PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
2 other identifiers
interventional
101
2 countries
37
Brief Summary
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started Nov 2017
Longer than P75 for phase_1 multiple-myeloma
37 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
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedStudy Start
First participant enrolled
November 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2024
CompletedResults Posted
Study results publicly available
March 18, 2025
CompletedMarch 18, 2025
March 1, 2025
6.1 years
August 16, 2017
January 8, 2025
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03
Hematological: Grade 4 neutropenia lasting \>5 days; Febrile neutropenia \<1000/mm\^3 with a single temperature of \>38.3 degree Celsius (C) or a sustained temperature of \>=38 degree C for more than one hour; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with \>= Grade 2 bleeding. Non-hematological: grade 4 adverse events (AEs); Grade 3 AE lasting \>=5 days despite optimal supportive care, with exception of AE attributed to cytokine release syndrome (CRS) event; grade 3 CRS, except those CRS that had a) not been maximally treated or b) improved to \<=grade 1 within 48 hours; grade 4 CRS; confirmed drug-induced liver injury (DILI) meeting Hy's law criteria; grade 4 laboratory abnormalities deemed clinically significant by the investigator reported Grade 4 AE; clinically important or persistent toxicities that were not included in above criteria were also be considered a DLT following review by the investigators and the sponsor.
Cycle 1 (21 Days)
Part 2: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria
ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hr. PR: \>=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by \>=90% or to \<200 mg/24 hr. If serum and urine M-protein were unmeasurable, \>=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
Part 2: Duration of Response (DOR) as Per IMWG Criteria
DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio \& absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum \& urine \& disappearance of any soft tissue plasmacytomas\&\<5% plasma cells in bone marrow aspirates.VGPR: serum \& urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum Mp plus urine Mp level \<100 mg/24 hr. PR: \>=50% reduction of serum Mp \& reduction in 24 hrs urinary Mp by \>=90% or to \<200 mg/24 hr.If serum \& urine Mp were unmeasurable, \>=50% decrease in difference between involved \& uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.
From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 34.3 months)
Secondary Outcomes (31)
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Part 1: ORR as Per IMWG Criteria
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
- +26 more secondary outcomes
Study Arms (4)
PF-06863135
EXPERIMENTALBCMA-CD3 bispecific antibody
PF-06863135 + dexamethasone
EXPERIMENTALBCMA-CD3 bispecific antibody + dexamethasone
PF-06863135 + lenalidomide
EXPERIMENTALBCMA-CD3 bispecific antibody + lenalidomide
PF-06863135 + pomalidomide
EXPERIMENTALBCMA-CD3 bispecific antibody + pomalidomide
Interventions
PF-06863135 will be administered intravenously or subcutaneously.
PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
Eligibility Criteria
You may qualify if:
- Relapsed/refractory multiple myeloma
- Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
- Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)
- Adequate bone marrow, hematological, kidney and liver function
- Resolved acute effects of any prior therapy to baseline severity
- Not pregnant
You may not qualify if:
- Recent history of other malignancies
- History of active autoimmune disorders
- Any form of primary immunodeficiency
- Active and clinically significant bacterial, fungal, or viral infection
- Evidence of active mucosal or internal bleeding
- History of severe immune-mediated adverse event with prior immunomodulatory treatment
- Major surgery within 4 weeks of study treatment start
- Radiation therapy within 2 weeks of study treatment start
- History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
- Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
- Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
- Requirement for systemic immune suppressive medication except as permitted in the protocol
- Current requirement for chronic blood product support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (37)
UCSD Medical Center - Encinitas
Encinitas, California, 92024, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
La Jolla, California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92037, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
UCSD Medical Center - Vista
Vista, California, 92081, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
UChicago Medicine - River East
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
Chicago, Illinois, 60637, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois, 60422, United States
UChicago Medicine Ingalls Memorial
Harvey, Illinois, 60426, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451, United States
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois, 60462, United States
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, 60477, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center at Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center at Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center at Nassau
Uniondale, New York, 11553, United States
Duke University Health System: Adult Bone Marrow Transplant Clinic
Durham, North Carolina, 27705, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Henry Joyce Cancer Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Investigational Drug Services, Baylor University Medical Center
Dallas, Texas, 75246, United States
Unit 57, Special Services Building
Calgary, Alberta, T2N 2T9, Canada
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9, Canada
MUHC, GLEN site
Montreal, Quebec, H4A3J1, Canada
Related Publications (3)
Lon HK, Hibma J, Jiang S, Sullivan S, Vandendries E, Skoura A, Wang D, Elmeliegy M. Population Exposure-Response Efficacy Analysis of Elranatamab (PF-06863135) in Patients with Multiple Myeloma. Target Oncol. 2025 Sep;20(5):803-819. doi: 10.1007/s11523-025-01168-y. Epub 2025 Aug 18.
PMID: 40826257DERIVEDElmeliegy M, Viqueira A, Vandendries E, Hickman A, Conte U, Irby D, Hibma J, Lon HK, Piscitelli J, Soltantabar P, Skoura A, Jiang S, Wang D. Dose Optimization of Elranatamab to Mitigate the Risk of Cytokine Release Syndrome in Patients with Multiple Myeloma. Target Oncol. 2025 Mar;20(2):349-359. doi: 10.1007/s11523-025-01134-8. Epub 2025 Feb 25.
PMID: 40000533DERIVEDBahlis NJ, Costello CL, Raje NS, Levy MY, Dholaria B, Solh M, Tomasson MH, Damore MA, Jiang S, Basu C, Skoura A, Chan EM, Trudel S, Jakubowiak A, Gasparetto C, Chu MP, Dalovisio A, Sebag M, Lesokhin AM. Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. Nat Med. 2023 Oct;29(10):2570-2576. doi: 10.1038/s41591-023-02589-w. Epub 2023 Oct 2.
PMID: 37783970DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2017
First Posted
August 31, 2017
Study Start
November 29, 2017
Primary Completion
January 19, 2024
Study Completion
January 19, 2024
Last Updated
March 18, 2025
Results First Posted
March 18, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not 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.