NCT03601078: Phase 2 -Efficacy and Safety of bb2121 in relapsed MM & in high risk Myeloma (KarMMa-2)
Updated: Oct 3, 2022
KarMMa-2
An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma (KarMMa-2)
This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1), in subjects with MM having progressed within one 18 months of initial treatment including autologous stem cell transplantation (ASCT) (Cohort 2a), and without ASCT (Cohort 2b) or, in subjects with inadequate response post ASCT during initial treatment (Cohort 2c) Approximately 181 subjects will be enrolled into one of two cohorts.
Cohort 1 will enroll approximately 73 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens.
Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse.
Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse.
Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy.
The cohorts will start in parallel and independently.
Sponsor
Bristol Myers Squibb
ClinicalTrials.gov Identifier: NCT03601078
Official Title: A Phase 2, Multicohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2)
First Posted : July 26, 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
- Arizona: Mayo Clinic Arizona
- California: University of California San Francisco
- Florida: Moffitt Cancer Center Tampa
- Georgia: Emory University Atlanta
- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston
- Massachusetts: Massachusetts General Hospital Boston
- Missouri: Washington University School of Medicine Saint Louis
- Nebraska: University of Nebraska Medical Center Omaha
- New Jersey: Hackensack University Medical Center
- New York: Memorial Sloan-Kettering Cancer Center New York
- New York: Tisch Cancer Institute Mount Sinai Hospital New York
- New York: Columbia University Medical Center New York
- North Carolina: Levine Cancer Institute Charlotte
- Tennessee: Sarah Cannon Research Institute Nashville
- Texas: The University of Texas MD Anderson Cancer Center Houston
- Texas: UT Southwestern Medical Center Dallas
- Wisconsin: Froedtert Memorial Milwaukee
- Washington: Swedish Cancer Inst Seattle
Locations
United States, Arizona
United States, California
United States, Florida
United States, Georgia
United States, Massachusetts
United States, Missouri
United States, Nebraska
United States, New Jersey
United States, New York
United States, North Carolina
United States, Tennessee
United States, Texas
United States, Washington
United States, Wisconsin
Europe
United Kingdom
France
Germany
Italy
Spain
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