Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
NCT ID: NCT05317416
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
811 participants
INTERVENTIONAL
2022-03-25
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A - Part 1
Elranatamab
Elranatamab
BCMA-CD3 bispecific antibody
Arm B - Part 1
Lenalidomide
Lenalidomide
Immunomodulatory drug
Arm B - Part 2
Lenalidomide
Lenalidomide
Immunomodulatory drug
Arm C - Part 2
Elranatamab
Elranatamab
BCMA-CD3 bispecific antibody
Interventions
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Elranatamab
BCMA-CD3 bispecific antibody
Lenalidomide
Immunomodulatory drug
Lenalidomide
Immunomodulatory drug
Elranatamab
BCMA-CD3 bispecific antibody
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
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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Banner Gateway Medical Center
Gilbert, Arizona, United States
Banner Gateway Medical Pavilion
Gilbert, Arizona, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Loyola University Chicago
Maywood, Illinois, United States
Ascentist Doctor Hospital
Leawood, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
Kansas City, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
WMCHealth Advanced Physician Services
Hawthorne, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
OhioHealth Arthur G.H. Bing, MD, Cancer Center
Columbus, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
Baylor University Medical Center
Dallas, Texas, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Shoalhaven District Memorial Hospital
Nowra, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
QScan Radiology Clinics
Clayfield, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Epworth Healthcare
East Melbourne, Victoria, Australia
Precision Haematology
East Melbourne, Victoria, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
Slade Pharmacy
Richmond, , Australia
Medizinische Universität Wien
Vienna, Vienna, Austria
Medizinische Universität Wien
Vienna, , Austria
Hanusch-Krankenhaus
Vienna, , Austria
Institut Jules Bordet
Anderlecht, Bruxelles-capitale, Région de, Belgium
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
Yvoir, Namur, Belgium
UZ Gent
Ghent, Oost-vlaanderen, Belgium
ZNA Middelheim
Antwerp, , Belgium
Zna Cadix
Antwerp, , Belgium
UZ Brussel
Brussels, , Belgium
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador, Estado de Bahia, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Clínica - Área Administrativa
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
Ribeirão Preto, São Paulo, Brazil
BP - A Beneficencia Portuguesa de São Paulo
São Paulo, São Paulo, Brazil
Clínica Médica São Germano LTDA
SP, São Paulo, Brazil
Fundação Doutor Amaral Carvalho
Jaú, , Brazil
Américas Medical City
Rio de Janeiro, , Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, , Brazil
ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
São Paulo, , Brazil
HU UNIFESP / SPDM - Hospital São Paulo
São Paulo, , Brazil
Universidade Federal de Sao Paulo
São Paulo, , Brazil
Hospital Japonês Santa Cruz
São Paulo, , Brazil
Clínica Médica São Germano S/S Ltda
São Paulo, , Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Windsor Regional Hospital Cancer Program
Windsor, Ontario, Canada
Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
Montreal, Quebec, Canada
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia
Fakultni nemocnice Ostrava
Ostrava, Moravskoslezský kraj, Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Oulun yliopistollinen sairaala
Oulu, North Ostrobothnia, Finland
Turku University Hospital
Turku, Southwest Finland, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, Finland
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, Haute-garonne, France
Pitie Salpetriere University Hospital
Paris, ORNE, France
Gustave Roussy
Villejuif, Val-de-marne, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, France
Chu Grenoble Alpes
La Tronche, , France
Hopital Claude Huriez - CHU de Lille
Lille, , France
Hôpital Saint Antoine
Paris, , France
Hopital Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours, , France
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin, , Germany
Klinikum Chemnitz gGMbH
Chemnitz, , Germany
Universitätsklinikum Essen
Essen, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Alexandra General Hospital of Athens
Athens, Attikí, Greece
Theageneio Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, Greece
University Hospital of Ioannina
Ioannina, Ípeiros, Greece
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, Hungary
Semmelweis University
Budapest, , Hungary
Dél-Pesti Centrumkórház
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
Nyíregyháza, , Hungary
Artemis hospital
Gurugram, Haryana, India
Medanta-The Medicity
Gurugram, Haryana, India
Fortis Memorial Research Institute
Gurugram, Haryana, India
Himalayan Institute Hospital Trust University
Dehradun, Uttarakhand, India
Tata Medical Center
Kolkata, West Bengal, India
Rajiv Gandhi Cancer Institute And Research Centre
Delhi, , India
Rabin Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Hadassah Mount Scopus Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Soroka Medical Center
Beersheba, Southern District, Israel
Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
Tel Aviv, TELL ABĪB, Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Policlinico "G. Rodolico"
Catania, Sicily, Italy
Azienda Ospedaliero Universitaria Senese
Siena, Tuscany, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona, , Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, , Italy
AOU Policlinico Umberto I
Roma, , Italy
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
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Kagoshima University Hospital
Kagoshima, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Japanese Red Cross Medical Center
Tokyo, , Japan
HagaZiekenhuis
The Hague, South Holland, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Isala
Zwolle, , Netherlands
Oslo Universitetssykehus Ullevål
Oslo, , Norway
Stavanger Universitetssykehus
Stavanger, , Norway
Centrum Medyczne Pratia Poznań
Skórzewo, Greater Poland Voivodeship, Poland
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne,
Gdansk, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
Warsaw, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea
Chonnam National University Hwasun Hospital
Hwasun Gun, Jeonranamdo, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Pusan National University Hospital
Busan, Pusan-kwangyǒkshi, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
Seoul, Seoul-teukbyeolsi [seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyungpook National University
Daegu, Taegu-kwangyǒkshi, South Korea
Kyungpook National University Hospital
Junggu, Taegu-kwangyǒkshi, South Korea
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruna, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona [barcelona], Spain
Institut Catala d' Oncologia. Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Clinica Universidad de Navarra
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, Spain
Hospital San Pedro de Alcántara
Cáceres, , Spain
Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
Girona, , Spain
Hospital La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Helsingborgs Lasarett
Helsingborg, Skåne LÄN [se-12], Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, Stockholms LÄN [se-01], Sweden
Södra Älvsborgs Sjukhus Borås
Borås, Västra Götalands LÄN [se-14], Sweden
Falu Lasarett
Falun, , Sweden
Universitetssjukhuset Örebro
Örebro, Örebro LÄN [se-18], Sweden
Universitetssjukhuset i Linköping
Linköping, Östergötlands LÄN [se-05], Sweden
CHUV (centre hospitalier universitaire vaudois)
Lausanne, Canton of Vaud, Switzerland
UniversitätsSpital Zürich
Zurich, Zürich (DE), Switzerland
Kantonsspital Baden
Baden, , Switzerland
Inselspital Bern
Bern, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Medipol Mega Universite Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
Sisli Florence Nightingale Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, İ̇zmir, Turkey (Türkiye)
Dokuz Eylul Universitesi Hastanesi
Izmir, İ̇zmir, Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals
Ankara, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, , Turkey (Türkiye)
Aydın Adnan Menderes Universitesi Hastanesi
Aydin, , Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri
Kayseri, , Turkey (Türkiye)
Özel Anadolu Sağlık Merkezi
Kocaeli, , Turkey (Türkiye)
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, England, United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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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-7
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508897-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C1071007
Identifier Type: -
Identifier Source: org_study_id