• Recruiting

NCT03601078: Phase 2 -Efficacy and Safety of bb2121 in relapsed MM & in high risk Myeloma (KarMMa-2)

Updated: Oct 3

KarMMa-2

karMMa-2 ide-cel cart myeloma

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

Celgene

Bristol Myers Squibb


2seventybio

 

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

 

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


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

 

- 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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