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ACTIVE NOT RECRUITING
NCT05257083
PHASE3

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

View on ClinicalTrials.gov

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

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.

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