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
NCT ID: NCT04649359
Last Updated: 2025-12-02
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
187 participants
INTERVENTIONAL
2021-02-02
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Elranatamab (cohort A)
BCMA-CD3 bispecific antibody
Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody
Elranatamab (cohort B)
BCMA-CD3 bispecific antibody
Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody
Interventions
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Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody
Eligibility Criteria
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Inclusion Criteria
* Measurable disease, as defined by at least 1 of the following:
1. Serum M-protein \>0.5 g/dL by SPEP
2. Urinary M-protein excretion \>200 mg/24 hours by UPEP
3. 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Beverly Hills Cancer Center
Beverly Hills, California, United States
The Regents of the University of California
Irvine, California, United States
Ronald Reagan UCLA Medical Center Drug information Center
Los Angeles, California, United States
The Regents of the University of California
Los Angeles, California, United States
UCLA Hematology/Oncology Clinic
Los Angeles, California, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States
Baptist Hospital of Miami
Miami, Florida, United States
Winship Cancer Institute @ Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Northwestern Medical Group
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Loyola University Chicago performing research at Loyola University Medical Center
Maywood, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
State University of Iowa
Iowa City, Iowa, United States
University of Iowa - Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hackensack University Medical Center
Edison, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Regional Cancer Care Associates, LLC
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
Weill Cornell Medical College - New York-Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
St Francis Physician Services Inc
Greenville, South Carolina, United States
St. Francis Hospital
Greenville, South Carolina, United States
Saint Francis Hospital Cancer Center
Greenville, South Carolina, United States
St Francis Eastside
Greenville, South Carolina, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Baylor University Medical Center, Baylor Scott & White
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Epworth Healthcare
East Melbourne, Victoria, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
The Alfred
Melbourne, Victoria, Australia
Epworth Healthcare
Richmond, Victoria, Australia
ZNA-Middelheim
Antwerp, , Belgium
ZNA Stuivenberg
Antwerp, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
CHU UCL Namur site Godinne
Yvoir, , Belgium
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Alberta Health Services and The Governors of The University of Alberta
Edmonton, Alberta, Canada
CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
CHU de Lille - Hopital Claude Huriez
Lille, , France
CHU de Nantes - Hôtel Dieu
Nantes, , France
Hopital Saint-Louis
Paris, , France
Hôpital Saint-Antoine
Paris, , France
Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique
Pierre-Bénite, , France
CHU de Poitiers, Pôle Régional de Cancérologie
Poitiers, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinik Schleswig-Holstein
Kiel, , Germany
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Iwate Medical University Hospital
Yahaba-cho, Iwate, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan
Yamagata University Hospital
Yamagata, , Japan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan, , Poland
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruna, Spain
Institut Catala d' Oncologia. Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Clinica Universitaria de Navarra
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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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.
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.
Gordan 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.
Elmeliegy 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.
Iida 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.
Mol 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.
Lesokhin 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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MagnetisMM-3
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504479-25-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C1071003
Identifier Type: -
Identifier Source: org_study_id
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