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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05257083 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Stichting European Myeloma Network |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
Overall Status | Recruiting |
Countries | Australia, Belgium, Canada, Czechia, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
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.
Active Comparator: Arm A: DVRd + ASCT+DVRd (Standard Therapy)
Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 4 induction cycles. Followed by ASCT and 2 cycles of DVRd consolidation, and lenalidomide maintenance therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years
Experimental: Arm B: DVRd followed by Ciltacabtagene Autoleucel
Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 6 induction cycles. Participants will receive a conditioning regimen (cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3 days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg), followed by lenalidomide post CAR-T cell therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist of 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years
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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Not yet recruiting
Address
University of Arkansas
Little Rock, Arkansas, 72205
Status
Not yet recruiting
Address
City of Hope
Duarte, California, 91010
Status
Not yet recruiting
Address
University of California San Francisco (UCSF)
San Francisco, California, 94143
Status
Not yet recruiting
Address
Stanford University
Stanford, California, 94305
Status
Not yet recruiting
Address
Moffitt Cancer Center
Tampa, Florida, 33612
Status
Not yet recruiting
Address
University of Chicago
Chicago, Illinois, 60637
Status
Not yet recruiting
Address
University of Iowa
Iowa City, Iowa, 52242
Status
Not yet recruiting
Address
The University of Kansas Cancer Center
Kansas City, Kansas, 66160
Status
Not yet recruiting
Address
University of Maryland Medical Center
Baltimore, Maryland, 21201
Status
Not yet recruiting
Address
Boston Medical Center
Boston, Massachusetts, 02118
Status
Not yet recruiting
Address
Mayo Clinic Hospital - Rochester
Rochester, Minnesota, 55902
Status
Not yet recruiting
Address
Mount Sinai Medical Venter
New York, New York, 10029
Status
Not yet recruiting
Address
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Status
Not yet recruiting
Address
University of Rochester
Rochester, New York, 14642
Status
Not yet recruiting
Address
Levine Cancer Institute
Charlotte, North Carolina, 28204
Status
Not yet recruiting
Address
The Ohio State University
Columbus, Ohio, 43210
Status
Not yet recruiting
Address
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Status
Not yet recruiting
Address
Univ. of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Status
Not yet recruiting
Address
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Status
Not yet recruiting
Address
University of Virginia
Charlottesville, Virginia, 22903
Status
Not yet recruiting
Address
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Status
Not yet recruiting
Address
Medical College Wisconsin
Milwaukee, Wisconsin, 53226
Status
Not yet recruiting
Address
Royal Adelaide Hospital
Adelaide, ,
Status
Not yet recruiting
Address
Princess Alexandra Hospital
Brisbane, ,
Status
Recruiting
Address
Royal Prince Alfred Hospital
Camperdown, ,
Status
Not yet recruiting
Address
Royal Brisbane and Womens Hospital
Herston, ,
Status
Recruiting
Address
Alfred Health
Melbourne, ,
Status
Not yet recruiting
Address
Austin Hospital
Melbourne, ,
Status
Recruiting
Address
Peter MacCallum Cancer Centre
Melbourne, ,
Status
Not yet recruiting
Address
St. Vincent's Hospital
Melbourne, ,
Status
Not yet recruiting
Address
Fiona Stanley Hospital
Murdoch, ,
Status
Not yet recruiting
Address
Calvary Mater Newcastle Hospital
Waratah, ,
Status
Not yet recruiting
Address
Westmead Hospital
Westmead, ,
Status
Recruiting
Address
UZA
Antwerpen, ,
Status
Recruiting
Address
UZ Leuven
Leuven, ,
Status
Not yet recruiting
Address
Tom Baker Cancer Center
Calgary, ,
Status
Not yet recruiting
Address
Cross Cancer Institute
Edmonton, ,
Status
Not yet recruiting
Address
McMaster University
Hamilton, ,
Status
Not yet recruiting
Address
Hopital Maisonneuve-Rosemont
Montréal, ,
Status
Not yet recruiting
Address
Mcgill University Health Centre
Montréal, ,
Status
Not yet recruiting
Address
Ottawa Hospital Research Institute
Ottawa, ,
Status
Not yet recruiting
Address
(CHU) Centre Hospitalier Universitaire de Quebec Laval
Québec, ,
Status
Not yet recruiting
Address
Princess Margaret Cancer Centre
Toronto, ,
Status
Not yet recruiting
Address
Vancouver General Hospital
Vancouver, ,
Status
Not yet recruiting
Address
Fakultni nemocnice Brno
Brno, ,
Status
Recruiting
Address
Fakultni nemocnice Hradec Kralove
Králová, ,
Status
Recruiting
Address
Fakutni nemocnice Ostrava
Ostrava, ,
Status
Recruiting
Address
Fakultni nemocnice Plzen
Plzen, ,
Status
Not yet recruiting
Address
Vseobecna fakultni nemocnice v Prague
Prague, ,
Status
Not yet recruiting
Address
CHRU de Lille - Hopital Claude Huriez
Lille, ,
Status
Not yet recruiting
Address
Hospices Civils De Lyon
Lyon, ,
Status
Not yet recruiting
Address
CHU De Nantes - Hématologie Clinique
Nantes, ,
Status
Not yet recruiting
Address
Aphp Direction
Paris, ,
Status
Not yet recruiting
Address
CHU Poitiers - Pôle régional de Cancérologie
Poitiers, ,
Status
Not yet recruiting
Address
Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis
Saint-Louis, ,
Status
Not yet recruiting
Address
CHU de Toulouse
Toulouse, ,
Status
Not yet recruiting
Address
University Hospital of Cologne
Cologne, ,
Status
Not yet recruiting
Address
Dresden
Dresden, ,
Status
Not yet recruiting
Address
Universitätsklinikum Hamburg - Eppendorf
Hamburg, ,
Status
Not yet recruiting
Address
Nationales Centrum für Tumorerkrankungen (NCT) Abt. Medizinische Onkologie
Heidelberg, ,
Status
Not yet recruiting
Address
University Hospital of Leipzig
Leipzig, ,
Status
Not yet recruiting
Address
Tübingen
Tübingen, ,
Status
Not yet recruiting
Address
University Hospital of Würzburg
Würzburg, ,
Status
Recruiting
Address
Attikon University General Hospital of Attica
Athens, ,
Status
Recruiting
Address
'G. Papanikolaou' Hospital of Thessaloniki
Thessaloníki, ,
Status
Not yet recruiting
Address
Hadassah University Hospita - Ein Kerem
Jerusalem, ,
Status
Not yet recruiting
Address
Sheba Medical Center
Ramat Gan, ,
Status
Not yet recruiting
Address
Tel Aviv Sourasky Medical Center
Tel Aviv, ,
Status
Not yet recruiting
Address
Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona
Ancona, ,
Status
Not yet recruiting
Address
Policlinico S Orsola Malpighi
Bologna, ,
Status
Not yet recruiting
Address
A.O.U. Policlinico S. Martino - Ematologia
Genova, ,
Status
Not yet recruiting
Address
ASST Grande Ospedale Metropolitano Niguarda
Milan, ,
Status
Not yet recruiting
Address
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, ,
Status
Not yet recruiting
Address
Fondazione Policlinico Universitario Agostino Gemelli
Roma, ,
Status
Not yet recruiting
Address
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin
Turin, ,
Status
Not yet recruiting
Address
Juntendo University Hospital
Bunkyō-Ku, ,
Status
Not yet recruiting
Address
Kyushu University Hospital - Hematology/Oncology
Fukuoka, ,
Status
Not yet recruiting
Address
Hokkaido University Hospital-Department of Hematology
Hokkaido, ,
Status
Not yet recruiting
Address
Hyogo College of Medicine
Hyōgo, ,
Status
Not yet recruiting
Address
Kanazawa University Hospital
Kanazawa, ,
Status
Not yet recruiting
Address
Nagoya City University Hospital - Department of Hematology & Oncology
Nagoya, ,
Status
Not yet recruiting
Address
Okayama University Hospital - Hematology/Oncology
Okayama, ,
Status
Not yet recruiting
Address
Osaka metropolitan university hospital
Osaka, ,
Status
Not yet recruiting
Address
Japanese Red Cross Medical Center - Hematology
Shibuya, ,
Status
Not yet recruiting
Address
Keio University Hospital - Hematology
Shinjuku-Ku, ,
Status
Not yet recruiting
Address
Tohoku University Hospital - Hematology
Tōhoku, ,
Status
Recruiting
Address
VU Medisch Centrum
Amsterdam, ,
Status
Recruiting
Address
University Medical Center Groningen
Groningen, ,
Status
Recruiting
Address
Radboud UMC
Nijmegen, ,
Status
Recruiting
Address
Erasmus MC
Rotterdam, ,
Status
Recruiting
Address
UMC Utrecht
Utrecht, ,
Status
Recruiting
Address
Oslo University Hospital Ullevål - Oncology
Oslo, ,
Status
Recruiting
Address
Hospital Universitario Germans Trias i Pujol
Badalona, ,
Status
Recruiting
Address
Hospital Clinic de Barcelona
Barcelona, ,
Status
Recruiting
Address
Instituto Catalán de Oncología
Barcelona, ,
Status
Not yet recruiting
Address
Hospital Universitario Ramón y Cajal
Madrid, , 28034
Status
Recruiting
Address
Clinica Universidad de Navarra
Madrid, ,
Status
Recruiting
Address
HOSP. UNIV. 12 DE OCTUBRE, Madrid
Madrid, ,
Status
Recruiting
Address
Hospital General Universitario Gregorio Marañón
Madrid, ,
Status
Recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, ,
Status
Recruiting
Address
Ramon y Cajal, Madrid
Madrid, ,
Status
Recruiting
Address
CLINICA UNIV. DE NAVARRA, Pamplona
Pamplona, ,
Status
Recruiting
Address
Hospital Universitario de Salamanca
Salamanca, ,
Status
Recruiting
Address
Hospital de Santiago de Compostela
Santiago De Compostela, ,
Status
Not yet recruiting
Address
Hosp. Virgen Del Rocio
Sevilla, ,
Status
Recruiting
Address
Hospital Universitario Virgen del Rocío
Sevilla, ,
Status
Recruiting
Address
Hospital Universitario la Fe, Valencia
Valencia, ,
Status
Recruiting
Address
Sahlgrenska Universitetssjukhuset
Göteborg, ,
Status
Recruiting
Address
Landstinget i Ostergotland-Universitetssjukhuset i Linkoping
Linköping, ,
Status
Recruiting
Address
Skånes University Hospital Lund
Lund, ,
Status
Not yet recruiting
Address
Akademiska Sjukhuset
Uppsala, ,
Status
Not yet recruiting
Address
Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
Basel, ,
Status
Not yet recruiting
Address
Bern Inselspital
Bern, ,
Status
Not yet recruiting
Address
Lausanne CHUV Département d'oncologie
Lausanne, ,
Status
Not yet recruiting
Address
UniversitaetsSpital Zürich
Zürich, ,
Status
Not yet recruiting
Address
Queen Elizabeth Medical Centre
Birmingham, ,
Status
Not yet recruiting
Address
University Hospital of Wales
Cardiff, ,
Status
Not yet recruiting
Address
Leeds Cancer Centre at St. James's University Hospital
Leeds, ,