A Phase 3 Study to Compare bb2121 Versus Standard Regimens in Patients with Relapsed and Refractory Multiple Myeloma KARMMA-3
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What's the purpose of this trial?

This phase 3 trial is comparing how effective and safe bb2121 is when compared to standard of care regimens in relapsed and refractory multiple myeloma.

This trial is currently open and accepting patients.


What's being studied?

  • Bortezomib is a type of cancer drug called a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body.
  • Carfilzomib is a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body.
  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Daratumumab is a type of cancer drug called a monoclonal antibody. Daratumumab attaches to a protein called CD38, which is present in high numbers on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.
  • Dexamethasone is a steroid given in conjunction with some cancer treatments.
  • Elotuzumab is a monoclonal antibody that targets and attaches to the SLAMF7 protein that may be found on multiple myeloma cells.
  • Fludarabine is a chemotherapy agent used in the treatment of cancer.
  • Idecabtagene Vicleucel is a Chimeric Antigen Receptor (CAR) T cell therapy. Your own T cells are removed and altered in a lab to recognize BCMA, a protein carried by multiple myeloma cells.
  • Ixazomib is a type of drug called a proteasome inhibitor that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
  • Lenalidomide is an immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.
  • Pomalidomide is an immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.

What will happen during the trial?

Patients joining this trial will be randomized (like flipping of a coin) into two separate groups, Arm A and Arm B. The majority of patients will be added to Arm A, and receive bb2121. Arm B will receive one of five standard regimens. If you are placed into Arm B, and your myeloma worsens during treatment, you may be able to elect to receive bb2121.

ARM A

  • Patients joining this arm will undergo treatment with bb2121. bb2121 is a CAR T cell product made using your own T cells, which are genetically altered in a lab. This process occurs over a 4-5 week period. If you need anti-myeloma treatment during the time that your T cells are being altered, you may receive up to one cycle of the one of the standard regimens being offered to Arm B, if your study doctor says it’s okay. Should you become ill however during this time you may not be able to receive bb2121.
  • Patients in this Arm will receive chemotherapy (fludarabine and cyclophosphamide) five days before receiving bb2121. This is used to remove some of your own immune cells to make room for bb2121, and to help your body accept bb2121 cells. You will receive this chemotherapy for three consecutive days.
  • When you receive bb2121, you will be admitted to the hospital for approximately 14 days. This is necessary so that your study doctors can monitor you very closely for any side effects.
  • Once you are discharged from the hospital, you will need to stay within a 30 minute drive from your study site and have a dedicated caregiver staying with you for the remainder of the 30 days following your bb2121 treatment. After that, you will need to have monthly assessments at your study site for the first two years.

ARM B

  • If you are randomized into this arm, you will receive one of five standard treatment regimens. Which one you receive will depend on your prior myeloma treatments, and your study doctor’s discretion. The five standard regimens are:
    • Daratumumab, Pomalidomide and Dexamethasone (DPd)
    • Daratumumab, Bortezomib, and Dexamethasone (DVd)
    • Ixazomib, Lenalidomide, and Dexamethasone (IRd)
    • Carfilzomib and low dose Dexamethasone (Kd)
    • Elotuzumab, Pomalidomide and low dose Dexamethasone (EPd)
  • The length of time that you receive treatment on this arm will depend on how well your myeloma responds to treatment.
  • If you are randomized into Arm B and your myeloma gets worse while participating, you may be able to still receive bb2121.

Additional Trial Information

Phase 3

Enrollment: 381 patients (estimated)

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You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

  • Patients must have a confirmed diagnosis of relapsed/refractory multiple myeloma and meet the trial’s measurable disease criteria.
  • Patients must have had 2-4 previous lines of therapy for their multiple myeloma.
  • Patients must have previously received Daratumumab, a proteasome inhibitor, and an immunomodulatory agent containing regimen for at least 2 cycles. (A cycle is a period of treatment followed by a period of rest (no treatment) that is repeated on a regular schedule)
  • Patients must be refractory (have not responded) to their last treatment.
  • Patients must have adequate bone marrow, kidney, liver, lung and cardiac function to participate.
  • Patients may not have central nervous system myeloma involvement.
  • Patients may not have previously had an allogeneic transplant.
View Additional Criteria

Trial Locations

There are additional locations that may be accepting patients that are not listed below. To find a participating center near you, please call SparkCures at (888) 828-2206.

All Trial Locations

View all clinical trial locations sorted by state.

Alabama

UAB Comprehensive Cancer Center University of Alabama at Birmingham

Birmingham, AL

Open and Accepting

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

California

KarMMa-3 Study Site

Los Angeles, CA

Open and Accepting

KarMMa-3 Study Site

Santa Monica, CA

Open and Accepting

KarMMa-3 Study Site

Stanford, CA

Open and Accepting

Colorado

KarMMa-3 Study Site

Aurora, CO

Open and Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Blood and Marrow Transplant Group of Georgia

Atlanta, GA

Open and Accepting

Illinois

Northwestern University Feinberg School of Medicine

Chicago, IL

Open and Accepting

Indiana

IU Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Maryland

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Massachusetts General Hospital

Boston, MA

Open and Accepting

Michigan

KarMMa-3 Study Site

Ann Arbor, MI

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

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

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

KarMMa-3 Study Site

New York, NY

Open and Accepting

North Carolina

KarMMa-3 Study Site

Durham, NC

Open and Accepting

Pennsylvania

Sidney Kimmel Cancer Center Thomas Jefferson University

Philadelphia, PA

Open and Accepting

Fox Chase Cancer Center Temple Health

Philadelphia, PA

Open and Accepting

Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

KarMMa-3 Study Site

Dallas, TX

Open and Accepting

KarMMa-3 Study Site

Houston, TX

Open and Accepting

Utah

KarMMa-3 Study Site

Salt Lake City, UT

Open and Accepting

Washington

Swedish Cancer Institute Cherry Hill Campus

Seattle, WA

Open and Accepting

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, 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).

Read more

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.

Read more
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