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'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.
  • Dexamethasone is a steroid given in conjunction with some cancer treatments.
  • Pomalidomide is an immunomodulatory drug that can help your body fight cancer by slowing tumor growth.

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.

Additional Trial Information

Phase 3

Enrollment: 450 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 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.
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

Arizona Clinical Research Center, Inc.

Tucson, AZ

Not Yet Accepting

California

UCLA Jonsson Comprehensive Cancer Center University of California Los Angeles

Los Angeles, CA

Not Yet Accepting

Colorado

Florida

Florida Cancer Specialists South

Fort Myers, FL

Not Yet Accepting

Florida Cancer Specialists North

St. Petersburg, FL

Not Yet Accepting

Kansas

University of Kansas Cancer Center

Kansas City, KS

Not Yet Accepting

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Not Yet Accepting

Michigan

Providence Hospital

Southfield, MI

Not Yet Accepting

Missouri

HCA Midwest Health

Kansas City, MO

Not Yet Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Not Yet Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Not Yet Accepting

Pennsylvania

Allegheny Health Network (West Penn)

Pittsburgh, PA

Open and Accepting

Tennessee

Tennessee Oncology Centennial Clinic

Nashville, TN

Not Yet Accepting

Washington

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Not Yet Accepting
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