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
NCT ID: NCT05257083
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
759 participants
INTERVENTIONAL
2023-10-10
2040-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
No interventions assigned to this group
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:
1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
2. 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
* 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)
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Stichting European Myeloma Network
NETWORK
Responsible Party
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Locations
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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
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 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
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
Fred Hutchinson Cancer Center
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
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 Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Instituto Catalán de Oncología
Barcelona, , 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
Countries
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Other Identifiers
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2021-003284-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMN28/68284528MMY3005
Identifier Type: -
Identifier Source: org_study_id