Multiple Myeloma Clinical Trial

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Summary

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 treatment-for-multiple-myeloma-induction-therapy/" >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 is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

760

Study ID:

NCT05317416

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 181 Locations for this study

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Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
Los Angeles California, 90095, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami Florida, 33176, United States
Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Investigational Drug Service, Emory University Clinic
Atlanta Georgia, 30322, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Alliance for Multispecialty Research, LLC
Merriam Kansas, 66204, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
University Of Mississippi Medical Center
Jackson Mississippi, 39213, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
OhioHealth Arthur G.H. Bing, MD, Cancer Center
Columbus Ohio, 43214, United States
OhioHealth Research Institute
Columbus Ohio, 43214, United States
OhioHealth Riverside Methodist Hospital
Columbus Ohio, 43214, United States
OhioHealth Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
Baylor Scott & White Medical Center - Temple
Temple Texas, 76508, United States
Pindara Private Hospital
Benowa Queensland, 4217, Australia
QScan Radiology Clinics
Clayfield Queensland, 4011, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Epworth Healthcare
East Melbourne Victoria, 3002, Australia
Precision Haematology
East Melbourne Victoria, 3002, Australia
St Vincent's Hospital (Melbourne)
Fitzroy Victoria, 3065, Australia
Slade Pharmacy
Richmond , 3121, Australia
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna Wien, 1090, Austria
Hanusch-Krankenhaus
Vienna , 1140, Austria
Medizinische Universität Wien
Wien , 1090, Austria
Institut Jules Bordet
Anderlecht Bruxelles-capitale, Région DE, 1070, Belgium
Grand Hôpital de Charleroi
Charleroi Hainaut, 6000, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
Yvoir Namur, 5530, Belgium
ZNA Middelheim
Antwerpen , 2020, Belgium
Zna Cadix
Antwerpen , 2030, Belgium
ZNA Stuivenberg
Antwerpen , 2030, Belgium
Zna Cadix
Antwerpen , 2060, Belgium
ZNA Stuivenberg
Antwerpen , 2060, Belgium
UZ Brussel
Brussel , 1090, Belgium
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador, Bahia, 41253, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre RIO Grande DO SUL, 90110, Brazil
Centro de Pesquisa Clínica - Área Administrativa
Porto Alegre RIO Grande DO SUL, 90850, Brazil
Hospital Mae de Deus
Porto Alegre RIO Grande DO SUL, 90880, Brazil
Ambulatório de QT Convênio
Jaú SÃO Paulo, 17210, Brazil
Hospital Amaral Carvalho
Jaú SÃO Paulo, 17210, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP
Ribeirão Preto SÃO Paulo, 14051, Brazil
BP - A Beneficencia Portuguesa de São Paulo
Sao Paulo SÃO Paulo, 01321, Brazil
Clínica Médica São Germano LTDA
SP SÃO Paulo, 04537, Brazil
Fundação Doutor Amaral Carvalho
Jaú , 17210, Brazil
Américas Medical City
Rio de Janeiro , 22775, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro , 22775, Brazil
ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
São Paulo , 01232, Brazil
HU UNIFESP / SPDM - Hospital São Paulo
São Paulo , 04024, Brazil
Universidade Federal de Sao Paulo
São Paulo , 04024, Brazil
Hospital Japonês Santa Cruz
São Paulo , 04122, Brazil
Clínica Médica São Germano S/S Ltda
São Paulo , 04537, Brazil
Tom Baker Cancer Center
Calgary Alberta, T2N4N, Canada
Dr. Everett Chalmers Regional Hospital
Fredericton New Brunswick, E3B 5, Canada
Saint John Regional Hospital
Saint John New Brunswick, E2L 4, Canada
Hamilton Health Sciences Corporation
Hamilton Ontario, L8L 8, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Windsor Regional Hospital Cancer Program
Windsor Ontario, N8W 1, Canada
Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,
Montreal Quebec, H1T 2, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSS
Montreal Quebec, H4J 1, Canada
Sun Yat-sen University Cancer Center
Guangzhou Guangdong, 51006, China
Tongji Hospital; Tongji Medical college; Huazhong University of Science and Technonogy
Wuhan Hubei, 43003, China
Institute of hematology&blood disease hospital
Tianjin Tianjin, 30002, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou Zhejiang, 32500, China
Shanghai Fourth People's Hospital
Shanghai , 20043, China
Fakultní nemocnice Brno Bohunice
Brno Brno-město, 625 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove Hradec Králové, 500 0, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba Moravskoslezský KRAJ, 708 5, Czechia
Fakultni nemocnice Ostrava
Ostrava Moravskoslezský KRAJ, 708 5, Czechia
Fakultni nemocnice Olomouc
Olomouc , 779 0, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 12808, Czechia
Oulun yliopistollinen sairaala
Oulu Pohjois-pohjanmaa, 90220, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki Uusimaa, 00029, Finland
Turku University Hospital
Turku Varsinais-suomi, 20520, Finland
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse Haute-garonne, 31100, France
Hopital Claude Huriez - CHU de Lille
Lille Nord, 59000, France
Pitie Salpetriere University Hospital
Paris Orne, 75013, France
Gustave Roussy
Villejuif Val-de-marne, 94800, France
Centre Hospitalier Universitaire de Poitiers
Poitiers Vienne, 86021, France
Chu Grenoble Alpes
La Tronche , 38700, France
Hopital Claude Huriez - CHU de Lille
Lille , 59037, France
Hôpital Saint Antoine
Paris Cedex 12 , 75571, France
Hopital Lyon Sud
Pierre Benite , 69495, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours , 37032, France
Hôpital Saint Antoine
Paris Île-de-france, 75571, France
Universitätsklinikum Würzburg
Würzburg Bayern, 97080, Germany
Universitaetsklinikum Koeln
Köln Nordrhein-westfalen, 50937, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz Rheinland-pfalz, 55131, Germany
Universitätsklinikum Leipzig
Leipzig Sachsen, 04103, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel Schleswig-holstein, 24105, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin , 12200, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
Berlin , 12203, Germany
Klinikum Chemnitz gGMbH
Chemnitz , 09116, Germany
Universitätsklinikum Essen
Essen , 45147, Germany
Klinikum rechts der Isar der Technischen Universität München
München , 81675, Germany
Evangelismos General Hospital of Athens
Athens Attikí, 106 7, Greece
Alexandra General Hospital of Athens
Athens Attikí, 115 2, Greece
Theageneio Cancer Hospital of Thessaloniki
Thessaloniki Kentrikí Makedonía, 546 3, Greece
Evangelismos Hospital
Athens , 10676, Greece
University Hospital of Ioannina
Ioannina Ípeiros, 455 0, Greece
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár Somogy, 7400, Hungary
Semmelweis University
Budapest , 1088, Hungary
Dél-Pesti Centrumkórház
Budapest , 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
Nyíregyháza , 4400, Hungary
Artemis hospital
Gurugram Haryana, 12200, India
Medanta-The Medicity
Gurugram Haryana, 12200, India
Fortis Memorial Research Institute
Gurugram Haryana, 12200, India
Christian Medical College Vellore
Ranipet Tamil NADU, 63251, India
Himalayan Institute Hospital Trust University
Dehradun Uttarakhand, 24814, India
Tata Medical Center
Kolkata WEST Bengal, 70016, India
Rajiv Gandhi Cancer Institute And Research Centre
Delhi , 11008, India
Soroka Medical Center
Be'er Sheva Hadarom, 84101, Israel
Rabin Medical Center
Petah-Tikva Hamerkaz, 49100, Israel
Sheba Medical Center
Ramat Gan Hamerkaz, 52621, Israel
Rambam Health Care Campus
Haifa Hatsafon, 31096, Israel
Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
Tel Aviv Tell Abīb, 64239, Israel
Shaare Zedek Medical Center
Jerusalem Yerushalayim, 90131, Israel
Hadassah Medical Center
Jerusalem Yerushalayim, 91120, Israel
Hadassah Mount Scopus Medical Center
Jerusalem Yerushalayim, 91240, Israel
Shaare Zedek Medical Center
Jerusalem , 90131, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola Emilia-romagna, 47014, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma Lazio, 00168, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano Lombardia, 20122, Italy
Policlinico "G. Rodolico"
Catania Sicilia, 95123, Italy
Azienda Ospedaliero Universitaria Senese
Siena Toscana, 53100, Italy
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena Toscana, 53100, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona , 60126, Italy
IRCCS - AOU di Bologna
Bologna , 40138, Italy
AOU Policlinico Umberto I
Roma , 00161, Italy
Nagoya City University Hospital
Nagoya Aichi, 467-8, Japan
Gunma University Hospital
Maebashi Gunma, 371-8, Japan
Iwate Medical University Hospital
Yahaba-cho, Shiwa-gun Iwate, 028-3, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto-shi Kyoto, 602-8, Japan
Tohoku University Hospital
Sendai Miyagi, 980-8, Japan
Hamamatsu University Hospital
Hamamatsu-shi Shizuoka, 431-3, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka, 411-8, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto , 860-0, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto , 602-8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
Osaka Metropolitan University Hospital
Osaka , 545-8, Japan
Japanese Red Cross Medical Center
Tokyo , 150-8, Japan
Yamagata University Hospital
Yamagata , 990-9, Japan
Gachon University Gil Medical Center
Namdong-gu Incheon-gwangyeoksi [incheon], 21565, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun Gun Jeonranamdo, 58128, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam Kyǒnggi-do, 13620, Korea, Republic of
Pusan National University Hospital
Busan Pusan-kwangyǒkshi, 49241, Korea, Republic of
Seoul National University Hospital
Seoul Seoul-teukbyeolsi [seoul], 03080, Korea, Republic of
Samsung Medical Center
Seoul Seoul-teukbyeolsi [seoul], 06351, Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
Seoul Seoul-teukbyeolsi [seoul], 06591, Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul Seoul-teukbyeolsi [seoul], 06591, Korea, Republic of
Kyungpook National University
Daegu Taegu-kwangyǒkshi, 41944, Korea, Republic of
Kyungpook National University Hospital
Jung-gu Taegu-kwangyǒkshi, 41944, Korea, Republic of
HagaZiekenhuis
Den Haag Zuid-holland, 2545 , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht , 6229 , Netherlands
Isala
Zwolle , 8025 , Netherlands
Haukeland Universitetssjukehus
Bergen Hordaland, 5021, Norway
Oslo Universitetssykehus Ullevål
Oslo , 0450, Norway
Stavanger Universitetssykehus
Stavanger , 4011, Norway
Centrum Medyczne Pratia Poznań
Skorzewo Wielkopolskie, 60-18, Poland
Uniwersyteckie Centrum Kliniczne,
Gdansk , 80-21, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan , 60-56, Poland
Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
Warszawa , 02-09, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku
Wroclaw , 50-36, Poland
Pratia Onkologia Katowice
Katowice Śląskie, 40-51, Poland
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela A Coruna, 15706, Spain
Hospital Universitari Vall d'Hebron
Barcelona Barcelona [barcelona], 08035, Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat Barcelona [barcelona], 08908, Spain
Hospital Universitari Mutua Terrassa
Terrassa Barcelona [barcelona], 08221, Spain
Institut Catala d' Oncologia. Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitari Mutua Terrassa
Terrassa Barcelona, 08221, Spain
Hospital Universitario de Salamanca
Salamanca Castilla Y LEÓN, 37007, Spain
Hospital Clínic de Barcelona
Barcelona Catalunya [cataluña], 08036, Spain
Clinica Universidad de Navarra
Madrid Madrid, Comunidad DE, 28027, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon Madrid, 28223, Spain
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
Gerona , 17007, Spain
Hospital La Princesa
Madrid , 28006, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitari i Politecnic La Fe
València , 46026, Spain
Helsingborgs Lasarett
Helsingborg Skåne LÄN [se-12], 251 8, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm Stockholms LÄN [se-01], 141 8, Sweden
Södra Älvsborgs Sjukhus Borås
Borås Västra Götalands LÄN [se-14], 501 8, Sweden
Falu Lasarett
Falun , 791 3, Sweden
Universitetssjukhuset Örebro
Örebro Örebro LÄN [se-18], 701 8, Sweden
Universitetssjukhuset i Linköping
Linköping Östergötlands LÄN [se-05], 581 8, Sweden
China Medical University Hospital
Taichung , 40447, Taiwan
Taichung Veterans General Hospital
Taichung , 407, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan , 333, Taiwan
Medipol Mega Universite Hastanesi
İstanbul İ̇stanbul, 34214, Turkey
Sisli Florence Nightingale Hastanesi
İstanbul İ̇stanbul, 34381, Turkey
Ege Universitesi Hastanesi
Izmir İ̇zmir, 35100, Turkey
Dokuz Eylul Universitesi Hastanesi
İzmir İ̇zmir, 35340, Turkey
Dokuz Eylul Universitesi Hastanesi
İzmir İ̇zmir, 35340, Turkey
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara , 06100, Turkey
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara , 06200, Turkey
Gazi Universitesi
Ankara , 06560, Turkey
Akdeniz Universitesi Hastanesi
Antalya , 07070, Turkey
Aydın Adnan Menderes Universitesi Hastanesi
Aydin , 09100, Turkey
Erciyes Universitesi Tıp Fakultesi Hastaneleri
Kayseri , 38030, Turkey
Özel Anadolu Sağlık Merkezi
Kocaeli , 41400, Turkey

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

760

Study ID:

NCT05317416

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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