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

What's the purpose of this trial?

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.

Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured for cohorts 1, 2a and 2b only.

This trial is currently open and accepting patients.

What will happen during the trial?

Additional Trial Information

Phase 2

Enrollment: 181 patients (estimated)

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Trial Locations

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Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Open and Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

Nebraska

University of Nebraska Medical Center Fred & Pamela Buffett Cancer Center

Omaha, NE

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Not Yet Accepting

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Washington

Swedish Cancer Institute Cherry Hill Campus

Seattle, WA

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting

Trial Links

Read the latest news and updates on this trial.

Highly Refractory Myeloma Has Deep and Durable Responses With Ide-cel

December 05, 2020

Patients with heavily pretreated multiple myeloma maintained durable responses with the chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel (ide-cel; bb2121) in updated findings presented from the phase 1 CRB-401 trial (NCT02658929).

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Updated Results of Ongoing Multicenter Phase I Study of bb2121 anti-BCMA CAR T Cell Therapy Continue to Demonstrate Deep and Durable Responses in Patients with Late-Stage Relapsed/Refractory Multiple Myeloma at ASCO Annual Meeting

June 01, 2018

Celgene Corporation and bluebird bio, Inc. today announced updated results from the ongoing CRB-401 phase I clinical study of bb2121, an investigational anti-B-cell maturation antigen (BCMA) CAR T cell therapy, in 43 patients with late-stage relapsed/refractory multiple myeloma.

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