A Phase III Study of Belantamab Mafodotin plus Pomalidomide and Dexamethasone vs Pomalidomide, Bortezomib and Dexamethasone in Participants with Relapsed / Refractory Multiple Myeloma DREAMM8
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What's the purpose of this trial?

The goal of this Phase 3 randomized clinical trial is to compare the efficacy and safety of Belantamab Mafodotin, Pomalidomide, and Dexamethasone against Bortezomib, Pomalidomide, and Dexamethasone.

This trial is currently open and accepting patients.

What will happen during the trial?

This study is seeking to enroll approximately 450 participants.

Participants will be randomly assigned into one of two different groups (also called treatment arms). This study is open label, which means that participants and their doctors will know which group they have been placed in.

ARM A

  • This group will receive Belantamab Mafodotin, Pomalidomide and Dexamethasone.
  • This group is structured to receive treatment in 28-day cycles.
    • Belantamab Mafodotin will be given intravenously on Day 1.
    • Pomalidomide will be given by mouth on Days 1-21.
    • Dexamethasone will be given by mouth on Days 1, 8, 15, and 22.
  • Participants in Arm A will be assessed by an eye specialist every four weeks for the first six cycles. At that time, eye screenings may be reduced to once every three months until end of treatment .
  • Participants in Arm A will be instructed to use eye drops 4-8 times daily while they are participating in the study.
  • Participants in Arm A will not be permitted to wear contact lenses while they are participating in the study.

ARM B

  • This group will receive Bortezomib, Pomalidomide and Dexamethasone.
  • This group is structured to receive treatment in 21-day cycles.
    • Bortezomib will be given by subcutaneous injection on Days 1, 4, 8, and 11 of cycles 1-8, and on Days 1 and 8 of cycles 9 and beyond.
    • Pomalidomide will be given by mouth on Days 1-14.
    • Dexamethasone will be given by mouth on the day of, and the day after a patient receives Bortezomib.
    • Participants in Arm B will be assessed by an eye specialist at the beginning of the study, every six months while participating, and at the end of their participation in the study.
  • Participants in both groups will be able to continue to participate in the study as long as their myeloma doesn’t get worse, and they don’t experience bad side effects.

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.

  • Patients must have a confirmed diagnosis of multiple myeloma and meet the trials measurable disease criteria.
  • Patients must have already had or are ineligible for an autologous transplant. Patients who have already had an autologous transplant must have had it greater than 100 days before joining this study.
  • Patients must have had at least one prior line of therapy including Lenalidomide.
  • Patients must have adequate major organ function.
  • Patients must not have had a prior allogeneic stem cell transplant.
  • Patients must not have previously received Pomalidomide.
  • Patients must not have previously received a BCMA targeted therapy.

Additional Trial Information

Phase 3

Enrollment: 300 patients (estimated)

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Trial Locations

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Arizona

Arizona Clinical Research Center, Inc.

Tucson, AZ

Open and Accepting

Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Florida

Florida Cancer Specialists - Fort Myers Cancer Center

Fort Myers, FL

Open and Accepting

Memorial Hospital West Memorial Healthcare System

Pembroke Pines, FL

Open and Accepting

Florida Cancer Specialists North

St. Petersburg, FL

Open and Accepting

Idaho

Kootenai Clinic Cancer Services - Coeur d'Alene

Coeur d'Alene, ID

Open and Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Missouri

HCA Midwest Health

Kansas City, MO

Open and Accepting

Pennsylvania

West Penn Hospital (Allegheny Health Network)

Pittsburgh, PA

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Washington

Fred Hutchinson / University of Washington Cancer Consortium Seattle Cancer Care Alliance (SCCA)

Seattle, WA

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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