Phase III study of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) versus Daratumumab, Bortezomib, and Dexamethasone (D-Vd) in participants with Relapsed/Refractory Multiple Myeloma DREAMM7
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What's the purpose of this trial?

This clinical trial is testing how effective the combination of Belantamab Mafodotin, Bortezomib and Dexamethasone is when compared to the combination of Daratumumab, Bortezomib and Dexamethasone in the treatment of relapsed/refractory multiple myeloma.

This trial is currently open and accepting patients.

What's being studied?

  • Belantamab Mafodotin (formerly GSK2857916) is an investigational product that acts as an antibody-drug conjugate (ADC) with anti-BCMA antibody that binds to BCMA on tumor cell surfaces causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity (ADCC).
  • Bortezomib is a type of cancer drug called a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body.
  • 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.

What will happen during the trial?

This trial is open-label, which means that both you and researchers will know which drugs you are receiving.

This trial is organized into two separate groups, also called arms.

ARM A

  • This arm will receive Belantamab Mafodotin, Bortezomib and Dexamethasone in 21 day cycles.
    • Belantamab Mafodotin will be given by intravenous infusion on Day 1 of each cycle.
    • Bortezomib will be given by subcutaneous injection on Days 1, 4, 8, and 11 for the first 8 cycles.
    • Dexamethasone will be given either as a pill or by intravenous injection on the day of and after you receive Bortezomib.
  • Patients participating in Arm A will need to have their eyes examined to monitor for potential side effects. Patients will need to see an eye specialist before they receive their first dose of Belantamab Mafodotin, and then once each cycle for the next four cycles. If you don’t develop eye side effects, you may be able to decrease your eye screenings to once every 6 months.

ARM B

  • This arm will receive Daratumumab, Bortezomib and Dexamethasone. During cycles 1-8, cycles will last 21 days, and cycles 9 and onward will be 28 days.
    • Daratumumab will be given by intravenous infusion on Days 1, 8, and 15 of cycles 1-3, and on Day 1 of cycles 4+.
    • Bortezomib will be given by subcutaneous infusion on Days 1, 4, 8, and 11 for the first 8 cycles.
    • Dexamethasone will be given as an intravenous injection at the first treatment and then by either a pill or by intravenous injection on the day of and after you receive Bortezomib.
See if you qualify

Additional Trial Information

Phase 3

Enrollment: 478 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 relapsed/refractory multiple myeloma.
  • Patients must have had at least one prior line of therapy.
  • Patients must not have received an autologous transplant within the past 100 days.
  • Patients must not have previously received an allogeneic transplant.
  • Patients must not have previously received an anti-BCMA therapy.
  • Patients must not be intolerant or refractory to Daratumumab or Bortezomib.
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Yuma Regional Medical Center

Yuma, AZ

Open and Accepting

Colorado

Rocky Mountain Cancer Centers Denver - Midtown

Denver, CO

Open and Accepting

Illinois

Illinois Cancer Specialists

Niles, IL

Open and Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Louisiana

Ochsner Medical Center

Jefferson, LA

Not Yet Accepting

Maryland

American Oncology Partners of Maryland, PA

Bethesda, MD

Not Yet Accepting

Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, MI

Not Yet Accepting

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

Nebraska

University of Nebraska Medical Center Fred & Pamela Buffett Cancer Center

Omaha, NE

Not Yet Accepting

North Carolina

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, NC

Not Yet Accepting

Ohio

Oncology Hematology Care, Inc.

Blue Ash, OH

Open and Accepting

Cleveland Clinic Taussig Cancer Institute

Cleveland, OH

Not Yet Accepting

Texas

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

Dallas, TX

Open and Accepting

Baylor Scott & White Hospital

Temple, TX

Open and Accepting

Texas Oncology

Tyler, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting

Virginia

Oncology & Hematology Associates

Roanoke, VA

Open and Accepting

Trial Links

Read the latest news and updates on this trial.

FDA Panel Supports Belantamab Mafodotin for Relapsed/Refractory Myeloma

July 14, 2020

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.

Read more
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