• Recruiting

NCT03651128: Phase 3 - Study of bb2121 Vs Standard Regimens Refractory Myeloma (RRMM) (KarMMa-3)

Updated: Oct 3

KarMMa-3

bb2121

Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

karmma3
 
KarMMa3 myeloma bb2121 trial
 

Relapsed & Refractory Myeloma

This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM).

The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.


Sponsor

Celgene


Bristol Myers Squibb

2senenty bio

 

ClinicalTrials.gov Identifier: NCT03651128

Official Title: A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

First Posted : August 29, 2018

Click here for details on ClinicalTrials.gov

 

CART - BCMA : National Cancer Institute

Idecabtagene Vicleucel : National Cancer Institute

Idecabtagene Vicleucel : MedlinePlus Drug Information

Idecabtagene Vicleucel

Idecabtagene Vicleucel (Code C117729)

Abecma

Anti-BCMA CAR T Cells BB2121

Anti-BCMA-CAR-transduced T Cells BB2121

BB2121

BCMA-specific CAR-expressing T Lymphocytes BB2121

Ide-cel

Idecabtagene Vicleucel

IDECABTAGENE VICLEUCEL

Bluebird Bio


Patient Education: Idecabtagene Vicleucel (CART Cell Therapy) - Immunotherapy

 

Biological: bb2121

Drug: Daratumumab

Drug: Pomalidomide

Drug: Dexamethasone

Drug: Bortezomib

Drug: Ixazomib

Drug: Lenalidomide

Drug: Carfilzomib

 

Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (dex) (DPd) OR

DARA in combination with bortezomib (BTZ) and low-dose dex (DVd) OR

Ixazomib (IXA) in combination with lenalidomide (LEN) and low-dose dex (IRd) OR

Carfilzomib (CFZ) in combination with low-dose dexamethasone (Kd) OR

Elotuzumab (ELO) in combination with POM and low-dose dexamethasone (EPd)

 

- Arizona: Mayo Clinic Arizona Scottsdale

- California: UCLA School of Medicine Los Angeles

- Florida: Mayo Clinic Jacksonville Florida

- Florida: Moffitt Cancer Center Tampa

- Georgia: Emory University Atlanta

- Alabama: University of Alabama at Birmingham

- Illinois: Northwestern University Chicago

- Indiana: Indiana University Indianapolis

- Massachusetts: Massachusetts General Hospital Boston

- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston

- Minnesota: Mayo Clinic Rochester Minnesota

- Missouri: Washington University School of Medicine Saint Louis

- New Jersey: Hackensack University Medical Center

- New York: Tisch Cancer Institute Mount Sinai Hospital New York

- New York: New York Presbyterian / Weill Cornell Medical College New York

- Pennsylvania: University of Pittsburgh Medical Center

- Pennsylvania: Fox Chase Cancer Center Philadelphia

- Tennessee: Sarah Cannon Research Institute Nashville

- Texas: The University of Texas MD Anderson Cancer Center Houston

- Texas: Baylor University Medical Center Dallas

 

2323 KarMMa-3: A Phase 3 Study of Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T Cell Therapy Vs Standard Regimens in Relapsed and Refractory Multiple Myeloma

Program: Oral and Poster Abstracts

Session: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster II

Sunday, December 6, 2020, 7:00 AM-3:30 PM

Click here for details

 

Bristol Myers Squibb and 2seventy bio Announce Topline Results from KarMMa-3 Trial Showing Abecma (idecabtagene vicleucel) Significantly Improves Progression-Free Survival Versus Standard Regimens in Relapsed and Refractory Multiple Myeloma

08/10/2022

Abecma is the first BCMA-directed CAR T cell therapy to demonstrate superiority versus standard regimens in relapsed and refractory multiple myeloma

PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced positive topline results from KarMMa-3, a Phase 3, global, randomized, multicenter, open-label study evaluating Abecma (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory after two to four prior lines of therapy and refractory to the last regimen.

Click here for details

Click here for details

 

Locations

United States, Alabama

United States, Arizona

United States, California

United States, Colorado

United States, Florida

United States, Georgia

United States, Illinois

United States, Indiana

United States, Kansas

United States, Maryland

United States, Massachusetts

United States, Michigan

United States, Minnesota

United States, Missouri

United States, New Jersey

United States, New York

United States, North Carolina

United States, Pennsylvania

United States, Tennessee

United States, Texas

United States, Utah

United States, Washington

United States, Wisconsin

Canada, Alberta

Canada, Ontario

Europe

United Kingdom

France

Germany

Italy

Netherlands

Spain

Belgium

Norway

Sweden

Switzerland

Asia

Japan

 

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