Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant (MagnetisMM-7)

A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elranatamab; Drug: Lenalidomide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 854
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Richmond, Australia, 3121
    • Slade Pharmacy
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Nowra, New South Wales, Australia, 2541
      • Shoalhaven District Memorial Hospital
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Pindara Private Hospital
    • Clayfield, Queensland, Australia, 4011
      • QScan Radiology Clinics
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Epworth Healthcare
    • East Melbourne, Victoria, Australia, 3002
      • Precision Haematology
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital (Melbourne)
• Austria
  • Vienna, Austria, 1090
    • Medizinische Universität Wien
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Antwerp, Belgium, 2030
    • ZNA Cadix
  • Brussels, Belgium, 1090
    • UZ Brussel
  • Bruxelles-capitale, Région de
    • Anderlecht, Bruxelles-capitale, Région de, Belgium, 1070
      • Institut Jules Bordet
  • Hainaut
    • Charleroi, Hainaut, Belgium, 6060
      • Grand Hôpital de Charleroi
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
  • Oost-vlaanderen
    • Ghent, Oost-vlaanderen, Belgium, 9000
      • UZ Gent
• Brazil
  • Rio de Janeiro, Brazil, 22775001
    • Instituto de Educação, Pesquisa e Gestão em Saúde
  • Rio de Janeiro, Brazil, 22775-001
    • Americas Medical City
  • São Paulo, Brazil, 04024-002
    • Universidade Federal de Sao Paulo
  • São Paulo, Brazil, 01232-010
    • ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
  • São Paulo, Brazil, 04024-002
    • HU UNIFESP / SPDM - Hospital São Paulo
  • São Paulo, Brazil, 04537-080
    • Clínica Médica São Germano S/S Ltda
  • São Paulo, Brazil, 04122-000
    • Hospital Japonês Santa Cruz
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41253-190
      • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
      • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
    • Porto Alegre, Rio Grande do Sul, Brazil, 90880-480
      • Hospital Mae de Deus
    • Porto Alegre, Rio Grande do Sul, Brazil, 90850-170
      • Centro de Pesquisa Clínica - Área Administrativa
  • São Paulo
    • Jaú, São Paulo, Brazil, 17210-080
      • Hospital Amaral Carvalho
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
    • SP, São Paulo, Brazil, 04537-080
      • Clínica Médica São Germano LTDA
    • São Paulo, São Paulo, Brazil, 01321-001
      • BP - A Beneficencia Portuguesa de São Paulo
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Arthur J.E. Child Comprehensive Cancer Centre
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5N5
      • Dr. Everett Chalmers Regional Hospital
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Saint John Regional Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L 8E7
      • Hamilton Health Sciences Corporation
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
    • Windsor, Ontario, Canada, N8W 1L9
      • Windsor Regional Hospital Cancer Program
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre
    • Montreal, Quebec, Canada, H1T 2M4
      • Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,
    • Montreal, Quebec, Canada, H4J 1C5
      • Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510555
      • Sun Yat-sen University Cancer Center
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Institute of hematology&blood disease hospital
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Prague, Czechia, 12808
    • Vseobecna fakultni nemocnice v Praze
  • Brno-město
    • Brno, Brno-město, Czechia, 625 00
      • Fakultní nemocnice Brno Bohunice
  • Hradec Králové
    • Hradec Králové, Hradec Králové, Czechia, 500 05
      • Fakultni nemocnice Hradec Kralove
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 708 52
      • Fakultni nemocnice Ostrava
• Finland
  • Oulu, Finland, 90220
    • Oulun Yliopistollinen Sairaala
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • Turku University Hospital
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
• France
  • Lille, France, 59037
    • Hopital Claude Huriez - CHU de Lille
  • Paris, France, 75571
    • Hôpital Saint Antoine
  • Pierre-Bénite, France, 69495
    • Hôpital Lyon Sud
  • Tours, France, 37032
    • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
  • Haute-garonne
    • Toulouse, Haute-garonne, France, 31100
      • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
  • ORNE
    • Paris, ORNE, France, 75013
      • Pitie Salpetriere University Hospital
  • Val-de-marne
    • Villejuif, Val-de-marne, France, 94800
      • Gustave Roussy
  • Vienne
    • Poitiers, Vienne, France, 86021
      • Centre Hospitalier Universitaire de Poitiers
• Germany
  • Berlin, Germany, 12200
    • Charité Universitätsmedizin Berlin Campus Benjamin Franklin
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • München, Germany, 81675
    • Klinikum rechts der Isar der Technischen Universität München
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • Universitätsklinikum Würzburg
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Universitätsmedizin Johannes Gutenberg Universität Mainz
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Universitatsklinikum Leipzig
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel
• Greece
  • Attikí
    • Athens, Attikí, Greece, 115 28
      • Alexandra General Hospital of Athens
  • Kentrikí Makedonía
    • Thessaloniki, Kentrikí Makedonía, Greece, 546 39
      • Theageneio Cancer Hospital of Thessaloniki
  • Ípeiros
    • Ioannina, Ípeiros, Greece, 455 00
      • University Hospital of Ioannina
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis University
  • Budapest, Hungary, 1097
    • Dél-Pesti Centrumkórház
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Nyíregyháza, Hungary, 4400
    • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
  • Somogy County
    • Kaposvár, Somogy County, Hungary, 7400
      • Somogy Megyei Kaposi Mor Oktato Korhaz
• India
  • Delhi, India, 110085
    • Rajiv Gandhi Cancer Institute And Research Centre
  • Haryana
    • Gurugram, Haryana, India, 122001
      • Artemis Hospital
    • Gurugram, Haryana, India, 122002
      • Fortis Memorial Research Institute
    • Gurugram, Haryana, India, 122001
      • Medanta-The Medicity
  • Uttarakhand
    • Dehradun, Uttarakhand, India, 248140
      • Himalayan Institute Hospital Trust University
  • West Bengal
    • Kolkata, West Bengal, India, 700160
      • Tata Medical Center
• Israel
  • Central District
    • Petah Tikva, Central District, Israel, 4910021
      • Rabin Medical Center
    • Ramat Gan, Central District, Israel, 5262100
      • Sheba Medical Center
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 9112001
      • Hadassah Medical Center
    • Jerusalem, Jerusalem, Israel, 9013102
      • Shaare Zedek Medical Center
    • Jerusalem, Jerusalem, Israel, 9124001
      • Hadassah Mount Scopus Medical Center
  • Northern District
    • Haifa, Northern District, Israel, 3109601
      • Rambam Health Care Campus
  • Southern District
    • Beersheba, Southern District, Israel, 8410101
      • Soroka Medical Center
  • TELL ABĪB
    • Tel Aviv, TELL ABĪB, Israel, 6423906
      • Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
• Italy
  • Ancona, Italy, 60126
    • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
  • Roma, Italy, 00161
    • AOU Policlinico Umberto I
  • Emilia-Romagna
    • Meldola, Emilia-Romagna, Italy, 47014
      • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Sicily
    • Catania, Sicily, Italy, 95123
      • Policlinico "G. Rodolico"
  • Tuscany
    • Siena, Tuscany, Italy, 53100
      • Azienda Ospedaliero Universitaria Senese
• Japan
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Kyoto, Japan, 602-8566
    • University Hospital,Kyoto Prefectural University of Medicine
  • Okayama, Japan, 701-1192
    • National Hospital Organization Okayama Medical Center
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Tokyo, Japan, 150-8935
    • Japanese Red Cross Medical Center
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
      • Gunma University Hospital
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Iwate
    • Yahaba-cho, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital
  • Kyoto
    • Kyoto, Kyoto, Japan, 602-8566
      • University Hospital,Kyoto Prefectural University of Medicine
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Nippon Medical School Hospital
  • Yamagata
    • Yamagata, Yamagata, Japan, 990-9585
      • Yamagata University Hospital
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum
  • Zwolle, Netherlands, 8025 AB
    • Isala
  • South Holland
    • The Hague, South Holland, Netherlands, 2545 AA
      • Hagaziekenhuis
• Norway
  • Oslo, Norway, 0450
    • Oslo Universitetssykehus Ullevål
  • Stavanger, Norway, 4011
    • Stavanger Universitetssykehus
• Poland
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne,
  • Poznan, Poland, 60-569
    • Uniwersytecki Szpital Kliniczny w Poznaniu
  • Warsaw, Poland, 02-097
    • Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
  • Warsaw, Poland, 02-781
    • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
  • Wroclaw, Poland, 50-367
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Greater Poland Voivodeship
    • Skórzewo, Greater Poland Voivodeship, Poland, 60-185
      • Centrum Medyczne Pratia Poznan
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-519
      • Pratia Onkologia Katowice
• South Korea
  • Incheon-gwangyeoksi [incheon]
    • Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea, 21565
      • Gachon University Gil Medical Center
  • Jeonranamdo
    • Hwasun Gun, Jeonranamdo, South Korea, 58128
      • Chonnam National University Hwasun Hospital
  • Kyǒnggi-do
    • Seongnam, Kyǒnggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
  • Pusan-kwangyǒkshi
    • Busan, Pusan-kwangyǒkshi, South Korea, 49241
      • Pusan National University Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
      • Samsung Medical Center
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06591
      • The Catholic Univ. of Korea Seoul St. Mary's Hospital
  • Taegu-kwangyǒkshi
    • Daegu, Taegu-kwangyǒkshi, South Korea, 41944
      • Kyungpook National University
    • Junggu, Taegu-kwangyǒkshi, South Korea, 41944
      • Kyungpook National University Hospital
• Spain
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcantara
  • Girona, Spain, 17007
    • Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28006
    • Hospital La Princesa
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Institut Catala d' Oncologia. Hospital Germans Trias i Pujol
  • Barcelona [barcelona]
    • Barcelona, Barcelona [barcelona], Spain, 08035
      • Hospital Universitari Vall d'Hebron
    • L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain, 08908
      • Institut Català d'Oncologia - L'Hospitalet
    • Terrassa, Barcelona [barcelona], Spain, 08221
      • Hospital Universitari Mutua Terrassa
  • Castille and León
    • Salamanca, Castille and León, Spain, 37007
      • Hospital Universitario de Salamanca
  • Catalunya [cataluña]
    • Barcelona, Catalunya [cataluña], Spain, 08036
      • Hospital Clinic De Barcelona
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quironsalud Madrid
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28027
      • Clinica Universidad de Navarra
    • Madrid, Madrid, Comunidad de, Spain, 28046
      • Hospital Universitario La Paz
• Sweden
  • Falun, Sweden, 791 31
    • Falu Lasarett
  • Skåne LÄN [se-12]
    • Helsingborg, Skåne LÄN [se-12], Sweden, 251 87
      • Helsingborgs lasarett
  • Stockholms LÄN [se-01]
    • Stockholm, Stockholms LÄN [se-01], Sweden, 141 86
      • Karolinska Universitetssjukhuset Huddinge
  • Västra Götalands LÄN [se-14]
    • Borås, Västra Götalands LÄN [se-14], Sweden, 501 82
      • Södra Älvsborgs Sjukhus Borås
  • Örebro LÄN [se-18]
    • Örebro, Örebro LÄN [se-18], Sweden, 701 85
      • Universitetssjukhuset Örebro
  • Östergötlands LÄN [se-05]
    • Linköping, Östergötlands LÄN [se-05], Sweden, 581 85
      • Universitetssjukhuset i Linköping
• Switzerland
  • Baden, Switzerland, 5404
    • Kantonsspital Baden
  • Winterthur, Switzerland, 8401
    • Kantonsspital Winterthur
  • Canton of Bern
    • Bern, Canton of Bern, Switzerland, 3010
      • Inselspital Bern
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • CHUV (centre hospitalier universitaire vaudois)
  • Zürich (DE)
    • Zurich, Zürich (DE), Switzerland, 8091
      • Universitatsspital Zurich
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06200
    • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
  • Ankara, Turkey (Türkiye), 06100
    • Ankara University Health Practice and Research Hospitals
  • Aydin, Turkey (Türkiye), 09100
    • Aydın Adnan Menderes Universitesi Hastanesi
  • Kayseri, Turkey (Türkiye), 38030
    • Erciyes Universitesi Tıp Fakultesi Hastaneleri
  • Kocaeli, Turkey (Türkiye), 41400
    • Özel Anadolu Sağlık Merkezi
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34214
      • Medipol Mega Universite Hastanesi
    • Istanbul, İ̇stanbul, Turkey (Türkiye), 34381
      • Sisli Florence Nightingale Hastanesi
  • İ̇zmir
    • Izmir, İ̇zmir, Turkey (Türkiye), 35100
      • Ege Universitesi Hastanesi
    • Izmir, İ̇zmir, Turkey (Türkiye), 35340
      • Dokuz Eylul Universitesi Hastanesi
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Belfast City Hospital
  • Glasgow, United Kingdom, G12 0YN
    • The Beatson West of Scotland Cancer Centre
  • Reading, United Kingdom, RG1 5AN
    • Royal Berkshire Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Addenbrooke's Hospital
  • England
    • Birmingham, England, United Kingdom, B15 2TH
      • Queen Elizabeth Hospital Birmingham
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner MD Anderson Cancer Center
    • Gilbert, Arizona, United States, 85234
      • Banner Gateway Medical Center
    • Gilbert, Arizona, United States, 85234
      • Banner Gateway Medical Pavilion
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology
    • Los Angeles, California, United States, 90095
      • UCLA Department of Medicine - Hematology/Oncology
    • Santa Monica, California, United States, 90404
      • UCLA Hematology/Oncology - Santa Monica
    • Santa Monica, California, United States, 90404
      • Santa Monica UCLA Medical Center & Orthopaedic Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute at Baptist Health, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute, Emory University
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Chicago
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Ascentist Doctor Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • American Oncology Partners, P.A. Dba MidAmerica Cancer Care
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Hawthorne, New York, United States, 10532
      • WMCHealth Advanced Physician Services
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research Institute
    • Columbus, Ohio, United States, 43214
      • OhioHealth Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43214
      • OhioHealth Arthur G.H. Bing, MD, Cancer Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Medical Center - Temple

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
• Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
• History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
• Partial Response or better according to IMWG criteria at the time of randomization
• Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
• ECOG performance status ≤1
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
• Not pregnant and willing to use contraception

Exclusion Criteria:

• Plasma cell leukemia
• Amyloidosis, Waldenström's macroglobulinemia
• POEMS syndrome
• Known active CNS involvement or clinical signs of myelomatous meningeal involvement
• Previous MM maintenance treatment
• Prior treatment with BCMA targeted therapy
• 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
• Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
• Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A - Part 1; Elranatamab	Drug: Elranatamab; BCMA-CD3 bispecific antibody
Active Comparator: Arm B - Part 1; Lenalidomide	Drug: Lenalidomide; Immunomodulatory drug
Active Comparator: Arm B - Part 2; Lenalidomide	Drug: Lenalidomide; Immunomodulatory drug
Experimental: Arm C - Part 2; Elranatamab	Drug: Elranatamab; BCMA-CD3 bispecific antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria	Assessed for up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Progression Free Survival by investigator per IMWG response criteria	Assessed for up to approximately 5 years
Duration of minimal residual disease negativity	Minimal residual disease negativity per IMWG criteria	Assessed for up to approximately 5 years
Sustained minimal residual disease negativity rate	Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months	Assessed for up to approximately 5 years
Complete response rate	Complete response rate by blinded independent central review and by investigator per IMWG criteria	Assessed for up to approximately 5 years
Duration of complete response	Duration of complete response by blinded independent central review and by investigator per IMWG criteria	Assessed for up to approximately 5 years
Frequency of adverse events	Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention	Up to 90 days after last dose
Pre-dose concentrations of elranatamab	Pharmacokinetics of elranatamab (trough concentrations of elranatamab)	Assessed for up to approximately 5 years
Post-dose concentrations of elranatamab	Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"	Assessed for up to approximately 5 years
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab	Immunogenicity of elranatamab	Assessed for up to approximately 5 years
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30	Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms	Assessed for up to approximately 5 years
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20	Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms	Assessed for up to approximately 5 years
Progression Free Survival 2	Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria	Assessed for up to approximately 5 years
Overall Survival	Defined as the time from randomization until death due to any cause	Assessed for up to approximately 5 years
Sustained MRD negative rate	Sustained Minimal Residual Disease negative rate per IMWG criteria as assessed via Next Generation Sequencing	24 months after randomization
Overall minimal residual disease negative rate	Minimal residual disease negative rate per IMWG criteria	Assessed for up to approximately 5 years
Severity of Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome	Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome severity assessed per ASH-ASTCT criteria	Assessed for up to approximately 5 years
Minimal residual disease Negative rate	per IMWG as assessed via next generation sequencing (NGS)	12 months after randomization
Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants	Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants	Assessed up to approximately 5 years
PFS by BICR per IMWG in IMWG 2025 standard-risk participant	PFS by BICR per IMWG in IMWG 2025 standard-risk participant	Assessed up to approximately 5 years
MRD-negative rate per IMWG 2025	Assessed via NGS in IMWG 2025 subgroups	12 months after randomization

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Estimated): August 4, 2027
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; monoclonal antibody; Lenalidomide; Newly diagnosed; Phase 3; Stem cell transplant; BCMA; Elranatamab; Targeted T-cell; MagnetisMM; MM7; B-cell Maturation Antigen; Autologous stem cell transplant (ASCT); Hematologic disease; Minimum residual disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Hematologic Diseases; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide
• Other Study ID Numbers: C1071007; MagnetisMM-7 (Other Identifier: Alias Study Number); 2023-508897-27-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No