab Premedication and Prophylaxis
Premedication is required prior to the administration of the first 4 doses of magrolimab and 
in case of reintroduction with repriming (Section 5.4.1). Premedication should include oral 
acetaminophen 650 to 1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV 
dexamethasone 4 to 20 mg, or comparable regimen. If less than 4 hours has elapsed since a 
prior dose of acetaminophen has been given, the dose of acetaminophen premedication may 
be omitted. Premedication can be given 1 to 3 hours prior to the start of infusion. 
Premedication decisions for subsequent infusions should be based on the treating physician’s 
clinical judgment and the presence/severity of prior IRRs. Guidance is provided in Table 24.
Postinfusion Monitoring
All patients should be monitored for 1 hour after infusion for priming, 
repriming/re-escalation, and maintenance doses during Cycle 1 (Sections 5.4.1 and 7.8.1). 
Postinfusion monitoring should begin after the infusion is complete. Postinfusion monitoring 
is not required for doses after Cycle 1 Day 29. Patients who experience any 
treatment-emergent AEs during the observation period should be further monitored, as 
clinically appropriate. Refer to Section 7.8.1.1 for postinfusion hemoglobin monitoring 
requirements.
Treatment Duration/Discontinuation
Patients may continue study treatment until they show evidence of disease progression, 
relapse, loss of clinical benefit, or unacceptable toxicity (further details about treatment 
discontinuation are provided in Section 3.4).
Treatment Delay and Repriming/Re-escalation for Magrolimab
Given the large CD47 antigen sink on normal cells, patients who have a long dose delay of 
magrolimab are required to be reprimed with magrolimab dosing to resaturate the CD47 
antigen sink. Guidelines for repriming/re-escalation for magrolimab after a dose delay are 
provided in Section 5.4.1.


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5.3.2.
Daratumumab
Study treatment for daratumumab in combination with magrolimab is shown in Table 6. 
Magrolimab will be administered as described in Section 5.3.1.
Table 6.
Dose Level and Schedule for Daratumumab in Combination With 
Magrolimab
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles are 28 Days)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Daratumumab
16 mg/kg IV
or
1800 mg SC
Days 8, 15, 22, 29
Days 1, 8, 15, 22
Days 1 and 15 (every 2 weeks) 
until Cycle 6 (total of 8 doses) 
followed by Day 1 (every 
4 weeks) for subsequent cycles 
IV = intravenous; SC = subcutaneous
Instructions for Daratumumab Administration
Daratumumab will be administered as an IV infusion or as an SC injection.
On days when daratumumab is coadministered with magrolimab, the required administration 
is as follows:
1) Preinfusion (IV) or preinjection (SC) medications for daratumumab 1 to 3 hours before 
(premedication)
2) Daratumumab IV infusion or SC injection
3) Postinfusion (IV) or postinjection (SC) medications for daratumumab (postmedication)
4) Preinfusion medications for magrolimab IV (first 4 doses)
5) Magrolimab IV infusion
There will be a minimum 1-hour observation period between the completion of daratumumab 
infusion/injection and the start of magrolimab infusion.
Instructions on dose modifications and delays are provided in Section 5.4.2. Management of 
IRRs is described in Section 7.8.2.
Premedication for Daratumumab
Administer the following premedications to reduce the risk of infusion/administration 
reactions to all patients 1 to 3 hours prior to every dose of daratumumab:
•
Methylprednisolone 100 mg, or equivalent, administered IV. Following the second 
administration, the dose of corticosteroid may be reduced (oral or IV methylprednisolone 
60 mg).


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•
Antipyretics (oral acetaminophen 650 to 1000 mg).
•
Antihistamine (oral or intravenous diphenhydramine 25 to 50 mg or equivalent).
Postmedication for Daratumumab
Administer postmedication to reduce the risk of delayed infusion/administration reactions to 
all patients as follows:
•
Administer oral corticosteroid (20 mg methylprednisolone or equivalent dose of an 
intermediate-acting or long-acting corticosteroid in accordance with local standards) on 
each of the 2 days following each daratumumab administration (beginning the day after 
the administration).
•
In addition, for any patients with a history of chronic obstructive pulmonary disease, 
consider prescribing postinfusion medications such as short and long-acting 
bronchodilators, and inhaled corticosteroids. Following the first 4 infusions, if the patient 
experiences no major infusion reactions, these additional inhaled postinfusion 
medications may be discontinued.
For the management of IRRs to daratumumab, please refer to Section 7.8.2.
Contraindications for Daratumumab
A contraindication to daratumumab includes those patients with a history of severe 
hypersensitivity (ie, anaphylactic reactions) to daratumumab or any of the components of the 
formulation.
Antiviral Prophylaxis for Daratumumab
Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting 
daratumumab and continue for 3 months following treatment.
5.3.3.
Pomalidomide and Dexamethasone
Study treatment for pomalidomide and dexamethasone in combination with magrolimab is 
shown in Table 7. Magrolimab will be administered as described in Section 5.3.1.


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Table 7.
Dose Level and Schedule for Pomalidomide and Dexamethasone in 
Combination With Magrolimab
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles are 28 Days)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Pomalidomide
4 mg PO
Days 1 to 21 (daily)
Days 1 to 21 (daily)
Days 1 to 21 (daily)
Dexamethasone
40 mg POa
Days 1, 8, 15, 22, 29
Days 1, 8, 15, 22
Days 1, 8, 15, 22
PO = orally
a
Dexamethasone starting dose is 20 mg in patients more than 75 years of age.
Instructions on dose modifications and delays for pomalidomide and dexamethasone are 
provided in Section 5.4.3 and Section 5.4.6, respectively. Refer to the reference USPIs, 
SmPCs, or applicable local or regional labels for toxicity management.
Premedication and Prophylaxis for Pomalidomide and Dexamethasone
No premedication is indicated for pomalidomide {POMALYST 2020}.
Pneumocystis jirovecii pneumonia prophylaxis should be considered, as per institutional 
guidelines, while on dexamethasone.
Contraindications for Pomalidomide
Refer to the reference USPIs, SmPCs, or applicable local or regional labels. Contraceptive 
requirements are outlined in Appendix 4.
5.3.4.
Carfilzomib and Dexamethasone
Study treatment for carfilzomib and dexamethasone in combination with magrolimab is 
shown in Table 8. Magrolimab will be administered as described in Section 5.3.1.


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Table 8.
Dose Level and Schedule for Carfilzomib and Dexamethasone in 
Combination With Magrolimab
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles are 28 Days)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Carfilzomib
20/70 mg/m2 IVa
Days 8 (20 mg/m2), 
15 (70 mg/m2), 
22 (70 mg/m2)
Days 1, 8, 15b 
Days 1, 8, 15b
Dexamethasone
40 mg PO or IVc
Days 8, 15, 22, and 29
Days 1, 8, 15, and 22
Days 1, 8, 15, and 22 
until Cycle 9 and Days 
1, 8, and 15 from Cycle 
10 onward
IV = intravenous; PO = orally
a
The recommended starting dose of carfilzomib is 20 mg/m2 on Cycle 1, Day 8. If tolerated, escalate the dose to 
70 mg/m2 on Cycle 1, Day 15, and thereafter.
b
From Cycle 2 onwards, carfilzomib will be given on Days 1, 8, and 15 of each cycle.
c
Dexamethasone starting dose is 20 mg in patients more than 75 years of age.
Instructions for Carfilzomib Administration
The relevant USPI, SmPC, or applicable local or regional label should be followed for the 
administration of carfilzomib and dexamethasone.
Carfilzomib will be administered as an IV infusion. Administer dexamethasone either PO or 
IV 30 minutes to 4 hours before carfilzomib.
On days when carfilzomib is coadministered with magrolimab, carfilzomib will be given 
first, followed by magrolimab. There will be a minimum 1-hour observation period between 
the completion of carfilzomib infusion and the start of magrolimab infusion.
Instructions on dose modifications and delays are provided in Section 5.4.4. Management of 
IRRs is described in Section 7.8.2.
Premedication and Prophylaxis for Carfilzomib and Dexamethasone
No premedication is indicated for carfilzomib.
Pneumocystis jirovecii pneumonia prophylaxis should be considered, as per institutional 
guidelines, while on dexamethasone.
5.3.5.
Bortezomib and Dexamethasone
Study treatment for bortezomib and dexamethasone in combination with magrolimab is 
shown in Table 9. Magrolimab will be administered as described in Section 5.3.1.


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Table 9.
Dose Level and Schedule for Bortezomib and Dexamethasone in 
Combination With Magrolimab
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles are 28 Days)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Bortezomib
1.3 mg/m2 SC or IVa
Days 8, 15, 22, 29
Days 1, 8, 15, 22
Days 1, 8 15, 22b
Dexamethasone
40 mg POc
Days 1, 8, 15, 22, 29
Days 1, 8, 15, 22
Days 1, 8, 15, 22d
IV = intravenous; PO = orally; SC = subcutaneous.
a
SC is preferred over IV, where feasible.
b
Maximum of 8 cycles in those who have previously received bortezomib.
c
Dexamethasone starting dose is 20 mg in patients more than 75 years of age.
d
Days 1, 8, 15, and 22 from Cycles 3 to 9 and then Days 1, 8, and 15 from Cycle 10 onward.
The maximum number of cycles is 8 in patients who have previously received bortezomib. 
On days when bortezomib is coadministered with magrolimab, bortezomib will be given 
first, followed by magrolimab. Both administrations will be separated by a minimum of 
1 hour.
Instructions on dose modifications and delays for bortezomib and dexamethasone are 
provided in Section 5.4.5 and Section 5.4.6, respectively.
Premedication and Prophylaxis for Bortezomib and Dexamethasone
No premedication is indicated for bortezomib {VELCADE 2019}.
Pneumocystis jirovecii pneumonia prophylaxis should be considered, as per institutional 
guidelines, while on dexamethasone {DEXAMETHASONE 2015}.
Postdose Monitoring
Refer to Section 7.8.5 for monitoring and dose-adjustment for peripheral neuropathy 
following administration of bortezomib. Refer to the reference USPI, SmPC, or applicable 
local or regional label for toxicity management for dexamethasone.
Contraindications for Bortezomib
Bortezomib is contraindicated in patients with acute diffuse infiltrative pulmonary and 
pericardial disease, plus those patients with hypersensitivity to the active substance or to any 
of the excipients {VELCADE 2019}.


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5.4.
Dose Modification and Delays
5.4.1.
Magrolimab
Magrolimab dose de-escalation in the safety run-in cohorts is described in Table 4. In the 
dose-expansion cohorts, magrolimab should not be dose reduced. Clinical safety and PK data 
from dose finding studies in both solid tumor and hematologic malignancies have not 
demonstrated any dose-dependent toxicities associated with magrolimab.
Dose reduction/modification may be allowed in certain circumstances (eg, with certain AEs), 
with approval by the sponsor. Magrolimab may be withheld if treatment-emergent and/or 
magrolimab-related AEs occur, until clinical resolution or improvement per the treating 
physician. Refer to Section 7.8.1 for details on management of magrolimab-related toxicities. 
In the rare event of needing to reduce the magrolimab dose in the dose-expansion cohorts due 
to toxicity, the schedule described for the safety run-in cohorts in Table 4 may be used in 
consultation with the sponsor. The magrolimab dose should be increased back to the RP2D 
when toxicity is resolved.
When the combination drugs (daratumumab, pomalidomide, carfilzomib, bortezomib or 
dexamethasone) are delayed due to toxicities, magrolimab should continue independently as 
per magrolimab administration schedule (Table 5). Continuous (every 2 weeks) dosing of 
magrolimab is needed in order to ensure optimal efficacious exposure. Magrolimab dosing 
days may only be adjusted by a maximum of ± 3 days in order to accommodate the 
administration of other medicines as presented in Appendix 2. Magrolimab may be withheld 
if treatment-emergent and/or related AEs occur, and will require approval by the sponsor if 
the delay is longer than 3 days.
Magrolimab will be permanently discontinued in patients who experience any Grade 4 
nonhematologic AEs related to magrolimab that do not improve to Grade 2 or pretreatment 
baseline levels within 14 days. Magrolimab will also be permanently discontinued in patients 
with Grade 4 hemolytic anemia which is defined as anemia with clinical and/or laboratory 
evidence of hemolysis with life-threatening consequences and/or urgent interventions are 
indicated. For dose delay criteria, magrolimab may be withheld if treatment-emergent and/or 
magrolimab-related AEs occur, which include all AEs that constitute a DLT, as defined in 
Section 3.1.1 of the protocol. Magrolimab may be reintroduced if the severity has recovered 
to Grade 2 or pretreatment baseline levels with the approval by the medical monitor.
If planned surgical procedures are needed for patients on-study treatment, magrolimab will 
be delayed and restarted in accordance with Table 10.


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Table 10.
Magrolimab Dosing Guidance for Planned Surgical Procedures on 
Study
Planned Surgical Procedure
Magrolimab Dose Guidance
Minimally Invasive Procedure
(Examples: Biopsies [Excluding Lung/Liver], 
Skin/Subcutaneous Lesion Removal, 
Cataract/Glaucoma/Eye Surgery/Cystoscopy)
Hold magrolimab dose 3 days prior to procedure and 
restart after 3 days
Moderately Invasive Procedure
(Examples: Lung/Liver Biopsy, Hysterectomy, 
Cholecystectomy, Hip/Knee Replacement, Minor 
Laparoscopic Procedures, Stent/Angiopathy)
Hold magrolimab dose 3 days prior to procedure and 
restart after 5 days
Highly Invasive Procedure
(Examples: CNS/Spine Surgery, Major Vascular 
Surgery, Cardiothoracic Surgery, Major 
Laparoscopic Surgery)
Hold magrolimab dose 3 days prior to procedure and 
restart after 7 days
CNS = central nervous system
Repriming and Re-escalation Guidelines
Repriming guidelines in Table 11 must be followed for patients with dose delays.
Table 11.
Repriming Guidelines
Dose
Dosing Frequency
Minimum Duration of Treatment 
Gap That Will Lead to Repriming
1 mg/kg
N/A – used at initial priming
2 weeks
Weekly
2 weeks
15 mg/kg
Every 2 weeks
4 weeks
Weekly
2 weeks
20 mg/kg
Every 2 weeks
4 weeks
Weekly
4 weeks
30 mg/kg
Every 2 weeks
4 weeks
The repriming/re-escalation magrolimab dosing regimen and assessments must follow Cycle 1 for magrolimab treatment 
and magrolimab-specific premedication administration and safety assessments as illustrated in the schedules of assessments 
and treatment administration (Appendix Table 2), and then switch to the schedule for the assigned cycle number for all 
assessments and study treatments.
During repriming, cycle numbering, efficacy, biomarker, PK, and immunogenicity 
assessments should continue as per assigned cycle number. The safety assessment must 
follow the Cycle 1 safety assessments and switch back to assigned cycle schedule 
subsequently.


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5.4.2.
Daratumumab
No dose reductions of daratumumab are allowed. Refer to Section 7.8.2 for details on 
management of IRRs. If any of the following criteria are met and the event cannot be 
ascribed to magrolimab, the daratumumab infusion/injection must be held to allow for 
recovery from toxicity. The criteria for a dose delay are:
•
Grade 3 thrombocytopenia with bleeding
•
Grade 4 neutropenia, if this is the second occurrence despite growth factor support
•
Febrile neutropenia of any grade
•
Neutropenia with infection of any grade
•
Grade 3 or higher nonhematologic toxicities with the following exceptions:
Grade 3 nausea that responds to antiemetic treatment within 7 days
Grade 3 vomiting that responds to antiemetic treatment within 7 days
Grade 3 diarrhea that responds to antidiarrheal treatment within 7 days
Grade 3 fatigue that was present at baseline or that lasts for < 7 days after the last 
administration of daratumumab
Grade 3 asthenia that was present at baseline or that lasts for < 7 days after the last 
administration of daratumumab
If a daratumumab administration does not commence within the prespecified window of the 
scheduled administration date, then the dose will be considered a missed dose. 
Administration may resume at the next planned dosing date (Table 12).
Table 12.
Management of Daratumumab-related Dosing Delays
Cycle
Frequency
Dose Held
Dosing Restart
1
Weekly
Days 8, 15, 22, and 29
> 3 days
Next planned weekly dosing 
date
2
Weekly
Days 1, 8, 15, and 22
> 3 days
Next planned weekly dosing 
date
3-6
Every 2 weeks (Q2W)
> 1 week
Next planned Q2W dosing 
date
7+
Every 4 weeks (Q4W)
> 2 weeks
Next planned Q4W dosing 
date
Q2W = every 2 weeks; Q4W = every 4 weeks


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A missed dose will not be made up.
Patients who permanently discontinue daratumumab may continue to receive magrolimab 
monotherapy in agreement with the sponsor. Patients who discontinue magrolimab will 
discontinue all other study treatments and will enter follow-up.
No formal studies of daratumumab have been conducted in patients with renal or hepatic 
impairment. Based on population PK analysis, no dosage adjustment is necessary in these 
patients. No dose adjustments are considered necessary in elderly patients. No interaction 
studies have been performed. Due to the high affinity to a unique epitope on CD38, 
daratumumab is not anticipated to alter drug-metabolizing enzymes, although interference 
with Indirect Antiglobulin Test (Indirect Coombs Test) and Serum Protein Electrophoresis 
and Immunofixation Tests have been noted.
5.4.3.
Pomalidomide
Recommended dose adjustments for the management of AEs as judged by the investigator to 
be related to pomalidomide are provided in Table 13. Dose modification decisions for 
pomalidomide will be at the investigator’s discretion per the reference USPI, SmPC, or 
applicable local or regional label. These documents should be consulted for use in special 
populations and drug-drug interactions.
To initiate a new cycle of pomalidomide following a dose interruption, the ANC must be 
≥ 1000/μL with or without G-CSF, the platelet count must be ≥ 50,000/μL, and 
nonhematologic AEs must be resolved or improved as outlined in Table 13.
If recovery from toxicities is prolonged and pomalidomide dose withholding is beyond 
14 days, then the dose of pomalidomide should be decreased by 1 dose-level when dosing is 
resumed in the new cycle (Table 14). The minimum permitted dose level for pomalidomide 
is 1 mg. No dose re-escalation is permitted for pomalidomide.
Patients who permanently discontinue pomalidomide may continue magrolimab with or 
without dexamethasone in agreement with the sponsor. Patients who discontinue magrolimab 
will discontinue all other study treatments and will enter follow-up.


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Table 13.
Pomalidomide Dose Modifications
Toxicity
Dose Modification
Neutropenia
Grade 4 Neutropenia (ANC < 500/μL)
or
Febrile Neutropenia 
(Fever ≥ 38.5 °C and ANC < 1000/μL)
Withhold the dose for remainder of cycle. If the patient was not 
receiving G-CSF therapy, G-CSF therapy may be started at the 
discretion of the Investigator.
On Day 1 of the next cycle, the dose of pomalidomide may be 
maintained if neutropenia was the only pomalidomide-related 
toxicity requiring a dose modification and G-CSF treatments 
are continued. Otherwise, decrease by 1 dose-level at start of 
next cycle.
Note, ANC must be ≥ 1000/μL to resume dosing.
Thrombocytopenia
Grade 4 Thrombocytopenia 
(Platelets < 25,000/μL)
Withhold the dose for remainder of cycle. Dosing may resume 
at 1 dose-level lower once the platelet count has recovered to 
≥ 50,000/μL
Grade 3 Rash 
Withhold dose for remainder of cycle. Decrease by 1 dose-level 
when dosing is resumed at next cycle (rash must be resolved or 
improved to ≤ Grade 1 before dose resumption).
Grade 4 Rash or Skin Exfoliation, Bullae, 
or any Other Severe Dermatologic 
Reaction
Permanently discontinue pomalidomide
≥ Grade 3 Constipation 
Withhold dose for remainder of cycle. Initiate bowel regimen.
Decrease by 1 dose-level when dosing is resumed at next cycle 
(constipation must be resolved or improved to ≤ Grade 2 before 
dose resumption)
Venous Thromboembolic Event
Withhold dose for remainder of cycle. Initiate anticoagulation 
treatment. Maintain dose level when dosing resumed at next 
cycle at discretion of the investigator.
Other ≥ Grade 3 Pomalidomide-related 
AEsa
Withhold dose for remainder of cycle. Decrease by 1 dose-level 
when dosing resumed at next cycle (AE must be resolved or 
improved to ≤ Grade 2 before restarting dosing)
AE = adverse event; ANC = absolute neutrophil count; G-CSF = granulocyte colony-stimulating factor
a
For Grade 3 or 4 AEs that are not considered to be related to pomalidomide, the investigator should consult with the 
Gilead medical monitor for dose interruptions and reductions.
Table 14.
Pomalidomide Dose Reduction Levels
Dose Level
Oral Pomalidomide Dose 
(Days 1 to 21 of 28-day Cycle)
Starting Dose
4 mg
Dose Level −1
3 mg
Dose Level −2
2 mg
Dose Level −3
1 mg


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5.4.4.
Carfilzomib
Table 15 details instructions for carfilzomib dose interruptions and reductions and Table 16 
outlines the dose reduction levels for carfilzomib; however, dose modification decisions for 
carfilzomib will be at the investigator’s discretion (in consultation with the medical monitor) 
per the reference USPI, SmPC, or applicable local or regional label. These documents should 
be consulted for use in special populations and drug-drug interactions.
Patients who permanently discontinue carfilzomib may continue to receive magrolimab 
monotherapy with or without dexamethasone in agreement with the sponsor. Patients who 
discontinue magrolimab will discontinue all other study treatments and will enter follow-up.


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Table 15.
Carfilzomib Dose Modifications
Hematologic Toxicity
Recommended Action
ANC less than 0.5 × 109/L
Withhold dose:
•
If recovered to greater than or equal to 
0.5 × 109/L, continue at the same dose level
For subsequent drops to less than 0.5 × 109/L, follow 
the same recommendations as above and consider 
1 dose-level reduction when restarting carfilzomib
Febrile neutropenia: ANC less than 0.5 × 109/L and 
an oral temperature more than 38.5 °C or 2 
consecutive readings of more than 38.0 °C for 
2 hours 
Withhold dose
•
If ANC returns to baseline grade and fever 
resolves, resume at the same dose level
Platelets less than 10 × 109/L or evidence of bleeding 
with thrombocytopenia
Withhold dose
•
If recovered to greater than or equal to 
10 × 109/L and/or bleeding is controlled, 
continue at the same dose level
For subsequent drops to less than 10 × 109/L, follow 
the same recommendations as above and consider 
1 dose-level reduction when restarting carfilzomib
Renal Toxicity
Recommended Action
Serum creatinine greater than or equal to 
2 × baseline, or
Creatinine clearance less than 15 mL/min, or 
creatinine clearance decreases to less than or equal to 
50% of baseline, or need for hemodialysis
Withhold dose and continue monitoring renal 
function (serum creatinine or creatinine clearance)
•
If attributable to carfilzomib, resume when renal 
function has recovered to within 25% of 
baseline; start at 1 dose-level reduction
•
If not attributable to carfilzomib, dosing may be 
resumed at the discretion of the healthcare 
provider
For patients on hemodialysis receiving carfilzomib, 
the dose is to be administered after the hemodialysis 
procedure 
Hepatic Impairment (Mild or Moderate)
Recommended Action
For patients with mild (total bilirubin 1 to 1.5 × ULN 
and any AST or total bilirubin ≤ ULN and 
AST > ULN) or moderate (total bilirubin > 1.5 to 
3 × ULN and any AST) hepatic impairment
Reduce the dose of carfilzomib by 25%
Other Nonhematologic Toxicity
Recommended Action
All other severe or life-threatening (Grade 3 or 
Grade 4) nonhematological toxicities 
Withhold until resolved or returned to baseline
Consider restarting the next scheduled treatment at 
1 dose-level reduction 
ANC = absolute neutrophil count; AST = aspartate aminotransferase; ULN = upper limit of normal


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Table 16.
Carfilzomib Dose Reduction Levels
Dose Level
Carfilzomib dose
Starting Dose
70 mg/m2
Dose Level −1 
56 mg/m2
Dose Level −2
45 mg/m2
Dose Level −3
36 mg/m2
If toxicity persists at 36 mg/m2, discontinue carfilzomib treatment.
Note: Infusion times remain unchanged during dose reduction(s).
5.4.5.
Bortezomib
Table 17 details instructions for bortezomib dose interruptions and reductions and Table 18 
outlines the dose reduction levels for bortezomib; however, dose modification decisions for 
bortezomib will be at the investigator’s discretion per the reference USPI, SmPC, or 
applicable local or regional label. These documents should be consulted for use in special 
populations and drug-drug interactions.
Patients who permanently discontinue bortezomib may continue to receive magrolimab 
monotherapy with or without dexamethasone in agreement with the sponsor. Patients who 
discontinue magrolimab will discontinue all other study treatments and will enter follow-up.
Table 17.
Bortezomib Dose Modifications 
Toxicity
Bortezomib Dose Modification
≥ Grade 3 Nonhematological 
Toxicity (excluding neuropathy)
Withhold bortezomib until the symptoms of the toxicity have 
resolved, bortezomib therapy may be reinitiated at reduced 
bortezomib dosing by 1 dose-level
Grade 4 Hematological Toxicity
Withhold bortezomib until the symptoms of the toxicity have 
resolved, bortezomib therapy may be reinitiated at reduced 
bortezomib dosing by 1 dose-level
Grade 1 Neuropathy Without Pain or 
Loss of Function
No action
Grade 1 Neuropathy with Pain or 
Grade 2 Neuropathy
Reduce bortezomib dosing by 1 level
Grade 2 Neuropathy with Pain or 
Grade 3 Neuropathy
Withhold bortezomib until toxicity resolves, bortezomib therapy may 
be reinitiated at a reduced dose level of 0.7 mg/m2 and change 
treatment schedule to once per week (Days 1 and 8 of a 21-day 
cycle)
Grade 4 Neuropathy
Permanently discontinue bortezomib


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Table 18.
Bortezomib Dose Reduction Levels
Dose Level
Bortezomib
Dose Level (SC or IV)
Starting Dose
1.3 mg/m2 on Days 1, 8, 15, and 22 of each cycle from Cycle 2
(Days 8, 15, 22, and 29 of Cycle 1)
Dose Level −1 
1.3 mg/m2 Days 1, 8, and 15 of each cycle from Cycle 2
Dose Level −2
1 mg/m2 Days 1, 8, and 15 only of each cycle
IV = intravenous; SC = subcutaneous
5.4.6.
Dexamethasone
Table 19 and Table 20 detail instructions for low-dose dexamethasone dose interruptions and 
reductions; however, dose withholding/resumption decision is at the investigator’s discretion 
per the reference USPI, SmPC, or applicable local or regional label.
Table 19.
Dose Reductions for Low-Dose Dexamethasone-related Toxicities
Toxicity
Low-Dose Dexamethasone Dose Modification
Dyspepsia (Grade 1 or 2)
Maintain dose and treat with histamine (H2) blockers or equivalent. 
Decrease by 1 dose-level if symptoms persist
Dyspepsia ≥ Grade 3
Withhold dose until symptoms are controlled. Add H2 blocker or equivalent 
and decrease 1 dose-level when dosing is resumed
Edema ≥ Grade 3
Use diuretics as needed and decrease dose by 1 dose-level
Confusion or Mood 
Alteration ≥ Grade 2
Withhold dose until symptoms resolve. When dosing is resumed decrease 
dose by 1 dose-level
Muscle Weakness (Steroid 
Myopathy) ≥ Grade 2
Withhold dose until muscle weakness < Grade 1. When dosing is resumed 
decrease dose by 1 dose-level
Hyperglycemia ≥ Grade 3
Decrease dose by 1 dose-level. Treat with insulin or oral hypoglycemic 
agents as needed
Acute Pancreatitis
Discontinue dexamethasone from treatment regimen
Other ≥ Grade 3 
Dexamethasone-related AEs
Stop dexamethasone dosing until the AE resolves to ≤ Grade 1. Decrease by 
1 dose-level when dosing is resumed
AE = adverse event
If recovery from toxicities is prolonged and dexamethasone dose withholding is beyond 
14 days, then the dose of dexamethasone will be decreased by 1 dose-level when dosing is 
resumed in the new cycle.


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Table 20.
Low-Dose Dexamethasone Dose Reduction Levels
Dose Level
≤ 75 years old
> 75 years old
Starting Dose
40 mg
20 mg
Dose Level −1
24 mg
12 mg
Dose Level −2
16 mg
8 mg
Dexamethasone may be discontinued if the patient is unable to tolerate 16 mg if ≤ 75 years 
old or 8 mg if > 75 years old. In the event of discontinuation of dexamethasone, other study 
medications will be continued per protocol.
5.5.
Prior and Concomitant Medications
All prior and concomitant medications, including all prescription, over-the-counter, herbal 
supplements, and IV medications and fluids received within 70 days prior to signing the 
informed consent form (ICF) through the 70-day safety follow-up visit should be recorded in 
the electronic case report form (eCRF).
Live vaccines are prohibited during the study, and for 3 months after the last dose of study 
treatment {Rubin 2014}.
5.5.1.
Prohibited Prior Medications
Prohibited medications prior to study enrollment are summarized in Table 21.
Table 21.
Prohibited Prior Medications
Medication
Length of Time Prior to Enrollment
Glucocorticoids (Prednisone > 40 mg/day or Equivalent)
14 days
Chemotherapy with Approved or Investigational Anticancer 
Therapeutics
28 days
Immunotherapy
28 days
CD47 or SIRPα-targeting Agents
None
Magrolimab in Combination with Daratumumab Cohort 
Only: No Prior Anti-CD38 Antibody Therapy
6 months
Magrolimab in Combination with Pomalidomide and 
Dexamethasone Cohort Only: No Prior Pomalidomide 
Therapy
6 months
Magrolimab in Combination with Carfilzomib and 
Dexamethasone Cohort Only: No Prior PI Therapy
6 months
Magrolimab in Combination with Bortezomib and 
Dexamethasone Cohort Only: No Prior PI Therapy
6 months
PI = proteasome inhibitor; SIRPα = signal regulatory protein alpha


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5.5.2.
Prohibited Concomitant Medications
Anticancer therapies including chemotherapy, targeted therapies, and immunotherapy (apart 
from study drugs) or radiation to large marrow reserves for either a palliative or therapeutic 
intent are not permitted while patients are on study.
Except for the protocol-specified regimens, long-term corticosteroids for nonmalignant 
conditions (eg, asthma, inflammatory bowel disease) equivalent to a dexamethasone dose 
> 4.0 mg/day or prednisone > 20 mg/day are not permitted. Corticosteroids given short-term 
(up to 2 weeks) for nonmalignant conditions are permitted provided that the cumulative dose 
is less than 40 mg per week dexamethasone equivalent. Medical monitor should be contacted 
in the event that short-term corticosteroid use is required greater than 2 weeks or at 
cumulative dose of more than 40 mg dexamethasone equivalent.
Plasmapheresis is not permitted at any time while the patient is receiving study treatment. 
For patients requiring plasmapheresis while on-study treatment, every attempt should be 
made to first document disease status by the IMWG 2016 criteria. Study treatment must be 
discontinued.
5.5.3.
Permitted and Required Concomitant Medications
Use of bisphosphonates, hematopoietic growth factors, hormonal therapy, luteinizing 
hormone-releasing hormone agonists for prostate cancer, hormonal maintenance therapy for 
breast cancers, treatment with RANKL inhibitors and other therapies including antibiotics, 
analgesics, antihistamines, or other medications and transfusions of RBCs, platelets, or 
fresh-frozen plasma are permitted at the discretion of the investigator. Radiation therapy to a 
pathological fracture site or to treat bone pain as well as any localized non-CNS therapy is 
allowed. Premedication and prophylaxis for AEs is permitted while on study treatment. 
Corticosteroid use is permitted for symptomatic treatment, premedication, pseudoprogression 
and/or specific patient conditions. Chronic high-dose steroid use is not recommended unless 
clinically indicated.
Thromboprophylaxis
An anticoagulant (eg, enteric-coated aspirin at standard prophylactic dose or other 
anticoagulant or antiplatelet medication, such as clopidogrel bisulfate, low molecular weight 
heparin, or warfarin), is a suggested concomitant medication in patients based on an 
individual benefit/risk assessment.
Tumor Lysis Syndrome Prophylaxis
An approved uric acid-lowering agent (eg, allopurinol) in patients at high risk for tumor lysis 
syndrome due to high tumor burden may be prescribed at the investigator’s discretion, per 
the reference USPI, SmPC, or applicable local or regional label.


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Bone Health Therapy
Concomitant bone health therapy is strongly recommended for all patients with evidence of 
lytic destruction of bone or with osteopenia {Gralow 2013, Terpos 2013}. Commercially 
available therapies are preferred when available, and should be used according to the 
manufacturer’s recommendations, as described in the reference USPI, SmPC, or applicable 
local or regional label, for patients with osteolytic or osteopenic myelomatous bone disease.
Patients who are using bisphosphonate or mAb therapy when they enter the study should 
continue the same treatment. Patients with evidence of lytic destruction of bone or with 
osteopenia who are not using a bisphosphonate or mAb at the time of enrollment should start 
a bisphosphonate or other bone health medications that have proven efficacy, such as mAbs, 
as soon as possible during Cycle 1 or 2 of treatment. Investigators should not start 
bisphosphonate or mAb therapy during the study unless it has been agreed with the sponsor 
that there is no sign of disease progression.
Antiviral Prophylaxis for Daratumumab
Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting 
daratumumab and continue for 3 months following treatment.
Refer to the prescribing information in the reference USPI, SmPC, or applicable local or 
regional label.
Proton-pump Inhibitor Required With Dexamethasone
A proton-pump inhibitor (omeprazole or equivalent) is required while on dexamethasone per 
the reference USPI, SmPC, or applicable local or regional label {DEXAMETHASONE 
2015}.
Prophylaxis for Pneumocystis jirovecii Pneumonia With Dexamethasone
Pneumocystis jirovecii pneumonia prophylaxis is recommended, as per institutional 
guidelines while on dexamethasone {DEXAMETHASONE 2015}.
COVID-19 Vaccine
There are no substantial safety data regarding the concomitant administration of the 
coronavirus disease 2019 (COVID-19) vaccines and magrolimab. Patients are allowed to 
receive the COVID-19 vaccine, and study visits should continue as planned if vaccination 
occurs while the patients is on the study. Investigators should follow local guidelines for 
concomitant administration of the COVID-19 vaccines with the study drug.


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5.6.
Accountability for Study Drug(s)
The investigator is responsible for ensuring adequate accountability of all used and unused 
study drug (kits, vials, etc) This includes acknowledgment of receipt of each shipment of 
study drug (quantity and condition). All used and unused study drug dispensed to patients 
must be returned to the site.
Each study site must keep accountability records that capture:
•
The date received and quantity of study drug kits (kits, vials, etc)
•
The date, patient number, and the study lot number dispensed
•
The date, quantity of used and unused study drug returned, along with the initials of the 
person recording the information
5.6.1.
Study Drug(s) Return or Disposal
Gilead recommends that used and unused study drug supplies be destroyed at the site. If the 
site has an appropriate standard operating procedure (SOP) for drug destruction as 
determined by Gilead, the site may destroy used (empty or partially empty) and unused study 
drug supplies in accordance with that site’s approved SOP. A copy of the site’s approved 
SOP will be obtained for the electronic trial master file. If study drug is destroyed at the site, 
the investigator must maintain accurate records for all study drugs destroyed. Records must 
show the identification and quantity of each unit destroyed, the method of destruction, and 
the person who disposed of the study drug. Upon study completion, copies of the study drug 
accountability records must be filed at the site. Another copy will be returned to Gilead.
If the site does not have an appropriate SOP for drug destruction, used and unused study drug 
supplies are to be sent to the designated disposal facility for destruction. The study monitor 
will provide instructions for return.
The study monitor will review study drug supplies and associated records at periodic 
intervals.


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6.
STUDY PROCEDURES
The study procedures to be conducted for each patient enrolled in the study are presented in 
tabular form in Appendix 2 and described in the text that follows.
The investigator must document any deviation from the protocol procedures and notify 
Gilead or the contract research organization.
6.1.
Patient Enrollment and Treatment Assignment
Entry into screening does not guarantee enrollment onto the study. In order to manage the 
total study enrollment, Gilead, at its sole discretion, may suspend screening and/or 
enrollment at any site or study-wide at any time.
Patients will be screened within 30 days before enrollment to determine eligibility for 
participation in the study. Standard-of-care procedures performed before obtaining informed 
consent may be used for screening.
Patients who are determined to be not eligible after screening may be rescreened once at the 
discretion of the investigator. Rescreening must be discussed with and approved by the 
sponsor on a case-by-case basis. Patients who are determined to be eligible for rescreening 
must be reconsented with a new screening number assigned.
Patients rescreening within 21 days of the signing of the original informed consent only need 
to repeat the assessment(s) that did not originally meet the eligibility criteria; all other initial 
screening assessments do not need to be repeated. Patients rescreening more than 21 days 
from the signing of the original informed consent must be reconsented, with a new screening 
number assigned, all screening procedures repeated.
In cases of technical failure, lab samples can be retested during screening period and patient 
will not be considered a screen failure. Patients who do not enroll within 30 days of 
screening will be screen failed.
6.2.
Pretreatment Assessments
The following will be performed and documented at screening (Appendix Table 1):
•
Obtain written informed consent
•
Obtain demographics and medical history, including MM history
•
Bone marrow sample for % plasma cells, morphology and cytogenetics (FISH) – these 
will be conducted locally. Additional sample will be sent centrally for biomarker and 
other correlative studies – refer to Section 6.5.4


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•
Myeloma frailty score calculation (patients ≥ 65 years of age) (Appendix 10)
•
ECOG performance status
•
Complete physical examination, including vital signs, body weight, and height
•
Peripheral neurological examination for residual neuropathy (patients enrolling onto 
bortezomib cohort)
•
12-lead electrocardiogram (ECG) (single)
•
Echocardiogram (ECHO) or multigated acquisition (scan) (MUGA)
•
FACT-MM questionnaire (as of Protocol Amendment 6, this assessment is not required)
•
Serum/plasma chemistry, hematology, and urinalysis assessments
•
Serum pregnancy test (females of childbearing potential)
•
Blood phenotyping or genotyping for minor antigens, type, and screen (any of the 4 blood 
groups A, B, AB, and O composing the ABO system [ABO]/Rhesus factor [Rh]), direct 
antiglobulin test (DAT)
•
Serum protein electrophoresis (SPEP) and 24-hour urine protein electrophoresis (UPEP)
•
SFLC
•
Serum immunofixation (SIFE)
•
Urine immunofixation (UIFE)
•
β2-microglobulin and quantitative immunoglobulin (Ig) levels
•
Hepatitis B, hepatitis C, and HIV
•
C-reactive protein (CRP)
•
Skeletal survey
•
Computed tomography (CT) (with or without positron emission tomography [PET]) or 
magnetic resonance imaging (MRI) assessment for extramedullary soft tissue 
plasmacytoma
•
Record all SAEs and any AEs related to protocol-mandated procedures occurring after 
signing of the ICF
•
Record prior and concomitant medications


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From the time of obtaining informed consent through the first administration of study drug, 
record all SAEs, as well as any AEs related to protocol-mandated procedures on the 
applicable eCRF. All other untoward medical occurrences observed during the screening 
period, including exacerbation or changes in medical history, are to be considered medical 
history. See Section 7, Adverse Events and Toxicity Management, for additional details.
6.2.1.
Screening Laboratory Assessments
Analytes and tests to be assessed by the local laboratory or specialty laboratories at screening 
are presented in Table 22.
Table 22.
Laboratory Analyte Listing (to be Performed at Screening)
Chemistry
(Serum or Plasma)
Hematology
Urinalysis
Other Laboratory 
Measurements
Sodium
Potassium
Chloride
Bicarbonate
Total protein
Albumin
Calcium
Magnesium
Phosphorus
Glucose
BUN or urea
Creatinine
Uric acid
Total bilirubin
Direct bilirubin
Indirect bilirubin
Lactate 
dehydrogenase
AST
ALT
Alkaline 
phosphatase
Red blood cell
Hemoglobin
Hematocrit
Platelets
WBC differential
Absolute neutrophil 
count
Eosinophils
Basophils
Lymphocytes
Monocytes
Reticulocytes
Haptoglobin
Prothrombin time
INR
aPTT or PTT
Red blood cell
Glucose
Protein
Urine pH
Ketones
Bilirubin
Urine specific gravity
Pregnancy test (serum)
C-reactive protein (CRP)
Serum free light chain (SFLC)
Serum protein electrophoresis 
(SPEP)
24-hour urine protein 
electrophoresis (UPEP)
Serum immunofixation (SIFE)
Urine immunofixation (UIFE)
Blood phenotyping or genotyping 
for minor antigens, type, and 
screen (ABO/Rh), direct 
antiglobulin test
β2-microglobulin and 
quantitative Ig levels
Hepatitis B and hepatitis C 
assessments: HBsAg, anti-HBc, 
-HCV antibody; HBV DNA and 
HCV RNA as required
HIV antibody
Peripheral blood smear
ALT = alanine aminotransferase; aPTT = activated partial thromboplastin time; AST = aspartate aminotransferase; 
BUN = blood urea nitrogen; HBV = hepatitis B virus; HCV = hepatitis C virus; anti-HBc = hepatitis B core antibody; 
HBsAg = hepatitis B surface antigen; Ig = immunoglobulin; INR = international normalized ratio; PTT = partial 
thromboplastin time; WBC = white blood cell


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6.2.2.
Type and Screen and Direct Antiglobulin Test
Magrolimab may interfere with RBC phenotyping due to expected coating of the RBC 
membrane. Due to the risk of developing anemia, and because magrolimab may make 
phenotyping difficult, ABO/Rh type, antibody screen, blood phenotyping or genotyping, and 
DAT need to be performed at screening before exposure to magrolimab, as described in 
Section 7.8.1.1.
RBC phenotyping/genotyping, ABO type and DAT need not be repeated if results dated 
before screening are available. Antibody screen need not be repeated if results dated before 
screening are available unless the patient was transfused since that time.
6.3.
Treatment Assessments
On study treatment assessments include evaluations of safety (Section 6.4) efficacy 
(Section 6.5), PROs (Section 6.6), PK (Section 6.7), immunogenicity (Section 6.8), and 
pharmacodynamics and biomarkers (Section 6.9). The schedule for on-treatment assessments 
is provided in Appendix Table 2.
6.4.
Safety Assessments
Safety will be evaluated by incidence of AEs, assessment of clinical laboratory test findings 
(chemistry, hematology, urinalysis), physical examination, 12-lead electrocardiogram, vital 
signs measurements, and other assessments as presented in Appendix 2.
6.4.1.
Adverse Events
At each visit, all AEs observed by the investigator or reported by the patient that occur after 
the first dose of study treatment through 70 days after the last dose of study treatment are to 
be reported using the applicable eCRF (Section 7.1.1). Full details on the definitions, 
assessment and reporting instructions for AEs are provided in Section 7.
6.4.2.
Laboratory Assessments
Analytes and tests to be assessed by the local laboratory or specialty laboratories during 
treatment are presented in Table 23. Refer to Section 7.8.1.1 for hemoglobin testing 
requirements predose and postdose monitoring for the first 2 magrolimab doses.


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Table 23.
Laboratory Analyte Listing (to be Performed During Treatment)
Chemistry
(Serum or Plasma)
Hematology
Urinalysis
Other Laboratory 
Measurements
Sodium
Potassium
Calcium
Chloride
Bicarbonate
Albumin
Glucose
BUN or urea
Creatinine
Uric acid
Total bilirubin
Direct bilirubin
Indirect bilirubin
Lactate dehydrogenase
AST
ALT
Alkaline phosphatase
Red blood cell
Hemoglobin
Platelets
WBC differential
Absolute neutrophil 
count
Lymphocytes
Reticulocytes
Haptoglobin
Red blood cell
Glucose
Protein
Urine pH
Ketones
Bilirubin
Urine specific 
gravity
Pregnancy test (urine)
C-reactive protein (CRP)
Pharmacokinetics
Serum free light chain (SFLC)
Serum protein electrophoresis 
(SPEP)
24-hour urine protein 
electrophoresis (UPEP)
Serum immunofixation (SIFE)
Urine immunofixation (UIFE)
β2-microglobulin and 
quantitative Ig levels
Antidrug antibodies
Receptor occupancya
Peripheral blood smear
ALT = alanine aminotransferase; AST = aspartate aminotransferase; BUN = blood urea nitrogen; Ig = immunoglobulin; 
WBC = white blood cell
a
Receptor occupancy samples will be collected at selected sites (as of Protocol Amendment 6, this assessment is not 
required).
6.4.3.
Vital Signs
Vital signs should include heart rate, respiratory rate, oxygen saturation, blood pressure, 
temperature, and weight. Height should be recorded during screening only. Weight should be 
recorded during screening, on Day 1 of each cycle, and Day 1 and Day 15 for Cycles 3 and 
up. Vital signs are to be recorded prior to infusion of magrolimab at the visits specified in the 
schedules of assessments in Appendix 2.
6.4.4.
Physical Examination
Complete physical examination should be performed at screening. Thereafter, 
symptom-directed physical examinations are acceptable and may also include routine 
examination of the skin (including fingers, toes, and ears) and neurologic system. A 
comprehensive peripheral neurological exam will be performed for patients receiving 
bortezomib.


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6.4.5.
Pregnancy Test
Pregnancy tests are required only for female patients of childbearing potential. Note that a 
woman is considered to be of childbearing potential following the initiation of puberty 
(Tanner Stage 2) until becoming postmenopausal, unless permanently sterile or with 
medically documented ovarian failure. Permanent sterilization includes hysterectomy, 
bilateral oophorectomy, or bilateral salpingectomy in a female patient of any age. Women are 
considered to be in a postmenopausal state when they are ≥ 54 years of age with cessation of 
previously occurring menses for ≥ 12 months without an alternative cause. In addition, 
women of < 54 years with amenorrhea of ≥ 12 months may also be considered 
postmenopausal if their follicle stimulating hormone (FSH) level is in the postmenopausal 
range and they are not using hormonal contraception or hormonal replacement therapy. A 
negative serum pregnancy test is required at screening, and a negative urine pregnancy test is 
required prior to study treatment administration on Cycle 1 Day 1. The Cycle 1 Day 1 
pregnancy test does not need to be repeated if the screening pregnancy test was performed 
within the 72 hours before study treatment administration. Pregnancy tests will also be 
required at Day 1 of each subsequent cycle. For patients in the cohort receiving magrolimab 
in combination with pomalidomide and dexamethasone, the first test should be performed 
within 10 to 14 days and the second test within 24 hours prior to prescribing pomalidomide 
therapy and then weekly during the first month. The test should then be performed monthly 
thereafter in females with regular menstrual cycles, or every 2 weeks in females with 
irregular menstrual cycles. For further details, refer to Appendix 4.
6.4.6.
Performance Status
Performance status will be scored using the ECOG performance status scale index 
(Appendix 7).
6.4.7.
12-lead Electrocardiogram
A 12-lead ECG will be performed at screening, at Cycle 1, and every other cycle after 
Cycle 1.
6.4.8.
Echocardiogram
All patients will have a baseline transthoracic ECHO (TTE) during screening, including 
assessments of systolic and diastolic left ventricular function and right ventricular function. 
Screening ECHO may be done within 30 days prior to enrollment, if performed as a part of 
standard of care. A MUGA scan is also allowed in lieu of ECHO.


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6.4.9.
Prior and Concomitant Medications
All concomitant medications taken by the patient while on study are to be documented. All 
prior and concomitant medications, including all prescription, over-the-counter, herbal 
supplements, and IV medications and fluids received within 30 days prior to signing the 
informed consent through the 70-day safety follow-up visit should be recorded in the eCRF. 
Note that any anticancer therapies after the study treatment period should also be collected 
per the schedule of assessments (Appendix Table 3).
6.4.10.
Peripheral Blood Smear Assessment
Peripheral smears should be collected per the schedule of assessments and assessed for 
standard cell morphology. These samples should be collected from the arm contralateral to 
the arm being used for drug infusion/injection, if possible. All other observed findings should 
be reported according to local laboratory hematopathology standard procedures. Peripheral 
smears will be assessed locally (see also Section 7.8).
6.5.
Efficacy Assessments
Efficacy will be determined using response criteria based on the IMWG 2016 criteria 
(Appendix 6). Efficacy assessments will be done in conjunction with bone marrow 
assessments, according to the schedule of assessments on Day 1 of Cycle 2 onward 
(Appendix Table 2).
Disease response and progression assessments include: SPEP, UPEP, SFLC, SIFE, and UIFE 
(Section 6.5.1), tumor response and MM disease assessment (Section 6.5.2), PD assessment 
(Section 6.5.3), bone marrow assessment (Section 6.5.4), MRD assessment (Section 6.5.5), 
bone lesion assessment (Section 6.5.5), and plasmacytoma evaluation (Section 6.5.7).
6.5.1.
Laboratory Assessments for Multiple Myeloma – Serum Protein 
Electrophoresis, Urine Protein Electrophoresis, Serum Free Light Chain, 
Serum Immunofixation, and Urine Immunofixation
Serum protein electrophoresis, UPEP, SFLC, SIFE, and UIFE will be conducted at a central 
or local laboratory (based on investigator preference) during screening and subsequently 
every 28 ± 7 days (starting from Cycle 1 Day 1) irrespective of cycle duration including dose 
delays and treatment discontinuation.
1) Serum: SPEP for M protein quantification, total serum protein, SIFE, and quantitative 
immunoglobulin assay.
a) SIFE is required at baseline and at suspected CR regardless of whether measurable 
M-protein was present at baseline
b) SIFE will also be performed at suspected disease progression or relapse from CR


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c) Patients with measurable disease in SPEP will be assessed for response based on 
SPEP and will not require SIFE routinely
d) All other serum tests will be followed at each tumor assessment
2) Urine: 24-hour urine collection for UPEP, urinary light chains, and UIFE. 
Twenty-four-hour urine must be collected with each cycle for all patients.
a) UIFE is required at baseline and to confirm CR, regardless of whether measurable 
M-protein was present at baseline
b) UIFE will also be performed at suspected disease progression or relapse from CR
c) Patients with measurable disease in UPEP will be assessed for response based on 
UPEP and will not require UIFE routinely
d) All other urine tests will be followed at each tumor assessment
e) Urine M-protein is not needed to document PR or minimal response (MR) if baseline 
urine M-protein was not measurable; however, it is still required for CR and VGPR.
3) Serum free light chain:
a) Patients without measurable serum M-protein (ie, < 0.5 g/dL) or urine M-protein 
(ie, < 200 mg/24 hours) and considered oligosecretory must have SFLC assessed at 
each cycle until progression
b) Patients with measurable disease in both SPEP and UPEP will be assessed for 
response based on these 2 tests and not by the SFLC assay
c) Serum must be collected at screening and time of SIFE and UIFE negativity to 
confirm CR and be sent to the central lab for SFLC analysis. This measurement is 
required to assess for sCR.
During each cycle, blood will be obtained for SFLC, SPEP, and SIFE and 24-hour urine 
samples will be obtained for UPEP and UIFE. Results for SPEP, UPEP, or SFLC must be 
available at screening and before enrollment. SPEP, UPEP, and SFLC will be repeated on 
Cycle 1 Day 1 (unless screening values are within 14 days of Cycle 1 Day 1). For IgA and 
IgD myelomas, quantitative immunoglobulin measurements are preferred for disease 
assessments; the same percentage changes apply as for serum M-spike.
6.5.2.
Tumor Response and Multiple Myeloma Disease Assessment
Investigator evaluation of disease response assessments will be based on central or local 
laboratory data (for SPEP, UPEP, SIFE, UIFE and SLFC) obtained every 28 ± 7 days until 
confirmed PD irrespective of cycle duration, including dose delays and treatment 
discontinuation. Where indicated, bone marrow samples (biopsy and/or aspirate; 
Section 6.5.4), bone lesion assessment (Section 6.5.5), and plasmacytoma evaluation 
(Section 6.5.7) will be analyzed and read locally.


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Patients will be evaluated for disease response and progression according to the IMWG 2016 
response criteria in Appendix 6. Disease status categories include sCR, CR, VGPR, PR, MR, 
SD, and PD. 
The following considerations should be given to response assessments:
•
All response categories require 2 consecutive assessments made at any time before 
initiation of any new therapy. Two consecutive readings of the applicable disease 
parameter (SPEP, UPEP, or SFLC), performed at any time (no minimum interval is 
required, it can be done the same day) are required; however, to confirm response or PD, 
2 discrete samples are required; testing cannot be based upon the splitting of a single 
sample.
•
All categories also require no known evidence of progression, including new bone 
lesions, if radiographic studies were performed.
•
Confirmation of CR or sCR requires bone marrow assessment (aspirate or biopsy); bone 
marrow assessments do not need to be repeated for confirmation.
•
Extramedullary plasmacytoma evaluation (if present at screening) (refer to Section 6.5.7)
•
Whenever more than 1 parameter is used to assess response, the overall assigned level of 
response is determined by the lower or lowest level of response.
•
Patients should be categorized as SD until they meet criteria for any response category or 
have documented PD.
•
Patients will continue in the last confirmed response category until there is confirmation 
of progression or improvement to a higher response status; patients cannot move to a 
lower response category.
•
If alternate therapy is started before confirming PD any additional testing during 
subsequent therapy can be used to confirm PD.
•
The lowest confirmed value before suspected progression will be used as baseline for 
calculation of progression; if a serum and/or urine spike is considered too low to 
quantitate, this value can be assigned as zero as a baseline for documentation of 
subsequent PD.
•
Any soft tissue plasmacytoma documented at baseline must undergo serial monitoring; 
otherwise, the patient is classified as not evaluable.
•
In patients with 2 M-protein bands at the start of therapy, the sum of the 2 spikes should 
be used for monitoring of disease.


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• 
Careful attention should be given to new positive immunofixation results appearing in 
patients who have achieved a CR, when the isotype is different, it probably represents 
oligoclonal immune reconstitution and should not be confused with relapse; these bands 
typically disappear over time. 
For patients with daratumumab interference on SIFE, a second reflex assay using the 
anti-idiotype mAb will be used to label daratumumab migration on the immunofixation 
electrophoresis (IFE) {Kumar 2016}. Patients that meet all other IMWG 2016 criteria for CR 
(Appendix 6), and whose positive IFE is confnm ed to be daratumumab, will be considered 
complete responders. Similarly, for patients with magrolimab interference on SIFE, a second 
reflex assay using the anti-idiotype mAb rhCD47 may be used to mitigate this effect. As 
daratumumab and magrolimab are monoclonal IgG kappa antibodies, additional semm 
samples may be utilized to monitor for potential interference with the IFE. 
6.5.3. 
Progressive Disease Assessment 
Confnmation of PD using 2 consecutive assessments will be required per the IMWG 2016 
criteria. The assessments outlined in Appendix 6 are required for PD. 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 sernm or 
urine M-spike at baseline, progression cannot be defined by increases in SFLC alone. 
6.5.4. 
Bone Marrow Assessments 
Bone maiTow assessments (including aspirate and core/ti·ephine biopsy specimens) are 
required for response assessments (for the confnmation of CR and sCR; refer to 
Section 6.5.2), including conventional cytogenetic analysis per local institutional standai·ds at 
each time point according to the schedules of assessments in Appendix 2. 
Details for prepai·ation and disti·ibution 
of aspirate and biopsy/ti·ephine specimens to the testing laboratories will be provided in the 
laborato1y manual for this study. 
Priority of samples for bone ma.n ow aspirate testing will be as follows: 
1) Response assessment (including PD) 
2) Other clinical reasons (which may take priority over MRD) 
3) MRD assessment 
4) Other biomarkers/genomic research (as of Protocol Amendment 6, these assessments are 
not required) 
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A bone marrow sample (aspirate slides and/or biopsy) will be obtained at the following time 
points:
5) A baseline bone marrow sample (aspirate and biopsy) will be obtained within 14 days 
prior to the first dose (baseline) on Cycle 1 Day 1 and will be used to quantify the percent 
(%) of myeloma cell involvement. A bone marrow sample obtained as standard of care 
may be used as baseline if taken within 45 days prior to enrollment and are sent to the 
central laboratory for processing. If a fresh aspirate and/or biopsy is obtained, in addition 
to baseline assessment of myeloma involvement, it will also be made available for 
biomarker studies.
6) Within 7 days prior to Cycle 2 Day 1 (before dose) for first response assessment and for 
biomarker studies.
7) From Cycle 3 onwards, it will be repeated as clinically indicated at suspected CR or sCR, 
and to confirm CR or sCR. A sample obtained at either suspected or confirmed CR/sCR 
will also be made available for MRD assessment.
6.5.5.
Minimal Residual Disease
Sequencing-based assays can identify MM cells to a frequency of below 1  10-5 of total 
WBCs. These rare myeloma cells are termed MRD, and their presence or absence following 
treatment is an independent prognostic factor for disease progression and relapse in all MM 
treatment paradigms.
Minimal residual disease in bone marrow is a biomarker measurement in this study. MRD 
will be measured by a next-generation sequencing (NGS)-based assay at multiple time points 
to further understand the efficacy and MOA of magrolimab combinations. For each screened, 
consenting patient, bone marrow aspirates will be collected before the first dose, within 
7 days prior to Cycle 2 Day 1, at Cycle 12 (± 2 weeks), and at suspected CR. The bone 
marrow aspirates will be processed and stored according to a protocol that is provided to the 
central lab. The samples will be analyzed centrally by the NGS-based MRD assay.
6.5.6.
Skeletal Survey
Skeletal survey will include lateral radiograph of the skull, anteroposterior and lateral views 
of the spine, and anteroposterior views of the pelvis, ribs, femora, and humeri. Low-dose 
whole body CT or fluorodeoxyglucose-PET/CT may be used in place of the skeletal survey. 
Bone lesion assessment (all patients) will be conducted at screening (may be within 30 days 
prior to enrollment) and will be repeated if worsening clinical symptoms suggest PD or as 
clinically indicated (development of compression fracture does not exclude response). The 
same method of assessment used at baseline will be used throughout the study. These 
imaging studies will be read locally. The number and location of skeletal lesions and whether 
they are lytic should be recorded on the eCRF. An on-treatment survey should record 
whether there is an increase in the number or size of lytic lesions.


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6.5.7.
Extramedullary Plasmacytoma Assessment
Extramedullary plasmacytoma evaluation will be conducted at screening in all patients. 
The evaluation may be done within 30 days prior to enrollment if performed as a part of 
standard of care. If an extramedullary plasmacytoma is detected, evaluation will be repeated 
during treatment to confirm a response of SD or better, or to confirm PD or as clinically 
indicated. Assessment of measurable sites of extramedullary disease will be performed and 
evaluated locally every cycle (by physical examination) for patients with plasmacytomas or 
as clinically indicated during treatment for other patients until confirmed CR or confirmed 
disease progression. In addition, radiological evaluation of extramedullary plasmacytomas 
will be conducted every 12 weeks (or every 3 cycles) in patients with radiological evidence 
of extramedullary plasmacytoma at baseline. The same technique, which may include CT 
(with or without PET) or MRI should be employed for each measurement of plasmacytoma 
dimensions as clinically appropriate (Appendix 6). A plasmacytoma that has been radiated is 
not suitable for response assessment; however, it must be monitored to assess for PD.
A sum of the products of the longest diameters and longest perpendicular diameter for all 
measurable lesions will be calculated at screening. This sum will be used as the reference for 
on-study assessments by which to characterize the objective tumor response. All tumor 
measurements must be made in millimeters. All documented measurable and nonmeasurable 
lesions are to be followed throughout the study. All assessments to be used for tumor 
response evaluation, including the baseline assessment, must be performed using the same 
method for repeat assessment.
Measurable disease are lesions that can be accurately measured in 2 dimensions and both 
diameters must be ≥ 20 mm when evaluated by standard CT scanning or ≥ 10 mm when 
evaluated by spiral CT scanning or MRI. The minimum diameter size should be at least twice 
the slice thickness.
Nonmeasurable disease are all other lesions (or sites of disease), including those that are too 
small (ie, do not meet above criteria), occur within a previously irradiated area (unless they 
are documented as new lesions since the completion of radiation therapy), bone lesions, 
leptomeningeal disease, ascites, pleural or pericardial effusion (exception for effusions 
documented by cytology as not malignant or present at baseline without progression), 
lymphangitis cutis/pulmonis, abdominal masses that are not pathologically/cytologically 
confirmed and followed by imaging techniques, and cystic lesions.
Bidimensional lesion measurements must be performed and recorded in the designated 
eCRF.


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6.6.1. 
Patient-Reported Outcome Assessments 
FACT-MM Questionnaire 
Final 
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Health-related quality of life (QOL) and potential for improvement over the course of the 
study will be assessed by the FACT-MM PRO questionnaire specific to the MM patient 
population {Facit.org 2009}. The FACT-MM consists of 41 questions (items) and repo1is on 
a 5-point Like1i-type scale on physical well-being, social/family well-being, emotional 
well-being, functional well-being, MM subscale (Appendix 9). The recall period is 7 days 
(past 7 days) and will take approximately 15 minutes to complete. 
The QOL questionnaire should be completed preferably before patients undergo any 
study-related procedures, including other study-related evaluations, discussions with medical 
personnel, physician and study treatment administration. 
As of Protocol Amendment 6, the FA CT-MM assessment is not required. 
6.7. 
Pharmacokinetic Assessments 
Magrolimab sernm concentration will be measured by a validated enzyme-linked 
immunosorbent assay (ELISA) immunoassay method. 
Blood samples for PK assessment will be collected before dosin 
accordin to the schedule of assessments in A 
endix 2. 
6.8. 
Immunogenicity 
Peripheral blood for immunogenicity assessments for ADA against magrolimab will be 
collected as described in the schedule of assessments in Appendix 2 in all patients. When 
collected on the day of study diu g dosing, the ADA blood sample must be collected at the 
same time as the pre-dose PK sample. The presence of anti-magrolimab antibodies will be 
determined by a validated immunoassay method. 
Sernm from venous blood samples collected from patients receiving daratumumab will be 
assessed for the generation of antibodies to daratumumab. Daratumumab concentration is 
also evaluated at all immunogenicity time points to ensure appropriate inte1pretation of 
immunogenicity data. When both sennn concentration and immunogenicity analyses are 
specified, they are perfo1med on aliquots from the same blood di·aw and no additional 
sampling is required. Procedures for sample collection, preparation, identification, storage, 
and shipment will be provided in the laborato1y manual or equivalent document 
A blood sample should be di·awn, if possible, for dete1mination of antibodies to 
daratumumab any time an infusion reaction is observed or repo1ied during the study. 
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Daratumumab serum concentration will also be determined from the same infusion reaction 
sample for the purpose of interpreting immunogenicity data.
6.9.
Pharmacodynamic and Biomarker Assessments
Biomarker samples will be collected to assess the pharmacodynamic, MOA, and treatment 
response biomarkers, and to define correlates of clinical efficacy and/or safety, as outlined in 
Section 3.8. Pharmacodynamic and biomarker assessments will be conducted as indicated in 
Appendix 2.
For additional details and instructions regarding sample requirements and procedures for 
sample collection, storage, and shipment, refer to the study laboratory manual.
As of Protocol Amendment 6, biomarker assessments are not required.
6.9.1.
Analyses of Peripheral Blood
Whole blood will be collected from participating patients at screening, Cycle 1 Day 15, 
Cycle 3 Day 1, and Cycle 6 Day 1 to explore the relationship between serum- and 
plasma-based biomarkers and patient response to treatment. Plasma collected at study start 
will be analyzed by ELISA for the determination of biomarkers including, but not limited to, 
soluble CD38 protein.
6.9.2.
Cancer Mutation Profiles and Mutation Burden
The pathogenesis of all cancers, including MM, has a basis in their acquired genetic 
mutations. The particular genetic mutations present in a patient’s cancer may render it 
sensitive or resistant to anticancer therapies, including magrolimab-based combinations. In 
some cases, if strongly associated with clinical benefit or the MOA of a drug, these genetic 
mutations can be used to select patients who are eligible for a given treatment. In other cases, 
the total number of mutations present in the genome of a given cancer (eg, rather than the 
specific genes mutated) can correlate with likelihood of response, such as is the case with 
some T cell checkpoint therapies. The myeloma cells in this study will be assessed by whole 
genome sequencing (WGS) at multiple time points before and after treatment, and the data 
will be compared to WGS of normal cells, in order to identify cancer-specific mutations and 
to understand the efficacy profile and the MOA for magrolimab across different genetic 
subtypes. Clonal evolution of MM cells will also be tracked while on treatment and at the 
time of relapse, in order to understand mechanism of resistance to magrolimab combinations.
6.9.3.
Changes in Immune Effector Cell Composition
Magrolimab is an immunotherapy, which exerts its anticancer effects through modulation of 
the patient’s immune cells. Nonclinical evidence suggests that magrolimab can induce 
macrophages to attack cancer cells, and that it can enhance cross-presentation of cancer 
neoantigens to adaptive immune cells, including T cells. Activation of the immune system 
can be associated with changes in immune cell frequency or localization to the tumor 


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microenvironment. In order to explore changes in the composition of immune cells as both 
pharmacodynamic biomarker and to inform MOA, MM patients in this study will be assessed 
by methods including, but not limited to, multiplex immunofluorescence and single cell RNA 
sequencing at multiple time points before and after treatment.
6.9.4.
Changes in Immune Effector Cell Signaling Molecules
Activation of the immune system can be associated with changes in expression or secretion 
of immune-regulatory molecules, including cytokines, chemokines, and others. Release of 
such molecules, and their concentration in the peripheral blood or tumor microenvironment, 
may serve as both pharmacodynamic biomarker and can inform MOA. MM patients in this 
study will be assessed for soluble protein factors in the peripheral plasma and/or bone 
marrow by methods potentially including, but not limited to, multiplex ELISA or 
aptamer-based measurement.
6.9.5.
Expression of Prophagocytic and Antiphagocytic Signals by Cancer Cells
Nonclinical studies suggest that the efficacy of magrolimab depends on the balance of pro- 
and antiphagocytic signals expressed by cancer cells. Magrolimab combination therapies, 
including those investigated as part of this clinical study, may derive their efficacy from the 
simultaneous blockade of antiphagocytic signals by magrolimab, and the increased 
expression of prophagocytic signals by the companion drug. In order to better define the 
efficacy and MOA of magrolimab combinations in MM, the surface profile of known pro- 
and antiphagocytic signals will be assessed on cancer cells at multiple time points before and 
after treatment using methods that include, but not limited to, flow cytometry and multiplex 
immunofluorescence.
6.10.
Posttreatment Assessments
Posttreatment assessments are presented in Appendix Table 3. 
Patients who discontinue study treatment are to return for an EOT visit for evaluation of 
safety within 7 days of their last dose or the decision to end study treatment. In addition, 
patients are to have a safety follow-up telephone call 70 days (± 7 days) after their last dose 
of study treatment. When an SAE or treatment-related AE is reported during the telephone 
call, the patient should come to the clinic for physical examination and blood tests, if 
clinically needed. Follow-up for ongoing SAEs or treatment-related AEs after the safety 
follow-up visit/call will stop if a patient begins another anticancer therapy. Pregnancy tests 
will continue at monthly intervals until end of contraception requirements outlined in 
Appendix 4. Testing may be done at home and the result self-reported by the patient.
6.11.
End of Study
All Patients: The end of the entire study for all patients is defined as the date on which the 
last patient remaining on study completes the last study visit/call or when the sponsor decides 
to end the study. The sponsor reserves the right to terminate the study at any time for any 
reason (including safety).


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Individual Patients: Patients are considered to have completed study paiiicipation altogether 
when they ai·e no longer followed for safety. 
6.12. 
Poststudy Care 
Upon withdrawal from study treatment, patients will receive the care upon which they and 
their physicians agree. Patients will be followed for AEs until the end of study as specified in 
Appendix Table 3. 
6.13. 
Sample Storage 
' 
than 15 yeai·s after the end of study or per country requirements. 
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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events and Serious Adverse Events
7.1.1.
Adverse Events
An AE is any untoward medical occurrence in a clinical study patient administered a study 
drug that does not necessarily have a causal relationship with the treatment. An AE can 
therefore be any unfavorable and/or unintended sign, symptom, or disease temporally 
associated with the use of a study drug, whether or not the AE is considered related to the 
study drug. AEs may also include pretreatment or posttreatment complications that occur as a 
result of protocol-specified procedures or special situations (Section 7.1.3).
An AE does not include the following:
•
Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and 
transfusion. The condition that led to the procedure may be an AE and must be reported.
•
Preexisting diseases, conditions, or laboratory abnormalities present or detected before 
the screening visit that do not worsen
•
Situations where an untoward medical occurrence has not occurred (eg, hospitalization 
for elective surgery, social and/or convenience admissions)
•
Overdose without clinical sequelae (Section 7.1.3)
•
Any medical condition or clinically significant laboratory abnormality with an onset date 
before the ICF is signed and not related to a protocol-associated procedure is not an AE 
but rather considered to be preexisting and should be documented as medical history.
•
Preexisting events that increase in severity or change in nature after study drug initiation 
or as a consequence of participation in the clinical study will also be considered AEs.
7.1.2.
Serious Adverse Events
An SAE is defined as an event that, at any dose, results in the following:
•
Death
•
A life-threatening situation (Note: The term “life-threatening” in the definition of 
“serious” refers to an event in which the patient 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.)
•
In-patient hospitalization or prolongation of existing hospitalization


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•
Persistent or significant disability/incapacity
•
A congenital anomaly/birth defect
•
A medically important event or reaction: Such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the patient or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is reportable 
under expedited reporting rules. Examples of medically important events include 
intensive treatment in an emergency room or at home for allergic bronchospasm; blood 
dyscrasias or convulsions that do not result in hospitalization; and development of drug 
dependency or drug abuse.
7.1.2.1.
Protocol-Specific Adverse Event/Serious Adverse Event Clarifications
Given the primary and secondary endpoints of the study, in order to maintain study integrity, 
the following events that are assessed as unrelated to study drug will not be considered 
AEs/SAEs:
•
Progression of MM
•
Deaths related to progression of MM
Events that are considered to represent progression of the underlying MM should not be 
recorded as AEs/SAEs. These data will be captured as efficacy assessment data only. If there 
is any uncertainty as to whether an event is due to disease progression, it should be reported 
as an AE/SAE.
Death that is attributed by the investigator as solely due to progression of MM and that 
occurs during the protocol-specified AE reporting period should be recorded only on the 
Death eCRF (ie, not collected as an SAE or an AE on the AE eCRF).
7.1.2.1.1.
Deaths Not Related to Progression of Multiple Myeloma
All other deaths (ie, deaths that are not due to MM progression) occurring during the 
protocol-specified AE reporting period, regardless of attribution, will be recorded on the AE 
eCRF and reported within 24 hours of awareness and no later than the next business day.
When recording a death on the eCRF, the event or condition that is considered the primary 
cause of death should be the AE term, and the outcome should be fatal. A patient can only 
have 1 AE (SAE) with outcome of death and severity of CTCAE Grade 5.
7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations 
Reports
Special situation reports (SSRs) include all reports of medication error, abuse, misuse, 
overdose, occupational exposure, drug interactions, exposure via breastfeeding, unexpected 
benefit, transmission of infectious agents via the product, counterfeit or falsified medicine, 
and pregnancy regardless of an associated AE.


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Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration or administration of a study drug while the medication is in the control of a 
health care professional, patient, or consumer. Medication errors may be classified as a 
medication error without an AE, which includes situations of missed dose, medication error 
with an AE, intercepted medication error, or potential medication error.
Abuse is defined as persistent or sporadic intentional excessive use of a study drug by a 
patient.
Misuse is defined as any intentional and inappropriate use of a study drug that is not in 
accordance with the protocol instructions or the reference USPI, SmPC, or applicable local or 
regional label.
An overdose is defined as an accidental or intentional administration of a quantity of a study 
drug given per administration or cumulatively that is above the maximum recommended dose 
as per protocol or in the product labeling (as it applies to the daily dose of the patient in 
question). In cases of a discrepancy in drug accountability, overdose will be established only 
when it is clear that the patient has taken the excess dose(s). Overdose cannot be established 
when the patient cannot account for the discrepancy, except in cases in which the investigator 
has reason to suspect that the patient has taken the additional dose(s).
Occupational exposure is defined as exposure to a study drug as a result of one’s professional 
or nonprofessional occupation.
Drug interaction is defined as any drug/drug, drug/food, or drug/device interaction.
Unexpected benefit is defined as an unintended therapeutic effect where the results are 
judged to be desirable and beneficial.
Transmission of infectious agents is defined as any suspected transmission of an infected 
agent through a Gilead study drug.
Counterfeit or falsified medicine is defined as any study drug with a false representation of 
(a) its identity, (b) its source, or (c) its history.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for 
causality and severity, and for final review and confirmation of accuracy of event 
information and assessments.
7.2.1.
Assessment of Causality for Study Drugs and Procedures
The investigator or qualified subinvestigator is responsible for assessing the relationship to 
study drug using clinical judgment and the following considerations:


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•
No: Evidence exists that the AE has an etiology other than the study drug. For SAEs, an 
alternative causality must be provided (eg, preexisting condition, underlying disease, 
intercurrent illness, concomitant medication).
•
Yes: There is reasonable possibility that the AE may have been caused by the study drug.
It should be emphasized that ineffective treatment should not be considered as causally 
related in the context of AE reporting.
The relationship to study procedures (eg, invasive procedures such as venipuncture or 
biopsy) should be assessed using the following considerations:
•
No: Evidence exists that the AE has an etiology other than the study procedure.
•
Yes: The AE occurred as a result of protocol procedures (eg, venipuncture).
7.2.2.
Assessment of Severity
The severity of AEs will be graded using the NCI CTCAE Version 5.0. For each episode, the 
highest grade attained should be reported as defined in the Toxicity Grading Scale 
(Appendix 5).
7.3.
Investigator Reporting Requirements and Instructions
7.3.1.
Requirements for Collection Prior to Study Drug Initiation
After informed consent, but prior to initiation of study medication, the following types of 
events must be reported on the applicable eCRFs: all SAEs and AEs related to 
protocol-mandated procedures.
7.3.2.
Adverse Events
Following initiation of study medication, all AEs, regardless of cause or relationship, will be 
collected until 70 days after last administration of study drug and reported on the eCRFs as 
instructed.
All AEs should be followed up until resolution or until the AE is stable, if possible. Gilead 
may request that certain AEs be followed beyond the protocol-defined follow-up period.
7.3.3.
Serious Adverse Events
All SAEs, regardless of cause or relationship, that occur after the patient first consents to 
participate in the study (ie, signing the ICF) and throughout the duration of the study, 
including the posttreatment follow-up visit, must be reported on the applicable eCRFs and to 
Gilead PS as instructed below in this section. This also includes any SAEs resulting from 
protocol-associated procedures performed after the ICF is signed.


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Any SAEs and deaths that occur after the posttreatment follow-up visit but within 70 days of 
the last dose of study drug, regardless of causality, should also be reported.
Investigators are not obligated to actively seek SAEs after the protocol-defined follow-up 
period; however, if the investigator learns of any SAEs that occur after the protocol-defined 
follow-up period has concluded and the event is deemed relevant to the use of study drug, the 
investigator should promptly document and report the event to Gilead PS.
Instructions for reporting SAEs are described in Section 7.4.1.
7.3.4.
Study Drug Special Situations Reports
All study drug SSRs that occur from study drug initiation and throughout the duration of the 
study, including the posttreatment follow-up visit, must be reported to Gilead PS 
(Section 7.4.2). AEs and SAEs resulting from SSRs must be reported in accordance to the 
AE and SAE reporting guidance (Section 7.4).
7.3.5.
Concomitant Therapy Reports
7.3.5.1.
Gilead Concomitant Therapy Special Situations Report
Special situation reports involving a Gilead concomitant therapy (not considered study drug), 
that occurs after the patient first consents to participate in the study (ie, signing the ICF) and 
throughout the duration of the study, including the posttreatment follow-up visit, must be 
reported to Gilead PS utilizing the paper SSR form (Section 7.4.2.2).
7.3.5.2.
Non-Gilead Concomitant Therapy Report
Special situations involving non-Gilead concomitant medications do not need to be reported 
on the SSR form; however, for special situations that result in AEs due to a non-Gilead 
concomitant medication, the AE should be reported on the AE form.
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
All clinical sequelae in relation to these SSRs will be reported as AEs or SAEs at the same 
time using the AE eCRF and/or the SAE report form. Details of the symptoms and signs, 
clinical management, and outcome will be reported, when available.


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7.4.
Reporting Process for Serious Adverse Events and Special Situation 
Reports
7.4.1.
Serious Adverse Event Reporting Process
•
For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and 
other documents are also to be transmitted by email or fax when requested and 
applicable. Transmission of such documents should occur without personal patient 
identification, maintaining the traceability of a document to the patient identifiers.
•
Additional information may be requested to ensure the timely completion of accurate 
safety reports.
•
Any medications necessary for treatment of the SAE must be recorded onto the 
concomitant medication section of the patient’s eCRF and the SAE narrative section of 
the Safety Report Form eCRF.
7.4.1.1.
Electronic Serious Adverse Event Reporting Process
•
Site personnel will record all SAE data on the applicable eCRFs and from there transmit 
the SAE information to Gilead PS within 24 hours of the investigator’s knowledge of the 
event from ICF signature throughout the duration of the study, including the 
protocol-required posttreatment follow-up period.
•
If it is not possible to record and transmit the SAE information electronically, record the 
SAE on the paper SAE reporting form and transmit within 24 hours:
Gilead PS
Email: Safety_fc@gilead.com 
or
Fax: 1-650-522-5477
•
If an SAE has been reported via a paper form because the eCRF database has been 
locked, no further action is necessary. If the database is not locked, any SAE reported via 
paper must be transcribed as soon as possible on the applicable eCRFs and transmitted to 
Gilead PS.
7.4.2.
Special Situations Reporting Process
7.4.2.1.
Paper Special Situations Reporting Process for Study Drug
•
All SSRs will be recorded on the special situations report form and transmitted by 
emailing or faxing the report form within 24 hours of the investigator’s knowledge of the 
event to the attention of Gilead PS from study drug initiation throughout the duration of 
the study, including the protocol required posttreatment follow-up period.


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Gilead PS
Email: Safety_fc@gilead.com 
or
Fax: 1-650-522-5477
7.4.2.2.
Reporting Process for Gilead Concomitant Medications
•
Special situations that involve concomitant medications manufactured by Gilead that are 
not considered study drug must be reported within 24 hours of the investigator’s 
knowledge of the event to Gilead PS utilizing the paper SSR form to:
Gilead PS
Email: Safety_fc@gilead.com 
or
Fax: 1-650-522-5477
•
Any inappropriate use of concomitant medications prohibited by this protocol should not 
be reported as “misuse,” but may be more appropriately documented as a protocol 
deviation.
•
Special situations involving non-Gilead concomitant medications do not need to be 
reported on the SSR form; however, special situations that result in AEs due to a 
non-Gilead concomitant medication, must be reported as an AE.
7.4.2.3.
Pregnancy Reporting Process
•
The investigator should report pregnancies in female patients who are identified after 
initiation of study drug and throughout the study, including the poststudy drug follow-up 
period, to Gilead PS using the pregnancy report form within 24 hours of becoming aware 
of the pregnancy. Contact details for transmitting the pregnancy report form are as 
follows:
Gilead PS
Email: Safety_fc@gilead.com 
or
Fax: 1-650-522-5477
•
The pregnancy itself is not considered an AE, nor is an induced elective abortion to 
terminate a pregnancy without medical reasons.
•
All other premature terminations of pregnancy (eg, a spontaneous abortion, an induced 
therapeutic abortion due to complications or other medical reasons) must be reported 
within 24 hours as an SAE, as described in Section 7.4.1. The underlying medical reason 
for this procedure should be recorded as the AE term.
•
A spontaneous abortion is always considered to be an SAE and will be reported as 
described in Section 7.4.1. Furthermore, any SAE occurring as an adverse pregnancy 
outcome after study must be reported to the Gilead PS.


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•
The patient should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome of the pregnancy should be reported to Gilead PS using the 
pregnancy outcome report form. If the end of the pregnancy occurs after the study has 
been completed, the outcome should be reported directly to Gilead PS. Gilead PS contact 
information is as follows: email: Safety_FC@gilead.com and fax: +1 (650) 522-5477.
•
Refer to Appendix 4 for Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements.
7.5.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA 
Code of Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant 
updates, and other country-specific legislation or regulations, Gilead may be required to 
expedite to worldwide regulatory agencies reports of SAEs which may be in the form of 
line-listings, serious adverse drug reactions, or suspected unexpected serious adverse 
reactions (SUSARs). In accordance with the EU Clinical Trials Directive (2001/20/EC), 
Gilead or a specified designee will notify worldwide regulatory agencies and the relevant 
IEC in concerned Member States of applicable SUSARs as outlined in current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the IB or relevant local or regional label as applicable.
All investigators will receive a safety letter notifying them of relevant SUSAR reports 
associated with any study drug. The investigator should notify the IRB or IEC of SUSAR 
reports as soon as is practical, where this is required by local regulatory agencies, and in 
accordance with the local institutional policy.
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not to be recorded as AEs or 
SAEs. However, laboratory abnormalities (eg, clinical chemistry, hematology, urinalysis) 
that require medical or surgical intervention or lead to study drug interruption, modification, 
or discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, ECG, x-rays, vital signs) that are associated 
with signs and/or symptoms must be recorded as an AE or SAE if they meet the definition of 
an AE or SAE as described in Sections 7.1.1 and 7.1.2. If the laboratory abnormality is part 
of a syndrome, record the syndrome or diagnosis (eg, anemia), not the laboratory result (ie, 
decreased hemoglobin).
Severity should be recorded and graded according to the NCI CTCAE Version 5.0. For AEs 
associated with laboratory abnormalities, the event should be graded on the basis of the 
clinical severity in the context of the underlying conditions; this may or may not be in 
agreement with the grading of the laboratory abnormality.


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7.7.
Abnormal Liver Function Tests
Liver toxicity will be evaluated for all patients.
In the absence of an explanation for increased liver function tests, such as viral hepatitis, 
preexisting or acute liver disease, or exposure to other agents associated with liver injury, the 
patient may be discontinued from the study treatment if the investigator determines that it is 
not in the patient’s best interest to continue. Discontinuation of treatment should be 
considered if there is an indication of severe liver injury according to Hy’s Law, defined by 
FDA Guidance for Industry, Drug-Induced Liver Injury: Premarketing Clinical Evaluation 
{U.S. Department of Health & Human Services (DHHS) 2009}, as follows:
•
Treatment-emergent ALT or AST elevation (≥ 3  ULN), AND
•
Treatment-emergent total bilirubin elevation (> 2  ULN), and absence of cholestasis 
(defined as alkaline phosphatase < 2  ULN), AND
•
No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, 
alcohol ingestion, congestive heart failure, worsening liver metastases).
7.8.
Toxicity Management
7.8.1.
Magrolimab
7.8.1.1.
Anemia, Blood Cross-matching, and Packed Red Blood Cell Transfusion 
Procedures
Magrolimab binds to RBCs and leads to erythrophagocytosis. CD47 is a member of the Rh 
complex in the RBCs membrane. Therefore, when magrolimab binds to CD47, it is likely to 
interfere with routine blood bank tests needed in case of transfusion. Notify blood transfusion 
centers/blood banks of this interference with blood bank testing and inform them that a 
patient will receive magrolimab.
In clinical studies, anemia is the most common treatment-related AE and is typically 
manifested as a decline in hemoglobin of about 0.5 g/dL to 1.5 g/dL observed in the first 1 to 
2 weeks of treatment. This decrease in hemoglobin level is acceptable in patients with no 
other significant diseases or medical conditions. However, for patients with significant 
diseases or medical conditions, such as unstable angina, ischemic heart disease, or 
uncontrolled diabetes mellitus, treatment-related anemia could be life-threatening or fatal. 
Significant drops (up to 3 g/dL) have been observed in early doses.
Within 24 hours prior to each of the first 2 doses of magrolimab infusion during initial 
treatment, all patients must have a documented hemoglobin ≥ 9 g/dL. Patients who do not 
meet these criteria must be transfused and have their hemoglobin rechecked to meet 9 g/dL 
prior to each of the first 2 doses of magrolimab.


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Patients with a low baseline hemoglobin level, especially those with cardiac history or risk 
factors, must be monitored closely after initial administrations of magrolimab as preexisting 
anemia could be exacerbated. Red blood cell transfusions are permitted prior to study 
treatment to ensure adequate hemoglobin level as per investigator’s clinical judgment. The 
need for RBC transfusions and anemia from other causes in patients with cancer, means that 
care has to be taken with RBC cross-matching and packed RBC transfusions.
Prior to initiation of magrolimab, ABO/Rh type, antibody screen, DAT, and extended RBC 
phenotyping (minor antigens such as CcDEe, Cw, MNSs, Kk, FyaFyb, and JkaJkb) will be 
performed for each patient. RBC genotyping instead of extended RBC phenotyping is 
acceptable for any patient. RBC genotyping (instead of an extended RBC phenotyping) must 
be performed if a patient received any RBC or whole blood transfusion within the previous 
3months (unless laboratory has availability for special techniques for performing 
phenotyping for patients with recent transfusion). Results must be available before the first 
dose of magrolimab.
For patients after exposure to magrolimab:
An additional hemoglobin must be checked 3 to 6 hours after the initiation of the first and 
second doses of magrolimab during initial treatment. The patient should be transfused as 
clinically appropriate. Investigators should consider additional hemoglobin monitoring 
during the first week of treatment in patients with symptoms of anemia or at increased risk 
for complications of anemia.
For all elective RBC and platelet transfusions, use leukocyte-reduced and gamma-irradiated 
units per institutional guidelines.
For RBC transfusions, phenotype/genotype matched units are preferred. However, 
CMV-seronegative units for CMV-seronegative patients will not be required for this study.
In case ABO/Rh type cannot be resolved, use pretreatment (historical) phenotype/genotype 
matched units for minor RBC antigens (CcDEe and Kk, to the feasible extent). Regarding the 
ABO type, institution can use historical blood group or O type as per the institutional 
guidelines.
For emergency transfusions, the transfusion centers may consider using emergency Group O 
red cells if phenotype/genotype matched units are not available.
Whenever possible, blood plasma therapy should be blood type specific. Platelets should be 
blood type compatible whenever possible and, if not, should have been tested and found not 
to have high titer anti-A or anti-B. Otherwise, plasma and platelet products can be provided 
as per the institutional policy.
A recent report has suggested that cross-match interference by RBCs due to treatment with 
magrolimab may be resolved by use of gamma-clone anti-IgG and multiple alloadsorptions 
with papain-treated RBC samples, pooled single donor apheresis platelets or commercial 
H.P.C product if required {Troughton 2018, Velliquette 2019}.


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Blood components for transfusion
•
For all elective RBC transfusions, leukocyte-reduced units matched for the phenotype of 
the patients (as described above) will be used. Where exact matching for all the specified 
blood groups proves impractical (eg, for MNS blood group), local sites will decide on the 
best matched donor units to be used. Cytomegalovirus (CMV) matching (ie, 
CMV-seronegative units for CMV-seronegative patients) will not be required for this 
study because it will limit the inventory for antigen matching.
•
If the cross-match is incompatible, the RBC units that are Coombs 
cross-match-incompatible will be selected (eg, phenotype-matched or least incompatible) 
for issue at the discretion of the local site’s transfusion service medical director or 
equivalent person, where available.
•
For emergency transfusions, the transfusion laboratory may consider using emergency 
Group O Rh negative units if phenotyped units are not available.
•
Blood plasma therapy will be blood type specific. Platelets will be blood type compatible 
whenever possible and, if not, will have been tested and found not to have high titer 
anti-A or anti-B.
•
A recent report has suggested that cross-match interference by RBCs due to treatment 
with magrolimab may be resolved by use of multiple alloadsorptions with papain-treated 
cells or pooled platelets {Velliquette 2019}. This strategy can be considered.
7.8.1.2.
Management of Infusion-related Reactions
Infusion-related reactions are defined by the NCI CTCAE, Version 5.0 (under the category 
“General disorders and administration site conditions”) as “a disorder characterized by 
adverse reaction to the infusion of pharmacological or biological substances” (Appendix 5). 
For the purposes of this study, the time frame for IRR assessment is the 24-hour period 
beginning from the start of the infusion. Premedication use described in Section 5.3.1 will be 
used to manage IRRs pre-emptively.
Recommendations for the management of IRRs are provided in Table 24:


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Table 24.
Management of Infusion-Related Reactions
Infusion-related Reactions
CTCAE Grade 
Management
Grade 1
Mild transient reaction.
Remain at bedside and monitor patient until recovery from symptoms.
Patients who experience IRRs with the first 4 doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion.
Grade 2
Requiring symptomatic 
treatment and prophylactic 
medications for ≤ 24 hours.
Interrupt magrolimab therapy per protocol and begin an IV infusion of normal 
saline and consider treating the patient with diphenhydramine 50 mg IV (or 
equivalent) and/or 500 to 750 mg of oral acetaminophen.
Remain at bedside and monitor patient until resolution of symptoms.
Corticosteroid therapy may also be given at the discretion of the investigator.
If the infusion is interrupted, wait until symptoms resolve, then restart the 
infusion at 50% of the original infusion rate.
If no further complications occur after 1 hour (± 10 minutes), the rate may be 
increased to 100% of the original infusion rate. Monitor the patient closely.
If symptoms recur, stop infusion and disconnect patient from the infusion 
apparatus. No further magrolimab will be administered at that visit. 
Patients who experience IRRs with the first 4 doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion.
The amount of magrolimab infused must be recorded on the eCRF.
Patients who experience a Grade 2 IRR during the postinfusion observation 
period that does not resolve to ≤ Grade 1 during that time should be observed 
until the AE resolves or stabilizes, with vital sign measurements as medically 
indicated for the management of the AE.
Grade 3-4
Grade 3: Prolonged reactions 
or recurrence of symptoms 
following initial improvement, 
or where hospitalization is 
indicated for other clinical 
sequelae.
Grade 4: Life-threatening 
consequences, where urgent 
intervention is indicated.
Immediately discontinue infusion of magrolimab.
Begin an IV infusion of normal saline, and consider treating the patient as 
follows: administer bronchodilators, epinephrine 0.2 to 1 mg of a 1:1000 
solution for SC administration or 0.1 to 0.25 mg of a 1:10,000 solution 
injected slowly for IV administration and/or diphenhydramine 50 mg IV with 
methylprednisolone 100 mg IV (or equivalent), as needed.
The patient should be monitored until the investigator is comfortable that the 
symptoms will not recur.
Patients who experience Grade 3 IRRs must be given premedication prior to 
subsequent doses. In this setting, premedication with oral acetaminophen 
(650 to 1000 mg), oral or IV diphenhydramine (25 to 50 mg), and IV 
dexamethasone (4 to 20 mg), or a comparable regimen, is recommended for 
the subsequent 2 doses. Continued premedication with corticosteroids beyond 
these 2 doses may be administered at the discretion of the treating physician.
Patients who receive premedication and still experience a recurrent Grade 3 
IRR or patients who experience a Grade 4 IRR at any time should be 
permanently discontinued from the study treatment.
For anaphylaxis, investigators should follow their institutional guidelines for 
treatment.
All patients with a Grade 3 or higher IRR will be observed until the AE 
resolves or stabilizes, with vital sign measurements and additional evaluations 
as medically indicated for the management of the AE.
AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; eCRF = electronic case report form; 
IRR = infusion-related reaction; IV = intravenous; SC = subcutaneous


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7.8.1.3.
Thromboembolic Events
Thromboembolic events, including deep vein thromboses and pulmonary embolisms, have 
been reported in some patients receiving magrolimab, sometimes early in therapy. Available 
data for magrolimab do not support a clear or consistent relationship between clinical 
thromboembolic events and magrolimab use. Patients should be closely monitored for the 
symptoms of thromboembolic events and treated accordingly.
7.8.1.4.
Severe Neutropenia 
Severe neutropenia and febrile neutropenia have been reported in patients treated with 
magrolimab. Close monitoring of hematologic parameters (Appendix Table 2) including 
neutrophils is required for all patients treated with magrolimab. Prophylactic antibiotics 
and/or antimycotics should be considered. Administer G-CSF if clinically indicated. 
Recommendations for magrolimab dose delay in case of severe neutropenia: 
•
For Grade 3 neutropenia without fever or infection, delay of magrolimab dosing is not 
recommended.
•
For Grade 4 neutropenia (ANC < 500/μL) without fever or infection, or Grade 3 or higher 
neutropenia with fever or infection, magrolimab dose delay should be considered. Upon 
resolution to Grade ≤ 2, resuming magrolimab at the same dose should be considered.
•
For persistent severe neutropenia or febrile neutropenia (> 2 occurrences), 
discontinuation of magrolimab can be considered.
7.8.1.5.
Serious Infections
Patients (with or without neutropenia) should be regularly monitored for signs and symptoms 
of infection. For patients with prolonged neutropenia or patients at risk, consider infection 
prophylaxis including antibiotics (eg, fluoroquinolone) or antifungal agents (eg, oral triazoles 
or parenteral echinocandin) in accordance with current guidelines.
For serious infections, hold magrolimab until the infection has resolved clinically. For 
serious infections that remain active for ≥ 14 days, consider discontinuation of magrolimab.
7.8.1.6.
Management of Pneumonitis
Pneumonitis has been infrequently observed in patients receiving magrolimab. Generally, 
immune-related AEs have not been observed in clinical use with magrolimab. In contrast to 
T-cell checkpoint inhibitors, magrolimab primarily exerts its antitumor efficacy through 
macrophage-mediated phagocytosis of tumor cells. Nonspecific T-cell or other host immune 
responses that are seen with T-cell checkpoint inhibitors have not been observed with 
magrolimab in nonclinical studies. Additionally, no events of macrophage activation 
syndrome or hemophagocytic lymphohistiocytosis have been reported in clinical studies.


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In instances of suspected pneumonitis, first rule out noninflammatory causes (eg, infections). 
If a noninflammatory cause is identified, treat accordingly and continue therapy per protocol. 
Evaluate with imaging (eg, chest x-ray or computed tomography) and pulmonary 
consultation.
Management of potential pneumonitis is detailed in Table 25 and follows the American 
Society of Clinical Oncology (ASCO) guidelines for immune-related AEs {Brahmer 2018}. 
Patients who experience Grade 3-4 pneumonitis will be permanently discontinued from study 
treatment.
Table 25.
Pneumonitis Management Algorithm
Pneumonitis
CTCAE Grade of 
Pneumonitis
Management
Follow-Up
Grade 1
Radiographic changes 
(CXR or CT) only.
Monitor for signs and symptoms 
weekly and consider monitoring 
with CXR.
Consider pulmonary and infectious 
disease consults.
Consider reimaging with CT in 3-4 weeks 
as clinically indicated.
May resume magrolimab with 
radiographic evidence of improvement or 
resolution.
If no clinical improvement or worsening, 
treat as Grade 2. 
Grade 2
Mild to moderate new 
symptoms.
Interrupt magrolimab therapy per 
protocol.
Pulmonary and infectious disease 
consults.
Consider empirical antibiotics.
Monitor signs and symptoms every 
2-3 days; consider hospitalization.
1 mg/kg/day oral prednisone or IV 
equivalent.
Consider bronchoscopy, lung 
biopsy.
Re-image every 1-3 days.
If improving to baseline, taper 
corticosteroids over 4-6 weeks and resume 
magrolimab therapy per protocol.
If no clinical improvement after 
48-72 hours or worsening, treat as 
Grade 3-4.
Grade 3-4
Severe new symptoms; 
new/worsening 
hypoxia; life-
threatening.
Discontinue magrolimab therapy.
Hospitalize.
Pulmonary and infectious disease 
consults.
1-2 mg/kg/day methylprednisolone 
IV or IV equivalent.
Add empirical antibiotics and 
consider prophylactic antibiotics for 
opportunistic infections.
Consider bronchoscopy, lung 
biopsy.
If improving to baseline, taper 
corticosteroids over 4-6 weeks.
If no clinical improvement after 48 hours 
or worsening, consider additional 
immunosuppression (eg, infliximab, 
cyclophosphamide, IV immunoglobulin, 
mycophenolate mofetil).
CT = computed tomography; CTCAE = Common Terminology Criteria for Adverse Events; CXR = chest x-ray; 
IV = intravenous.


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7.8.1.7.
Management of Other Nonhematologic Adverse Events
Magrolimab will be permanently discontinued in patients who experience any Grade 4 
nonhematologic AEs related to magrolimab that do not improve to Grade 2 or pretreatment 
baseline levels within 14 days. Magrolimab will also be permanently discontinued in patients 
with Grade 4 hemolytic anemia which is defined as anemia with clinical and/or laboratory 
evidence of hemolysis with life-threatening consequences and/or urgent interventions are 
indicated. For dose delay criteria, magrolimab may be withheld if treatment-emergent and/or 
magrolimab-related AEs occur, which include all AEs that constitute a DLT, as defined in 
Section 3.1.1 of the protocol. Magrolimab may be reintroduced if the severity has recovered 
to Grade 2 or pretreatment baseline levels with the approval by the medical monitor.
7.8.2.
Daratumumab
Management of Infusion-related Reactions
Both systemic and administration-related reactions, including severe of life-threatening 
reactions and local injection-site reactions can occur with both IV and SC formulations of 
daratumumab. Severe reactions included hypoxia, dyspnea, hypertension and tachycardia. 
Other signs and symptoms of systemic administration-related reactions may include 
respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, 
allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritis, 
chills, vomiting, nausea, and hypotension {DARZALEX 2020, DARZALEX FASPRO 
2020}.
•
Monitoring: signs and symptoms for systemic administration-related reactions, especially 
following first and second infusions/injections.
For Grades 1, 2, or 3: the infusion rate should be reduced when restarting the infusion 
(for IV formulations).
For Grade 4 (anaphylactic reaction or other life-threatening reaction): immediately 
and permanently discontinue daratumumab.
Consider administering corticosteroids and other medications after the administration 
of daratumumab depending on dosing regimen and medical history to minimize the 
risk of delayed (defined as occurring the day after administration) systemic 
administration-related reactions.
For local reactions: the most frequent (> 1%) injection-site reaction was injection-site 
erythema. These local reactions occurred a median of 7 minutes (range: 0 minutes to 
4.7 days) after starting administration of daratumumab. Monitor for local reactions 
and consider symptomatic management.


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7.8.3.
Pomalidomide
Refer to the reference USPI, SmPC, or applicable local or regional label for instructions on 
monitoring, toxicity management, and potential drug interactions during administration of 
pomalidomide.
7.8.4.
Carfilzomib
Refer to the reference USPI, SmPC, or applicable local or regional label for instructions on 
monitoring, toxicity management, and potential drug interactions during administration of 
carfilzomib.
7.8.5.
Bortezomib
Refer to the reference USPI, SmPC, or applicable local or regional label for instructions on 
monitoring, toxicity management, and potential drug interactions during administration of 
bortezomib.
Monitoring and Dose Adjustment for Peripheral Neuropathy
Bortezomib treatment causes a peripheral neuropathy that is predominantly sensory. 
However, cases of severe sensory and motor peripheral neuropathy have been reported. 
Patients with pre-existing symptoms (numbness, pain or a burning feeling in the feet or 
hands) and/or signs of peripheral neuropathy may experience worsening peripheral 
neuropathy (including ≥ Grade 3) during treatment with bortezomib {VELCADE 2019}.
Patients should be monitored for symptoms of neuropathy, such as a burning sensation, 
hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. Patients 
experiencing new or worsening peripheral neuropathy may require change in the dose and 
schedule of bortezomib.
Following dose adjustments, improvement in or resolution of peripheral neuropathy was 
reported in 51% of patients with ≥ Grade 2 peripheral neuropathy in the relapsed MM study. 
Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who 
discontinued due to Grade 2 neuropathy or who had ≥ Grade 3 peripheral neuropathy in the 
Phase 2 MM studies. The long-term outcome of peripheral neuropathy has not been studied 
in mantle cell lymphoma.
7.8.6.
Dexamethasone
Refer to the reference USPI, SmPC, or applicable local or regional label for instructions on 
monitoring and toxicity management following administration of dexamethasone.


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8.1. 
8.1.1. 
STATISTICAL CONSIDERATIONS 
Analysis Objectives and Endpoints 
Study Objectives 
Final 
Amendment6 
The study objectives and endpoints are provided in Section 2. Additional details are provided 
in Sections 8.1.2, 8.1.3, and 8.1.4. 
8.1.2. 
Primary Endpoints 
The prima1y endpoint for the safety nm-in coho1ts is as follows: 
• 
Incidence ofDLTs, AEs and laborato1y abnonnalities according to the NCI CTCAE 
Version 5.0 (Appendix 5). 
The prima1y endpoint for the dose-expansion coho1ts is as follows: 
• 
Objective response rate, defined as the percentage of patients who achieve sCR, CR, 
VGPR, or PR 
8.1.3. 
Secondary Endpoints for Dose-expansion Cohorts 
The secondaiy endpoints are as follows: 
• 
Incidence of AEs and laborato1y abnonnalities according to the NCI CTCAE Version 5.0 
(Appendix 5). 
• 
Duration of response: DOR is measured from the eai·liest date of sCR, CR, VGPR, or PR, 
whichever is first recorded, until the earliest date of doclllllented PD, doclllllented 
relapse, or death from any cause, whichever occurs first. Those who are not observed to 
have doclllllented relapse, documented PD, or death will be censored at the date of their 
last response assessment. 
• 
Magrolimab concentration versus time 
• 
Measurements of ADA against magrolimab 
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8.2.
Planned Analyses
The final analysis will be performed after all patients have completed the study, outstanding 
data queries have been resolved or adjudicated as unresolvable, and the data have been 
cleaned and finalized.
8.3.
Analysis Conventions
8.3.1.
Analysis Sets
8.3.1.1.
Efficacy
The primary analysis set for efficacy analysis is the Full Analysis Set (FAS). The FAS 
includes all enrolled patients who took at least 1 dose of study treatment with treatment 
group designated according to the planned treatment assigned at enrollment.
8.3.1.2.
Safety
The primary analysis set for safety analyses is the Safety Analysis Set. It includes all patients 
who took at least 1 dose of study treatment with treatment group designated according to the 
actual treatment received. This analysis set will be used in the analyses of safety endpoints as 
well as study treatment administration. All data collected during treatment up to 70 days after 
treatment discontinuation will be included in the safety summaries.
The DLT-Evaluable Analysis Set includes all patients in the Safety Analysis Set who are 
enrolled in the safety run-in cohorts and fulfill either of the following criteria:
•
Experienced a DLT after initiation of the first infusion of magrolimab during the DLT 
assessment period (Section 3.1.1)
•
Completed DLT assessment period and received at least 3 infusions of magrolimab and 
the following cohort-specific criteria:
Magrolimab in combination with daratumumab cohort: Completed at least 2 doses of 
daratumumab
Magrolimab in combination with pomalidomide and dexamethasone cohort: 
Completed at least 10 doses of pomalidomide and 2 doses of dexamethasone
Magrolimab in combination with carfilzomib and dexamethasone cohort: Completed 
at least 2 doses of carfilzomib and 2 doses of dexamethasone
Magrolimab in combination with bortezomib and dexamethasone cohort: Completed 
at least 2 doses of bortezomib and 2 doses of dexamethasone
The recommended dose for the expansion cohorts will be based on the DLT-Evaluable 
Analysis Set.


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8.3.1.3.
Pharmacokinetics
The PK Analysis Set includes all enrolled patients who received at least 1 dose of 
magrolimab and have at least 1 measurable posttreatment serum concentration of 
magrolimab.
8.3.1.4.
Immunogenicity
The Immunogenicity Analysis Set includes all enrolled patients who received at least 1 dose 
of magrolimab and have at least 1 evaluable anti-magrolimab antibody test result.
8.3.1.5.
Biomarker
The Biomarker Analysis Set includes all enrolled patients who received at least 1 dose of 
magrolimab and have the evaluable baseline and on-study measurements to provide 
interpretable results for the specific parameters of interest.
8.3.1.6.
Demographic and Baseline Characteristics
The All Enrolled Analysis Set includes all patients who received a study patient 
identification number in the study after screening. This will be the primary analysis set for 
analyses of patient demographic and baseline characteristics, enrollment, and disposition.
8.3.2.
Data Handling Conventions
By-patient listings will be created for important variables from each eCRF module. Summary 
tables for continuous variables will contain the following statistics: N (number in analysis 
set), n (number with data), mean, standard deviation, 95% CIs for the mean, median, 
minimum, and maximum. Summary tables for categorical variables will include: N, n, 
percentage, and 95% CIs for the percentage. Unless otherwise indicated, 95% CIs for binary 
variables will be calculated using the binomial distribution (exact method) and will be 
2-sided. Data will be described and summarized by treatment cohort.
The baseline value used in each analysis will be the last (most recent) pretreatment value 
before or on the first dosing date of study treatment. As appropriate, changes from baseline to 
each subsequent time point will be described and summarized. Similarly, as appropriate, the 
maximum change from baseline during the study will also be described and summarized. 
Graphical techniques (ie, waterfall plots, Kaplan-Meier [KM] curves, line plots) may be used 
when such methods are appropriate and informative. Analyses will be based on observed data 
unless methods for handling missing data are specified. If there is a significant degree of 
nonnormality, analyses may be performed on log-transformed data or nonparametric tests may 
be applied, as appropriate.


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8.4. 
Demographic and Baseline Characteristics Analysis 
Final 
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Demographic and baseline measurements will be summarized using standard descriptive 
methods. Demographic summaries will include sex, race/ethnicity, and age. Baseline data 
will include a summaiy of body weight, height, body mass index, ECOG perfonnance status, 
and MM status. 
8.5. 
8.5.1. 
Efficacy Analysis 
Primary Analysis 
For the primaiy efficacy endpoint ORR, the point estimate and the coITesponding 2-sided 
exact 95% CI using Clopper-Pearson method will be provided for each coho1i . Objective 
response rate will also be tested against the historical control rate of 25% using I-group 
Chi-squai·e test for each cohort sepai·ately. 
8.5.2. 
Secondary Analyses 
The medians, first quaiiile (Ql), and third quartile (Q3) of DOR will be estimated using the 
KM method along with the coITesponding 95% Cls, respectively. KM curves will be 
provided. For DOR, the analysis will include only patients who achieve objective response. 
8.6. 
Safety Analysis 
All safety data collected on or after the date that any dmg in a study treatment regimen was 
first administered up to the date of the last dose of any dmg in a study treatment regimen plus 
70 days will be summarized by treatment coho1i based on the Safety Analysis Set. 
Dose-liiniting toxicities will be summai·ized based on the DLT-Evaluable Set for safety 
nm-in coho1is. Data for the pretreatment will be included in data listings. For categorical 
safety data, including incidence of AEs and categorizations of laborato1y data, the number 
and percentage of patients will be summai·ized. For continuous safety data, including 
laborato1y data, the number of patients, mean, standard deviation, minimum, quartiles, 
median, and maximum will be summai·ized. 
8.6.1. 
Extent of Exposure 
A patient's extent of exposure to study diug data will be generated from the study diug 
adininistration data. Exposure data will be summai·ized for each dmg sepai·ately by treatment 
coho1i . 
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8.6.2.
Adverse Events
Clinical and laboratory AEs will be coded using the MedDRA. System organ class, 
high-level group term, high-level term, preferred term, and lower-level term will be attached 
to the clinical database.
Events will be summarized on the basis of the date of onset for the event. A 
treatment-emergent AE will be defined as any AE that begins on or after the date of first dose 
of any study drug up to the date of last dose of any study drug plus 70 days.
Summaries (number and percentage of patients) of treatment-emergent AEs (by system organ 
class, and preferred term) will be provided by treatment cohort.
AEs that occurred before exposure to study treatment will be reported in data listings and 
appropriately identified as nontreatment-emergent AEs
8.6.3.
Laboratory Evaluations
Selected laboratory data (using conventional units) will be summarized using only observed 
data. Data and change from baseline at all scheduled time points will be summarized.
Graded laboratory abnormalities will be defined using the grading scheme in Appendix 5.
Incidence of treatment-emergent laboratory abnormalities, defined as posttreatment results 
that increase at least 1 toxicity grade from baseline to the date of last dose of any study drug 
plus 70 days, will be summarized by treatment cohort. If baseline data are missing, then any 
graded abnormality (ie, at least Grade 1) will be considered a treatment-emergent 
abnormality.
Laboratory abnormalities that occur before the first dose of any study drug or 70 days after 
the last dose of any study drug will be included in a data listing.
8.6.4.
Other Safety Evaluations
Vital signs and physical examination findings will be summarized at select time points. 
Details will be provided in the statistical analysis plan.
8.7.
Pharmacokinetic Analysis
The PK Analysis Set will be used for summaries of PK concentration of magrolimab versus 
time. Due to the sparse nature of PK collection, PK parameters will not be calculated.
Summary statistics will be presented for magrolimab serum concentrations at each scheduled 
time point. Descriptive graphical plots of individual serum concentration versus time profiles 
and mean concentration versus time profiles will be generated.


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Missing concentrntion values will be reported as is in data listings. Concentration values 
below lower limit of quantitation will be handled as zero in sUIIllnaiy statistics and reported 
as is in data listings. 
All data from this study may be combined with PK data from other Gilead clinical studies 
and analyzed using a population PK model. Such an analysis would be repo1ted sepai·ately. 
8.8. 
Immunogenicity Analysis 
Innnunogenicity will be assessed using a 3-tier-screen, confnmato1y, and titer-approach 
on study sainples using a validated immunoassay. The rate and magnitude of 
anti-magrolimab antibody incidence, prevalence, persistence, and transience will be 
summarized for the Irmnuno enici Anal sis Set. Titer sUllllllai·ies ma also be enerated, if 
8.9. 
Sample Size 
For each of the dose-expansion coho1ts, a sample size of 30 (24 expansion patients together 
with the 6 patients from the safety nm-in cohort), provides 86.1 % power for a I-group 
Chi-squai·e test at a I-sided alpha of 0.1 to detect an ORR of~ 45% for the combination 
treatment compai·ed with a historical control ORR of25%. 
The historical control ORR of 25% is based on outcomes from the MAMMOTH study; the 
subset of patients treated with any dai·atumlllllab-containing regimen, including daratumumab 
in combination with an IMiD or PI, following at least 1 prior treatment { Gandhi 2019}. 
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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with the International 
Council for Harmonisation (ICH) E6(R2) addendum to its guideline for GCP and applicable 
laws and regulations.
9.1.2.
Financial Disclosure
The investigator and subinvestigators will provide prompt and accurate documentation of 
their financial interest or arrangements with Gilead or proprietary interests in the study drug 
during the course of a clinical study. This documentation must be provided prior to the 
investigator’s (and any subinvestigator’s) participation in the study. The investigator and 
subinvestigator agree to notify Gilead of any change in reportable interests during the study 
and for 1 year following completion of the study. Study completion is defined as the date 
when the last patient completes the protocol-defined activities.
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval
The investigator (or Gilead as appropriate according to local regulations) will submit this 
protocol, ICF, and any accompanying material to be provided to the patient (such as 
advertisements, patient information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB/IEC. The investigator will not begin any study patient activities 
until approval from the IRB/IEC has been documented and provided as a letter to the 
investigator.
Before implementation, the investigator will submit to and receive documented approval 
from the IRB/IEC any modifications made to the protocol or any accompanying material to 
be provided to the patient after initial IRB/IEC approval, with the exception of those 
necessary to reduce immediate risk to study patients.
9.1.4.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study before undertaking any study-related procedures. The 
investigator must use the most current IRB- or IEC-approved ICF for documenting written 
informed consent. Each ICF (or assent as applicable) will be appropriately signed and dated 
by the patient or the patient’s legally authorized representative, the person conducting the 
consent discussion, and an impartial witness (if required by IRB or IEC or local 
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The ICF will inform patients about genomic testing and/or planned sample retention. In 
addition to the study-specific ICF to be signed by each patient participating in the study, 
patients will be required to document agreement to provide additional samples or to allow the 
use of the remainder of their already-collected specimens for 
, in 
accordance with applicable regulations. In addition to the study-specific ICF to be signed by 
each patient participating in the study, patients will be required to document agreement to 
provide additional samples for
. The results of the tests done on the 
samples will not be given to the patient or the investigator.
9.1.5.
Confidentiality
The investigator must ensure that patients’ anonymity will be strictly maintained and that 
their identities are protected from unauthorized parties. Only an identification code and any 
other unique identifier(s) as allowed by local law (such as year of birth) will be recorded on 
any form or biological sample submitted to Gilead, IRB/IEC, or the laboratory. Laboratory 
specimens must be labeled in such a way as to protect patient identity while allowing the 
results to be recorded to the proper patient. Refer to specific laboratory instructions. NOTE: 
The investigator must keep a screening log with details for all patients screened and enrolled 
in the study, in accordance with the site procedures and regulations. Patient data will be 
processed in accordance with all applicable regulations.
The investigator agrees that all information received from Gilead, including but not limited to 
the IB, this protocol, case report forms (CRFs)/eCRFs, study drug information, and any other 
study information, remain the sole and exclusive property of Gilead during the conduct of the 
study and thereafter. This information is not to be disclosed to any third party (except 
employees or agents directly involved in the conduct of the study or as required by law) 
without prior written consent from Gilead. The investigator further agrees to take all 
reasonable precautions to prevent the disclosure by any employee or agent of the study site to 
any third party or otherwise into the public domain.
9.1.6.
Case Report Forms
For each patient consented, an eCRF casebook will be completed by an authorized study staff 
member whose training for this function is completed in the electronic data capture (EDC) 
system. The eCRF casebook will only capture the data required per the protocol schedules of 
events and procedures. The Inclusion/Exclusion Criteria and Enrollment eCRFs should be 
completed only after all data related to eligibility have been received. Data entry should be 
performed in accordance with the CRF Completion Guidelines provided by the sponsor. 
Subsequent to data entry, a study monitor will perform source data verification within the 
EDC system. System-generated or manual queries will be issued in the EDC system as data 
discrepancies are identified by the monitor or Gilead staff who routinely review the data for 
completeness, correctness, and consistency. The site investigator or site coordinator, or other 
designee is responsible for responding to the queries in a timely manner, within the system, 
either by confirming the data as correct or updating the original entry, and providing the 
reason for the update (eg, data entry error). Original entries as well as any changes to data 
fields will be stored in the audit trail of the system. At a minimum, prior to any interim time 
CCI
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points or database lock (as instructed by Gilead), the investigator will use his/her login 
credentials to confirm that the forms have been reviewed and that the entries accurately 
reflect the information in the source documents. At the conclusion of the study, Gilead will 
provide the site investigator with a read-only archive copy of the data entered by that 
site. This archive must be stored in accordance with the records retention requirements 
outlined in Section 9.1.7.
9.1.7.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the 
study to be fully documented and the study data to be subsequently verified. These 
documents should be classified into at least the following 2 categories: (1) investigator’s 
study file and (2) patient clinical source documents.
The investigator’s study file will contain the protocol/amendments, CRFs/eCRFs, IRB/IEC 
and governmental approval with correspondence, the ICF, drug records, staff curriculum 
vitae and authorization forms, and other appropriate documents and correspondence.
The required source data should include sequential notes containing at least the following 
information for each patient:
•
Patient identification
•
Documentation that patient meets eligibility criteria, ie, medical history, physical 
examination, and confirmation of diagnosis (to support inclusion and exclusion criteria)
•
Documentation of the reason(s) a consented patient is not enrolled
•
Participation in study (including study number)
•
Study discussed and date of informed consent
•
Dates of all visits
•
Documentation that protocol-specific procedures were performed
•
Results of efficacy parameters, as required by the protocol
•
Start and end date (including dose regimen) of study drug, including dates of dispensing 
and return
•
Record of all AEs and other safety parameters (start and end date; causality and severity) 
and documentation that adequate medical care has been provided for any AE
•
Concomitant medication (start and end date; dose if relevant; dose changes)
•
Date of study completion and reason for early discontinuation, if it occurs


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All clinical study documents must be retained by the investigator for at least 2 years or 
according to local laws, whichever is longer, after the last approval of a marketing 
application in an ICH region (ie, US, Europe, or Japan) and until there are no pending or 
planned marketing applications in an ICH region; or, if no application is filed or if the 
application is not approved for such indication, for 2 years after the investigation is 
discontinued and regulatory authorities have been notified. Investigators may be required to 
retain documents longer if specified by regulatory requirements, by local regulations, or by 
an agreement with Gilead. The investigator must notify Gilead before destroying any clinical 
study records.
Should the investigator wish to assign the study records to another party or move them to 
another location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the study site for any or all 
of the documents, special arrangements must be made between the investigator and Gilead to 
store these records securely away from the site so that they can be returned sealed to the 
investigator in case of an inspection. When source documents are required for the continued 
care of the patient, appropriate copies should be made for storage away from the site.
9.1.8.
Investigator Inspections
The investigator will make available all source documents and other records for this study to 
Gilead’s appointed study monitors, to IRBs/IECs, or to regulatory authority or health 
authority inspectors.
9.1.9.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.
9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications may be made only by the sponsor.
9.2.2.
Study Report and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies) 
when applicable and in accordance with local regulatory requirements. Gilead will ensure 
that the report meets the standards set out in the ICH Guideline for Structure and Content of 
Clinical Study Reports (ICH E3). Note that an abbreviated report may be prepared in certain 
cases. For studies with sites in countries following the EU Regulation No. 536/2014, a CSR 
will be submitted within 1 year (6 months for pediatric studies, in accordance with 
Regulation [EC] No. 1901/2006) after the global end of study (as defined in Section 6.11). 


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Investigators in this study may communicate, orally present, or publish study data in 
scientific journals or other scholarly media in accordance with the Gilead clinical trial 
agreement.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol (eg, attendance at investigator meetings). If required under the applicable statutory 
and regulatory requirements, Gilead will capture and disclose to federal and state agencies 
any expenses paid or reimbursed for such services, including any clinical study payments, 
meal, travel expenses or reimbursements, consulting fees, and any other transfer of value.
9.3.2.
Access to Information for Monitoring
The monitor is responsible for routine review of the CRF/eCRF at regular intervals 
throughout the study to verify adherence to the protocol and the completeness, consistency, 
and accuracy of the data being entered on them. The monitor should have access to any 
patient records needed to verify the entries in the CRF/eCRF. The investigator agrees to 
cooperate with the monitor to ensure that any problems detected through any type of 
monitoring (central, on-site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority the 
investigator agrees to notify the Gilead medical monitor immediately. The investigator agrees 
to provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both Gilead and the investigator reserve the right to terminate the study at any time. Should 
this be necessary, both parties will arrange discontinuation procedures and notify the patients, 
appropriate regulatory authority, IRB, and IEC. In terminating the study, Gilead and the 
investigator will ensure that adequate consideration is given to the protection of the patients’ 
interests.


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10.
REFERENCES
Advani R, Flinn I, Popplewell L, Forero A, Bartlett NL, Ghosh N, et al. CD47 Blockade by 
Hu5F9-G4 and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med 
2018;379 (18):1711-21.
Brahmer J, Lacchetti C, Schneider B, Atkins M, Brassil K, Caterino J, et al. Management of 
Immune-Related Adverse Events in Patients Treated With Immune 
Checkpoint Inhibitor Therapy: American Society of Clinical Oncology 
Clinical Practice Guideline. J Clin Oncol 2018;36 (17).
Chao MP, Alizadeh AA, Tang C, Jan M, Weissman-Tsukamoto R, Zhao F, et al. Therapeutic 
antibody targeting of CD47 eliminates human acute lymphoblastic leukemia. 
Cancer Res 2011a;71 (4):1374-84.
Chao MP, Alizadeh AA, Tang C, Myklebust JH, Varghese B, Gill S, et al. Anti-CD47 
antibody synergizes with rituximab to promote phagocytosis and eradicate 
non-Hodgkin lymphoma. Cell 2010a;142:699-713.
Chao MP, Jaiswal S, Weissman-Tsukamoto R, Alizadeh AA, Gentles AJ, Volkmer J, et al. 
Calreticulin Is the Dominant Pro-Phagocytic Signal on Multiple Human 
Cancers and Is Counterbalanced by CD47. Science translational medicine 
2010b;2 (63):63ra94.
Chao MP, Majeti R, Weissman IL. Programmed cell removal: a new obstacle in the road to 
developing cancer. Nat Rev Cancer. 2012;12 (1):58-67.
Chao MP, Tang C, Pachynski RK, Chin R, Majeti R, Weissman IL. Extranodal dissemination 
of non-Hodgkin lymphoma requires CD47 and is inhibited by anti-CD47 
antibody therapy. Blood 2011b;118 (18):4890-901.
Chari A, Vogl DT, Gavriatopoulou M, Nooka AK, Yee AJ, Huff CA, et al. Oral Selinexor-
Dexamethasone for Triple-Class Refractory Multiple Myeloma. N Engl J Med 
2019;381 (8):727-38.
Chen JY, McKenna KM, Choi TS, Duan J, Brown L, Stewart JJ, et al. RBC-Specific CD47 
Pruning Confers Protection and Underlies the Transient Anemia in Patients 
Treated with Anti-CD47 Antibody 5F9 [Abstract]. Blood (ASH Annual 
Meeting Abstracts) 2018;132 (Suppl 1):2327.
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 
1976;16:31-41.
DARZALEX, Janssen Biotech Inc. DARZALEX (daratumumab) injection, for intravenous 
use. U.S. Prescribing Information. Horsham, PA. Revised August. 2020:


Magrolimab
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DARZALEX FASPRO, Janssen Biotech Inc. DARZALEX FASPRO™ (daratumumab and 
hyaluronidase-fihj) injection, for subcutaneous use. U.S. Prescribing 
Information. Horsham, PA. Revised May. 2020:
de Weers M, Tai YT, van der Veer MS, Bakker JM, Vink T, Jacobs DC, et al. Daratumumab, 
a novel therapeutic human CD38 monoclonal antibody, induces killing of 
multiple myeloma and other hematological tumors. J Immunol 2011;186 
(3):1840-8.
DEXAMETHASONE, Roxane Laboratories Inc. DEXAMETHASONE Tablets, 
DEXAMETHASONE Oral Solution, and DEXAMETHASONE Oral 
Solution, Intensol ™ (Concentrate). U.S. Prescribing Information. Columbus, 
OH. Revised February. 2015:
Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, et al. 
Safety and efficacy of pomalidomide plus low-dose dexamethasone in 
STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. 
Blood 2016;128 (4):497-503.
Edris B, Weiskopf K, Volkmer AK, Volkmer JP, Willingham SB, Contreras-Trujillo H, et al. 
Antibody therapy targeting the CD47 protein is effective in a model of 
aggressive metastatic leiomyosarcoma. Proc Natl Acad Sci U S A 2012;109 
(17):6656-61.
Facit.org. Fact-MM (Version 4). Available at: https://www.facit.org/. 17 July. 2009:
Gandhi UH, Cornell RF, Lakshman A, Gahvari ZJ, McGehee E, Jagosky MH, et al. 
Outcomes of patients with multiple myeloma refractory to CD38-targeted 
monoclonal antibody therapy [Author Manuscript]. Leukemia 2019;33 
(9):2266-75.
Gorgun G, Calabrese E, Soydan E, Hideshima T, Perrone G, Bandi M, et al. 
Immunomodulatory effects of lenalidomide and pomalidomide on interaction 
of tumor and bone marrow accessory cells in multiple myeloma. Blood 
2010;116 (17):3227-37.
Gralow JR, Biermann JS, Farooki A, Fornier MN, Gagel RF, Kumar R, et al. NCCN Task 
Force Report: Bone Health In Cancer Care. J Natl Compr Canc Netw 2013;11 
(Suppl 3):S1-50; quiz S1.
Hideshima T, Chauhan D, Shima Y, Raje N, Davies FE, Tai YT, et al. Thalidomide and its 
analogs overcome drug resistance of human multiple myeloma cells to 
conventional therapy. Blood 2000;96 (9):2943-50.
Ivanova A, Qaqish BF, Schell MJ. Continuous toxicity monitoring in phase II trials in 
oncology. Biometrics 2005;61 (2):540-5.


Magrolimab
Protocol GS-US-558-5915
Final
Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 127
02 November 2023
Ivanova A, Wang K. Bivariate isotonic design for dose-finding with ordered groups. Stat 
Med 2006;25 (12):2018-26.
Jaiswal S, Jamieson CH, Pang WW, Park CY, Chao MP, Majeti R, et al. CD47 Is Up-
Regulated on Circulating Hematopoietic Stem Cells and Leukemia Cells to 
Avoid Phagocytosis. Cell 2009;138 (2):271-85.
Kim D, Wang J, Willingham SB, Martin R, Wernig G, Weissman IL. Anti-CD47 antibodies 
promote phagocytosis and inhibit the growth of human myeloma cells. 
Leukemia 2012;26 (12):2538-45.
Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, et al. International 
Myeloma Working Group consensus criteria for response and minimal 
residual disease assessment in multiple myeloma. Lancet Oncol 2016;17 
(8):e328-e46.
KYPROLIS, Onyx Pharmaceuticals I. KYPROLIS® (carfilzomib) for injection, for 
intravenous use. U.S. Prescribing Information. Thousand Oaks, CA. Revised 
March. 2021:
Li MO, Wan YY, Flavell RA. T cell-produced transforming growth factor-beta1 controls T 
cell tolerance and regulates Th1- and Th17-cell differentiation. Immunity 
2007;26 (5):579-91.
Li S, Pal R, Monaghan SA, Schafer P, Ouyang H, Mapara M, et al. IMiD immunomodulatory 
compounds block C/EBP{beta} translation through eIF4E down-regulation 
resulting in inhibition of MM. Blood 2011;117 (19):5157-65.
Linderoth E, Helke S, Lee V, Mutukura T, Wong M, Lin GH, et al. The anti-myeloma 
activity of TTI-621 (SIRPalphaFc), a CD47-blocking immunotherapeutic, is 
enhanced when combined with a proteasome inhibitor [Abstract 2653]. 
American Association for Cancer Research Annual Meeting; 2017 01-05 
April; Washington, DC. 
Liu J, Wang L, Zhao F, Tseng S, Narayanan C, Shura L, et al. Pre-Clinical Development of a 
Humanized Anti-CD47 Antibody with Anti-Cancer Therapeutic Potential. 
PLoS One. 2015;10 (9):e0137345.
Lonial S, Lee HC, Badros A, Trudel S, Nooka AK, Chari A, et al. Belantamab mafodotin for 
relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, 
randomised, open-label, phase 2 study. Lancet Oncol 2020;21 (2):207-21.
Majeti R, Chao MP, Alizadeh AA, Pang WW, Jaiswal S, Gibbs KD, Jr., et al. CD47 Is an 
Adverse Prognostic Factor and Therapeutic Antibody Target on Human Acute 
Myeloid Leukemia Stem Cells. Cell 2009;138 (2):286-99.


Magrolimab
Protocol GS-US-558-5915
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Gilead Sciences, Inc. 
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CONFIDENTIAL
Page 128
02 November 2023
Mark TM, Coleman M, Niesvizky R. Preclinical and clinical results with pomalidomide in 
the treatment of relapsed/refractory multiple myeloma. Leuk Res 2014;38 
(5):517-24.
Miguel JS, Weisel K, Moreau P, Lacy M, Song K, Delforge M, et al. Pomalidomide plus 
low-dose dexamethasone versus high-dose dexamethasone alone for patients 
with relapsed and refractory multiple myeloma (MM-003): a randomised, 
open-label, phase 3 trial. Lancet Oncol 2013;14 (11):1055-66.
Overdijk MB, Jansen JH, Nederend M, Lammerts van Bueren JJ, Groen RW, Parren PW, et 
al. The Therapeutic CD38 Monoclonal Antibody Daratumumab Induces 
Programmed Cell Death via Fcgamma Receptor-Mediated Cross-Linking. J 
Immunol 2016;197 (3):807-13.
Overdijk MB, Verploegen S, Bogels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, 
et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of 
the therapeutic antibody daratumumab in lymphoma and multiple myeloma. 
mAbs 2015;7 (2):311-21.
Palumbo A, Bringhen S, Mateos MV, Larocca A, Facon T, Kumar SK, et al. Geriatric 
assessment predicts survival and toxicities in elderly myeloma patients: an 
International Myeloma Working Group report. Blood 2015;125 (13):2068-74.
Palumbo A, Bringhen S, Rossi D, Magarotto V, Di Raimondo F, Ria R, et al. A Prospective, 
Randomized, Phase III Study of Bortezomib, Melphalan, Prednisone and 
Thalidomide (VMPT) Versus Bortezomib, Melphalan and Prednisone (VMP) 
in Elderly Newly Diagnosed Myeloma Patients [Abstract]. Blood 2008;112 
(11):652.
POMALYST, Celgene Corporation. POMALYST® (pomalidomide) capsules, for oral use. 
U.S. Prescribing Information. Summit, NJ. Revised May. 2020:
Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and 
management. Am J Hematol 2020;95 (5):548-67.
Richards J, Bouchlaka MN, Puro RJ, Capoccia BJ, Hiebsch RR, Donio MJ, et al. Highly 
Differentiated Anti-CD47 Antibody, AO-176, Potently Inhibits Hematologic 
Malignancies Alone and in Combination [Abstract]. Blood 2019;134 (Suppl 
1):1844.
Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin DH, et al. Extended 
follow-up of a phase II trial in relapsed, refractory multiple myeloma: final 
time-to-event results from the SUMMIT trial. Cancer 2006;106 (6):1316-9.


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Richardson PG, Mark TM, Lacy MQ. Pomalidomide: new immunomodulatory agent with 
potent antiproliferative effects. Crit Rev Oncol Hematol 2013;88 Suppl 1:S36-
44.
Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, et al. 
Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N 
Engl J Med 2005;352 (24):2487-98.
Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, et al. Safety 
and efficacy of bortezomib in high-risk and elderly patients with relapsed 
multiple myeloma. Br J Haematol 2007;137 (5):429-35.
Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA 
clinical practice guideline for vaccination of the immunocompromised host. 
Clin Infect Dis 2014;58 (3):e44-100.
Rychak E, Mendy D, Shi T, Ning Y, Leisten J, Lu L, et al. Pomalidomide in combination 
with dexamethasone results in synergistic anti-tumour responses in pre-
clinical models of lenalidomide-resistant multiple myeloma. Br J Haematol 
2016;172 (6):889-901.
Sikic BI, Lakhani N, Patnaik A, Shah SA, Chandana SR, Rasco D, et al. First-in-Human, 
First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients 
With Advanced Cancers. J Clin Oncol 2019;37 (12):946-53.
Sun J, Muz B, Alhallak K, Markovic M, Gurley S, Wang Z, et al. Targeting CD47 as a Novel 
Immunotherapy for Multiple Myeloma. Cancers 2020;12 (2):305.
Terpos E, Morgan G, Dimopoulos MA, Drake MT, Lentzsch S, Raje N, et al. International 
Myeloma Working Group recommendations for the treatment of multiple 
myeloma-related bone disease. J Clin Oncol 2013;31 (18):2347-57.
Troughton MC, Simmons LW, Langley C, Youssef M, Marques MB. A Novel Use of 
Human Platelet Concentrate to Resolve Interference of Anti-CD47 in 
Serologic Testing [IGT46]. Transfusion 2018;58 (S2):179A-80A.
U.S. Department of Health & Human Services (DHHS), Food & Drug Administration 
(FDA), Center for Drug Evaluation and Research (CDER), Center for 
Biologics Evaluation and Research (CBER). Guidance for Industry: Drug-
Induced Liver Injury: Premarketing Clinical Evaluation. July, 2009.
VELCADE, Millennium Pharmaceuticals Inc. VELCADE® (bortezomib) for injection, for 
subcutaneous or intravenous use. U.S. Prescribing Information. Cambridge, 
MA. Revised April. 2019:
Velliquette RW, Aeschlimann J, Kirkegaard J, Shakarian G, Lomas-Francis C, Westhoff 
CM. Monoclonal anti-CD47 interference in red cell and platelet testing. 
Transfusion 2019;59 (2):730-7.


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Vo MC, Yang S, Jung SH, Chu TH, Lee HJ, Lakshmi TJ, et al. Synergistic Antimyeloma 
Activity of Dendritic Cells and Pomalidomide in a Murine Myeloma Model. 
Frontiers in immunology 2018;9:1798.
Willingham SB, Volkmer JP, Gentles AJ, Sahoo D, Dalerba P, Mitra SS, et al. The CD47-
signal regulatory protein alpha (SIRPa) interaction is a therapeutic target for 
human solid tumors. Proc Natl Acad Sci U S A 2012;109 (17):6662-7.


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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Schedules of Assessments
Appendix 3.
Pandemic Risk Assessment and Mitigation Plan
Appendix 4.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 5.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities
Appendix 6.
Disease Response Criteria Based on International Myeloma Working Group 
(IMWG) 2016 Criteria
Appendix 7.
Eastern Cooperative Oncology Group Performance Status
Appendix 8.
Cockcroft-Gault Method for Estimating Creatinine Clearance
Appendix 9.
FACT-MM (Version 4) {Facit.org 2009}
Appendix 10.
Myeloma Frailty Score Calculator
Appendix 11.
Amendment History


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Appendix 1.
Investigator Signature Page
GILEAD SCIENCES, INC.
333 LAKESIDE DRIVE
FOSTER CITY, CA 94404
STUDY ACKNOWLEDGMENT
A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With 
Relapsed/Refractory Multiple Myeloma
GS-US-558-5915 Protocol Amendment 6; 02 November 2023
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval.
[See appended electronic signature]
Name (Printed)
Medical Monitor
Signature
[See appended electronic signature]
Date
INVESTIGATOR STATEMENT
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated.
I will provide all study personnel under my supervision copies of the protocol and access to 
all information provided by Gilead Sciences, Inc. I will discuss this material with them to 
ensure that they are fully informed about the drugs and the study.
Principal Investigator Name (Printed)
Signature
Date
Site Number
PPD


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Appendix 2.
Schedules of Assessments
Appendix Table 1.
Schedule of Assessments – Screening
Study
Assessment
Day −30 to −1
Informed Consenta
X
Demographics
X
Medical History, Including MM History
X
Bone Marrow Sampleb 
X
Myeloma Frailty Score Calculation (Patients ≥ 65 Years of Age)c
X
ECOG Performance Status
X
Vital Signs, Height, and Weightd
X
Complete Physical Examination
X
Peripheral Neurological Examination for Residual Neuropathy 
(Patients Enrolling onto Bortezomib Cohort)e
X
12-lead ECG 
X
Echocardiogram/MUGA Scan
X
Serum or Plasma Chemistryf
X
Hematologyf
X
Urinalysisf
X
Pregnancy Testg
X
Blood Phenotyping or genotyping for minor antigens, Type, and Screen (ABO/Rh), DAT
X
Serum Protein Electrophoresis (SPEP)
X
24-Hour Urine Protein Electrophoresis (UPEP) 
X
Serum Free Light Chain (SFLC)
X
Serum Immunofixation (SIFE)
X
Urine Immunofixation (UIFE)
X
β2-microglobulin and Quantitative Ig Levels
X
Hepatitis B, Hepatitis C, and HIV
X
C-Reactive Protein (CRP)
X
Skeletal Survey
X
CT (± PET) or MRI Assessment for Extramedullary Soft Tissue Plasmacytoma
X
SAEs and AEs Related to Protocol-mandated Procedures
X
Prior and Concomitant Medications
X
ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; AE = adverse events; CT = computed 
tomography; DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; 
FSH = follicle-stimulating hormone; Ig = immunoglobin; MM = multiple myeloma; MRI = magnetic resonance imaging; 
MUGA = multigated acquisition (scan); PET = positron emission tomography; Rh = Rhesus factor; SAE =serious adverse 
events
a
Screening must be completed prior to enrollment. Enrollment must occur within 30 days of signing informed consent.


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b
A baseline bone marrow sample (aspirate slides and biopsy) will be obtained within 14 days prior to first dose 
(baseline) on Cycle 1 Day 1 and will be used to quantify the percent of myeloma cell involvement. A bone marrow 
sample obtained as standard of care may be used as baseline if taken within 45 days prior to enrollment and are sent to 
the central laboratory for processing.
c
This is applicable to patients ≥ 65 years of age (Appendix 10).
d
Height should be recorded during screening only.
e
Patients should be assessed for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, 
paresthesia, discomfort, neuropathic pain or weakness.
f
Specific analytes listed in Table 22.
g
Serum pregnancy test will be conducted at screening. Screening pregnancy test may be used as the Cycle 1 Day 1 test if 
performed within 72 hours of first dose; additional guidance is provided in Section 6.4.5. For patients in the cohort 
receiving magrolimab in combination with pomalidomide and dexamethasone, the first test should be performed within 
10 to 14 days and the second test within 24 hours prior to prescribing pomalidomide therapy. FSH test is required for 
female patients who are < 54 years old who are not on hormonal contraception and who have stopped menstruating for 
≥ 12 months but do not have documentation of ovarian hormonal failure.


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Appendix Table 2.
Schedule of Assessments – Treatment Period
Cycle 1 lasts for 35 days; all other Cycles last for 28 days
1a
2
3
4+
Visit Window (Days)
None
± 3b
± 3b
± 3b
± 3b
Cycle Day
1
8
15
22
29
1
8
15
22
1
8
15
22
1
8
15
22
Serum or Plasma Chemistryb
X
X
X
X
X
X
X
X
X
Hematologyb
Xaa
Xaa
X
X
X
X
X
X
X
X
Haptoglobin
X
X
X
Peripheral smear
X
X
X
Urinalysisb
X
X
X
X
X
X
X
X
X
Pregnancy Testc
X
X
X
X
C-Reactive Protein (CRP)
X
X
X
Antidrug Antibodiesb
X
X
X
Xd
Pharmacokineticse
X
X
X
X
Xd
Serum Protein Electrophoresis (SPEP)
X
X
X
24-Hour Urine Protein Electrophoresis 
(UPEP)
X
X
X
Serum Free Light Chain (SFLC)
X
X
X
β2-microglobulin and Quantitative Ig 
Levelsf
X
Serum Immunofixation (SIFE)g
X
X
X
Urine Immunofixation (UIFE)h
X
X
X
Skeletal Survey
Xi
Buccal Swabj
X


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Cycle 1 lasts for 35 days; all other Cycles last for 28 days
1a
2
3
4+
Visit Window (Days)
None
± 3b
± 3b
± 3b
± 3b
Cycle Day
1
8
15
22
29
1
8
15
22
1
8
15
22
1
8
15
22
Bone Marrow Samplek
X
IMWG Response Assessment
X
X
X
MRD Assessmentl
X
CT (± PET) or MRI Assessment for 
Extramedullary Soft Tissue 
Plasmacytomam
X
Vital Signsn
X
X
X
X
X
X
X
X
X
X
X
X
12-lead ECGo
X
X
Xo
Symptom-directed Physical 
Examination
X
X
X
X
X
X
Peripheral Neurological Examination 
(Bortezomib Cohort)p
X
X
X
X
X
X
X
X
X
X
X
X
ECOG Performance Status
X
X
X
X
X
X
Adverse Events
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Concomitant Medications
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Premedication for Magrolimabq
X
X
X
X
Magrolimabr
Xy
Xy
X
X
X
X
X
X
X
X
X
X
X
Daratumumabs IV or SCt
X
X
X
X
X
X
X
X
X
X
X
X
Pomalidomidet
Days 1 to 21
Days 1 to 21
Days 1 to 21
Days 1 to 21
Carfilzomib IVt,u
X
X
X
X
X
X
X
X
X
X
X
X
Bortezomib SC or IVt,v
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X


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Cycle 1 lasts for 35 days; all other Cycles last for 28 days
1a
2
3
4+
Visit Window (Days)
None
± 3b
± 3b
± 3b
± 3b
Cycle Day
1
8
15
22
29
1
8
15
22
1
8
15
22
1
8
15
22
Dexamethasonew,x
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
CR = complete response; CT = computed tomography; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EOT = end of treatment; Ig = immunoglobulin; 
IV = intravenous; IMWG = International Myeloma Working Group; MRD = minimal residual disease; MRI = magnetic resonance imaging; PBMC = peripheral blood 
mononuclear cell; PD = progressive disease; PET = positron emission tomography; PRO = patient-reported outcome; SC = subcutaneous; sCR = stringent complete response; 
SPEP = serum protein electrophoresis; UPEP = urine protein electrophoresis
a
In cases of magrolimab repriming following a treatment delay (Section 5.4.1), efficacy, biomarker, PK, and immunogenicity assessments should follow the schedule of the 
assigned cycle number. Magrolimab dosing and the safety assessment must follow Cycle 1, and then subsequently switch back to the next assigned cycle schedule. 
Magrolimab should not be given on consecutive days. Refer to footnote (t) for premedication requirement.
b
Pretreatment assessments are to be collected within 24 hours prior to any study treatment administration for assessments listed in Appendix Table 1; specific analytes for 
serum or plasma chemistry, hematology, and urinalysis are listed in Table 23
c
Urine pregnancy test. Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; additional 
guidance is provided in Section 6.4.5. For patients in the cohort receiving magrolimab in combination with pomalidomide and dexamethasone, the first test should be 
performed within 10 to 14 days and the second test within 24 hours prior to prescribing pomalidomide therapy, and then weekly during the first month, then monthly 
thereafter in females with regular menstrual cycles, or every 2 weeks in females with irregular menstrual cycles.
d
Should be collected Cycle 5 Day 1, Cycle 7 Day 1, Cycle 10 Day 1, and Cycle 13 Day 1.
e
Samples will be collected within 72 hours before the first dose of magrolimab and within 12 hours before subsequent doses of magrolimab.
f
To be performed for patients with IgA and IgD myelomas and when clinically indicated eg, recurrent infections.
g
Serum immunofixation is performed if SPEP shows no measurable protein, at suspected CR and at suspected PD.
h
Urine immunofixation is performed if UPEP shows no measurable protein and at suspected CR.
i
Skeletal survey will be repeated if worsening clinical symptoms suggest PD or as clinically indicated.
j
Buccal swab sample collected from enrolled patient before or at Cycle 1 Day 1, predose. If the sample is missed, it can be taken later on in the study.
k
Bone marrow samples will be obtained within 14 days prior to the first dose (baseline) on Cycle 1 Day 1 and within 7 days prior to Cycle 2 Day 1 (before dose). From Cycle 3 
onwards, it will be repeated as clinically indicated for response assessment at suspected CR or sCR and to confirm CR or sCR. A sample obtained at either suspected or 
confirmed CR/sCR may also be made available for MRD assessment. 
l
Only in patients with suspected or confirmed CR or sCR and during specific landmark analyses – refer to Section 6.5.4.
m
CT/MRI/CT-PET for extramedullary soft tissue plasmacytoma is performed every 12 weeks or every 3 cycles starting from Cycle 4 Day 1 for patients who were found to 
have extramedullary soft tissue plasmacytoma at screening/baseline.
n
Vital signs prior to infusion/injection of any study treatment. Weight at Day 1 of each cycle, and Day 1 and 15 for Cycles 3 and up. Details are provided in Section 6.4.3.
o
12-lead ECGs will be performed at Cycle 1, and every other cycle thereafter (Cycle 3, Cycle 5 etc.).
p
Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness.
q
Premedication with acetaminophen, diphenhydramine, and corticosteroids is required prior to the administration of the first 4 doses of study treatment and in case of 
reintroduction with repriming.
r
Monitor patients for 1-hour after infusion during Cycle 1.


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s
Daratumumab can be given as IV or SC during Days 8, 15, 22 and 29 of Cycle 1, Days 1, 8, 15 and 22 of Cycle 2, Days 1 and 15 from Cycle 3 through to Cycle 6 and then 
Cycle 7 onwards Day 1 of each cycle.
t
Daratumumab, pomalidomide, carfilzomib and bortezomib are only given to patients assigned to the individual cohorts for these drugs.
u
20 mg/m2 on Cycle 1 Day 8 and 70 mg/m2 for all subsequent doses.
v
Bortezomib is given on Days 8, 15, 22, and 29 during Cycle 1 and Days 1, 8, 15, and 22 during subsequent cycles. The maximum number of cycles is 8 in patients who have 
previously received bortezomib; SC is preferred over IV, where feasible.
w
For carfilzomib and bortezomib cohorts only, given weekly until Cycle 9 and then Days 1, 8, and 15 from Cycle 10 onwards.
x
Dexamethasone is administered to patients in the pomalidomide, carfilzomib, and bortezomib cohorts as part of myeloma treatment and may be administered in the 
daratumumab cohort as part of pre- and/or postmedication. Refer to each cohort-specific dosing for dexamethasone.
y
Within 24 hours prior to each of the first 2 doses of magrolimab infusion during initial treatment, all patients must have a documented hemoglobin ≥ 9 g/dL. Patients who do 
not meet these criteria must be transfused and have their hemoglobin rechecked to meet 9 g/dL prior to each of the first 2 doses of magrolimab. An additional hemoglobin 
must be checked 3 to 6 hours after the initiation of the first and second doses of magrolimab during initial treatment (as described in Section 7.8.1.1).


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Appendix Table 3.
Schedule of Assessments – Posttreatment
EOT Visit
Safety Follow-up Visit/Call 
(Telephone)a
Within 7 Days After Last Dose or 
EOT Decision
70 Days
After Last Dose
Visit Window
± 7 Days
± 7 Days
Serum or Urine Pregnancy Test
Q4Wb
CBC with Differential, Platelet Count, Reticulocytes
X
Serum or Plasma Chemistry
X
Pharmacokinetics
X
Antidrug Antibodies 
X
Serum Protein Electrophoresis
X
24-Hour Urine Protein Electrophoresis (UPEP)
X
Serum Free Light Chain (SFLC)
X
Serum Immunofixation (SIFE)
X
Urine Immunofixation (UIFE)
X
β2-microglobulin and Quantitative Ig Levels
X
Skeletal Survey
X
Vital Signs
X
Symptom Driven Physical Examination
X
ECOG Performance Status
X
IMWG Response Assessmentc
X
Minimal Residual Disease Assessmentd
X
CCI
CCI
-
I 


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EOT Visit
Safety Follow-up Visit/Call 
(Telephone)a
Within 7 Days After Last Dose or 
EOT Decision
70 Days
After Last Dose
Visit Window
± 7 Days
± 7 Days
CT (± PET) or MRI Assessment of Extramedullary Soft Tissue Plasmacytomae
X
Adverse Eventsf
X
X
Concomitant Medications
X
X
New Anticancer Therapyg
X
X
AE = adverse event; CBC = complete blood count; CR = complete response; CT = computed tomography; ECOG = Eastern Cooperative Oncology Group; EOT = end of 
treatment; Ig = immunoglobulin; IMWG = International Myeloma Working Group; MRI = magnetic resonance imaging; PET = positron emission tomography; 
Q4W = every 4 weeks; SAE = serious adverse event.
a
If the patient experiences a treatment-related AE or an SAE (regardless of attribution), the patient must be asked to come to the site.
b
Pregnancy tests should be taken at monthly intervals until end of contraception requirement.
c
Response assessment at EOT visit not required if performed within the last 30 days or progressive disease has been documented.
d
In patients with suspected or confirmed CR only.
e
Only in patients who were found to have extramedullary soft tissue plasmacytoma at screening/baseline or during the study.
f
Report all AEs through the safety follow-up visit/call, and any treatment-related SAEs thereafter.
g
Collect new anticancer therapy data following the last dose of study treatment.


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Appendix 3.
Pandemic Risk Assessment and Mitigation Plan
During an ongoing pandemic, potential risks associated with patients being unable to attend 
study visits have been identified for this study.
These potential risks and mitigation plans can be summarized as follows:
1) Schedule of assessments:
a) Physical examination:
i)
In order to limit a patient’s time in the clinic, a virtual visit may be conducted for the 
physical examination assessment. Vital signs may be omitted. However, dosing and 
biological sample collection should occur per protocol in the clinic.
b) Dosing:
i)
Patients may be unable to return to the site for a number of visits to receive the study 
drug, or the site may be unable to accept any patient visits. Without study drugs, the 
patient would not be able to stay on the study drug as planned per protocol.
Mitigation plan: If permitted by local regulations and ethics committee (EC)/institutional 
review boards (IRBs), combination agents (ie, daratumumab, carfilzomib, or bortezomib) 
may be administered at a clinic closer to the patient, under the supervision of a physician 
specializing in the treatment of multiple myeloma (MM) provided that all facilities for 
managing infusion-related reactions, anaphylaxis and other acute emergencies are 
available. If necessary, a dosing delay for magrolimab must be discussed with the 
sponsor in this instance. A virtual study visit, via phone or video conferencing, must be 
performed prior to remote dosing. At the earliest opportunity, the site will schedule in 
person patient visits and return to the protocol’s regular schedule of assessments. A 
qualified courier may be considered to ship the drug from sites to the alternate clinic.
c) General patient selection guidance:
i)
To minimize patients receiving red blood cell transfusions, we recommend selecting 
patients with higher hemoglobin thresholds at baseline and use intravenous iron 
and/or erythropoietin where clinically indicated.
2) Study drug supplies to patients and sites:
a) Patients may be unable to return to the site for a number of visits to get the study drug, or 
the site may be unable to accept any patient visits. Without study drugs, the patient would 
not be able to stay on the study drug as planned per protocol.


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Mitigation plan: If permitted by local EC/IRB/regulatory authority as applicable, and with 
sponsor’s approval, study drug supplies may be provided to the patient from the site without 
a clinic visit. It must be confirmed that the patient may safely continue on study drug as 
determined by the principal investigator. A virtual study visit, via phone or video 
conferencing, must be performed prior to remote study drug resupply. At the earliest 
opportunity, the site will schedule in-person patient visits and return to the protocol’s regular 
schedule of assessments. A qualified courier may be utilized to ship the study drug from sites 
to study patients, and a qualified vendor may be utilized to perform infusions in the patients’ 
local vicinity.
b) Shipments of study drug could be delayed from the sponsor to the investigational site 
because of transportation issues. Without study drug patient would not be able to stay on 
the study drug as planned per protocol.
Mitigation plan: The sites’ study drug inventory should be closely monitored. Site staff 
should notify the sponsor or delegate if they foresee shortage in study drug inventory or if 
there is any interruption in local shipping service. The sponsor will continue to monitor 
inventory at the study drug depot and study sites. Manual shipments will be triggered as 
necessary.
3) Patient safety monitoring and follow-up:
a) Patients may be unable or unwilling to come to the study site for their scheduled study 
visits as required per protocol.
Mitigation plan: For patients who may be unable or unwilling to visit the study site for their 
scheduled study visits as required per protocol, the principal investigator or qualified 
delegate will conduct a virtual study visit, via phone or video conferencing, to assess the 
patient within target visit window date whenever possible. During the virtual study visit, the 
following information at minimum will be reviewed:
i)
Confirm if patient has experienced any AEs/SAEs/special situations (including 
pregnancy) and follow-up on any unresolved AE/SAEs.
ii) Review current list of concomitant medications and document any new concomitant 
medications.
iii) If applicable, confirm patients study drug supply is sufficient to last until the next 
planned visit date. If study drug resupply is needed it will be provided as described 
above in (2).
iv) If applicable, remind patient to maintain current dosing and to keep all dispensed 
study drug kits for return at the next on-site visit.


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b) Patients may be unable or unwilling to travel to the site for planned assessments (eg, 
safety blood draws); hence samples may not be analyzed at the site laboratory and/or sent 
for central laboratory analyses.
Mitigation plan: Accredited local laboratories that are not affiliated with the site may be 
utilized as appropriate to monitor patient safety until the patient can return to the site for their 
regular follow-up per protocol. Any laboratory assessments conducted at a local lab due to 
the pandemic will be documented accordingly. Pregnancy testing may be performed using a 
home urine pregnancy test if local lab pregnancy testing is not feasible. Alternative sample 
handling and storage may be possible for samples routinely sent to the central laboratory; 
sites should refer to the study laboratory manual and discuss with the sponsor for further 
guidance.
c) Patients may be unable or unwilling to attend the study visit to sign an updated ICF 
version if there is an update.
Mitigation plan: The site staff will follow their approved consent process and remain in 
compliance with local EC/IRB and national laws and regulations. Remote consent will be 
allowed if has been approved by the local EC/IRB. The consent process will be documented 
and confirmed by normal consent procedure at the earliest opportunity.
4) Protocol and monitoring compliance:
a) Protocol deviations may occur, in case scheduled visits cannot occur as planned per 
protocol.
Mitigation plan: If it is not possible to complete a required procedure, an unscheduled visit 
should be conducted as soon as possible when conditions allow. The situation should be 
recorded and explained as a protocol deviation. Any missed patient visits or deviation to the 
protocol due to the pandemic must be reported in the eCRF and described in the clinical 
study report. Any virtual study visits that are conducted in lieu of clinic visits due to the 
pandemic will be documented as a protocol deviation related to the pandemic.
b) Monitors may be unable to carry out source data review or source data verification, or 
study drug accountability or assess protocol and GCP compliance. This may lead to 
delays in source data verification, an increase in protocol deviations, or under-reporting 
of AEs.
Mitigation plan: The study monitor is to remain in close communication with the site to 
ensure data entry and query resolution. The study monitor is to reference the Study 
Monitoring Plan for guidance on how to conduct a remote monitoring visit. The study staff is 
to save and document all relevant communication in the study files. The status of sites that 
cannot accept monitoring visits and/or patients on site, must be tracked centrally and updated 
on a regular basis.


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5) Missing data and data integrity:
a) There may be an increased amount of missing data due to patients missing 
visits/assessments. This could have an impact on the analysis and the interpretation of 
clinical study data.
Mitigation plan: Implications of a pandemic on methodological aspects for the study will be 
thoroughly assessed and documented, and relevant actions will be taken as appropriate (ie, 
modification of the statistical analysis plan) and in compliance with regulatory authorities’ 
guidance. Overall, the clinical study report will describe the impact of the pandemic on the 
interpretability of study data.
Risks will be assessed continuously, and temporary measures will be implemented to mitigate 
these risks as part of a mitigation plan, as described above. These measures will be 
communicated to the relevant stakeholders as appropriate and are intended to provide alternative 
methods that will ensure the evaluation and assessment of the safety of patients who are enrolled 
in this study.
Since these potential risks are considered mitigated with the implementation of these measures, 
the expected benefit-risk assessment of study drugs in study patients remains unchanged.


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Appendix 4.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1) Definitions
a) Definition of Childbearing Potential
For the purposes of this study, a female born patient is considered of childbearing potential 
following the initiation of puberty (Tanner stage 2) until becoming postmenopausal, unless the 
patient is permanently sterile or has medically documented ovarian failure.
Women are considered to be in a postmenopausal state when they are ≥ 54 years of age with 
cessation of previously occurring menses for ≥ 12 months without an alternative cause. In 
addition, women of < 54 years of age with amenorrhea of ≥ 12 months may also be considered 
postmenopausal if their FSH level is in the postmenopausal range and they are not using 
hormonal contraception or hormonal replacement therapy.
Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female patient of any age.
b) Definition of Male Fertility
For the purposes of this study, a male born patient is considered fertile after the initiation of 
puberty unless the patient is permanently sterile by bilateral orchidectomy or medical 
documentation.
2) Cohort Receiving Magrolimab in Combination With Daratumumab
a) Study Drug Effects on Pregnancy and Hormonal Contraception
Magrolimab is contraindicated in pregnancy as a higher incidence of total pregnancy loss has 
been observed in and embryo-fetal development toxicity study in cynomolgus monkeys and there 
is a strong suspicion of human fetotoxicity in early pregnancy based on the nonclinical data. For 
magrolimab, there is no anticipated PK interaction with progestin or other steroids based on the 
distinct clearance pathways.
Based on the MOA and findings in animal studies, daratumumab (DARZALEX® FASPRO and 
DARZALEX®) can cause fetal harm when administered to a pregnant woman {DARZALEX 
2020, DARZALEX FASPRO 2020}. Due to the high affinity to a unique epitope on CD38, 
daratumumab is not anticipated to alter drug-metabolizing enzymes.
Refer to the latest version of the magrolimab IB for additional information. Refer to the reference 
USPI, SmPC, or applicable local or regional label for information on the potential risks of 
treatment with daratumumab.


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b) Contraception Requirements for Female Patients of Childbearing Potential
The inclusion of female patients of childbearing potential requires the use of highly effective 
contraceptive measures with a failure rate of < 1% per year. They must have a negative serum 
pregnancy test at screening and a negative pregnancy test is required prior to study treatment 
administration on Cycle 1 Day 1. The Cycle 1 Day 1 pregnancy test does not need to be repeated 
if the screening pregnancy test was performed within 72 hours before study treatment 
administration. Pregnancy tests will be performed at the beginning of each cycle thereafter 
(described in the protocol) until the end of contraception requirement.
Duration of required contraception for female patients in this clinical study cohort should start 
from screening visit until 3 months after the last dose of the latest administered study drug.
Female patients must agree to 1 of the following contraceptive methods:
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the patient’s preferred and usual lifestyle.
Or
Consistent and correct use of 1 of the following methods of birth control listed below:
•
Hormonal or nonhormonal intrauterine device (IUD)
•
Subdermal contraceptive implant
•
Bilateral tubal occlusion (upon medical assessment of surgical success)
•
Vasectomy in the male partner (upon medical assessment of surgical success)
Or
Female patients who wish to use a hormonally based method must use it in conjunction with a 
barrier method, preferably a male condom. Hormonal methods are restricted to those associated 
with the inhibition of ovulation. Hormonally based contraceptives and barrier methods permitted 
for use in this protocol are as follows:
•
Hormonal methods (each method must be used with a barrier method, preferably male 
condom)
Oral contraceptives (either combined or progesterone only)
Injectable progesterone
Transdermal contraceptive patch
Contraceptive vaginal ring


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•
Barrier methods (each method must be used with a hormonal method)
Male condom (with or without spermicide)
Female condom (with or without spermicide)
Diaphragm with spermicide
Cervical cap with spermicide
Sponge with spermicide
Inclusion of methods of contraception in this list of permitted methods does not imply that the 
method is approved in any country or region. Methods should only be used if locally approved.
Female patients must also refrain from egg donation, cryopreservation of cells, and in vitro 
fertilization during treatment and until the end of contraception requirement. If needed, female 
patients should be advised to seek advice about egg donation and cryopreservation prior to 
treatment.
c) Contraception Requirements for Male Patients
Male patients with female partners of childbearing potential must use condoms during treatment 
and until 3 months after last dose of the latest administered study drug. If the female partner of 
childbearing potential is not pregnant, use of any locally approved contraceptive measure should 
also be considered.
Male patients must also refrain from sperm donation and cryopreservation of cells during 
treatment and until the end of contraception requirement. If needed, male patients should be 
advised to seek advice about sperm donation and cryopreservation prior to treatment.
d) Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.
e) Procedures to be Followed in the Event of Pregnancy
Female patients will be instructed to notify the investigator if they become pregnant or suspect 
they are pregnant at any time from start of the study to 3 months after last study drug dose. Study 
drug must be discontinued immediately. Male patients whose partner has become pregnant or 
suspects she is pregnant from the start of the study to 3 months after the last study drug dose 
must also report the information to the investigator.
Instructions for reporting pregnancy and pregnancy outcome are outlined in Section 7.4.2.3.


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3) Cohort Receiving Magrolimab in Combination With Pomalidomide and 
Dexamethasone
a) Study Drug Effects on Pregnancy and Hormonal Contraception
Magrolimab is contraindicated in pregnancy as a higher incidence of total pregnancy loss has 
been observed in and embryo-fetal development toxicity study in cynomolgus monkeys and there 
is a strong suspicion of human fetotoxicity in early pregnancy based on the nonclinical data. For 
magrolimab, there is no anticipated PK interaction with progestin or other steroids based on the 
distinct clearance pathways.
For magrolimab, there is no anticipated PK interaction with progestin or other steroids based on 
the distinct clearance pathways.
Based on the MOA and findings from animal studies, pomalidomide (POMALYST®) can cause 
embryo-fetal harm when administered to a pregnant female and is contraindicated during 
pregnancy {POMALYST 2020}. Advise females of reproductive potential that they must avoid 
pregnancy while taking pomalidomide. Based on findings in animals, female fertility may be 
compromised by treatment with pomalidomide. Pomalidomide does not inhibit or induce 
cytochrome P450 (CYP) enzymes or transporters in vitro.
Based on findings from clinical and animal reproduction studies, corticosteroids, including 
dexamethasone, can cause fetal harm when administered to a pregnant woman 
{DEXAMETHASONE 2015}. Coadministration of dexamethasone with contraceptives that are 
CYP3A4 substrates may decrease the concentration of these drugs. This may result in loss of 
efficacy of these drugs.
Refer to the latest version of the magrolimab IB for additional information.
Because of the embryo-fetal risk, pomalidomide is available only through a restricted program 
under a risk evaluation and mitigation strategy (REMS), the “POMALYST REMS” program in 
the US. Refer to the current prescribing information from the reference USPI, SmPC, or 
applicable local or regional label for information on the potential risks of treatment with 
pomalidomide and dexamethasone.
b) Contraception Requirements for Female Patients of Childbearing Potential
The inclusion of female patients of childbearing potential requires the use of highly effective 
contraceptive measures with a failure rate of < 1% per year. Two negative pregnancy tests must 
be obtained prior to initiating therapy. The first test should be performed within 10 to14 days and 
the second test within 24 hours prior to prescribing pomalidomide therapy. Tests should be 
performed weekly during the first month and monthly thereafter in females with regular 
menstrual cycles, or every 2 weeks in females with irregular menstrual cycles. Pregnancy tests 
will be performed at the beginning of each cycle (described in the protocol) until the end of 
contraception requirement.


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Duration of required contraception for female patients in this clinical study cohort should start 
4 weeks prior to initiating treatment, during therapy, during dose interruptions, and continuing 
until 3 months after the last dose of the latest administered study drug.
While taking pomalidomide, female patients must agree to 1 of the following contraceptive 
methods:
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the patient’s preferred and usual lifestyle.
Or
Consistent and correct use of 2 methods of birth control including 1 of the following:
•
Nonhormonal IUD
•
Hormonal IUD
•
Bilateral tubal occlusion (upon medical assessment of surgical success)
•
Vasectomy in the male partner (upon medical assessment of surgical success)
And
•
A barrier method
Male condom (with or without spermicide)
Female condom (with or without spermicide)
Diaphragm with spermicide
Cervical cap with spermicide
Sponge with spermicide
The following hormonal methods may not be used during dexamethasone administration and for 
4 weeks after the last dose of dexamethasone. If the patient continues on study, hormonal 
methods may be used 4 weeks after discontinuation of dexamethasone.
Female patients who wish to use a hormonally based method must use it in conjunction with a 
barrier method, preferably a male condom. Hormonal methods are restricted to those associated 
with the inhibition of ovulation. Hormonally based contraceptives and barrier methods permitted 
for use in this protocol are as follows:


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•
Hormonal methods (each method must be used with a barrier method, preferably male 
condom)
Oral contraceptives (either combined or progesterone only)
Injectable progesterone
Transdermal contraceptive patch
Contraceptive vaginal ring
Subdermal contraceptive implant
Inclusion of methods of contraception in this list of permitted methods does not imply that the 
method is approved in any country or region. Methods should only be used if locally approved.
Female patients must also refrain from egg donation, cryopreservation of cells, and in vitro 
fertilization during treatment and until the end of contraception requirement. If needed, female 
patients should be advised to seek advice about egg donation and cryopreservation prior to 
treatment.
c) Contraception Requirements for Male Patients
Male patients with female partners of childbearing potential must use condoms during treatment 
and until 3 months after last dose of the latest administered study drug. If the female partner of 
childbearing potential is not pregnant, use of any locally approved contraceptive measure should 
also be considered.
Male patients must also refrain from sperm donation and cryopreservation of cells during 
treatment and until the end of contraception requirement. If needed, male patients should be 
advised to seek advice about sperm donation and cryopreservation prior to treatment.
d) Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.
e) Procedures to be Followed in the Event of Pregnancy
Female patients will be instructed to notify the investigator if they become pregnant or suspect 
they are pregnant at any time from start of the study to 3 months after the last study drug dose. 
Study drug must be discontinued immediately. Male patients whose partner has become pregnant 
or suspects she is pregnant from the start of study to 3 months after the last study drug dose must 
also report the information to the investigator.
Instructions for reporting pregnancy and pregnancy outcome are outlined in Section 7.4.2.3.


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4) Cohort Receiving Magrolimab in Combination With Carfilzomib and Dexamethasone
a) Study Drug Effects on Pregnancy and Hormonal Contraception
Magrolimab is contraindicated in pregnancy as a higher incidence of total pregnancy loss has 
been observed in and embryo-fetal development toxicity study in cynomolgus monkeys and there 
is a strong suspicion of human fetotoxicity in early pregnancy based on the nonclinical data. For 
magrolimab, there is no anticipated PK interaction with progestin or other steroids based on the 
distinct clearance pathways.
For magrolimab, there is no anticipated PK interaction with progestin or other steroids based on 
the distinct clearance pathways.
Carfilzomib (Kyprolis) is contraindicated in pregnancy as a malformative effect has been 
demonstrated/suspected or is unknown taking into consideration class effects or a strong 
suspicion of human teratogenicity/fetotoxicity in early pregnancy based on nonclinical data 
{KYPROLIS 2021}. Carfilzomib has demonstrated/suspected or has insufficient data to exclude 
the possibility of a clinically relevant interaction with hormonal contraception that results in 
reduced contraception efficacy. Therefore, hormonal contraception is not recommended as a 
contraceptive method either solely or as a part of a contraceptive regimen.
Based on findings from clinical and animal reproduction studies, corticosteroids, including 
dexamethasone, can cause fetal harm when administered to a pregnant woman 
{DEXAMETHASONE 2015}. Coadministration of dexamethasone with contraceptives that are 
CYP3A4 substrates may decrease the concentration of these drugs. This may result in loss of 
efficacy of these drugs.
Refer to the latest version of the magrolimab IB for additional information. Refer to the regional 
prescribing information from the reference USPI, SmPC, or applicable local or regional label for 
information on the potential risks of treatment with carfilzomib and dexamethasone.
b) Contraception Requirements for Female Patients of Childbearing Potential
The inclusion of female patients of childbearing potential requires the use of highly effective 
contraceptive measures with a failure rate of < 1% per year. They must also not rely on 
hormone-containing contraceptives as a form of birth control during the study. They must have a 
negative serum pregnancy test at screening and a negative pregnancy test is required prior to 
study treatment administration on Cycle 1 Day 1. The Cycle 1 Day 1 pregnancy test does not 
need to be repeated if the screening pregnancy test was performed within the 72 hours before 
study treatment administration. Pregnancy tests will be performed at the beginning of each cycle 
thereafter (described in the protocol) until the end of contraception requirement.
Duration of required contraception for female patients in this clinical study should start from the 
screening visit until 6 months after the last dose carfilzomib or 3 months after the last dose of 
magrolimab, whichever is later.


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Female patients must agree to 1 of the following contraceptive methods:
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the patient’s preferred and usual lifestyle.
Or
Consistent and correct use of 1 of the following methods of birth control listed below:
•
Nonhormonal IUD
•
Bilateral tubal occlusion (upon medical assessment of surgical success)
•
Vasectomy in the male partner (upon medical assessment of surgical success)
Inclusion of methods of contraception in this list of permitted methods does not imply that the 
method is approved in any country or region. Methods should only be used if locally approved.
Female patients must also refrain from egg donation and in vitro fertilization during treatment 
and until the end of contraception requirement.
c) Contraception Requirements for Male Patients
Male patients with female partners of childbearing potential must use condoms during treatment 
and until 3 months after the last dose of the latest administered study drug. If the female partner 
of childbearing potential is not pregnant, use of any locally approved contraceptive measure 
should also be considered.
Male patients must also refrain from sperm donation and cryopreservation of cells during 
treatment and until the end of contraception requirement. If needed, male patients should be 
advised to seek advice about sperm donation and cryopreservation prior to treatment.
d) Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.
e) Procedures to be Followed in the Event of Pregnancy
Female patients will be instructed to notify the investigator if they become pregnant or suspect 
they are pregnant at any time from start of the study to 6 months after the last dose of carfilzomib 
or 3 months after the last dose of magrolimab, whichever is later. Study drug must be 
discontinued immediately. Male patients whose partner has become pregnant or suspects she is 
pregnant from the start of study to 3 months after the last study drug dose must also report the 
information to the investigator.
Instructions for reporting pregnancy and pregnancy outcome are outlined in Section 7.4.2.3.


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5) Cohort Receiving Magrolimab in Combination With Bortezomib and Dexamethasone
a) Study Drug Effects on Pregnancy and Hormonal Contraception
Magrolimab is contraindicated in pregnancy as a higher incidence of total pregnancy loss has 
been observed in and embryo-fetal development toxicity study in cynomolgus monkeys and there 
is a strong suspicion of human fetotoxicity in early pregnancy based on the nonclinical data. For 
magrolimab, there is no anticipated PK interaction with progestin or other steroids based on the 
distinct clearance pathways.
For magrolimab, there is no anticipated PK interaction with progestin or other steroids based on 
the distinct clearance pathways.
Based on the MOA and findings in animals, bortezomib (VELCADE®) can cause fetal harm 
when administered to a pregnant woman {VELCADE 2019}. Based on the MOA and findings in 
animals, bortezomib may have an effect on female fertility. In vitro studies indicate that 
bortezomib is a weak inhibitor of the CYP isozymes 1A2, 2C9, 2C19, 2D6, and 3A4.
Based on findings from clinical and animal reproduction studies, corticosteroids, including 
dexamethasone, can cause fetal harm when administered to a pregnant woman 
{DEXAMETHASONE 2015}. Coadministration of dexamethasone with contraceptives that are 
CYP3A4 substrates may decrease the concentration of these drugs. This may result in loss of 
efficacy of these drugs.
Refer to the latest version of the magrolimab IB for additional information. Refer to the regional 
prescribing information from the reference USPI, SmPC, or applicable local or regional label for 
information on the potential risks of treatment with bortezomib and dexamethasone.
b) Contraception Requirements for Female Patients of Childbearing Potential
The inclusion of female patients of childbearing potential requires the use of highly effective 
contraceptive measures with a failure rate of < 1% per year. They must have a negative serum 
pregnancy test at screening and a negative pregnancy test is required prior to study treatment 
administration on Cycle 1 Day 1. The Cycle 1 Day 1 pregnancy test does not need to be repeated 
if the screening pregnancy test was performed within the 72 hours before study treatment 
administration. Pregnancy tests will be performed at the beginning of each cycle thereafter 
(described in the protocol) until the end of contraception requirement.
Duration of required contraception for female patients in this clinical study should start from the 
screening visit until 7 months after the last dose bortezomib or 3 months after the last dose of 
magrolimab, whichever is later.


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Female patients must agree to 1 of the following contraceptive methods:
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the patient’s preferred and usual lifestyle.
Or
Consistent and correct use of 1 of the following methods of birth control listed below:
•
Nonhormonal IUD
•
Hormonal IUD (must be used in conjunction with a barrier method)
•
Bilateral tubal occlusion (upon medical assessment of surgical success)
•
Vasectomy in the male partner (upon medical assessment of surgical success)
The following hormonal methods may not be used during dexamethasone administration and for 
4 weeks after the last dose of dexamethasone. If the patient continues on study, hormonal 
methods may be used 4 weeks after discontinuation of dexamethasone.
Female patients who wish to use a hormonally based method must use it in conjunction with a 
barrier method, preferably a male condom. Hormonal methods are restricted to those associated 
with the inhibition of ovulation. Hormonally based contraceptives and barrier methods permitted 
for use in this protocol are as follows:
•
Hormonal methods (each method must be used with a barrier method, preferably male 
condom)
Oral contraceptives (either combined or progesterone only)
Injectable progesterone
Transdermal contraceptive patch
Contraceptive vaginal ring
Subdermal contraceptive implant
•
Barrier methods (each method must be used with a hormonal method)
Male condom (with or without spermicide)
Female condom (with or without spermicide)
Diaphragm with spermicide


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Cervical cap with spermicide
Sponge with spermicide
Inclusion of methods of contraception in this list of permitted methods does not imply that the 
method is approved in any country or region. Methods should only be used if locally approved.
Female patients must also refrain from egg donation, cryopreservation of cells, and in vitro 
fertilization during treatment and until the end of contraception requirement. If needed, female 
patients should be advised to seek advice about egg donation and cryopreservation prior to 
treatment.
c) Contraception Requirements for Male Patients
Male patients with female partners of childbearing potential must use condoms during treatment 
and until 4 months after the last dose of the latest administered study drug. If the female partner 
of childbearing potential is not pregnant, use of any locally approved contraceptive measure 
should also be considered.
Male patients must also refrain from sperm donation and cryopreservation of cells during 
treatment and until the end of contraception requirement. If needed, male patients should be 
advised to seek advice about sperm donation and cryopreservation prior to treatment.
d) Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.
e) Procedures to be Followed in the Event of Pregnancy
Female patients will be instructed to notify the investigator if they become pregnant or suspect 
they are pregnant at any time from start of the study to 7 months after the last dose of bortezomib 
or 3 months after the last dose of magrolimab, whichever is later. Study drug must be 
discontinued immediately. Male patients whose partner has become pregnant or suspects she is 
pregnant from the start of study to 4 months after the last study drug dose must also report the 
information to the investigator.
Instructions for reporting pregnancy and pregnancy outcome are outlined in Section 7.4.2.3.


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Appendix 5.
Toxicity Grading Scale for Severity of Adverse Events and 
Laboratory Abnormalities
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_R 
eference_8.5x11.pdf


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Appendix 6.
Disease Response Criteria Based on International Myeloma Working 
Group (IMWG) 2016 Criteria
Appendix Table 4.
IMWG 2016 MRD Criteria
Response 
MRD Criteria
Sustained 
MRD-negative
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)a
Flow 
MRD-negative
Absence of phenotypically aberrant clonal plasma cells by NGFb on bone marrow aspirates 
using the EuroFlow standard operation procedure for MRD detection in MM (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 2 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 cellsc or higher
Imaging plus 
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; MFC = multicolor flow cytometry; 
MM = multiple myeloma; MRD = minimal residual disease; NGF = next-generation flow; NGS = next-generation sequencing; 
PET = positron emission tomography; SUV = standard uptake value
a
Sustained MRD negativity when reported should also annotate the method used (eg, sustained flow MRD-negative, 
sustained sequencing MRD-negative).
b
Bone marrow multicolor flow cytometry should follow NGF guidelines. The reference NGF method is an 8-color 2-tube 
approach, which has been extensively validated. The 2-tube approach improves reliability, consistency, and sensitivity 
because of the acquisition of a greater number of cells. The 8-color technology is widely available globally and the NGF 
method has already been adopted in many flow laboratories worldwide. The complete 8-color method is most efficient using 
a lyophilized mixture of antibodies which reduces errors, time, and costs. Five million cells should be assessed. The MFC 
method employed should have a sensitivity of detection of at least 1 in 10⁵ plasma cells.
c
DNA sequencing assay on bone marrow sample should use a validated assay such as LymphoSIGHT (Sequenta).


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Appendix Table 5.
Standard IMWG 2016 Response Criteria
Response 
IMWG Criteria
Stringent 
Complete 
Response (sCR)
Complete response as defined below, plus normal FLC ratioa 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)
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
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 per 24 h
Partial Response 
(PR)
≥ 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by ≥ 90% or 
to < 200 mg per 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 (sum of 
products of 2 longest perpendicular diameters [SPD])b 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 to 89%.
In addition to the above listed criteria, if present at baseline, a ≥ 50% reduction in the size 
(SPD)b of soft tissue plasmacytomas is also required
Stable Disease 
(SD)
Not recommended for use as an indicator of response; stability of disease is best described 
by providing the time-to-progression estimates. Not meeting criteria for complete response, 
very good partial response, partial response, minimal response, or progressive disease
Progressive 
Disease (PD) c,d
Any 1 or more of the following criteria:
•
Increase of 25% from lowest confirmed response value in 1 or more of the following 
criteria:
•
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 SPDb 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/μL) if this is the only 
measure of disease 


Magrolimab
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Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 159
02 November 2023
Response 
IMWG Criteria
Clinical Relapse
Clinical relapse requires 1 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. It is not 
used in calculation of time to progression or progression-free survival but is listed 
as something that can be reported optionally or for use in clinical practice;
•
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 
SPDb of the measurable lesion;
•
Hypercalcemia (> 11 mg/dL);
•
Decrease in hemoglobin of ≥ 2 g/dL not related to therapy or other 
nonmyeloma-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
Relapse from 
Complete 
Response (to be 
Used Only if the 
Endpoint is 
Disease-free 
Survival)
Any 1 or more of the following criteria:
•
Reappearance of serum or urine M-protein by immunofixation or electrophoresis;
•
Development of ≥ 5% plasma cells in the bone marrow;
•
Appearance of any other sign of progression (ie, new plasmacytoma, lytic bone 
lesion, or hypercalcemia see above)
Relapse from 
MRD Negative 
(to be Used Only 
if the Endpoint is 
Disease-free 
Survival)
Any 1 or more of the following criteria:
•
Loss of MRD-negative state (evidence of clonal plasma cells on NGF or NGS, or 
positive imaging study for recurrence of myeloma);
•
Reappearance of serum or urine M-protein by immunofixation or electrophoresis;
•
Development of ≥ 5% clonal plasma cells in the bone marrow;
•
Appearance of any other sign of progression (ie, new plasmacytoma, lytic bone 
lesion, or hypercalcemia)
CR = complete response; CRAB = Calcium, Renal Failure, Anemia, Bone Lesions; CT = computed tomography; 
FLC = free-light chain; IMWG = International Myeloma Working Group; MR = minimal response; 
MRD = minimal disease residue; MRI = magnetic resonance imaging; PD = progressive disease; 
PET = positron emission tomography; PR = partial response; sCR = stringent complete response; SD = stable disease; 
SFLC = serum free light chain; SPD = sum of products of 2 longest perpendicular diameters; UK = United Kingdom; 
VGPR = very good partial response
a
All recommendations regarding clinical uses relating to SFLC levels or FLC ratio are based on results obtained with the 
validated Freelite test (Binding Site, Birmingham, UK).
b
Plasmacytoma measurements should be taken from the CT portion of the PET/CT, or MRI scans, or dedicated CT scans 
where applicable. For patients with only skin involvement, skin lesions should be measured with a ruler. Measurement of 
tumor size will be determined by the SPD.
c
Positive immunofixation alone in a patient previously classified as achieving a complete response will not be considered 
progression. For purposes of calculating time to progression and progression-free survival, patients who have achieved a 
complete response and are MRD-negative should be evaluated using criteria listed for progressive disease. Criteria for 
relapse from a complete response or relapse from MRD should be used only when calculating disease-free survival.
d
In the case where a value is felt to be a spurious result per physician discretion (eg, a possible laboratory error), that value 
will not be considered when determining the lowest value.


Magrolimab
Protocol GS-US-558-5915
Final
Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 160
02 November 2023
Appendix Table 6.
Required Baseline and Follow-up Tests for Response Assessment 
Using IMWG 2016 Criteria
Every Response 
Assessment Time 
Point (Every Cycle)
If Electrophoresis 
Shows No 
Measurable 
Protein
At 
Suspected 
CR
At Suspected 
Progression 
(Clinical or 
Biochemical)
Serum Electrophoresis (Serum 
M-spike ≥ 1 g/dL)a
X
X
X
Serum Immunofixation (Any)
X
X
X
Urine Electrophoresis (Urine 
M-spike ≥ 200 mg/24 h)
X
X
X
Urine Immunofixation
X
X
SFLC
Serum M-spike < 1 g/dL, 
Urine M-spike < 200 mg/24 h, 
but Involved Ig FLC is 
≥ 10 mg/dL
X
X
X
Any
−
X
X
Bone Marrow Aspirate/Biopsy
Serum M-spike, Urine 
M-spike, or Involved Ig FLC 
not Meeting Above Criteria 
but Bone Marrow Plasma Cell 
Percentage ≥ 30%
Xb
X
Any
−
X
Extramedullary plasmocytoma 
assessment
Serum M-spike, Urine 
M-spike, Involved Ig FLC or 
Bone Marrow not Meeting 
Above Criteria, but at Least 
One Lesion that has a Single 
Diameter of ≥ 2 cm
Xb 
X
Any
-
X
Hemoglobin, Serum Calcium, 
Creatinine (Any)
X
X
CR= complete response; FLC = free light chain; Ig = immunoglobulin; IMWG = International Myeloma Working Group; 
SFLC = serum free-light chain; SPEP = serum protein electrophoresis; UPEP = urine protein electrophoresis; X = test performed; 
− = test not performed
a
A baseline M-spike of ≥ 0.5 g/dL is acceptable if very good partial response or higher is the response endpoint to be 
measured and in situations where progression-free survival or time to progression are the endpoints of interest.
b
To be done every 3 or 4 cycles till a plateau or CR, or as clinically indicated and then at suspected progression.
c
Source: {Kumar 2016}


Magrolimab
Protocol GS-US-558-5915
Final
Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 161
02 November 2023
Appendix 7.
Eastern Cooperative Oncology Group Performance Status
Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative 
Oncology Group. Am J Clin Oncol. 1982;5:649-655. Available online: 
http://ecog-acrin.org/resources/ecog-performance-status. Accessed 18 February 2020.


Magrolimab
Protocol GS-US-558-5915
Final
Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 162
02 November 2023
Appendix 8.
Cockcroft-Gault Method for Estimating Creatinine Clearance
Formulas for calculating the estimated creatinine clearance (eCcr) are provided in 
Appendix Table 7. The formula appropriate to the units in which serum creatinine was measured 
and the patient’s gender should be used.
Appendix Table 7.
Cockcroft-Gault Formula for Predication of Creatinine Clearance
Serum 
Creatinine 
Units
Gender
Formula
(140−patient age [years])  patient weight [kilograms]  1
72  patient serum creatinine [mg/dL]
(140−patient age [years])  patient weight [kilograms]  0.85
mg/dL
Males
Females
     eCcr              =
[mL/min]
     eCcr              =
[mL/min]
72  patient serum creatinine [mg/dL]
(140−patient age [years])  patient weight [kilograms]  1.23
Patient serum creatinine [mg/dL]
(140−patient age [years])  patient weight [kilograms]  1.04
M/dL
Males
Females
     eCcr              =
[mL/min]
     eCcr              =
[mL/min]
Patient serum creatinine [mg/dL]
eCcr = estimated creatinine clearance
Source: {Cockcroft 1976}


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Protocol GS-US-558-5915
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Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 163
02 November 2023
Appendix 9.
FACT-MM (Version 4) {Facit.org 2009}
Below is a list of statements that other people with your illness have said are important. Please 
circle or mark one number per line to indicate your response as it applies to the past 
7 days.
PHYSICAL WELL-BEING 
Not 
A little 
Some-
Quite 
Very 
at all 
bit 
what 
ll bit 
much 
GP! 
I have a lack of energy ............... .... .............. ................ .... .. 
0 
1 
2 
3 
4 
GP2 
I have nausea ........................... ........................................... 
0 
1 
2 
3 
4 
GPJ 
Because of my physical condition, I have trouble 
meeting the needs of my family ....................... .................. 
0 
1 
2 
3 
4 
GP4 
I have pain ................................................................ .......... 
0 
1 
2 
.., 
4 
.) 
GP5 
I am bothered by side effects of treatment... ...................... 
0 
1 
2 
3 
4 
GP6 
I feel ill .. ........ ......................... ................... ......................... 
0 
1 
2 
3 
4 
GP? 
I am forced to spend time in bed ..................... .................. 
0 
1 
2 
3 
4 
SOCIAL/FAMILY \\'ELL-BEING 
Not 
A little 
Some-
Quite 
Very 
at all 
bit 
what 
ll bit 
much 
GS! 
I feel close to my friends ................................................... 
0 
1 
2 
3 
4 
GS2 
I get emotional supp01t from my family ............................ 
0 
1 
2 
3 
4 
I get suppo1i from my friends ............................................ 
0 
1 
2 
.., 
4 
GSJ 
.) 
GS4 
My family has accepted my illness ........... ....................... .. 
0 
1 
2 
3 
4 
GS5 
I am satisfied with family communication about my 
illness ............................................. .................................... 
0 
1 
2 
3 
4 
GS6 
I feel close to my paiiner ( or the person who is my 
main supp01i) ....... ...................... .... ......................... ........... 
0 
1 
2 
.., 
4 
.) 
Ql 
Regardless ofyour c11rre11t level of sexual activity, please 
ans.rer thefolloll'ing question. Ifyou prefer not to ans1rer 
it, please check this box 
and go to the next section. 
I am satisfied with my sex life ... ....................................... 
0 
1 
2 
3 
4 
English (Univmal) 
l 7 July2009 
Copyright 1987, 1997 
Pagel o-f 3 


Magrolimab
Protocol GS-US-558-5915
Final
Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 164
02 November 2023
Please circle or mark one number per line to indicate your response as it applies to the past 
7 days.
EMOTIONAL \\1ELL-BEING 
GEi 
I feel sad ............................. ................................................ 
GE2 
I am satisfied with how I am coping with my illness ........ 
GEJ 
I am losing hope in the fight against my illness ................ 
GE4 
I feel nervous ........... ...................................................... .... 
GE5 
I wony about dying ................................. ...................... .... 
GE6 
I wony that my condition will get worse ........................... 
FUNCTIONAL WELL-BEING 
Gfl 
I am able to work (include work at home) ......................... 
GF2 
My work (include work at home) is fulfilling ................... 
GF3 
I am able to enjoy life ........................................................ 
GF4 
I have accepted my illness ................................................. 
GF5 
I am sleeping well .............................................................. 
GF6 
I am enjoying the things I usually do for fun ..................... 
GF7 
I am content with the quality of my life right now ............ 
E.Dgleh (Uni,·er;al) 
Cop,-riol,t 1987, 1997 
Not 
at all 
0 
0 
0 
0 
0 
0 
Not 
at all 
0 
0 
0 
0 
0 
0 
0 
A little 
bit 
1 
1 
1 
1 
1 
1 
A little 
bit 
1 
1 
1 
1 
1 
1 
1 
Some-
what 
2 
2 
2 
2 
2 
2 
Some-
what 
2 
2 
2 
2 
2 
2 
2 
Quite 
a bit 
3 
3 
3 
.., 
J 
3 
3 
Quite 
a bit 
3 
3 
.., 
J 
.., 
J 
3 
3 
3 
Very 
much 
4 
4 
4 
4 
4 
4 
Very 
much 
4 
4 
4 
4 
4 
4 
4 
17 July 2009 
P;iie, 2 of 3 


Magrolimab
Protocol GS-US-558-5915
Final
Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 165
02 November 2023
Please circle or mark one number per line to indicate your response as it applies to the past 
7 days.
ADDITIONAL CONCERNS 
P2 
I have ce1tain parts of my body where I experience 
pain ........................ ............................................................ 
HI 
I feel weak all over ............ ................ ......................... ....... 
ll 
BMT 
I get tired easily ... ......................... ............... ................... ... 
• 
HIS 
I have h·ouble concentrating .. ...................... ...................... 
NJ 
I wony about getting infections ............ ............ ................. 
LEU 
I feel discouraged about my illness ................................... 
3 
Because of my illness, I have difficulty planning for the 
LEU 
fuh1re .. ... .... ......................... ... ........ ..................................... 
4 
LEU 
I wony that I might get new symptoms of my illness .. ..... 
6 
BRM 
I have emotional ups and downs ........................................ 
9 
BPI 
I have bone pain ..... ............................................................ 
An 
I need help doing my usual activities ........... ..................... 
14 
MM 
I have h·ouble walking because of pain ....................... ...... 
I 
Hl7 
I feel fatigued ..................................................................... 
ES 
I have gained weight .......................................................... 
10 
English (Unive~al) 
Copyri,ht 1987, 1997 
Not 
A little 
Some-
at all 
bit 
what 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
0 
1 
2 
Quite 
a bit 
.., ., 
3 
3 
3 
3 
.., ., 
.., ., 
3 
3 
.., ., 
.., ., 
3 
3 
3 
Very 
much 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
4 
l 7 July2009 
Page 3 of 3 


Magrolimab
Protocol GS-US-558-5915
Final
Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 166
02 November 2023
Appendix 10.
Myeloma Frailty Score Calculator
The Myeloma Frailty score on this study will be calculated using the Myeloma Frailty score 
calculator: available at http://www.myelomafrailtyscorecalculator.net/ {Palumbo 2015}.
The myeloma frailty score calculator was developed by International Myeloma Working Group 
for the prognosis of myeloma patients ≥ 65 years of age. This frailty score predicts mortality and 
the risk of toxicity in elderly myeloma patients. The International Myeloma Working group 
proposes this score for the measurement of frailty in the treatment decision-making process and 
in designing future clinical trials. 


Magrolimab 
Protocol GS-US-558-5915 
Gilead Sciences, Inc. 
Appendix 11. 
Amendment History 
Final 
Amendment6 
A high-level summaiy of this amendment is provided in tabular fonn in Appendix Table 8. 
Minor changes such as the con ection of typographic enors, grainmai·, or fo1m atting ai·e not 
detailed. 
Separate summaiy of change documents for earlier amendments ai·e available upon request. 
A sepai·ate tracked change (red-lined) document compai·ing Amendment 5 with this ainendment 
will be made available upon the publication of this protocol. 
Appendix Table 8. 
Amendment 6 (02 November 2023) 
Rationale fo1· Key Changes Included in Amendment 6 
Removal of posttreatment follow-up for disease progression and survival 
follow-up assessments and seconda1y endpoints for progression-free survival 
(PFS) and overall (OS) as efficacy data will no longer be collected after the 
end-of-treatment (EOT) visit. 
Guidance for the use of corticosteroids as premedication for the first few infusions 
of magrolimab has been incorporated to align with the information in Edition 12 
of the Investigator's Brochure .. 
Clarification of standard of care procedure language incorporated from 
Administrative Amendment 1 for Protocol Amendment 5. 
Removal of receptor occupancy assessment. 
Removal of the requirement for multiple myeloma, tumor response, and bone 
man-ow assessments to be performed by a central laboratory. These assessments 
may now be perfo1med by a central or local laboratory based on investigator 
preference. 
Removal of FACT-MM questionnaire assessment as patient-repo1ted outcome 
data are no longer required. 
Guidance for the management of infusion-related reactions has been updated to 
incorporate the use of co1ticosteroids as premedication during the first few 
infusions of magrolimab, and to incorporate guidance for discontinuation of 
magrolimab in ce1tain cases. This was done to align with the infonnation in 
Edition 12 of the Investigator's Brochure. 
CONFIDENTIAL 
Page 167 
Affected Sections 
Synopsis, Sections 2, 3.5, 
3.6, 6.10, 6.11, 6.12, 6.13, 
6.5.2, 8.1.3, 8.5.2, and 
Appendix Table 3 
Sections 2, 8.1.4, and 8.5.3 
Synopsis, Sections 2, 6.5.4, 
6.9, 8.1.4, 8.9, 
Appendix Table 2, and 
Appendix Table 3 
Section 5.3.1 
Section 6.1 
Section 6.4.2, Table 23 and 
Appendix Table 2 
Sections 6.5.1, 6.5.2, 6.5.3 
and 6.5.4 
Synopsis, Sections 2, 6.6.1, 
8.1.4, 8.5.3 
Appendix Table 1, 
Appendix Table 2, 
Appendix Table 3 
Section 7.8.1.2, Table 24 
02 November 2023 


Magrolimab
Protocol GS-US-558-5915
Final
Gilead Sciences, Inc. 
Amendment 6
CONFIDENTIAL
Page 168
02 November 2023
Rationale for Key Changes Included in Amendment 6
Affected Sections
Toxicity management section for magrolimab has been updated to include 
guidelines for dose delay and discontinuation in case of severe neutropenia and 
serious infections to align with the information in Edition 12 of the Investigator’s 
Brochure.
Sections 7.8.1.4 and 7.8.1.5
Removal of primary analysis as final analysis will occur sooner than originally 
planned; therefore, primary analysis is no longer required.
Section 8.2.1
Clarification that assessment of quantitative Ig levels is to be performed for 
patients with IgA and IgD myelomas to align with Section 6.5.1.
Appendix Table 2
Contraception appendix has been updated to reflect the latest nonclinical 
embryo-fetal development toxicity data.
Appendix 4
Global Patient Safety (GLPS) has been updated to Patient Safety (PS) to reflect 
the new department name.
Throughout the protocol, as 
required


Prot GS-US-558-5915 amd-6
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
02-Nov-2023
20:44:50
PPD

SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN
Study Title:
A Phase 2 Multi-Arm Study of Magrolimab Combinations in 
Patients with Relapsed/Refractory Multiple Myeloma 
Name of Test Drug:
Magrolimab 
Study Number:
GS-US-558-5915
Protocol Version (Date):
Protocol Amendment 6 (02 November, 2023)
Analysis Plan Version:
Version 1.0
Analysis Plan Date:
13 May 2024
Analysis Plan Author(s):
CONFIDENTIAL AND PROPRIETARY INFORMATION
PPD
(r) GILEAU 
-


Magrolimab
GS-US-558-5915
Statistical Analysis Plan 
Final
CONFIDENTIAL
Page 2
13 May 2024
TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN ...............................................................................................................................1
TABLE OF CONTENTS................................................................................................................................................2
LIST OF IN-TEXT TABLES .........................................................................................................................................3
LIST OF IN-TEXT FIGURES........................................................................................................................................3
LIST OF ABBREVIATIONS.........................................................................................................................................4
1.
INTRODUCTION..................................................................................................................................................6
1.1.
Study Objectives and Endpoints................................................................................................................6
1.2.
Study Design .............................................................................................................................................7
1.2.1.
Safety Run-in Cohorts .............................................................................................................8
1.2.2.
Dose-expansion Cohorts..........................................................................................................9
1.3.
Sample Size and Power .............................................................................................................................9
2.
TYPE OF PLANNED ANALYSIS......................................................................................................................10
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES.............................................................................11
3.1.
Analysis Sets ...........................................................................................................................................11
3.1.1.
All Screened Analysis Set .....................................................................................................11
3.1.2.
All Enrolled Analysis Set ......................................................................................................11
3.1.3.
Full Analysis Set....................................................................................................................11
3.1.4.
Safety Analysis Set................................................................................................................11
3.1.5.
Dose-Limiting Toxicity (DLT) Evaluable Analysis Set .......................................................12
3.1.6.
Pharmacokinetic Analysis Set ...............................................................................................12
3.1.7.
Immunogenicity Analysis Set................................................................................................12
3.2.
Subject Grouping.....................................................................................................................................12
3.3.
Strata and Covariates...............................................................................................................................13
3.4.
Examination of Subject Subgroups .........................................................................................................13
3.5.
Adjustment for Multiplicity.....................................................................................................................13
3.6.
Missing Data and Outliers.......................................................................................................................13
3.6.1.
Missing Data..........................................................................................................................13
3.6.2.
Outliers ..................................................................................................................................13
3.7.
Data Handling Conventions and Transformations ..................................................................................13
3.8.
Analysis Visit Windows..........................................................................................................................14
3.8.1.
Definition of Study Day ........................................................................................................14
3.8.2.
Analysis Visit Windows........................................................................................................14
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window .................................................................................................................................15
3.9.
Assessment of COVID-19 Impact...........................................................................................................15
4.
PROTOCOL DEVIATIONS................................................................................................................................16
5.
SUBJECT INFORMATION ................................................................................................................................17
5.1.
Patient Enrollment and Disposition.........................................................................................................17
5.2.
Extent of Study Drug Exposure...............................................................................................................17
5.3.
Demographics and Baseline characteristics ............................................................................................18
5.4.
Medical History.......................................................................................................................................19
5.5.
Prior and Concomitant Medications........................................................................................................19
5.6.
Post Treatment Anti-cancer Therapies ....................................................................................................20
6.
EFFICACY ANALYSES.....................................................................................................................................21


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Statistical Analysis Plan 
Final
CONFIDENTIAL
Page 3
13 May 2024
6.1.
Primary Efficacy Endpoints ....................................................................................................................21
6.1.1.
Definition of the Primary Efficacy Endpoints.......................................................................21
6.1.2.
Statistical Hypothesis for the Primary Efficacy Endpoint.....................................................21
6.1.3.
Analysis of the Primary Efficacy Endpoint...........................................................................21
6.2.
Secondary Efficacy Endpoints ................................................................................................................21
6.2.1.
Definition of Secondary Efficacy Endpoints.........................................................................21
6.2.2.
Analysis Methods for Secondary Efficacy Endpoints...........................................................22
7.
SAFETY ANALYSES.........................................................................................................................................23
7.1.
Adverse Events and Deaths.....................................................................................................................23
7.1.1.
Adverse Event Dictionary .....................................................................................................23
7.1.2.
Adverse Event Severity .........................................................................................................23
7.1.3.
Relationship of Adverse Events to Study Treatment ............................................................23
7.1.4.
Serious Adverse Events.........................................................................................................23
7.1.5.
Treatment-Emergent Adverse Events....................................................................................23
7.1.6.
Summaries of Adverse Events and Deaths............................................................................24
7.1.7.
Additional Analysis of Adverse Events ................................................................................26
7.2.
Laboratory Evaluations ...........................................................................................................................27
7.2.1.
Summaries of Numeric Laboratory Results ..........................................................................28
7.2.2.
Graded Laboratory Values ....................................................................................................28
7.2.3.
Liver-related Laboratory Evaluations....................................................................................29
7.2.4.
Shifts Relative to the Baseline Grade....................................................................................30
7.3.
Body Weight and Vital Signs..................................................................................................................30
7.4.
Other Safety Measures ............................................................................................................................30
8.
PHARMACOKINETIC (PK) AND IMMUNOGENICITY ANALYSES..........................................................31
8.1.
PK Sample Collection .............................................................................................................................31
8.2.
PK Analyses ............................................................................................................................................31
8.3.
Immunogenicity analysis.........................................................................................................................32
9.
BIOMARKER ANALYSIS .................................................................................................................................34
10.
REFERENCES.....................................................................................................................................................35
11.
SOFTWARE.........................................................................................................................................................36
12.
SAP REVISION...................................................................................................................................................37
13.
APPENDICES......................................................................................................................................................38
LIST OF IN-TEXT TABLES
Table 1-1.
Safety Run-in Cohorts ...............................................................................................................6
Table 1-2.
Dose-expansion Cohorts............................................................................................................6
Table 1-3.
Magrolimab Dose Level and Schedule (All Dose-expansion Cohorts).....................................9
Table 3-1.
Analysis Visit Windows for Lab By-visit Summaries ............................................................14
LIST OF IN-TEXT FIGURES
Figure 1-1.
Study Schema ............................................................................................................................8


Magrolimab
GS-US-558-5915
Statistical Analysis Plan 
Final
CONFIDENTIAL
Page 4
13 May 2024
LIST OF ABBREVIATIONS
AE
adverse event
ADA
antidrug antibody
ALT
alanine aminotransferase
AST
aspartate aminotransferase
ATC
anatomical therapeutic chemical
BMI
body mass index
BSA
body surface area
BLQ
below the limit of quantitation
CI
confidence interval
CR
complete response
CRF
case report form
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
DLT
dose-limiting toxicity
DOR
duration of response
ECOG
Eastern Cooperative Oncology Group
FAS
Full Analysis Set
HLT
high-level term
LLT
lower-level term
IV
intravenous
KM
Kaplan-Meier
LOQ
limit of quantitation
MedDRA
Medical Dictionary for Regulatory Activities
MM
Multiple Myeloma
NCI
National Cancer Institute
ORR
objective response rate
PD
progressive disease
PK
pharmacokinetic(s)
PR
partial response
PT
preferred term
Q1, Q3
first quartile, third quartile
QRS
electrocardiographic deflection between the beginning of the Q wave and termination of the 
S wave representing time for ventricular depolarization
QT
electrocardiographic interval between the beginning of the Q wave and termination of the 
T wave representing the time for both ventricular depolarization and repolarization to occur
QTc
QT interval corrected for heart rate
QTcF
QT interval corrected for heart rate using Fridericia’s formula
RP2D
recommended Phase 2 dose


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RR
electrocardiographic interval representing the time measurement between the R wave of one 
heartbeat and the R wave of the preceding heartbeat
SAP
statistical analysis plan
sCR
stringent complete response
SD
stable disease
StD
standard deviation
SOC
system organ class
SRT
Safety Review Team
TEAE
treatment-emergent adverse event
TFLs
tables, figures, and listings
ULN
upper limit of normal
VGPR
very good partial response
WHO
World Health Organization


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1.
INTRODUCTION
This statistical analysis plan (SAP) describes the statistical analysis methods and defines key 
elements including variable definitions for analysis of data of Study GS-US-558-5915 in support 
of the synoptic clinical study report (CSR). This SAP is based on the study protocol amendment 
6 dated 02 November 2023. Any changes made after the finalization of the SAP will be 
documented in the CSR.
1.1.
Study Objectives and Endpoints
Table 1-1.
Safety Run-in Cohorts
Primary Objective
Primary Endpoint
•
To evaluate the safety and tolerability of 
magrolimab in combination with other anticancer 
therapies and to determine the recommended 
Phase 2 dose (RP2D) of magrolimab for the 
following combinations in patients with 
relapsed/refractory multiple myeloma (MM):

Magrolimab in combination with 
daratumumab

Magrolimab in combination with 
pomalidomide and dexamethasone

Magrolimab in combination with carfilzomib 
and dexamethasone

Magrolimab in combination with bortezomib 
and dexamethasone
•
The incidence of dose-limiting toxicities (DLTs), 
adverse events (AEs), and laboratory 
abnormalities according to the National Cancer 
Institute (NCI) Common Terminology Criteria for 
Adverse Events (CTCAE) Version 5.0 
Table 1-2.
Dose-expansion Cohorts
Primary Objective
Primary Endpoint
•
To evaluate the efficacy of magrolimab in 
combination with other anticancer therapies in 
patients with relapsed/refractory MM as 
determined by objective response rate (ORR)
•
ORR, defined as the percentage of patients who 
achieve stringent complete response (sCR), 
complete response (CR), very good partial 
response (VGPR), or partial response (PR)a
Secondary Objectives
Secondary Endpoints
•
To evaluate the safety and tolerability of 
magrolimab in combination with other anticancer 
therapies
•
The incidence of AEs and laboratory abnormalities 
according to the NCI CTCAE Version 5.0
•
To investigate other parameters of efficacy 
including the duration of response 
•
Duration of response (DOR)a
•
To evaluate the pharmacokinetics (PK) and 
immunogenicity of magrolimab in combination 
with other anticancer therapies in patients with 
relapsed/refractory MM
•
Magrolimab concentration versus time
•
Measurements of antidrug antibody (ADA) against 
magrolimab


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1.2.
Study Design
This is a Phase 2, open-label, multicenter, multi-arm study evaluating magrolimab in 
combination with anticancer therapies for patients with relapsed/refractory MM. This study will 
include safety run-in cohorts for the following combination therapies:
•
Magrolimab in combination with daratumumab
•
Magrolimab in combination with pomalidomide and dexamethasone
•
Magrolimab in combination with carfilzomib and dexamethasone
•
Magrolimab in combination with bortezomib and dexamethasone – this cohort will only be 
initiated at the sponsor’s discretion based upon the preliminary safety and efficacy results 
from the carfilzomib/dexamethasone combination cohort.
After completion of the safety run-in cohorts, dose-expansion cohorts using the same 
combination therapies will occur.
The study schema is presented in Figure 1-1.
CCI


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Figure 1-1.
Study Schema
IMiD = immunomodulatory drug; PI = proteasome inhibitor; RP2D = recommended Phase 2 dose
Approximately 153 patients will be enrolled in the study, with up to 27 in each safety run-in 
cohort (up to 9 patients at each of the 3 possible dose levels; total up to 81 patients) and 
approximately 72 patients in the dose-expansion cohorts. 
1.2.1.
Safety Run-in Cohorts
All safety run-in cohorts may progress concurrently. The DLT assessment period will be the first 
cycle (35 days). Patients who are not evaluable (Section 3.1.5) for DLT assessment will be 
replaced. 
For each of the safety run-in cohorts, a 6 + 3 de-escalation algorithm will be implemented. Six 
patients will be enrolled in each of the safety run-in cohorts. Dose de-escalation decisions will be 
made after the first 6 patients in each cohort have completed the Cycle 1 DLT evaluation period 
and the Safety Review Team (SRT) has reviewed safety and clinical data for the first cycle as 
follows:
•
If no more than 1 patient experienced a DLT in Cycle 1, enrollment into the dose-expansion 
cohort will begin at this dose level.
•
If 2 patients experienced DLTs, 3 additional patients will be enrolled into the cohort at the 
same dose level. If no additional DLTs occur in these 3 patients, the dose level will be 
deemed safe by the SRT. If 1 or more DLTs occur in these 3 patients, a lower-dose cohort 
will be evaluated using the same 6 + 3 de-escalation algorithm to define the recommended 
dose for the combination regimens.
Patients with relapsed 
/refractory multiple myeloma 
who have had 3 or more prior 
therapies including an IMiD 
and a Pl 
Safety Run-in 
n=6 to 9 ( up to 3 dose levels) 
Magrolimab + Daratumumab 
Safety Run-in 
n=6 to 9 (up to 3 dose levels) 
Magrolimab + Pomalidomide + 
Dexamethasone 
Safety Run-in 
n=6 to 9 (up to 3 dose levels) 
Magrolimab + Carfilzomib + 
Dexamethasone 
Safety evaluation 
and RP2D 
Safety evaluation 
and RP2D 
Safety evaluation 
and RP2D 
Dose Expansion 
n=24 
Magrolimab + Daratumumab 
Dose Expansion 
n=24 
Magrolimab + Pomalidomide + 
Dexamethasone 
Dose Expansion 
n=24 
Magrolimab + Carfilzomib + 
Dexamethasone 
Bortezomib + Dexamethasone may be initiated based on the preliminary safety and efficacy of the 
Carfilzomib + Dexamethasone cohort. If initiated, bortezomib cohort only requires I prior line of therapy 
Safety Run-in 
n=6 to 9 (up to 3 dose levels) 
Magrolimab + Bortezomib + 
Dexamethasone 
Safety evaluation 
and RP2D 
Dose Expansion 
n=24 
Magrolimab + Bortezomib + 
Dexamethasone 


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•
If more than 2 patients experienced DLTs, another 6 patients will be enrolled at a lower dose 
and evaluated in the same manner to define the recommended dose for the combination 
regimens.
The RP2D will be determined by Gilead in discussion with SRT based on all relevant clinical 
and PK data from all patients treated in the safety run-in cohorts.
1.2.2.
Dose-expansion Cohorts
Once any of the safety run-in cohorts has been completed and an RP2D established for that 
combination, a dose-expansion cohort using the dose level and schedule specified in Table 1-3 
may be initiated. Each dose-expansion cohort may enroll up to 24 patients. Patients may be 
enrolled simultaneously into the dose-expansion cohorts without an observation period between 
patients.
Table 1-3.
Magrolimab Dose Level and Schedule (All Dose-expansion Cohorts)
Dose Schedule (Cycle 1 is 35 Days; All Other Cycles are 28 Days)
RP2Da
Cycle 1
Cycle 2
Cycle 3+
30 mg/kg
1 mg/kg IV Day 1 (priming dose)
and
30 mg/kg IV Days 8, 15, 22, 29
30 mg/kg IV
Days 1, 8, 15, 22
30 mg/kg IV
Days 1, 15
20 mg/kg
1 mg/kg IV Day 1 (priming dose)
and
20 mg/kg IV Days 8, 15, 22, 29
20 mg/kg IV
Days 1, 8, 15, 22
20 mg/kg IV
Days 1, 15
15 mg/kg
1 mg/kg IV Day 1 (priming dose)
and
15 mg/kg IV Days 8, 15, 22, 29
15 mg/kg IV
Days 1, 8, 15, 22
15 mg/kg IV
Days 1, 15
IV = intravenous; RP2D = recommended Phase 2 dose
a
RP2D as determined in the safety run-in cohorts.
1.3.
Sample Size and Power
For each of the dose-expansion cohorts, a sample size of 30 (24 expansion patients together with 
the 6 patients from the safety run-in cohort), provides 86.1% power for a 1-group Chi-square test 
at a 1sided alpha of 0.1 to detect an ORR of ≥ 45% for the combination treatment compared with 
a historical control ORR of 25%.
The historical control ORR of 25% is based on outcomes from the MAMMOTH study; the 
subset of patients treated with any daratumumab containing regimen, including daratumumab in 
combination with an IMiD or PI, following at least 1 prior treatment {Gandhi 2019}. 


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2.
TYPE OF PLANNED ANALYSIS
There is no planned interim analyses. The final analysis will be performed after all patients have 
completed the study, outstanding data queries have been resolved or adjudicated as unresolvable, 
and the data have been cleaned and finalized.


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3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES
Analysis results will be presented using descriptive statistics. For categorical variables, the 
number and percentage of patients in each category will be presented; for continuous variables, 
the number of patients (n), mean, standard deviation (StD) or standard error (SE), median, first 
quartile (Q1), third quartile (Q3), minimum, and maximum will be presented.
By-patient listings will be presented for all patients in the All Enrolled Analysis Set, unless 
otherwise specified, and sorted by cohort, patient ID number, visit date, and time (if applicable). 
Data collected on log forms, such as AEs, will be presented in chronological order within the 
patient. Age, sex at birth, race, and ethnicity will be included in the listings, as space permits.
3.1.
Analysis Sets
Analysis sets define the patients to be included in an analysis. Analysis sets and their definitions 
are provided in this section. The analysis set will be identified and included as a subtitle of each 
table, figure, and listing.
For each analysis set, the number and percentage of patients eligible for inclusion will be 
summarized by cohort.
3.1.1.
All Screened Analysis Set
The All Screened Analysis Set includes all patients who receive a study screening identification 
(ID) number in the study at screening stage.
3.1.2.
All Enrolled Analysis Set
The All Enrolled Analysis Set includes all patients who receive a study patient identification (ID) 
number in the study after screening. This will be the primary analysis set for analyses of patient 
demographic and baseline characteristics, enrollment, and disposition.
3.1.3.
Full Analysis Set
The primary analysis set for efficacy analysis is the Full Analysis Set (FAS). The FAS includes 
all enrolled patients who took at least 1 dose of study treatment with treatment group designated 
according to the planned treatment assigned at enrollment.
3.1.4.
Safety Analysis Set
The primary analysis set for safety analyses is the Safety Analysis Set. It includes all patients 
who received at least 1 dose of study treatment with treatment group designated according to the 
actual treatment received. This analysis set will be used in the analyses of safety endpoints and 
study treatment administration. All data collected during treatment up to 70 days after treatment 
discontinuation will be included in the safety summaries.


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3.1.5.
Dose-Limiting Toxicity (DLT) Evaluable Analysis Set
The DLT Evaluable Analysis Set includes all patients in the Safety Analysis Set who are 
enrolled in the safety run-in cohorts and fulfill either of the following criteria:
•
Experienced a DLT after initiation of the first infusion of magrolimab during the DLT 
assessment period (i.e. the first Cycle (35 days))
•
Completed DLT assessment period and received at least 3 infusions of magrolimab and the 
following cohort-specific criteria:
Magrolimab in combination with daratumumab cohort: Completed at least 2 doses of 
daratumumab
Magrolimab in combination with pomalidomide and dexamethasone cohort: Completed 
at least 10 doses of pomalidomide and 2 doses of dexamethasone
Magrolimab in combination with carfilzomib and dexamethasone cohort: Completed at 
least 2 doses of carfilzomib and 2 doses of dexamethasone
Magrolimab in combination with bortezomib and dexamethasone cohort: Completed at 
least 2 doses of bortezomib and 2 doses of dexamethasone
The recommended dose for the expansion cohorts will be based on the DLT Evaluable Analysis 
Set.
3.1.6.
Pharmacokinetic Analysis Set
The PK Analysis Set includes all enrolled patients who received at least 1 dose of magrolimab 
and have at least 1 measurable posttreatment serum concentration of magrolimab.
3.1.7.
Immunogenicity Analysis Set
The Immunogenicity Analysis Set includes all enrolled patients who received at least 1 dose of 
magrolimab and have at least 1 evaluable anti-magrolimab antibody test result.
3.2.
Subject Grouping
For analyses based on the Full Analysis Set, patients will be grouped according to the treatment 
to which they were assigned. For analyses based on the Safety Analysis Set, patients will be 
grouped according to the actual treatment received. 
Safety Run-in cohorts and corresponding Dose-expansion cohorts will be grouped together to be 
summarized in tables except for DLT related summaries, which include Safety Run-in cohorts 
only. 
For the PK Analysis Set and the Immunogenicity Analysis Set, patients will be grouped 
according to the actual treatment they received.


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3.3. 
Strata and Covariates 
This study does not use a strntified randomization schedule when emolling patients. 
3.4. 
Examination of Subject Subgroups 
No subgroup analysis is planned. 
3.5. 
3.6. 
3.6.1. 
Adjustment for Multiplicity 
Missing Data and Outliers 
Missing Data 
In general, missing data will not be imputed unless methods for handling missing data are 
specified. Exceptions are presented in this doclllllent Appendix 2. 
3.6.2. 
Outliers 
Outliers will be identified during the data management and data analysis process, but no 
sensitivity analyses will be conducted. All data will be included in the data analysis. 
3.7. 
Data Handling Conventions and Transformations 
Final 
Baseline value is defined as the last measurement that was observed on or prior to the date of 
first dose of study treatment, unless othe1w ise specified. 
Non-PK data that are continuous in nature but are less than the lower limit of quantitation (LOQ) 
or above the upper LOQ will be imputed as follows: 
• 
A value that is 1 unit less than the lower LOQ at the same precision level of the originally 
repo1ied value will be used to calculate descriptive statistics if the datum is reported in the 
f01m of"< x" (where xis considered the lower LOQ). For example, if the values are repo1ied 
as < 50 and < 5.0, values of 49 and 4.9, respectively, will be used to calculate summaiy 
statistics. An exception to this rnle is any value repo1ied as < 1 or < 0.1, etc. For values 
repo1ied as < 1 or < 0.1, a value of0.9 or 0.09, respectively, will be used to calculate 
sunnnaiy statistics. 
• 
A value that is 1 unit above the upper LOQ will be used to calculate descriptive statistics if 
the datum is repo1ied in the fonn of"> x" (where xis considered the upper LOQ). Values 
with decimal points will follow the same logic as above. 
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•
The lower or upper LOQ will be used to calculate descriptive statistics if the datum is 
reported in the form of “≤ x” or “≥ x” (where x is considered the lower or upper LOQ, 
respectively).
If methods based on the assumption that the data are normally distributed are not adequate, 
analyses may be performed on transformed data or nonparametric analysis methods may be used, 
as appropriate.
3.8.
Analysis Visit Windows
3.8.1.
Definition of Study Day
Study day will be calculated from the first dosing date of study drug (ie, the first dosing date of 
any study drug) and derived as follows:
•
For post dose study days: Assessment Date – First Dosing Date + 1
•
For days prior to the first dose: Assessment Date – First Dosing Date 
Therefore, study day 1 is the day of the first dose of any study drug administration. 
3.8.2.
Analysis Visit Windows
Subject visits might not occur on protocol-specified days. Therefore, for the purpose of analysis, 
observations will be assigned to analysis windows. The analysis windows for lab are provided in 
Table 3-1.
Table 3-1.
Analysis Visit Windows for Lab By-visit Summaries
Visit Window Study Day
Analysis Visit
Nominal Study Day
Lower Limit
Upper Limit
Baseline
1a
Week 1
8
1b
11
Week 2
15
12
18
Week 3
22
19
25
Week 4
29
26
32
Week 5
36
33
39
Week 6
43
40
46
Week 7
50
47
53
Week 8
57
54
63
Week 10
71
64
77
Week xx
xx*7+1
(xx-1)*7+1
(xx+1)*7
a
Prior to first dose date time.
b
Post first dose date time.


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For any data relating to unscheduled visits, the following exceptions will be made:
•
An unscheduled visit prior to the first dosing of the study drug will be included in the 
calculation of the baseline value, if applicable.
•
Unscheduled visits after the first dosing of study drug will be included in determining the 
maximum postbaseline toxicity grade and anti-magrolimab antibody status.
•
Response assessments performed at unscheduled visits after the date of first dose of study 
drug will be included in the analyses of the efficacy endpoints.
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window
If multiple valid, nonmissing measurements exist in an analysis window, records will be chosen 
based on the following rules if a single value is needed:
•
For baseline, the last nonmissing value on or prior to the first dosing date of study drug will 
be selected, unless specified differently. If there are multiple records with the same time or 
no time recorded on the same day, the baseline value will be the arithmetic average of the 
measurements for continuous data, or the measurement with the lowest severity for 
categorical data.
•
For postbaseline values:
The record closest to the nominal day for that visit will be selected.
If there are 2 records that are equidistant from the nominal day, the later record will be 
selected.
If there is more than 1 record on the selected day, the arithmetic average will be taken for 
continuous data and the worse severity will be taken for categorical data, unless 
otherwise specified.
3.9.
Assessment of COVID-19 Impact
This study was ongoing during the coronavirus (COVID-19) pandemic which has an impact on 
the study conduct. Some patients were unable to attend onsite visits due to shelter in place 
guidelines, site closures, or other reasons. The following special situations due to COVID-19 
may be handled in the analysis:
•
Study treatment or study discontinuation due to COVID-19
•
Protocol deviations due to COVID-19
•
Missed and Virtual Visits due to COVID-19


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4.
PROTOCOL DEVIATIONS 
A by-patient listing will be provided for those patients who did not meet at least 1 eligibility 
(inclusion or exclusion) criterion. The listing will present the eligibility criterion (or criteria if 
more than 1 deviation) that patients did not meet and related comments, if collected.
Protocol deviations occurring after patients entered the study are documented during routine 
monitoring. The number and percentage of patients with important protocol deviations, with 1, 2, 
or 3 or more important protocol deviations, and the total number of important protocol deviations 
by deviation reason (e.g., nonadherence to study drug, violation of select inclusion/exclusion 
criteria) will be summarized by cohort for the All Enrolled Analysis Set. A by-patient listing will 
be provided for those patients with important protocol deviation.


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5.
SUBJECT INFORMATION
5.1.
Patient Enrollment and Disposition
A summary of patient enrollment will be provided by cohort for each country, investigator and 
overall. The summary will present the number and percentage of patients enrolled. For each 
column, the denominator for the percentage calculation will be the total number of patients 
analyzed for that column.
A summary of patient disposition will be provided by cohort. This summary will present the 
number of patients screened, the number of patients enrolled, and the number of patients in each 
of the categories listed below:
•
Full Analysis Set 
•
Safety Analysis Set 
•
DLT-evaluable Analysis Set
•
Study drug discontinuation with the reasons 
•
Study discontinuation with the reasons 
For the status of study drug and study completion and reasons for discontinuation, the number 
and percentage of patients in each category will be provided. The denominator for the percentage 
calculation will be the total number of patients in the All Enrolled Analysis Set corresponding to 
that column. 
The following by-patient listings will be provided by patient ID number in ascending order to 
support the above summary tables:
•
Reasons for study drug discontinuation
•
Reasons for screen failure (will be provided by screening ID number in ascending order)
•
Reasons for study discontinuation
5.2.
Extent of Study Drug Exposure 
Extent of exposure to study drugs (ie. magrolimab,daratumumab, pomalidomide, 
dexamethasone, carfilzomib, and bortezomib (when applicable) will be examined by assessing 
the total duration of exposure to each study drug respectively.  


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Total duration of exposure to each study drug will be defined for a patient as last dosing date 
minus first dosing date plus 1 day, regardless of any temporary interruptions in study drug 
administration, and will be expressed in weeks using up to 1 decimal place. 
The total duration of exposure to each study drug will be summarized using descriptive statistics 
for continuous variables, as well as using the number and percentage of patients exposed for at 
least the following time periods: 1 day, 1 week, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 
20 weeks, 24 weeks, etc. Summaries will be provided for the Safety Analysis Set.
The number of cycles patients were exposed to each study drug will be summarized using 
descriptive statistics, as well as the number and percentage of subjects exposed to a given cycle 
category (eg, 1 cycle, ≥1, ≥2, ≥3, etc).
The number and percentage of patients who have infusion interruption, dose reduction, dose 
delay, or dose missed for study drug and the reasons will be summarized.
A by-patient listing of magrolimab administration will be provided by cohort, patient ID number 
(in ascending order), and visit (in chronological order). 
5.3.
Demographics and Baseline characteristics  
Patient demographic variables (eg, age, sex, race, ethnicity) and baseline characteristics (eg, 
body weight [in kg], height [in cm], body mass index [BMI; in kg/m2], Body Surface Area 
[BSA; in m2]) and Eastern Cooperative Oncology Group (ECOG) status at baseline as well as 
type and stage of myeloma will be summarized by cohort and overall using descriptive statistics 
for continuous variables and using number and percentage of patients for categorical variables. 
The ECOG status at baseline is the ECOG status at screening. The summary of demographic data 
will be provided for the All Enrolled Analysis Set.
A by-patient demographic listing, including the informed consent date, will be provided by 
cohort and patient ID number in ascending order.
Other baseline characteristics, including but not limited to time since disease diagnosis, type of 
myeloma, stage at diagnosis and screening, cytogenetic results at baseline, clonal plasma cell 
Results, and Extramedullary plasmacytoma, will also be listed
In deriving the time since disease diagnosis, all partial dates of diagnosis and last regimen will be 
identified, and the partial dates will be imputed as follows:
•
If day and month are missing but year is available, then the imputed day and month will be 
01 Jan.
•
If a day is missing but the month and year are available, then the imputed day will be the first 
day of the month.
•
A partial date will not be imputed if the year is missing.


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5.4.
Medical History
Prior anti-cancer therapies that patients received will be summarized. The details of prior anti-
cancer therapy will be listed by cohort and patient ID number in ascending order including line 
of therapy, regimen name, regimen start/stop date and best response of the regimen.
For prior anti-cancer therapies, number of prior regimens, time since the completion of last 
regimen, and time since disease progression in the last regimen will be summarized using 
descriptive statistics based on the All Enrolled Analysis Set. 
A partial completion date will be imputed using the same algorithm defined above for imputing 
partial date of diagnosis. 
5.5.
Prior and Concomitant Medications
Medications collected at screening and during the study will be coded using the current version 
of the World Health Organization (WHO) Drug dictionary.
Prior and concomitant medications will be coded using the World Health Organization (WHO) 
Drug Dictionary. 
Prior medications include medication with a start and end date prior to the first dose of study 
drug.
Concomitant medications are defined as medications taken while a subject took study drug. Use 
of concomitant medications will be summarized by anatomical therapeutic chemical (ATC) drug 
class Level 2 preferred name using the number and percentage of patients for cohort. A subject 
reporting the same medication more than once will be counted only once when calculating the 
number and percentage of patients who received that medication. The summary will be ordered 
alphabetically by ATC medical class and then by preferred term in descending overall frequency 
within each ATC medical class. For drugs with the same frequency, sorting will be done 
alphabetically.
For the purposes of analysis, any medications with a start date prior to or on the first dosing date 
of study drug and continued to be taken after the first dosing date, or started after the first dosing 
date but prior to or on 70 days after the last dosing date of study drug will be considered 
concomitant medications. Medications started and stopped on the same day as the first dosing 
date or 70 days after the last dosing date of study drug will also be considered concomitant. 
Medications with a stop date prior to the date of first dosing date of study drug or a start date 
after the last dosing date of study drug plus 70 days will be excluded from the concomitant 
medication summary. If a partial stop date is entered, any medication with the month and year (if 
day is missing) or year (if day and month are missing) prior to the date of first study drug 
administration will be excluded from the concomitant medication summary. If a partial start date 
is entered, any medication with the month and year (if day is missing) or year (if day and month 
are missing) after the study drug stop date plus 70 days will be excluded from the concomitant 
medication summary. Medications with completely missing start and stop dates will be included 
in the concomitant medication summary, unless otherwise specified. Analysis will be based on 
the Safety Analysis Set. No formal statistical testing is planned.


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5.6.
Post Treatment Anti-cancer Therapies
Post-treatement anti-cancer therapies will be provided in a by patient listing sorted by cohort, 
patient ID. 


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6.
EFFICACY ANALYSES
6.1.
Primary Efficacy Endpoints
6.1.1.
Definition of the Primary Efficacy Endpoints
The primary endpoint for the dose-expansion cohorts is Objective response rate (ORR), defined 
as the percentage of patients who achieve sCR, CR, VGPR, or PR, as determined by the 
investigator based on International Myeloma Working Group (IMWG) 2016 criteria 
(Appendix 1) while on study prior to initiation of any new anti-cancer therapy (including SCT).
6.1.2.
Statistical Hypothesis for the Primary Efficacy Endpoint 
The primary efficacy null hypothesis for each of the dose-expansion cohorts to be tested is:
          𝐻0: ORR ≤ 25%
𝐻1: ORR >  25%
6.1.3.
Analysis of the Primary Efficacy Endpoint
The analysis of primary efficacy endpoint will be based on confirmed response assessments 
using the FAS. 
For the primary efficacy endpoint ORR, the point estimate and the corresponding 2-sided exact 
95% CI using ClopperPearson method will be provided for each cohort. Objective response rate 
will also be tested against the historical control rate of 25% at 1-sided alpha of 0.1 significance 
level using Chi-square test for each cohort separately.
6.2.
Secondary Efficacy Endpoints
6.2.1.
Definition of Secondary Efficacy Endpoints
The secondary efficacy endpoint for the dose-expansion cohorts is Duration of Response (DOR), 
which is measured from the earliest date of confirmed sCR, CR, VGPR, or PR, whichever is first 
recorded, until the earliest date of confirmed documented PD (or the first unconfirmed PD after 
confirmed objective response when the PD is the last evaluable response assessment), 
documented relapse, or death from any cause, whichever occurs first. Those who are not 
observed to have documented relapse, documented PD, or death will be censored at the date of 
their last response assessment. If patients start taking new anti-cancer therapies (excluding SCT) 
before relapse, or PD, or death, duration of response will be censored at the last response 
assessment prior to the initiation of the new anti-cancer therapies.


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6.2.2.
Analysis Methods for Secondary Efficacy Endpoints
The median, first quartile (Q1), and third quartile (Q3) for DoR will be estimated using the 
Kaplan-Meier (KM) method along with the corresponding 95% CIs. KM curves will be 
provided. The proportion of patients who are event-.free at benchmark time points, such as 
6 months and 12 months from the first dosing date, will be estimated by cohort using the KM 
method and the corresponding 95% CIs will be reported. For DOR, the analysis will include only 
patients who achieve a confirmed objective response (sCR, CR, VGPR, or PR).


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7.
SAFETY ANALYSES
7.1.
Adverse Events and Deaths
All Adverse Events (AEs) will be listed. The focus of AE summarization will be on treatment 
emergent adverse events (TEAEs).
7.1.1.
Adverse Event Dictionary
Clinical and laboratory adverse events (AEs) will be coded using the current version of 
MedDRA. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), 
preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. 
7.1.2.
Adverse Event Severity
Adverse events are graded by the investigator as Grade 1, 2, 3, 4, or 5 according to CTCAE 
Version 5.0.  The severity grade of events for which the investigator did not record severity will 
be categorized as “missing” for tabular summaries and data listings. The missing category will 
be listed last in summary presentation.
7.1.3.
Relationship of Adverse Events to Study Treatment
Related AEs are those for which the investigator selected “Related” on the AE CRF to the 
question of “Related to Study Treatment” Relatedness will always default to the investigator’s 
choice, not that of the medical monitor. Events for which the investigator did not record 
relationship to study drug will be considered related to study drug for summary purposes. 
However, by-patient data listings will show the relationship as missing.
7.1.4.
Serious Adverse Events
Serious adverse events (SAEs) will be identified and captured as SAEs if the AEs met the 
definitions of SAEs that were specified in the study protocol. SAEs captured and stored in the 
clinical database will be reconciled with the SAE database from the Gilead Drug Safety and 
Public Health Department before data finalization.
7.1.5.
Treatment-Emergent Adverse Events 
7.1.5.1.
Definition of Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as any AEs occurring on or after the 
date of initiation of study drug and no later than 70 days after the date of the last dose of study 
drug or the initiation of any new anti-cancer therapy or SCT, whichever comes first. 


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7.1.5.2.
Incomplete Dates
If the onset date of the AE is incomplete and the AE stop date is not prior to the first dosing date 
of study drug, then the month and year (or year alone if month is not recorded) of onset 
determine whether an AE is treatment-emergent. The event is considered treatment-emergent if 
both of the following 2 criteria are met:
•
The AE onset is the same as or after the month and year (or year) of the first dosing date of 
study drug, and
•
The AE onset date is the same as or before the month and year (or year) of the date 
corresponding to the cutoff date of TEAE period, which is defined as the 70 days after the 
study drug last dose date or the day before initiation of any new anti-cancer therapy including 
SCT,  whichever occurs first.  
An AE with completely missing onset and stop dates, or with the onset date missing and a stop 
date later than the first dosing date of study drug, will be considered to be treatment emergent. In 
addition, an AE with the onset date missing and incomplete stop date with the same or later 
month and year (or year alone if month is not recorded) as the first dosing date of study drug will 
be considered treatment emergent.
In case when the AE onset date is incomplete and needs to be imputed, the following algorithm 
will be followed:
•
If the day is missing but the month and year are available, then the imputed day will be the 
first dosing date if they have the same month and year, or the first day of the month 
otherwise.
•
If the day and month are missing but year is available, then the imputed day and month will 
be the first dosing date if they have the same year, or 01Jan otherwise.
7.1.6.
Summaries of Adverse Events and Deaths
TEAEs and deaths will be summarized by cohort based on the Safety Analysis Set unless 
otherwise specified. 
7.1.6.1.
Summaries of TEAEs
A brief, high-level summary of the number and percentage of patients who experienced at least 
one TEAE in the categories described below will be provided. All deaths observed in the study 
will also be included in this summary.


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For the TEAE categories described below, summaries will be provided by SOC and PT (and 
maximum severity where applicable):
•
TEAEs 
•
TEAEs with Grade 3 or higher
•
TE SAEs
•
TEAEs leading to death
The number and percentage of patients who experienced at least one TEAE will be provided and 
summarized by PT and severity in descending order of total frequency:
•
TEAEs 
•
TEAEs with Grade 3 or higher
•
TE SAEs
•
TEAEs related to any study drug
•
TEAEs related to magrolimab
For the AE categories described below, summaries will be provided by PT in descending order 
of total frequency:
•
TEAEs
•
TEAEs with Grade 3 or higher 
•
TE SAEs 
•
TE SAEs related to any study drug
•
TE SAEs related to magrolimab
•
TEAEs leading to discontinuation of any study drug
•
TEAEs leading to discontinuation of magrolimab
•
TEAEs leading to  interruption of any study drug
•
TEAEs leading to interruption of magrolimab
•
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Multiple events will be counted only once per patient in each summary. Adverse events will be 
summarized and listed first in alphabetic order of SOC and then by PT in descending order of 
total frequency within each SOC. For summaries by PT, multiple events will be counted only 
once per patient for each preferred term. For summaries by severity, the most severe severity will 
be used for those AEs that occurred more than once in a given patient during the study. 
In addition, by-patient data listings will be provided for the following:
•
All AEs
•
All AEs leading to death 
A flag will be included in the listings to indicate whether the event is treatment emergent.
7.1.6.2.
Summaries of Death
A summary (number and percentage of patients) of deaths will be provided. The summary will 
include the following categories:
•
All deaths
•
Deaths within 30 days of the first dosing of any study drug
•
Deaths beyond 30 days of the first dosing of any study drug
•
Deaths within 70 days of the last dosing of any study drug
•
Deaths beyond 70 days of the last dosing of any study drug.
A by-patient listing of all deaths occurred during this study will be listed by cohort and patient 
ID number in ascending order.
7.1.7.
Additional Analysis of Adverse Events
7.1.7.1.
Dose Limiting Toxicity
DLT will be summarized by PT and severity for each cohort based on DLT-Evaluable Analysis 
Set (Section 3.1.5). The details will be provided in patient data listings.
7.1.7.2.
Infusion-Related Reaction (IRR)
 Infusion-related reaction are defined by the NCI CTCAE Version 5.0 (under the category 
“General disorders and administration site conditions”) as “a disorder characterized by adverse 
reaction to the infusion of pharmacological or biological substances”. For the purpose of this 
study, they are defined as AEs that occur within the 24-hour period beginning from the start of 
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The number and percentage of patients who experienced any of the infusion reaction AEs will be 
summarized by PT.
7.1.7.3.
Treatment-Emergent Adverse Events (TEAE) of Special Interest
Number and percentage of subjects with the following TEAEs of special interest will be 
summarized by search category and PT: 
•
Anaemia (MST Anemia Extravascular Transient Hemolysis) 
•
Infusion Related Reaction (IRR) (SMQ-Hypersensitivity Narrow Terms) + within one day of 
latest infusion 
•
Transfusion reactions due to magrolimab interference with RBC typing (Gilead’s MST)
•
Thromboembolic Events (SMQ- Embolic and Thrombotic Events Broad Terms)
•
Pneumonitis (SMQ- Interstitial Lung Disease Broad Terms)
•
Serious infection (SOC: Infections and infestations [just SAE in this SOC])
•
Severe neutropenia (PTs : ≥ Grade 3  Neutrophil count decreased, ≥ Grade 3 Neutropenia 
and, ≥ Grade 3 Febrile neutropenia)
7.1.7.4.
Other Important Safety Topics 
The number and percentage of patients with the following AEs of important safety topics will be 
summarized by search category and PT: 
•
Immune-Mediated Events (SMQ-Immune-mediate and autoimmune disorder Narrow Terms)
•
Hemorrhages (SMQ- Hemorrhages Broad Terms)
7.2.
Laboratory Evaluations
Laboratory data collected during the study will be analyzed and summarized using both 
quantitative and qualitative methods. Summaries of laboratory data will be provided for the 
Safety Analysis Set and will include data collected up to and including the date of last dose of 
study drug plus 70 days for patients who permanently discontinued study drug, or the day before 
initiation of new anticancer therapy including SCT (whichever is earlier). The analysis will be 
based on values reported in conventional units. When values are below the LOQ, they will be 
listed as such, and the closest imputed value will be used for the purpose of calculating summary 
statistics as specified in Section 3.7. 
No formal statistical testing is planned.


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7.2.1.
Summaries of Numeric Laboratory Results
Descriptive statistics will be provided by cohort for laboratory tests (eg, chemistry, hematology, 
coagulation) as follows:
•
Baseline values 
•
Postbaseline maximum value
•
Postbaseline minimum value
•
Change and percentage change from baseline to postbaseline maximum value
•
Change and percentage change from baseline to postbaseline minimum value
A baseline laboratory value will be defined as the last measurement obtained on or prior to the 
date/time of first dose of study drug. Change from baseline to a postbaseline visit will be defined 
as the postbaseline value minus the baseline value. The mean, median, Q1, Q3, minimum, and 
maximum values will be displayed to the reported number of digits; StD values will be displayed 
to the reported number of digits plus 1.
Median (Q1, Q3) of the observed values will be plotted using a line plot by cohort and visit for 
the laboratory tests including but not limited to hemoglobin.
In the case of multiple values associated with a visit, data will be selected for analysis as 
described in Section 3.8.3.
7.2.2.
Graded Laboratory Values
The CTCAE Version 5.0 will be used to assign toxicity grades (0 to 4) to laboratory results for 
analysis. Grade 0 includes all values that do not meet the criteria for an abnormality of at least 
Grade 1. For laboratory tests with criteria for both increased and decreased levels, analyses for 
each direction (ie, increased, decreased) will be presented separately.
Local labs will be graded based on central lab normal ranges with in-house macro. 
7.2.2.1.
Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last 
dose of study drug plus 70 days for patients who permanently discontinued study drug, or the 
day before initiation of new anticancer therapy including SCT (whichever is earlier).  If the 
relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed 
within the time frame specified above will be considered treatment emergent.


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7.2.2.2.
Summaries of Laboratory Abnormalities
Laboratory data that are categorical will be summarized using the number and percentage of 
patients in the study with the given response at baseline and each scheduled postbaseline time 
point.
The TE laboratory abnormalities summaries (number and percentage of patients) will be 
provided by lab test and cohort; patients will be categorized according to the most severe 
postbaseline abnormality grade for a given lab test.
For all summaries of laboratory abnormalities, the denominator is the number of patients with 
nonmissing postbaseline values up to 70 days after the last dosing date or the day before 
initiation of new anticancer therapy including SCT (whichever is earlier).
A by-patient listing of treatment-emergent Grade 3 or 4 laboratory abnormalities will be 
provided by patient ID number and visit in chronological order. This listing will include all test 
results that were collected throughout the study for the lab test of interest, with all applicable 
severity grades displayed. 
7.2.3.
Liver-related Laboratory Evaluations
Liver-related abnormalities after initial study drug dosing will be examined and summarized 
using the number and percentage of patients who were reported to have the following laboratory 
test values for postbaseline measurements:
•
Aspartate aminotransferase (AST): > 3 times of the upper limit of reference range  (ULN)
•
Alanine aminotransferase (ALT): > 3 x ULN
•
AST or ALT: > 3 x ULN
•
Total bilirubin: > 2 x ULN
•
AST or ALT > 3 x ULN and total bilirubin > 2 x ULN
•
AST or ALT > 3 x ULN and total bilirubin > 2 x ULN and alkaline phosphatase (ALP) 
< 2 x ULN
The summary will include data from all postbaseline visits up to 70 days after the last dose of 
study drug. For individual laboratory tests, patients will be counted once based on the most 
severe postbaseline values. For the composite endpoints of AST or ALT, total bilirubin, and 
ALP, patients will be counted once when the criteria are met at the same postbaseline visit date. 
The denominator is the number of patients in the Safety Analysis Set who have nonmissing 
postbaseline values of all relevant tests at the same postbaseline visit date. 


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7.2.4.
Shifts Relative to the Baseline Grade
Shift tables will be presented by showing change in severity grade from baseline to the worst 
postbaseline grade for hematology and chemistry laboratory tests. 
7.3.
Body Weight and Vital Signs
No summary or listing of body weight, BMI, or vital signs will be provided to aligh with the 
planned scope of the study synotic CSR.
7.4.
Other Safety Measures
A by-patient listing of ECOG performance status will be provided by cohort and patient ID 
number in ascending order.


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8.
PHARMACOKINETIC (PK) AND IMMUNOGENICITY 
ANALYSES
8.1.
PK Sample Collection
Blood samples for evaluating magrolimab serum concentrations will be collected as described in 
Protocol Appendix 2.
8.2.
PK Analyses 
The magrolimab PK concentration will be summarized for the PK Analysis Set. Individual 
subject’s concentration data for magrolimab will be listed based on the sampling time point. 
Magrolimab PK data will be summarized per nominal time point using descriptive statistics. 
Summary statistics (n, mean, SD, coefficient of variation [%CV], median, min, max, Q1, and 
Q3) will be presented for magrolimab serum concentration data at time point. 
The sample size (number of patients) at each time point will be based on the number of patients 
with nonmissing concentration data at that time point. Missing concentration values will be 
reported as is in data listings. The number of patients with concentration BLQ will be presented 
for each time point. For summary statistics, BLQ values will be treated as 0. 
Sparse PK concentration values that are BLQ will be presented as “BLQ” in the concentration 
data listing. 
At predose, if all concentration values are BLQ, then the mean, and order statistics (minimum, 
Q1, median, Q3, and maximum) will be displayed as 0 and the rest of the summary statistics (ie, 
SD and CV) will be missing. If any values are non-BLQ, then the number of samples, order 
statistics, and all summary statistics will be displayed.
At any given postdose time point, if more than one-third of the patients have a concentration 
value of BLQ, then only the number of samples and order statistics will be displayed; otherwise, 
order statistics and summary statistics will be displayed.
The following conventions will be used for the presentation of order statistics for postdose time 
points: 
•
If at least 1 subject has a concentration value of BLQ for the time point, the minimum value 
will be displayed as “BLQ.”
•
If more than 25% of the patients have a concentration data value of BLQ for a given time 
point, the minimum and Q1 values will be displayed as “BLQ.” 
•
If more than 50% of the patients have a concentration data value of BLQ for a given time 
point, the minimum, Q1, and median values will be displayed as “BLQ.” 


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•
If more than 75% of the patients have a concentration data value of BLQ for a given time 
point, the minimum, Q1, median, and Q3 values will be displayed as “BLQ.” 
•
If all patients have concentration data values of BLQ for a given time point, all order 
statistics (minimum, Q1, median, Q3, and maximum) will be displayed as “BLQ.”
Due to the sparse nature of PK collection, PK parameters will not be calculated.
8.3.
Immunogenicity analysis
The rate and magnitude of magrolimab anti-drug antibody (ADA) prevalence, incidence, 
persistence, and transience will be summarized for the Immunogenicity Analysis Set. 
Neutralizing antibody occurrence rate will also be summarized.
ADA Prevalence: the proportion of subjects who had at least one positive ADA sample 
(baseline or post-baseline) based on the Immunogenicity Analysis Set.
Treatment-Induced ADA Rate: the proportion of subjects who had negative baseline ADA 
sample and at least one positive post-treatment ADA sample based on subjects who had both 
non-missing baseline and at least one post-treatment ADA result reported (i.e. ADA Incidence 
Analysis Set).
Treatment-Boosted ADA Rate: the proportion of subjects who had positive baseline ADA 
sample and at least one positive post-treatment ADA sample and the (max titer of the post-
treatment ADA) / (titer of baseline ADA) >= 4 based on the ADA Incidence Analysis Set.
ADA Incidence (treatment-emergent ADA): the proportion of subjects who had treatment-
induced or treatment-boosted ADA based on subjects who had non-missing baseline ADA 
sample and at least one post-treatment ADA result reported in Immunogenicity Analysis Set.
Persistent ADA is defined as:
a) Treatment-Induced ADA detected at two or more sampling time points during the treatment 
(including follow-up period if any), where the first and last ADA-positive sample (irrespective of 
any negative samples in between) are separated by a period of 16 weeks or longer.
or
b) Treatment-Induced ADA detected in the last sampling time point of the treatment study 
period.
ADA Persistence Rate: the proportion of subjects who had persistent ADA based on the ADA 
Incidence Analysis Set.


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Transient ADA is defined as: 
Final 
Treatment-Induced ADA that does not meet the definition of persistent ADA. The propo1iion of 
subjects who had transient ADA is based on the subjects evaluable for ADA incidence. 
Neutralizing antibody (NAb) Incidence: the propo1iion of subjects who had at least one 
positive neutralizing antibody result repo1ied based on the treatment-emergent ADA (treatment-
induced or treatment-boosted ADA) among the subjects evaluable for ADA incidence. 
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9.
BIOMARKER ANALYSIS
Biomarker analyses will be provided by the biomarker sciences group, and methods will be 
described in a separate Biomarker Analysis Plan.


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10.
REFERENCES
Gandhi UH, Cornell RF, Lakshman A, Gahvari ZJ, McGehee E, Jagosky MH, et al. Outcomes of 
patients with multiple myeloma refractory to CD38-targeted monoclonal antibody 
therapy [Author Manuscript]. Leukemia 2019;33 (9):2266-75.
Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, et al. International Myeloma 
Working Group consensus criteria for response and minimal residual disease 
assessment in multiple myeloma. Lancet Oncol 2016;17 (8):e328-e46.


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11.
SOFTWARE
SAS® Software Version 9.4. SAS Institute Inc., Cary, NC, USA.


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12.
SAP REVISION
Revision Date
(DD MMM YYYY)
Section
Summary of Revision
Reason for Revision


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13.
APPENDICES
Appendix 1.
Disease Response Criteria Based on International Myeloma Working 
Group (IMWG) 2016 Criteria
Appendix Table 1.
IMWG 2016 MRD Criteria 
Response 
MRD Criteria
Sustained 
MRD-negative
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)a
Flow 
MRD-negative
Absence of phenotypically aberrant clonal plasma cells by NGFb on bone marrow aspirates 
using the EuroFlow standard operation procedure for MRD detection in MM (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 2 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 cellsc or higher
Imaging plus 
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; MFC = multicolor flow cytometry; 
MM = multiple myeloma; MRD = minimal residual disease; NGF = next-generation flow; NGS = next-generation sequencing; 
PET = positron emission tomography; SUV = standard uptake value
a
Sustained MRD negativity when reported should also annotate the method used (eg, sustained flow MRD-negative, 
sustained sequencing MRD-negative).
b
Bone marrow multicolor flow cytometry should follow NGF guidelines. The reference NGF method is an 8-color 2-tube 
approach, which has been extensively validated. The 2-tube approach improves reliability, consistency, and sensitivity 
because of the acquisition of a greater number of cells. The 8-color technology is widely available globally and the NGF 
method has already been adopted in many flow laboratories worldwide. The complete 8-color method is most efficient using 
a lyophilized mixture of antibodies which reduces errors, time, and costs. Five million cells should be assessed. The MFC 
method employed should have a sensitivity of detection of at least 1 in 10⁵ plasma cells.
c
DNA sequencing assay on bone marrow sample should use a validated assay such as LymphoSIGHT (Sequenta).


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Appendix Table 2.
Standard IMWG 2016 Response Criteria
Response 
IMWG Criteria
Stringent 
Complete 
Response (sCR)
Complete response as defined below, plus normal FLC ratioa 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)
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
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 per 24 h
Partial Response 
(PR)
≥ 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by ≥ 90% or 
to < 200 mg per 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 (sum of 
products of 2 longest perpendicular diameters [SPD])b 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 to 89%.
In addition to the above listed criteria, if present at baseline, a ≥ 50% reduction in the size 
(SPD)b of soft tissue plasmacytomas is also required
Stable Disease 
(SD)
Not recommended for use as an indicator of response; stability of disease is best described 
by providing the time to progression estimates. Not meeting criteria for complete response, 
very good partial response, partial response, minimal response, or progressive disease
Progressive 
Disease (PD) c,d
Any 1 or more of the following criteria:
•
Increase of 25% from lowest confirmed response value in 1 or more of the following 
criteria:
•
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 SPDb 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/μL) if this is the only 
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Response 
IMWG Criteria
Clinical Relapse
Clinical relapse requires 1 or more of the following criteria:
•
Direct indicators of increasing disease and/or end organ dysfunction (CRAB features) 
related to the underlying clonal plasmacell proliferative disorder. It is not used in 
calculation of time to progression or progression-free survival but is listed as something 
that can be reported optionally or for use in clinical practice;
•
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 SPDb
•
of the measurable lesion;
•
Hypercalcemia (> 11 mg/dL);
•
Decrease in hemoglobin of ≥ 2 g/dL not related to therapy or other nonmyeloma-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
Relapse from 
Complete 
Response (to be 
Used Only if the 
End Point is 
Disease-free 
Survival)
Any 1 or more of the following criteria:
•
Reappearance of serum or urine M-protein by immunofixation or electrophoresis;
•
Development of ≥ 5% plasma cells in the bone marrow;
•
Appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, 
or hypercalcemia see above)
Relapse from 
MRD Negative 
(to be Used Only 
if the End Point is 
Disease-free 
Survival)
Any 1 or more of the following criteria:
•
Loss of MRD-negative state (evidence of clonal plasma cells on NGF or NGS, or 
positive imaging study for recurrence of myeloma);
•
Reappearance of serum or urine M-protein by immunofixation or electrophoresis;
•
Development of ≥ 5% clonal plasma cells in the bone marrow;
•
Appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, 
or hypercalcemia)
CR = complete response; CRAB = Calcium, Renal Failure, Anemia, Bone Lesions; CT = computed tomography; FLC = free 
light chain; IMWG = International Myeloma Working Group; MR = minimal response; MRD = minimal disease residue; 
MRI = magnetic resonance imaging; PD = progressive disease; PET = positron emission tomography; PR = partial response; 
sCR = stringent complete response; SD = stable disease; SFLC = serum free light chain; SPD = sum of products of 2 longest 
perpendicular diameters; UK = United Kingdom; VGPR = very good partial response
a
All recommendations regarding clinical uses relating to SFLC levels or FLC ratio are based on results obtained with the 
validated Freelite test (Binding Site, Birmingham, UK).
b
Plasmacytoma measurements should be taken from the CT portion of the PET/CT, or MRI scans, or dedicated CT scans 
where applicable. For patients with only skin involvement, skin lesions should be measured with a ruler. Measurement of 
tumor size will be determined by the SPD.
c
Positive immunofixation alone in a patient previously classified as achieving a complete response will not be considered 
progression. For purposes of calculating time to progression and progression-free survival, patients who have achieved a 
complete response and are MRDnegative should be evaluated using criteria listed for progressive disease. Criteria for 
relapse from a complete response or relapse from MRD should be used only when calculating diseasefree survival.
d
In the case where a value is felt to be a spurious result per physician discretion (eg, a possible laboratory error), that value 
will not be considered when determining the lowest value.


Magrolimab
GS-US-558-5915
Statistical Analysis Plan 
Final
CONFIDENTIAL
Page 41
13 May 2024
Appendix Table 3.
Required Baseline and Follow-up Tests for Response Assessment 
Using IMWG 2016 Criteria
Every Response 
Assessment Time 
Point (Every Cycle)
If Electrophoresis 
Shows No 
Measurable 
Protein
At 
Suspected 
CR
At Suspected 
Progression 
(Clinical or 
Biochemical)
Serum Electrophoresis (Serum 
M-spike ≥ 1 g/dL)a
X
X
X
Serum Immunofixation (Any)
X
X
X
Urine Electrophoresis (Urine 
M-spike ≥ 200 mg/24 h)
X
X
X
Urine Immunofixation
X
X
SFLC
Serum M-spike < 1 g/dL, 
Urine M-spike < 200 mg/24 h, 
but Involved Ig FLC is 
≥ 10 mg/dL
X
X
X
Any
−
X
X
Bone Marrow Aspirate/Biopsy
Serum M-spike, Urine 
M-spike, or Involved Ig FLC 
not Meeting Above Criteria 
but Bone Marrow Plasma Cell 
Percentage ≥ 30%
Xb
X
Any
−
X
58568 Serum M-spike, Urine 
M-spike, Involved Ig FLC or 
Bone Marrow not Meeting 
Above Criteria, but at Least 
One Lesion that has a Single 
Diameter of ≥ 2 cm
Xb 
X
Any
-
X
Hemoglobin, Serum Calcium, 
Creatinine (Any)
X
X
CR= complete response; FLC = free light chain; Ig = immunoglobulin; IMWG = International Myeloma Working Group; 
SFLC = serum free-light chain; SPEP = serum protein electrophoresis; UPEP = urine protein electrophoresis; X = test performed; 
− = test not performed
a
A baseline M-spike of ≥ 0.5 g/dL is acceptable if very good partial response or higher is the response end point to be 
measured and in situations where progression-free survival or time to progression are the end points of interest.
b
To be done every 3 or 4 cycles till a plateau or CR, or as clinically indicated and then at suspected progression.
Source: {Kumar 2016}


GS-US-558-5915-SAP_v1.0
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Biostatistics eSigned
13-May-2024
20:16:19
Clinical Development
eSigned
15-May-2024
22:11:10
PPD
PPD-