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NCT04923893: Phase 3 - VRd followed by Cilta-cel Vs VRd f/b Rd - NDMM- (No ASCT planned) CARTITUDE-5

Updated: Oct 3, 2022

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)

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

Janssen Research & Development, LLC


Legend Biotech

 

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


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 A... | Global Trial Finder (janssen.com)

 

CART - BCMA : National Cancer Institute

JNJ-68284528 - ciltacabtagene autoleucel


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


Click here for details

 

- 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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