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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elranatamab (cohort A)

BCMA-CD3 bispecific antibody

Group Type EXPERIMENTAL

Elranatamab (PF-06863135)

Intervention Type DRUG

BCMA-CD3 bispecific antibody

Elranatamab (cohort B)

BCMA-CD3 bispecific antibody

Group Type EXPERIMENTAL

Elranatamab (PF-06863135)

Intervention Type DRUG

BCMA-CD3 bispecific antibody

Interventions

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Elranatamab (PF-06863135)

BCMA-CD3 bispecific antibody

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
* 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

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

The Regents of the University of California

Irvine, California, United States

Site Status

Ronald Reagan UCLA Medical Center Drug information Center

Los Angeles, California, United States

Site Status

The Regents of the University of California

Los Angeles, California, United States

Site Status

UCLA Hematology/Oncology Clinic

Los Angeles, California, United States

Site Status

UCLA Ronald Reagan Medical Center

Los Angeles, California, United States

Site Status

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Baptist Hospital of Miami

Miami, Florida, United States

Site Status

Winship Cancer Institute @ Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Site Status

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Site Status

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

Northwestern Medical Group

Chicago, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Loyola University Chicago performing research at Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Indiana Blood and Marrow Transplantation

Indianapolis, Indiana, United States

Site Status

State University of Iowa

Iowa City, Iowa, United States

Site Status

University of Iowa - Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States

Site Status

Norton Women's and Children's Hospital

Louisville, Kentucky, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Hackensack University Medical Center

Edison, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Regional Cancer Care Associates, LLC

Hackensack, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care

New York, New York, United States

Site Status

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, United States

Site Status

Weill Cornell Medical College - New York-Presbyterian Hospital

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

St Francis Physician Services Inc

Greenville, South Carolina, United States

Site Status

St. Francis Hospital

Greenville, South Carolina, United States

Site Status

Saint Francis Hospital Cancer Center

Greenville, South Carolina, United States

Site Status

St Francis Eastside

Greenville, South Carolina, United States

Site Status

Baylor Scott & White Research Institute

Dallas, Texas, United States

Site Status

Baylor University Medical Center, Baylor Scott & White

Dallas, Texas, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Epworth Healthcare

East Melbourne, Victoria, Australia

Site Status

St Vincent's Hospital (Melbourne)

Fitzroy, Victoria, Australia

Site Status

The Alfred

Melbourne, Victoria, Australia

Site Status

Epworth Healthcare

Richmond, Victoria, Australia

Site Status

ZNA-Middelheim

Antwerp, , Belgium

Site Status

ZNA Stuivenberg

Antwerp, , Belgium

Site Status

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status

CHU UCL Namur site Godinne

Yvoir, , Belgium

Site Status

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Alberta Health Services and The Governors of The University of Alberta

Edmonton, Alberta, Canada

Site Status

CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada

Site Status

CHU de Lille - Hopital Claude Huriez

Lille, , France

Site Status

CHU de Nantes - Hôtel Dieu

Nantes, , France

Site Status

Hopital Saint-Louis

Paris, , France

Site Status

Hôpital Saint-Antoine

Paris, , France

Site Status

Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

Pierre-Bénite, , France

Site Status

CHU de Poitiers, Pôle Régional de Cancérologie

Poitiers, , France

Site Status

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status

Universitätsklinikum Hamburg - Eppendorf

Hamburg, , Germany

Site Status

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Universitätsklinik Schleswig-Holstein

Kiel, , Germany

Site Status

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Site Status

Gunma University Hospital

Maebashi, Gunma, Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

Iwate Medical University Hospital

Yahaba-cho, Iwate, Japan

Site Status

Tohoku University Hospital

Sendai, Miyagi, Japan

Site Status

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan

Site Status

Yamagata University Hospital

Yamagata, , Japan

Site Status

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

Site Status

Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

Poznan, , Poland

Site Status

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruna, Spain

Site Status

Institut Catala d' Oncologia. Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Clinica Universitaria de Navarra

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario Doctor Peset

Valencia, , Spain

Site Status

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United States Australia Belgium Canada France Germany Japan Poland Spain United Kingdom

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.

Reference Type DERIVED
PMID: 40830740 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40826257 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40495704 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40000533 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38794892 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38078866 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37582952 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C1071003

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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