Study Stopped
A business decision was made by Pfizer to terminate the study and not proceed with the Phase 2 expansion of this study. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA
3 other identifiers
interventional
46
2 countries
25
Brief Summary
The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Oct 2021
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedStudy Start
First participant enrolled
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2025
CompletedResults Posted
Study results publicly available
February 23, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2026
CompletedApril 24, 2026
April 1, 2026
3.3 years
October 8, 2021
February 4, 2026
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation
DLT- Hematological:Grade (G)4 neutropenia \>5 days; febrile neutropenia; G\>=3 neutropenia, infection; G4 thrombocytopenia; G3 thrombocytopenia and G\>=2 bleeding. Non-hematological: G\>=4 adverse events(AEs); G3 cytokine release syndrome(CRS) \[except CRS not been maximally treated or improved to G\<=1 in 48 hours\]; G3 AEs (except AEs attributed to CRS, G3 nausea, vomiting, diarrhea that improve to G2\<=72 hours after maximal medical management has been initiated, G3 fatigue \< 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G3-4 laboratory abnormalities(except not associated with clinical sequelae and improve to G=\<2 in 72 hours); G2 clinically important/persistent AEs(cause significant dose delay/reduction) may be DLT; G3 injection site reaction, allergic reaction, anaphylaxis. Common Terminology Criteria for Adverse Events(CTCAE) version 5.0: G1:mild AE, G2:moderate, G3:severe, G4:life-threatening consequences; urgent intervention indicated, G5:death related to AE.
From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days)
SSB: Number of Participants With DLTs- Phase 1b
Hematological: G4 neutropenia \>5 days; febrile neutropenia; G\>=3 neutropenia with infection; G4 thrombocytopenia; G3 thrombocytopenia with G\>=2 bleeding. Non-hematological: G\>=4 AEs; G3 CRS (except CRS events: not been maximally treated or improved to grade \<=1 within 48 hours); G3 AEs (except: AEs attributed to CRS, G3 nausea, vomiting and diarrhea that improve to G2\<=72 hours after maximal medical management has been initiated, G3 fatigue \< 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G 3-4 laboratory abnormalities (except: not associated with clinical sequelae and improve to G=\<2 within 72 hours); Other clinically important/persistent AEs (that cause significant dose delay/reduction) may be DLT; G3 injection site reaction. CTCAE version 5.0: G1: Mild AE, G2: Moderate, G3: Severe, G4: Life-threatening consequences; urgent intervention indicated, G5: Death related to AE.
From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 42 days)
Secondary Outcomes (32)
SSA: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs- Phase 1b
From treatment initiation till study completion
SSA: Number of Participants With Severity of AEs According to Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Grading Criteria 2019- Phase 1b
From treatment initiation till study completion
SSA: Number of Participants With Severity of AEs According to Immune Effector Cell-associated Neurotoxicity Syndrome ICANS Graded According to ASTCT Grading Criteria 2019- Phase 1b
From treatment initiation till study completion
SSA: Number of Participants With Laboratory Abnormalities- Phase 1b
From treatment initiation till study completion
SSA: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria as Determined by Investigator- Phase 1b
From treatment initiation till study completion
- +27 more secondary outcomes
Study Arms (2)
Sub-Study A
EXPERIMENTALBCMA-CD3 bispecific antibody + gamma secretase inhibitor
Sub-Study B
EXPERIMENTALBCMA-CD3 bispecific antibody + immunomodulatory drug
Interventions
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
BCMA-CD3 bispecific antibody + immunomodulatory
Eligibility Criteria
You may qualify if:
- Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy
- Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody
- Measurable disease defined by at least one of the following:
- Serum M-protein \>/= 0.5 g/dL by SPEP
- Urinary M-protein excretion \>/= 200 mg/24 hours by UPEP
- Serum immunoglobulin FLC \>/= 10 mg/dL (\>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
- ECOG performance status 0 -1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade \</= 1
You may not qualify if:
- Active plasma cell leukemia
- Amyloidosis
- Stem cell transplant with 12 weeks prior to enrollment, or active GVHD
- POEMS syndrome
- Any active uncontrolled bacterial, fungal, or viral infection
- Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
- Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)
- Sub-Study A Only: Previous treatment with BCMA bispecific antibody
- Sub-Study B Only: Previous treatment with BCMA directed therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (25)
Banner Gateway Medical Center
Gilbert, Arizona, 85234, United States
Banner Gateway Medical Pavilion
Gilbert, Arizona, 85234, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Banner Health d.b.a. Banner MD Anderson Cancer Center
Phoenix, Arizona, 85012, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
Clinical Research Advisors
Encino, California, 91316, United States
Clinical Research Advisors
Los Angeles, California, 90020, United States
Cedars Sinai Medical Center Oncology IDS Pharmacy Attn:Suwicha Limvorasak ,PharmaD
Los Angeles, California, 90048, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI)
Los Angeles, California, 90048, United States
Clinical Research Advisors
Los Angeles, California, 90048, United States
Cedars-Sinai Tarzana
Tarzana, California, 91356, United States
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida, 33146, United States
University of Miami
Coral Gables, Florida, 33146, United States
Sylvester Comprehensive Cancer Center- Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
UHealth Tower
Miami, Florida, 33136, United States
The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
OIDS, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Also Imaging Facility)
Baltimore, Maryland, 21231, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Phase 2 of SSA was not conducted, based on sponsor's decision.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2021
First Posted
October 25, 2021
Study Start
October 27, 2021
Primary Completion
February 13, 2025
Study Completion
March 11, 2026
Last Updated
April 24, 2026
Results First Posted
February 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.