- Recruiting
NCT03651128: Phase 3 - Study of bb2121 Vs Standard Regimens Refractory Myeloma (RRMM) (KarMMa-3)
Updated: Oct 3, 2022
KarMMa-3
bb2121
Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)
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
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
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
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
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.
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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