NCT04923893: Phase 3 - VRd followed by Cilta-cel Vs VRd f/b Rd - NDMM- (No ASCT planned) CARTITUDE-5
- Recruiting
- Dec 1, 2021
- 3 min read
Updated: Jan 27, 2024
CARTITUDE-5
Phase 3
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (CARTITUDE-5)
The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (CARTITUDE-5)
Sponsor
ClinicalTrials.gov Identifier: NCT04923893
Official Title: A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
First Posted : June 11, 2021
Click here for details on ClinicalTrials.gov
CART
JNJ-68284528
Ciltacabtagene Autoleucel
Drug: Bortezomib
Drug: Dexamethasone
Drug: Lenalidomide
Drug: Cilta-cel
Drug: Cyclophosphamide
Drug: Fludarabine
1835 Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed By Ciltacabtagene Autoleucel Versus Vrd Followed By Lenalidomide and Dexamethasone (Rd) Maintenance in Patients with Newly Diagnosed Multiple Myeloma Not Intended for Transplant: A Randomized, Phase 3 Study (CARTITUDE-5)
Program: Oral and Poster Abstracts
Session: 731. Autologous Transplantation: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Clinical Trials, Biological, Clinical Research, Plasma Cell Disorders, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Diseases, Therapies, Lymphoid Malignancies, Infusion
Saturday, December 11, 2021, 5:30 PM-7:30 PM
- California: University of California San Francisco
- Iowa: University of Iowa Iowa city
- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston
- Massachusetts: Massachusetts General Hospital Boston
- Michigan: Barbara Ann Karmanos Cancer Institute Detroit
- Minnesota: Mayo Clinic Rochester Minnesota
- New York: Memorial Sloan-Kettering Cancer Center New York
- New York: Columbia University Medical Center New York
- North Carolina: Levine Cancer Institute Charlotte
- Pennsylvania: University of Pittsburgh Medical Center
- Texas: UT Southwestern Medical Center Dallas
- Wisconsin: Medical College Of Wisconsin Milwaukee
Locations
United States, California
United States, Connecticut
United States, Florida
United States, Iowa
United States, Kansas
United States, Kentucky
United States, Maryland
United States, Massachusetts
United States, Michigan
United States, Minnesota
United States, New York
United States, North Carolina
United States, Pennsylvania
United States, Texas
United States, Virginia
United States, Wisconsin
Canada
Canada, Alberta
Canada, Ontario
Canada, Quebec
Argentina
Brazil
Europe
United Kingdom
France
Germany
Italy
Netherlands
Spain
Austria
Belgium
Czechia
Denmark
Finland
Greece
Hungary
Ireland
Norway
Poland
Portugal
Sweden
Switzerland
Asia
Israel
Korea, Republic of
Japan
Australia
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