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 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.
View Full Description Full 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.
View Eligibility Criteria Eligibility Criteria Inclusion Criteria: Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan. Measurable disease, as assessed by central laboratory, at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. ECOG performance status of grade 0 or 1 Clinical laboratory values within prespecified range. Exclusion Criteria: Prior treatment with CAR-T therapy directed at any target. Any prior BCMA target therapy. Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization. Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
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There are 32 Locations for this study
University of Arkansas Little Rock Arkansas, 72205, United States
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City of Hope Duarte California, 91010, United States
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UC San Diego Health Moores Cancer Center San Diego California, 92037, United States
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University of California San Francisco (UCSF) San Francisco California, 94143, United States
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Stanford University Stanford California, 94305, United States
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Moffitt Cancer Center Tampa Florida, 12902, United States
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Emory University Hospital Atlanta Georgia, 30322, United States
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University of Chicago Chicago Illinois, 60637, United States
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University of Iowa Iowa City Iowa, 52242, United States
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The University of Kansas Cancer Center Kansas City Kansas, 66160, United States
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University of Maryland Medical Center Baltimore Maryland, 21201, United States
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Massachusetts General Hospital Boston Massachusetts, 02114, United States
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Boston Medical Center Boston Massachusetts, 02118, United States
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Beth Israel Deaconess Medical Center Boston Massachusetts, 02215, United States
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Dana-Farber Cancer Institute Boston Massachusetts, 02215, United States
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Karmanos Cancer Institute Detroit Michigan, 48201, United States
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Mayo Clinic Hospital - Rochester Rochester Minnesota, 55902, United States
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Montefiore M-E Center Bronx New York, 10461, United States
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Mount Sinai Medical Venter New York New York, 10029, United States
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Memorial Sloan-Kettering Cancer Center New York New York, 10065, United States
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University of Rochester Rochester New York, 14642, United States
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Levine Cancer Institute Charlotte North Carolina, 28204, United States
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Duke Cancer Institute Durham North Carolina, 27710, United States
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Cleveland Clinic Cleveland Ohio, 44195, United States
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The Ohio State University Columbus Ohio, 43210, United States
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Thomas Jefferson University Hospital Philadelphia Pennsylvania, 19107, United States
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Univ. of Pittsburgh Medical Center (UPMC) Pittsburgh Pennsylvania, 15213, United States
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University of Texas Southwestern Medical Center Dallas Texas, 75390, United States
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University of Virginia Charlottesville Virginia, 22903, United States
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Fred Hutchinson Cancer Center Seattle Washington, 98109, United States
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University of Wisconsin Hospital and Clinics Madison Wisconsin, 53792, United States
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Medical College Wisconsin Milwaukee Wisconsin, 53226, United States
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Royal Adelaide Hospital Adelaide , , Australia
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Princess Alexandra Hospital Brisbane , , Australia
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Royal Prince Alfred Hospital Camperdown , , Australia
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Royal Brisbane and Womens Hospital Herston , , Australia
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Alfred Health Melbourne , , Australia
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Austin Hospital Melbourne , , Australia
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Peter MacCallum Cancer Centre Melbourne , , Australia
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St. Vincent's Hospital Melbourne , , Australia
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Fiona Stanley Hospital Murdoch , , Australia
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Calvary Mater Newcastle Hospital Waratah , , Australia
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Westmead Hospital Westmead , , Australia
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Tom Baker Cancer Center Calgary , , Canada
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Cross Cancer Institute Edmonton , , Canada
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McMaster University Hamilton , , Canada
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Hopital Maisonneuve-Rosemont Montréal , , Canada
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Mcgill University Health Centre Montréal , , Canada
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Ottawa Hospital Research Institute Ottawa , , Canada
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(CHU) Centre Hospitalier Universitaire de Quebec Laval Québec , , Canada
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Princess Margaret Cancer Centre Toronto , , Canada
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Vancouver General Hospital Vancouver , , Canada
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Fakultni nemocnice Brno Brno , , Czechia
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Fakultni nemocnice Hradec Kralove Králová , , Czechia
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Fakutni nemocnice Ostrava Ostrava , , Czechia
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Fakultni nemocnice Plzen Plzen , , Czechia
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Vseobecna fakultni nemocnice v Prague Prague , , Czechia
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CHRU de Lille - Hopital Claude Huriez Lille , , France
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Hospices Civils De Lyon Lyon , , France
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CHU De Nantes - Hématologie Clinique Nantes , , France
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CHU Poitiers - Pôle régional de Cancérologie Poitiers , , France
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Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis Saint-Louis , , France
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CHU de Toulouse Toulouse , , France
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University Hospital of Cologne Cologne , , Germany
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Universitätsklinikum Hamburg - Eppendorf Hamburg , , Germany
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Nationales Centrum für Tumorerkrankungen (NCT) Abt. Medizinische Onkologie Heidelberg , , Germany
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University Hospital of Leipzig Leipzig , , Germany
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University Hospital of Würzburg Würzburg , , Germany
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Attikon University General Hospital of Attica Athens , , Greece
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'G. Papanikolaou' Hospital of Thessaloniki Thessaloníki , , Greece
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Hadassah University Hospita - Ein Kerem Jerusalem , , Israel
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Sheba Medical Center Ramat Gan , , Israel
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Tel Aviv Sourasky Medical Center Tel Aviv , , Israel
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Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona Ancona , , Italy
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Policlinico S Orsola Malpighi Bologna , , Italy
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A.O.U. Policlinico S. Martino - Ematologia Genova , , Italy
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ASST Grande Ospedale Metropolitano Niguarda Milan , , Italy
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Milan , , Italy
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Fondazione Policlinico Universitario Agostino Gemelli Roma , , Italy
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A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin Turin , , Italy
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Juntendo University Hospital Bunkyō-Ku , , Japan
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Kyushu University Hospital - Hematology/Oncology Fukuoka , , Japan
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Hokkaido University Hospital-Department of Hematology Hokkaido , , Japan
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Hyogo College of Medicine Hyōgo , , Japan
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Kanazawa University Hospital Kanazawa , , Japan
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Nagoya City University Hospital - Department of Hematology & Oncology Nagoya , , Japan
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Okayama University Hospital - Hematology/Oncology Okayama , , Japan
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Osaka metropolitan university hospital Osaka , , Japan
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Japanese Red Cross Medical Center - Hematology Shibuya , , Japan
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Keio University Hospital - Hematology Shinjuku-Ku , , Japan
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Tohoku University Hospital - Hematology Tōhoku , , Japan
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VU Medisch Centrum Amsterdam , , Netherlands
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University Medical Center Groningen Groningen , , Netherlands
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Radboud UMC Nijmegen , , Netherlands
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Erasmus MC Rotterdam , , Netherlands
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UMC Utrecht Utrecht , , Netherlands
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Oslo University Hospital Ullevål - Oncology Oslo , , Norway
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Hospital Universitario Germans Trias i Pujol Badalona , , Spain
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Hospital Clinic de Barcelona Barcelona , , Spain
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Instituto Catalán de Oncología Barcelona , , Spain
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Hospital Universitario Ramón y Cajal Madrid , 28034, Spain
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Hospital General Universitario Gregorio Marañón Madrid , , Spain
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Hospital Universitario 12 de Octubre Madrid , , Spain
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CLINICA UNIV. DE NAVARRA, Pamplona Pamplona , , Spain
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Hospital Universitario de Salamanca Salamanca , , Spain
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Hospital de Santiago de Compostela Santiago De Compostela , , Spain
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Hospital Universitario Virgen del Rocío Sevilla , , Spain
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Hospital Universitario la Fe, Valencia Valencia , , Spain
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Sahlgrenska Universitetssjukhuset Göteborg , , Sweden
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Landstinget i Ostergotland-Universitetssjukhuset i Linkoping Linköping , , Sweden
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Skånes University Hospital Lund Lund , , Sweden
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Akademiska Sjukhuset Uppsala , , Sweden
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Universitaetsspital Basel - Zentrum fur Hamato-Onkologie Basel , , Switzerland
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Bern Inselspital Bern , , Switzerland
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Lausanne CHUV Département d'oncologie Lausanne , , Switzerland
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UniversitaetsSpital Zürich Zürich , , Switzerland
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Queen Elizabeth Medical Centre Birmingham , , United Kingdom
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University Hospital of Wales Cardiff , , United Kingdom
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Leeds Cancer Centre at St. James's University Hospital Leeds , , United Kingdom
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