Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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
Study ID: NCT05257083
Conditions
Study Description
Brief 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.
Detailed Description: Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel \[cilta-cel\]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is being evaluated to treat participants with multiple myeloma. The primary hypothesis is that in transplant-eligible participants with newly diagnosed multiple myeloma (NDMM), cilta-cel will significantly improve progression-free survival (PFS) and Sustained MRD-negative CR rate compared with Autologous Stem Cell Transplant (ASCT). Approximately 750 participants (375 per arm) will be randomly assigned in a 1:1 ratio into 2 arms.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago, Chicago, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
The University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Mayo Clinic Hospital - Rochester, Rochester, Minnesota, United States
Mount Sinai Medical Venter, 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
Levine Cancer Institute, Charlotte, North Carolina, United States
The Ohio State University, Columbus, Ohio, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Univ. of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Medical College Wisconsin, Milwaukee, Wisconsin, United States
Royal Adelaide Hospital, Adelaide, , Australia
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
St. Vincent's Hospital, Melbourne, , Australia
Fiona Stanley Hospital, Murdoch, , Australia
Calvary Mater Newcastle Hospital, Waratah, , Australia
Westmead Hospital, Westmead, , Australia
UZA, Antwerpen, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Tom Baker Cancer Center, Calgary, , Canada
Cross Cancer Institute, Edmonton, , Canada
McMaster University, Hamilton, , Canada
Hopital Maisonneuve-Rosemont, Montréal, , Canada
Mcgill University Health Centre, Montréal, , 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, Plzen, , Czechia
Vseobecna fakultni nemocnice v Prague, Prague, , Czechia
CHRU de Lille - Hopital Claude Huriez, Lille, , France
Hospices Civils De Lyon, Lyon, , France
CHU De Nantes - Hématologie Clinique, Nantes, , France
Aphp Direction, Paris, , 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
Dresden, Dresden, , Germany
Universitätsklinikum Hamburg - Eppendorf, Hamburg, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) Abt. Medizinische Onkologie, Heidelberg, , 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, Thessaloníki, , Greece
Hadassah University Hospita - Ein Kerem, Jerusalem, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona, Ancona, , Italy
Policlinico S Orsola Malpighi, Bologna, , Italy
A.O.U. Policlinico S. Martino - Ematologia, Genova, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Milan, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin, Turin, , Italy
Juntendo University Hospital, Bunkyō-Ku, , 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, , 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, Sevilla, , Spain
Hospital Universitario la Fe, Valencia, Valencia, , Spain
Sahlgrenska Universitetssjukhuset, Göteborg, , 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
Bern Inselspital, Bern, , Switzerland
Lausanne CHUV Département d'oncologie, Lausanne, , Switzerland
UniversitaetsSpital Zürich, Zürich, , Switzerland
Queen Elizabeth Medical Centre, Birmingham, , United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
Leeds Cancer Centre at St. James's University Hospital, Leeds, , United Kingdom
Contact Details
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