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) Verified

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 is an upcoming trial that has not yet started accepting patients.


What's being studied?

  • Belantamab Mafodotin (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.
  • 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 that attaches to myeloma cells in your body and may directly attack them or help your immune system recognize and attack them.
  • Dexamethasone is a steroid given in conjunction with some cancer treatments that also has anti-cancer activity.

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.

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.

Colorado

Rocky Mountain Cancer Centers Denver - Midtown

Denver, CO

Upcoming Center

Illinois

Illinois Cancer Specialists

Niles, IL

Upcoming Center

Kansas

University of Kansas Cancer Center

Kansas City, KS

Upcoming Center

Louisiana

Ochsner Medical Center

Jefferson, LA

Upcoming Center

Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, MI

Upcoming Center

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Upcoming Center

Nebraska

New York

North Carolina

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, NC

Upcoming Center

Levine Cancer Institute Atrium Health

Charlotte, NC

Upcoming Center

Texas

Baylor Scott & White Hospital

Temple, TX

Upcoming Center

Texas Oncology

Tyler, TX

Upcoming Center

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Upcoming Center

Virginia

Oncology & Hematology Associates

Roanoke, VA

Upcoming Center

Washington

MultiCare Institute for Research & Innovation

Tacoma, WA

Upcoming Center

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Upcoming Center
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