MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Last updated: February 27, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoproliferative Disorders

Multiple Myeloma

Cancer

Treatment

Bortezomib

Dexamethasone

Carfilzomib

Clinical Study ID

NCT06152575
C1071032
2023-507871-23-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).

This study is seeking participants who:

  • Are 18 years of age or older and have MM.

  • Have received treatments before for MM.

  • Have MM that has returned or not responded to their most recent treatment.

Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.

Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.

The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:

  • a shot under the skin at the study clinic

  • through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.

Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).

The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prior diagnosis of multiple myeloma as defined by International Myeloma WorkingGroup (IMWG) criteria and previously received 1 to 4 prior lines of therapyincluding prior anti-cluster of differentiation 38 (CD38) antibody and priorlenalidomide.

  • Documented evidence of progressive disease or failure to achieve a response to lastline of therapy per IMWG criteria.

  • Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involvedimmunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLCratio (<0.26 or >1.65).

  • Have clinical laboratory values within the specified range.

  • ECOG (Eastern Cooperative Oncology Group) performance status ≤2.

  • Not pregnant or breastfeeding and willing to use contraception.

Exclusion

Exclusion Criteria:

  • Smoldering multiple myeloma.

  • Plasma cell leukemia.

  • Amyloidosis.

  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skinabnormalities (POEMS) syndrome.

  • Known central nervous system (CNS) involvement or clinical signs of myelomatousmeningeal involvement.

  • Stem cell transplant within 12 weeks prior to enrolment, or active graft versus hostdisease.

  • Any active, uncontrolled bacterial, fungal, or viral infection.

  • Any other active malignancy within 3 years prior to enrolment (exceptions include,adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)

  • Previous treatment with a B cell maturation antigen (BCMA)-directed therapy orCD3-redirecting therapy.

  • Unable to receive investigator's choice therapy.

  • Live attenuated vaccine within 4 weeks of the first dose of study intervention.

  • Administration with an investigational product (e.g. drug or vaccine) within 30 dayspreceding the first dose of study intervention used in this study.

Study Design

Total Participants: 492
Treatment Group(s): 6
Primary Treatment: Bortezomib
Phase: 3
Study Start date:
February 08, 2024
Estimated Completion Date:
December 30, 2027

Connect with a study center

  • Instituto Alexander Fleming

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
    Argentina

    Active - Recruiting

  • Hospital Universitario Austral

    Pilar, Buenos Aires 1629
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires

    Ciudad de Buenos Aires, Ciudad Autónoma DE Buenos Aires C1199ABB
    Argentina

    Active - Recruiting

  • Hospital Italiano de La Plata

    La Plata, 1900
    Argentina

    Active - Recruiting

  • UZ Brussel

    Brussels, Bruxelles-capitale, Région DE 1090
    Belgium

    Active - Recruiting

  • Grand Hôpital de Charleroi

    Charleroi, Hainaut 6000
    Belgium

    Site Not Available

  • Grand Hôpital de Charleroi

    Gilly, Hainaut 6060
    Belgium

    Active - Recruiting

  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi

    Yvoir, Namur 5530
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, Oost-vlaanderen 9000
    Belgium

    Site Not Available

  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

    Porto Alegre, RIO Grande DO SUL 90110-270
    Brazil

    Active - Recruiting

  • Centro de Pesquisa Clínica - Área Administrativa

    Porto Alegre, RIO Grande DO SUL 90850-170
    Brazil

    Active - Recruiting

  • Hospital Mae de Deus

    Porto Alegre, RIO Grande DO SUL 90880-480
    Brazil

    Active - Recruiting

  • Clínica Médica São Germano LTDA

    SP, SÃO Paulo 04537-080
    Brazil

    Site Not Available

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    Sao Paulo, SÃO Paulo 04543-000
    Brazil

    Site Not Available

  • Americas Centro de Oncologia Integrado

    Rio de Janeiro, 22775001
    Brazil

    Active - Recruiting

  • Instituto de Educação, Pesquisa e Gestão em Saúde

    Rio de Janeiro, 22793-080
    Brazil

    Active - Recruiting

  • Clínica Médica São Germano S/S Ltda

    São Paulo, 04537-080
    Brazil

    Site Not Available

  • ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis

    São Paulo, 01232-010
    Brazil

    Site Not Available

  • HU UNIFESP / SPDM - Hospital São Paulo

    São Paulo, 04024-002
    Brazil

    Active - Recruiting

  • Hospital do Coracao

    São Paulo, 04003-905
    Brazil

    Site Not Available

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    São Paulo, 01401-002
    Brazil

    Site Not Available

  • Universidade Federal de Sao Paulo

    São Paulo, 04024-002
    Brazil

    Active - Recruiting

  • The Moncton Hospital

    Moncton, New Brunswick E1C 6Z8
    Canada

    Active - Recruiting

  • Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ

    Montreal, Quebec H4J 1C5
    Canada

    Active - Recruiting

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Fakultní nemocnice Brno Bohunice

    Brno, Brno-město 625 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, Olomoucký KRAJ 779 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Praha 10 100 34
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 12808
    Czechia

    Site Not Available

  • Rigshospitalet

    Copenhagen, Hovedstaden 2100
    Denmark

    Active - Recruiting

  • Aarhus Universitetshospital, Skejby

    Aarhus, Midtjylland 8200
    Denmark

    Active - Recruiting

  • Aalborg Universitetshospital, Syd

    Aalborg, Nordjylland 9000
    Denmark

    Active - Recruiting

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa 33520
    Finland

    Site Not Available

  • Oulun yliopistollinen sairaala

    Oulu, Pohjois-pohjanmaa 90220
    Finland

    Site Not Available

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Pohjois-savo 70210
    Finland

    Site Not Available

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

    Helsinki, Uusimaa 00029
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, Varsinais-suomi 20520
    Finland

    Active - Recruiting

  • Hôpital NOVO

    Cergy Pontoise, Val-d'oise 95303
    France

    Active - Recruiting

  • Hôpital NOVO

    Pontoise, Val-d'oise 95300
    France

    Active - Recruiting

  • CHD Vendee

    La Roche-sur-Yon, Vendée 85000
    France

    Site Not Available

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    Paris, 75679
    France

    Active - Recruiting

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Centre Hospitalier de Cornouaille

    Quimper, 29107
    France

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

    Tours, 37032
    France

    Active - Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg, Baden-württemberg 79106
    Germany

    Active - Recruiting

  • Universitaetsklinikum Ulm

    Ulm, Baden-württemberg 89081
    Germany

    Active - Recruiting

  • Vivantes Klinikum Am Urban

    Berlin, 10249
    Germany

    Active - Recruiting

  • Asklepios Altona

    Hamburg, 22763
    Germany

    Site Not Available

  • St. Barbara-Klinik Hamm-Heessen

    Hamm, 59073
    Germany

    Active - Recruiting

  • Diakonissen-Stiftungs-Krankenhaus Speyer

    Speyer, 67346
    Germany

    Site Not Available

  • University Hospital of Alexandroupolis

    Alexandroupolis, Anatolikí Makedonía KAI Thráki 681 00
    Greece

    Site Not Available

  • Alexandra General Hospital of Athens

    Athens, Attikí 115 28
    Greece

    Active - Recruiting

  • Evangelismos General Hospital of Athens

    Athens, Attikí 106 76
    Greece

    Site Not Available

  • "Theagenio" Cancer Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía 540 07
    Greece

    Site Not Available

  • University Hospital of Ioannina

    Ioannina, Ípeiros 455 00
    Greece

    Site Not Available

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-romagna 47014
    Italy

    Active - Recruiting

  • P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO

    Milano, Lombardia 20153
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, Marche 60126
    Italy

    Site Not Available

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicilia 90127
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, Toscana 50134
    Italy

    Active - Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia IRCCS

    Milano, 20141
    Italy

    Active - Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi 467-8602
    Japan

    Active - Recruiting

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi 441-8570
    Japan

    Active - Recruiting

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime 790-0024
    Japan

    Active - Recruiting

  • Gunma University Hospital

    Maebashi, Gunma 371-8511
    Japan

    Active - Recruiting

  • National Hospital Organization Shibukawa Medical Center

    Shibukawa, Gunma 377-0280
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital

    Kobe, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Iwate Medical University Hospital

    Shiwa-gun Yahaba-cho, Iwate 028-3695
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
    Japan

    Site Not Available

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo 113-8603
    Japan

    Active - Recruiting

  • Japanese Foundation for Cancer Research

    Koto, Tokyo 135-8550
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Koto, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520
    Japan

    Active - Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Active - Recruiting

  • Okayama Rosai Hospital

    Okayama, 702-8055
    Japan

    Active - Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Active - Recruiting

  • Maastricht UMC+

    Maastricht, Limburg 6229 HX
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk

    Dordrecht, Zuid-holland 3318 AT
    Netherlands

    Active - Recruiting

  • Akershus Universitetssykehus

    Lørenskog, Akershus 1474
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim, Sør-trøndelag 7030
    Norway

    Active - Recruiting

  • Sykehuset i Vestfold

    Tønsberg, Vestfold 3103
    Norway

    Active - Recruiting

  • Oslo Universitetssykehus Ullevål

    Oslo, 0450
    Norway

    Site Not Available

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [barcelona] 08916
    Spain

    Active - Recruiting

  • Cetir-Ascires

    Barcelona, Barcelona [barcelona] 08029
    Spain

    Active - Recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona [barcelona] 08221
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña] 08036
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia (ICO) - Girona

    Girona, Girona [gerona] 17007
    Spain

    Active - Recruiting

  • ASCIRES ECG Médica S.L

    València, Valenciana, Comunitat 46004
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Centro de Diagnóstico y Resonancia Magnética

    Salamanca, 37004
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Active - Recruiting

  • Universitetssjukhuset Örebro

    Örebro, Örebro LÄN [se-18] 701 85
    Sweden

    Active - Recruiting

  • Falu Lasarett

    Falun, 791 31
    Sweden

    Active - Recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham, England B15 2TH
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, London, CITY OF W12 0HS
    United Kingdom

    Site Not Available

  • St Bartholomew's Hospital

    London, London, CITY OF EC1A 7BE
    United Kingdom

    Active - Recruiting

  • Churchill Hospital

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Active - Recruiting

  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire ST4 6QG
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital (Sutton)

    London, Sutton SM2 5PT
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG
    United Kingdom

    Active - Recruiting

  • New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Infirmary Cancer Care

    Mobile, Alabama 36607
    United States

    Site Not Available

  • Beverly Hills Cancer Center

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Community Cancer Institute

    Clovis, California 93611
    United States

    Site Not Available

  • University of California

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • UCHealth Harmony

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • University of Colorado Health - Harmony

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Longs Peak Hospital

    Longmont, Colorado 80504
    United States

    Active - Recruiting

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida 33176
    United States

    Site Not Available

  • BRCR Global

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • BRCR Global

    Tamarac, Florida 33321
    United States

    Site Not Available

  • BRCR Global - Tamarac

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Community Health Network, Inc.

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Ascentist Doctor Hospital

    Leawood, Kansas 66211
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Merriam, Kansas 66204
    United States

    Site Not Available

  • O'Brien Pharmacy

    Mission, Kansas 66205
    United States

    Site Not Available

  • Bryan Medical Center

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • NHO Revive Research Institute, LLC

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Atlantic Health System Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • WMCHealth Advanced Physician Services

    Hawthorne, New York 10532
    United States

    Active - Recruiting

  • Cayuga Cancer Center at Cayuga Park

    Ithaca, New York 14850
    United States

    Site Not Available

  • Cayuga Medical Center

    Ithaca, New York 14850
    United States

    Site Not Available

  • Westchester Medical Center

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • TriHealth Cancer Institute-Good Samaritan Hospital

    Cincinnati, Ohio 45220
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • St Francis Cancer Center

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy

    Dallas, Texas 75246
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist Willowbrook Hospital

    Houston, Texas 77070
    United States

    Site Not Available

  • Houston Methodist Sugar Land Hospital

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas 76508
    United States

    Site Not Available

  • WVU Cancer Institute

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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