A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

759

Participants

Timeline

Start Date

October 10, 2023

Primary Completion Date

June 30, 2033

Study Completion Date

August 31, 2040

Conditions
Multiple Myeloma
Interventions
DRUG

Daratumumab

Daratumumab will be administered SC.

DRUG

Bortezomib

Bortezomib will be administered SC.

DRUG

Lenalidomide

Lenalidomide will be administered orally.

DRUG

Dexamethasone

Dexamethasone will be administered orally.

DRUG

Cilta-cel

Cilta-cel will be administered intravenously

DRUG

Cyclophosphamide

Cyclophosphamide will be administered intravenously.

DRUG

Fludarabine

Fludarabine will be administered intravenously.

Trial Locations (109)

10029

Mount Sinai Medical Venter, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

10461

Montefiore M-E Center, The Bronx

12902

Moffitt Cancer Center, Tampa

14642

University of Rochester, Rochester

19107

Thomas Jefferson University Hospital, Philadelphia

21201

University Of Maryland Medical Center, Baltimore

22903

University of Virginia, Charlottesville

27705

Duke University Medical Center, Durham

28034

Hospital Universitario Ramón y Cajal, Madrid

28204

Levine Cancer Institute, Charlotte

30322

Emory University Hospital, Atlanta

43210

The Ohio State University, Columbus

44195

Cleveland Clinic, Cleveland

48201

Karmanos Cancer Center, Detroit

52242

University of Iowa, Iowa City

53226

Medical College Wisconsin, Milwaukee

55902

Mayo Clinic Hospital - Rochester, Rochester

60637

University of Chicago, Chicago

72205

University of Arkansas, Little Rock

75390

University of Texas Southwestern Medical Center, Dallas

91010

City of Hope, Duarte

92037

UC San Diego Health Moores Cancer Center, San Diego

94143

University of California San Francisco (UCSF), San Francisco

94305

Stanford University, Stanford

98109

Fred Hutchinson Cancer Center, Seattle

02114

Massachusetts General Hospital, Boston

02118

Boston Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

Unknown

Princess Alexandra Hospital, Brisbane

Royal Prince Alfred Hospital, Camperdown

Royal Brisbane and Womens Hospital, Herston

Alfred Health, Melbourne

Austin Hospital, Melbourne

Peter MacCallum Cancer Centre, Melbourne

Fiona Stanley Hospital, Murdoch

Calvary Mater Newcastle Hospital, Waratah

Westmead Hospital, Westmead

Jules Bordet Instituut, Anderlecht

UZA, Antwerp

UZ Gent, Ghent

UZ Leuven, Leuven

Cross Cancer Institute, Edmonton

McMaster University, Hamilton

Hopital Maisonneuve-Rosemont, Montreal

Mcgill University Health Centre, Montreal

Ottawa Hospital Research Institute, Ottawa

(CHU) Centre Hospitalier Universitaire de Quebec Laval, Québec

Princess Margaret Cancer Centre, Toronto

Vancouver General Hospital, Vancouver

Fakultni nemocnice Brno, Brno

Fakultni nemocnice Hradec Kralove, Králová

Fakutni nemocnice Ostrava, Ostrava

Fakultni nemocnice Plzen, Pilsen

Vseobecna fakultni nemocnice v Prague, Prague

CHRU de Lille - Hopital Claude Huriez, Lille

Hospices Civils De Lyon, Lyon

CHU De Nantes - Hématologie Clinique, Nantes

CHU Poitiers - Pôle régional de Cancérologie, Poitiers

Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis, Saint-Louis

CHU de Toulouse, Toulouse

University Hospital of Cologne, Cologne

Universitätsklinikum Hamburg - Eppendorf, Hamburg

University Hospital of Leipzig, Leipzig

Tübingen, Tübingen

University Hospital of Würzburg, Würzburg

Attikon University General Hospital of Attica, Athens

'G. Papanikolaou' Hospital of Thessaloniki, Thessaloniki

Hadassah Medical Center, Jerusalem

Sheba medical center, Ramat Gan

Tel Aviv Sourasky Medical Center, Tel Aviv

Juntendo University Hospital, Bunkyō City

Kyushu University Hospital - Hematology/Oncology, Fukuoka

Hokkaido University Hospital-Department of Hematology, Hokkaido

Hyogo College of Medicine, Hyōgo

Kanazawa University Hospital, Kanazawa

Nagoya City University Hospital - Department of Hematology & Oncology, Nagoya

Okayama University Hospital - Hematology/Oncology, Okayama

Osaka metropolitan university hospital, Osaka

Japanese Red Cross Medical Center - Hematology, Shibuya City

Keio University Hospital - Hematology, Shinjuku-Ku

Tohoku University Hospital - Hematology, Tōhoku

VU Medisch Centrum, Amsterdam

University Medical Center Groningen, Groningen

Radboud UMC, Nijmegen

Erasmus MC, Rotterdam

UMC Utrecht, Utrecht

Oslo University Hospital Ullevål - Oncology, Oslo

Hospital Universitario Germans Trias i Pujol, Badalona

Hospital Clinic de Barcelona, Barcelona

Instituto Catalán de Oncología, Barcelona

Hospital General Universitario Gregorio Marañón, Madrid

Hospital Universitario 12 de Octubre, Madrid

CLINICA UNIV. DE NAVARRA, Pamplona, Pamplona

Hospital Universitario de Salamanca, Salamanca

Hospital de Santiago de Compostela, Santiago de Compostela

Hospital Universitario Virgen del Rocío, Seville

Hospital Universitario la Fe, Valencia, Valencia

Sahlgrenska Universitetssjukhuset, Gothenburg

Landstinget i Ostergotland-Universitetssjukhuset i Linkoping, Linköping

Skånes University Hospital Lund, Lund

Akademiska Sjukhuset, Uppsala

Universitaetsspital Basel - Zentrum fur Hamato-Onkologie, Basel

Universitaetsspital Bern, Inselspital, Bern

Centre Hospitalier Universitaire Vaudois (CHUV)Département d'oncologie, Lausanne

Universitaetsspital Zuerich -Universitaeren Herzzentrum Zuerich, Zurich

Queen Elizabeth Medical Centre, Birmingham

University Hospital of Wales, Cardiff

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Stichting European Myeloma Network

NETWORK

NCT05257083 - A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma | Biotech Hunter | Biotech Hunter