Multiple Myeloma Clinical Trial

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)

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT05257083

Recruitment Status:

Recruiting

Sponsor:

Stichting European Myeloma Network

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There are 23 Locations for this study

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University of Arkansas
Little Rock Arkansas, 72205, United States More Info
Van Rhee
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City of Hope
Duarte California, 91010, United States More Info
Htut
Contact
University of California San Francisco (UCSF)
San Francisco California, 94143, United States More Info
Chung
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Stanford University
Stanford California, 94305, United States More Info
Sidana
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Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Freeman
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University of Chicago
Chicago Illinois, 60637, United States More Info
Jakubowiak
Contact
University of Iowa
Iowa City Iowa, 52242, United States More Info
Strouse
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The University of Kansas Cancer Center
Kansas City Kansas, 66160, United States More Info
Shune
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University of Maryland Medical Center
Baltimore Maryland, 21201, United States More Info
Kocoglu
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Boston Medical Center
Boston Massachusetts, 02118, United States More Info
Petrocca
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Mayo Clinic Hospital - Rochester
Rochester Minnesota, 55902, United States More Info
Lin
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Mount Sinai Medical Venter
New York New York, 10029, United States More Info
Rossi
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Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States More Info
Shah
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University of Rochester
Rochester New York, 14642, United States More Info
Lipe
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Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Voorhees
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The Ohio State University
Columbus Ohio, 43210, United States More Info
Khan
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Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Gergis
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Univ. of Pittsburgh Medical Center (UPMC)
Pittsburgh Pennsylvania, 15213, United States More Info
Agha
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University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Anderson
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University of Virginia
Charlottesville Virginia, 22903, United States More Info
Foster
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University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States More Info
Callander
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Medical College Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Dhakal
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Royal Adelaide Hospital
Adelaide , , Australia More Info
Lee
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Princess Alexandra Hospital
Brisbane , , Australia More Info
Abro
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Royal Prince Alfred Hospital
Camperdown , , Australia More Info
Ho
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Royal Brisbane and Womens Hospital
Herston , , Australia More Info
Butler
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Alfred Health
Melbourne , , Australia More Info
Spencer
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Austin Hospital
Melbourne , , Australia More Info
Hocking
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Peter MacCallum Cancer Centre
Melbourne , , Australia More Info
Khot
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St. Vincent's Hospital
Melbourne , , Australia More Info
Quach
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Fiona Stanley Hospital
Murdoch , , Australia More Info
Sidiqi
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Calvary Mater Newcastle Hospital
Waratah , , Australia More Info
Janowski
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Westmead Hospital
Westmead , , Australia More Info
Micklethwaite
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UZA
Antwerpen , , Belgium More Info
Anguille
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UZ Gent
Gent , , Belgium More Info
Kint
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UZ Leuven
Leuven , , Belgium More Info
Delforge
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Tom Baker Cancer Center
Calgary , , Canada More Info
Bahlis
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Cross Cancer Institute
Edmonton , , Canada More Info
Chu
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McMaster University
Hamilton , , Canada More Info
Aljama
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Hopital Maisonneuve-Rosemont
Montréal , , Canada More Info
LeBlanc
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Mcgill University Health Centre
Montréal , , Canada More Info
Sebag
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Ottawa Hospital Research Institute
Ottawa , , Canada More Info
Visram
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(CHU) Centre Hospitalier Universitaire de Quebec Laval
Québec , , Canada More Info
Lemeiux
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Princess Margaret Cancer Centre
Toronto , , Canada More Info
Stewart
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Vancouver General Hospital
Vancouver , , Canada More Info
Song
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Fakultni nemocnice Brno
Brno , , Czechia More Info
Pour
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Fakultni nemocnice Hradec Kralove
Králová , , Czechia More Info
Radocha
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Fakutni nemocnice Ostrava
Ostrava , , Czechia More Info
Hajek
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Fakultni nemocnice Plzen
Plzen , , Czechia More Info
Jungova
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Vseobecna fakultni nemocnice v Prague
Prague , , Czechia More Info
Špička
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CHRU de Lille - Hopital Claude Huriez
Lille , , France More Info
Manier
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Hospices Civils De Lyon
Lyon , , France More Info
Karlin
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CHU De Nantes - Hématologie Clinique
Nantes , , France More Info
Moreau
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Aphp Direction
Paris , , France More Info
Mohty
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CHU Poitiers - Pôle régional de Cancérologie
Poitiers , , France More Info
Leleu
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Leleu
Principal Investigator
Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis
Saint-Louis , , France More Info
Arnulf
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CHU de Toulouse
Toulouse , , France More Info
Perrot
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University Hospital of Cologne
Cologne , , Germany More Info
Scheid
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Dresden
Dresden , , Germany More Info
Teipel
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Universitätsklinikum Hamburg - Eppendorf
Hamburg , , Germany More Info
Weisel
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Nationales Centrum für Tumorerkrankungen (NCT) Abt. Medizinische Onkologie
Heidelberg , , Germany More Info
Raab
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University Hospital of Leipzig
Leipzig , , Germany More Info
Merz
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Tübingen
Tübingen , , Germany More Info
Besemer
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University Hospital of Würzburg
Würzburg , , Germany More Info
Einsele
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Attikon University General Hospital of Attica
Athens , , Greece More Info
Terpos
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'G. Papanikolaou' Hospital of Thessaloniki
Thessaloníki , , Greece More Info
Sakellari
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Hadassah University Hospita - Ein Kerem
Jerusalem , , Israel More Info
Gatt
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Sheba Medical Center
Ramat Gan , , Israel More Info
Magen
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Tel Aviv Sourasky Medical Center
Tel Aviv , , Israel More Info
Cohen
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Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi Di Ancona
Ancona , , Italy More Info
Offidani
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Offidani
Principal Investigator
Policlinico S Orsola Malpighi
Bologna , , Italy More Info
Cavo
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A.O.U. Policlinico S. Martino - Ematologia
Genova , , Italy More Info
Aquino
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Aquino
Principal Investigator
ASST Grande Ospedale Metropolitano Niguarda
Milan , , Italy More Info
Cafro
Contact
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan , , Italy More Info
Corradini
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Fondazione Policlinico Universitario Agostino Gemelli
Roma , , Italy More Info
De Stefano
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A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette, Turin
Turin , , Italy More Info
Bruno
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Juntendo University Hospital
Bunkyō-Ku , , Japan More Info
Ando
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Kyushu University Hospital - Hematology/Oncology
Fukuoka , , Japan More Info
Mori
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Hokkaido University Hospital-Department of Hematology
Hokkaido , , Japan More Info
Teshima
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Hyogo College of Medicine
Hyōgo , , Japan More Info
Yoshihara
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Kanazawa University Hospital
Kanazawa , , Japan More Info
Miyamoto
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Nagoya City University Hospital - Department of Hematology & Oncology
Nagoya , , Japan More Info
Iida
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Okayama University Hospital - Hematology/Oncology
Okayama , , Japan More Info
Fujii
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Osaka metropolitan university hospital
Osaka , , Japan More Info
Nakashima
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Japanese Red Cross Medical Center - Hematology
Shibuya , , Japan More Info
Ishida
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Keio University Hospital - Hematology
Shinjuku-Ku , , Japan More Info
Shimizu
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Tohoku University Hospital - Hematology
Tōhoku , , Japan More Info
Yokoyama
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VU Medisch Centrum
Amsterdam , , Netherlands More Info
Van de Donk
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University Medical Center Groningen
Groningen , , Netherlands More Info
Roeloffzen
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Radboud UMC
Nijmegen , , Netherlands More Info
De Kort
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Erasmus MC
Rotterdam , , Netherlands More Info
Broijl
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UMC Utrecht
Utrecht , , Netherlands More Info
Minnema
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Oslo University Hospital Ullevål - Oncology
Oslo , , Norway More Info
Weum Abrahamsen
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Hospital Universitario Germans Trias i Pujol
Badalona , , Spain More Info
Oriol Rocafiguera
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Hospital Clinic de Barcelona
Barcelona , , Spain More Info
De Larrea Rodriguez
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Instituto Catalán de Oncología
Barcelona , , Spain More Info
Sureda Balari
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Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain More Info
Blanchard Rodríguez
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Clinica Universidad de Navarra
Madrid , , Spain More Info
Rodriguez Otero
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HOSP. UNIV. 12 DE OCTUBRE, Madrid
Madrid , , Spain More Info
Martínez-López
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Hospital General Universitario Gregorio Marañón
Madrid , , Spain More Info
Encinas Rodríguez
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Hospital Universitario 12 de Octubre
Madrid , , Spain More Info
Martínez López
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Ramon y Cajal, Madrid
Madrid , , Spain More Info
Blanchard
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CLINICA UNIV. DE NAVARRA, Pamplona
Pamplona , , Spain More Info
Rodríguez Otero
Contact
Hospital Universitario de Salamanca
Salamanca , , Spain More Info
Mateos
Contact
Mateos
Principal Investigator
Hospital de Santiago de Compostela
Santiago De Compostela , , Spain More Info
González Pérez
Contact
Hosp. Virgen Del Rocio
Sevilla , , Spain More Info
Ortega
Contact
Hospital Universitario Virgen del Rocío
Sevilla , , Spain More Info
Reguera Ortega
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Hospital Universitario la Fe, Valencia
Valencia , , Spain More Info
de la Rubia
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Sahlgrenska Universitetssjukhuset
Göteborg , , Sweden More Info
Hansson
Contact
Landstinget i Ostergotland-Universitetssjukhuset i Linkoping
Linköping , , Sweden More Info
Lagerlof
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Skånes University Hospital Lund
Lund , , Sweden More Info
Wichert
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Akademiska Sjukhuset
Uppsala , , Sweden More Info
Carlson
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Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
Basel , , Switzerland More Info
Heim
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Bern Inselspital
Bern , , Switzerland More Info
Pabst
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Lausanne CHUV Département d'oncologie
Lausanne , , Switzerland More Info
Cairoli
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UniversitaetsSpital Zürich
Zürich , , Switzerland More Info
Müller
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Queen Elizabeth Medical Centre
Birmingham , , United Kingdom More Info
Ferguson
Contact
University Hospital of Wales
Cardiff , , United Kingdom More Info
Bygrave
Contact
Leeds Cancer Centre at St. James's University Hospital
Leeds , , United Kingdom More Info
Cook
Contact

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT05257083

Recruitment Status:

Recruiting

Sponsor:


Stichting European Myeloma Network

How clear is this clinincal trial information?

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