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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
Sponsor: Stichting European Myeloma Network
Summary
The purpose of this study is to compare the efficacy 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 newly diagnosed multiple myeloma patients.
Official title: A Phase 3 Randomized Study Comparing 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 Who Are Transplant Eligible
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
759
Start Date
2023-10-10
Completion Date
2040-08
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Daratumumab
Daratumumab will be administered SC.
Bortezomib
Bortezomib will be administered SC.
Lenalidomide
Lenalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered orally.
Cilta-cel
Cilta-cel will be administered intravenously
Cyclophosphamide
Cyclophosphamide will be administered intravenously.
Fludarabine
Fludarabine will be administered intravenously.
Locations (106)
University of Arkansas
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
UC San Diego Health Moores Cancer Center
San Diego, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Stanford University
Stanford, California, United States
Moffit Cancer Center
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University Of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Mount Sinai Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Montefiore M-E Center
The Bronx, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington Medical
Seattle, Washington, United States
Medical College Wisconsin
Milwaukee, Wisconsin, United States
Princess Alexandra Hospital
Brisbane, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Royal Brisbane and Womens Hospital
Herston, Australia
Alfred Health
Melbourne, Australia
Austin Hospital
Melbourne, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
Fiona Stanley Hospital
Murdoch, Australia
Calvary Mater Newcastle Hospital
Waratah, Australia
Westmead Hospital
Westmead, Australia
Jules Bordet Instituut
Anderlecht, Belgium
UZA
Antwerp, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Cross Cancer Institute
Edmonton, Canada
McMaster University
Hamilton, Canada
Hopital Maisonneuve-Rosemont
Montreal, Canada
Mcgill University Health Centre
Montreal, Canada
Ottawa Hospital Research Institute
Ottawa, Canada
(CHU) Centre Hospitalier Universitaire de Quebec Laval
Québec, Canada
Princess Margaret Cancer Centre
Toronto, Canada
Vancouver General Hospital
Vancouver, Canada
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Hradec Kralove
Králová, Czechia
Fakutni nemocnice Ostrava
Ostrava, Czechia
Fakultni nemocnice Plzen
Pilsen, Czechia
CHRU de Lille - Hopital Claude Huriez
Lille, France
Hospices Civils De Lyon
Lyon, France
CHU De Nantes - Hématologie Clinique
Nantes, France
CHU Poitiers - Pôle régional de Cancérologie
Poitiers, France
Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis
Saint-Louis, France
CHU de Toulouse
Toulouse, France
University Hospital of Cologne
Cologne, Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg, Germany
University Hospital of Leipzig
Leipzig, Germany
Tübingen
Tübingen, Germany
University Hospital of Würzburg
Würzburg, Germany
Attikon University General Hospital of Attica
Athens, Greece
'G. Papanikolaou' Hospital of Thessaloniki
Thessaloniki, Greece
Hadassah Medical Center
Jerusalem, Israel
Sheba medical center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Juntendo University Hospital
Bunkyō City, Japan
Kyushu University Hospital - Hematology/Oncology
Fukuoka, Japan
Hokkaido University Hospital-Department of Hematology
Hokkaido, Japan
Hyogo College of Medicine
Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Japan
Nagoya City University Hospital - Department of Hematology & Oncology
Nagoya, Japan
Okayama University Hospital - Hematology/Oncology
Okayama, Japan
Osaka metropolitan university hospital
Osaka, Japan
Japanese Red Cross Medical Center - Hematology
Shibuya City, Japan
Keio University Hospital - Hematology
Shinjuku-Ku, Japan
Tohoku University Hospital - Hematology
Tōhoku, Japan
VU Medisch Centrum
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Radboud UMC
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
Oslo University Hospital Ullevål - Oncology
Oslo, Norway
Hospital Universitario Germans Trias i Pujol
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Instituto Catalán de Oncología
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
CLINICA UNIV. DE NAVARRA, Pamplona
Pamplona, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario la Fe, Valencia
Valencia, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Landstinget i Ostergotland-Universitetssjukhuset i Linkoping
Linköping, Sweden
Skånes University Hospital Lund
Lund, Sweden
Akademiska Sjukhuset
Uppsala, Sweden
Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
Basel, Switzerland
Universitaetsspital Bern, Inselspital
Bern, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)Département d'oncologie
Lausanne, Switzerland
Universitaetsspital Zuerich -Universitaeren Herzzentrum Zuerich
Zurich, Switzerland
Queen Elizabeth Medical Centre
Birmingham, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom