MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb
MAGNETISMM-3 AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
3 other identifiers
interventional
187
10 countries
87
Brief Summary
The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Feb 2021
Typical duration for phase_2 multiple-myeloma
87 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
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedStudy Start
First participant enrolled
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2022
CompletedResults Posted
Study results publicly available
October 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedDecember 2, 2025
November 1, 2025
1.4 years
November 6, 2020
June 15, 2023
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria
ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum M-protein \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. If serum \& urine M-protein were unmeasurable, VGPR \& PR: \>=90% \& \>=50% decrease in difference respectively between involved \& uninvolved sFLC levels \& if present at baseline, \>=90% \& \>=50% reduction in soft tissue plasmacytomas' size.
From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Secondary Outcomes (21)
Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants With Extramedullary Disease (EMD) at Baseline
From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants Without EMD at Baseline
From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Duration of Response (DOR) as Per IMWG Criteria by BICR
From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Duration of Response as Per IMWG Criteria by Investigator Assessment
From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Complete Response Rate (CRR) as Per IMWG Criteria by BICR
From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
- +16 more secondary outcomes
Study Arms (2)
Elranatamab (cohort A)
EXPERIMENTALBCMA-CD3 bispecific antibody
Elranatamab (cohort B)
EXPERIMENTALBCMA-CD3 bispecific antibody
Interventions
BCMA-CD3 bispecific antibody
Eligibility Criteria
You may qualify if:
- Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
- Measurable disease, as defined by at least 1 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
- Refractory to at least one IMiD
- Refractory to at least one PI
- Refractory to at least one anti-CD38 antibody
- Relapsed/refractory to last anti-myeloma regimen
- Cohort A: has not received prior BCMA-directed therapy
- Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)
- ECOG performance status ≤2
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
- Not pregnant and willing to use contraception
You may not qualify if:
- Smoldering multiple myeloma
- Active Plasma cell leukemia
- Amyloidosis
- POEMS syndrome
- Stem cell transplant within 12 weeks prior to enrollment
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (87)
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
The Regents of the University of California
Irvine, California, 92697, United States
Ronald Reagan UCLA Medical Center Drug information Center
Los Angeles, California, 90095, United States
The Regents of the University of California
Los Angeles, California, 90095, United States
UCLA Hematology/Oncology Clinic
Los Angeles, California, 90095, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Winship Cancer Institute @ Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Emory University
Atlanta, Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Loyola University Chicago performing research at Loyola University Medical Center
Maywood, Illinois, 60153, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237, United States
State University of Iowa
Iowa City, Iowa, 52242, United States
University of Iowa - Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Hackensack University Medical Center
Edison, New Jersey, 08837, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Regional Cancer Care Associates, LLC
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, 11101, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York, New York, 10021, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10021, United States
Weill Cornell Medical College - New York-Presbyterian Hospital
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10065, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
St Francis Physician Services Inc
Greenville, South Carolina, 29601, United States
St. Francis Hospital
Greenville, South Carolina, 29601, United States
Saint Francis Hospital Cancer Center
Greenville, South Carolina, 29607, United States
St Francis Eastside
Greenville, South Carolina, 29615, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75204, United States
Baylor University Medical Center, Baylor Scott & White
Dallas, Texas, 75246, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Epworth Healthcare
East Melbourne, Victoria, 3002, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065, Australia
The Alfred
Melbourne, Victoria, 3004, Australia
Epworth Healthcare
Richmond, Victoria, 3121, Australia
ZNA-Middelheim
Antwerp, 2020, Belgium
ZNA Stuivenberg
Antwerp, 2060, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
CHU UCL Namur site Godinne
Yvoir, 5530, Belgium
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T3N 4N1, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Alberta Health Services and The Governors of The University of Alberta
Edmonton, Alberta, T6G 2C8, Canada
CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, H4A 3J1, Canada
CHU de Lille - Hopital Claude Huriez
Lille, 59037, France
CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
Hopital Saint-Louis
Paris, 75010, France
Hôpital Saint-Antoine
Paris, 75012, France
Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique
Pierre-Bénite, 69495, France
CHU de Poitiers, Pôle Régional de Cancérologie
Poitiers, 86021, France
Klinikum Chemnitz gGmbH
Chemnitz, 09113, Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg, 20246, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinik Schleswig-Holstein
Kiel, 24105, Germany
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Iwate Medical University Hospital
Yahaba-cho, Iwate, 028-3695, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, 150-8935, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan, 60-569, Poland
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruna, 15706, Spain
Institut Catala d' Oncologia. Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Clinica Universitaria de Navarra
Madrid, 28027, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Publications (7)
Elmeliegy M, Soltantabar P, Hibma J, Ashman O, Wang D, Lon HK. Elranatamab Fixed Dosing: A Safe, Effective, and Convenient Dosing Approach. Target Oncol. 2025 Sep;20(5):821-831. doi: 10.1007/s11523-025-01170-4. Epub 2025 Aug 19.
PMID: 40830740DERIVEDLon 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: 40826257DERIVEDGordan LN, Bensimon AG, Mu F, Kim N, Wu B, Lin D, Paner A, Fowler J, Marshall A, Van Sanden S, Ammann E, Goble J, Zhang X, Le HH, Min EE, Garrison LP Jr. Cost per responder for teclistamab and elranatamab in relapsed or refractory multiple myeloma in the United States. J Med Econ. 2025 Dec;28(1):910-920. doi: 10.1080/13696998.2025.2514909. Epub 2025 Jun 14.
PMID: 40495704DERIVEDElmeliegy 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: 40000533DERIVEDIida S, Ito S, Yokoyama H, Ishida T, Nagai Y, Handa H, Ito S, Kamei Y, Nakamura M, Suzuki K. Elranatamab in Japanese patients with relapsed/refractory multiple myeloma: results from MagnetisMM-2 and MagnetisMM-3. Jpn J Clin Oncol. 2024 Sep 4;54(9):991-1000. doi: 10.1093/jjco/hyae068.
PMID: 38794892DERIVEDMol I, Hu Y, LeBlanc TW, Cappelleri JC, Chu H, Nador G, Aydin D, Schepart A, Hlavacek P. A matching-adjusted indirect comparison of the efficacy of elranatamab versus physician's choice of treatment in patients with triple-class exposed/refractory multiple myeloma. Curr Med Res Opin. 2024 Feb;40(2):199-207. doi: 10.1080/03007995.2023.2277850. Epub 2024 Jan 24.
PMID: 38078866DERIVEDLesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, Rodriotaguez-Otero P, Martinez-Lopez J, Koehne G, Touzeau C, Jethava Y, Quach H, Depaus J, Yokoyama H, Gabayan AE, Stevens DA, Nooka AK, Manier S, Raje N, Iida S, Raab MS, Searle E, Leip E, Sullivan ST, Conte U, Elmeliegy M, Czibere A, Viqueira A, Mohty M. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023 Sep;29(9):2259-2267. doi: 10.1038/s41591-023-02528-9. Epub 2023 Aug 15.
PMID: 37582952DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to character limitation in outcome measure description, SPD definition is provided here. SPD was defined as the sum of the products of the maximal perpendicular diameters of measured lesions. Data for only those primary and secondary outcome measures whose analysis is complete and final have been reported. Data for remaining secondary outcome measures will be posted upon completion of analysis at secondary completion date.
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2020
First Posted
December 2, 2020
Study Start
February 2, 2021
Primary Completion
June 17, 2022
Study Completion (Estimated)
December 31, 2026
Last Updated
December 2, 2025
Results First Posted
October 25, 2023
Record last verified: 2025-11
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.