A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
MAGNETISMM-5
AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
3 other identifiers
interventional
944
22 countries
90
Brief Summary
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Oct 2021
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedStudy Start
First participant enrolled
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
ExpectedMay 5, 2026
May 1, 2026
4.6 years
August 11, 2021
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part 1 Safety Lead-In: Incidence of dose limiting toxicities
First 42 days after first elranatamab dose
Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
Part 3: Frequency of treatment-emergent adverse events
First 84 days after first elranatamab dose
Secondary Outcomes (18)
Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Overall survival
From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Objective response rate per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Duration of response per International Myeloma Working Group criteria
From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Time to response per International Myeloma Working Group criteria
From date of randomization to date of confirmed objective response, assessed up to 51 months
- +13 more secondary outcomes
Study Arms (6)
Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
EXPERIMENTALPart 2 Randomized Arm A: Elranatamab
EXPERIMENTALPart 2 Randomized Arm B: Elranatamab + Daratumumab
EXPERIMENTALPart 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
ACTIVE COMPARATORPart 3 Arm D: Elranatamab
EXPERIMENTALPart 3 Arm E: Elranatamab + Daratumumab
EXPERIMENTALInterventions
subcutaneous
Daratumumab / hyaluronidase, subcutaneous
oral
Eligibility Criteria
You may qualify if:
- Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
- Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL.
- Urinary M-protein excretion ≥200 mg/24 hours.
- Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
- Prior anti-multiple myeloma therapy including treatment with lenalidomide.
- 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.
- Plasma cell leukemia.
- Amyloidosis.
- POEMS Syndrome.
- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
- Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Previous treatment with a BCMA-directed therapy.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (90)
Clovis Community Medical Center
Clovis, California, 93611, United States
Community Regional Medical Center
Fresno, California, 93721, United States
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80634, United States
Sylvester Comprehensive Cancer Center - Aventura
Aventura, Florida, 33180, United States
Sylvester Comprehensive Cancer Center - Coral Springs
Coral Springs, Florida, 33065, United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, 33021, United States
University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065, United States
Hospital Universitario Austral
Presidente Derqui, Buenos Aires, B1629AHJ, Argentina
Pindara Private Hospital
Benowa, Queensland, 4217, Australia
QScan Radiology Clinics
Clayfield, Queensland, 4011, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, 4120, Australia
Slade Pharmacy
Richmond, Victoria, 3121, Australia
Linear Clinical Research
Perth, Western Australia, 6009, Australia
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador, Estado de Bahia, 41253-190, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
Clínica Médica São Germano LTDA
SP, São Paulo, 04537-080, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, 22793-080, Brazil
HU UNIFESP / SPDM - Hospital São Paulo
São Paulo, 04024-002, Brazil
Clínica Médica São Germano S/S Ltda
São Paulo, 04537-080, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 04543-000, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 04544-000, Brazil
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1T2M4, Canada
Saskatoon Cancer Center
Saskatoon, Saskatchewan, S7N4H4, Canada
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510555, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, 301636, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, 100730, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Fakultní nemocnice Brno Bohunice
Brno, Brno-m?sto, 625 00, Czechia
Fakultni Nemocnice Plzen
Plzen - Lochotin, Plzeň Region, 304 60, Czechia
Fakultni poliklinika
Prague, Praha 2, 120 00, Czechia
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, 00029, Finland
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, Limousin, 87042, France
Hôpital Saint Antoine
Paris, 75571, France
Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique
Pierre-Bénite, 69495, France
Charité Universitätsmedizin Berlin
Berlin, 12203, Germany
Universitätsklinikum rechts der Isar, Technische Universität München (TUM)
München, 81675, Germany
Alexandra General Hospital of Athens
Athens, Attikí, 115 28, Greece
Theageneio Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, 546 39, Greece
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
National Hospital Organization Shibukawa Medical Center
Shibukawa, Gunma, 377-0280, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Akita University Hospital
Akita, 010-8543, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460, Mexico
North Shore Hospital
Auckland, 0622, New Zealand
Labtests Auckland Ltd.
Auckland, 1060, New Zealand
Aotearoa Clinical Trials
Auckland, 2025, New Zealand
Waikato District Health Board, Waikato Hospital
Hamilton, 3204, New Zealand
Palmerston North Hospital
Roslyn, 4414, New Zealand
Oslo Universitetssykehus Ullevål
Oslo, 0450, Norway
St Olavs Hospital
Trondheim, 7030, Norway
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii
Bydgoszcz, 85-168, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-367, Poland
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona [barcelona], 08908, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario de Toledo
Toledo, Other, 45007, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitari De Girona Doctor Josep Trueta
Girona, 17007, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Skånes Universitetssjukhus Lund
Lund, Skåne LÄN [se-12], 22185, Sweden
Falu Lasarett
Falun, 791 82, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 41345, Sweden
Universitetssjukhuset Örebro
Örebro, Örebro LÄN [se-18], 701 85, Sweden
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Ege Universitesi Hastanesi
Izmir, İ̇zmir, 35100, Turkey (Türkiye)
Dokuz Eylul Universitesi Hastanesi
Izmir, İ̇zmir, 35340, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi
Antalya, 07070, Turkey (Türkiye)
University Hospital of Wales
Cardiff, South Glamorgan, CF14 4XW, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2021
First Posted
August 25, 2021
Study Start
October 4, 2021
Primary Completion
April 27, 2026
Study Completion (Estimated)
May 31, 2027
Last Updated
May 5, 2026
Record last verified: 2026-05
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.