A Phase 3 Study of Belantamab Mafodotin Plus VRd vs. VRd in Transplant Ineligible Newly Diagnosed Multiple Myeloma Patients (DreaMM9) Verified

What's the purpose of this trial?

This goal of this Phase 3 clinical trial is to test how safe and effective Belantamab Mafodotin is when combined with Bortezomib, Lenalidomide, and Dexamethasone. Researchers want to determine the safest and most effective dose of Belantamab Mafodotin, and study whether it can improve your myeloma when combined with the other study drugs.

This trial is currently open and 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.
  • Dexamethasone is a steroid used to treat multiple myeloma.
  • Lenalidomide is an immunomodulatory drug that helps your body fight cancer by stimulating antibody formation and also by slowing tumor growth.

What will happen during the trial?

This trial is seeking approximately 810 patients. Patients will receive the study drugs over 21 or 28 day cycles and can continue to receive the study drugs as long as they are benefitting from them, don’t develop bad side effects, and their myeloma does not get worse.

While participating in this study patients will need to have additional eye exams and screenings and are not allowed to wear contact lenses. Patients may need to give themselves eye drops each day as long as they are receiving Belantamab Mafodotin.

This trial is organized into two separate parts. It is open label, which means that both the patients and doctors will know which part and group they are participating in, and which drugs they are receiving. At this time, patients joining this study will be participating in Part 1.


Part 1 of the study will look at how people react to and how the body uses belantamab mafodotin at different doses when taken together with bortezomib, lenalidomide and dexamethasone. We also want to know how the combination of these drugs affects your cancer. We will give people in the study different doses of belantamab mafodotin.  The other three drugs will be given at the doses allowed in the country where you are.  The effects of the study drugs, both good and bad, will be studied.

There are five planned dose levels of Belantamab Mafodotin. At least three patients will receive a dose before researchers decide to give the next group of patients an increased dose of Belantamab Mafodotin.

  • Cycles 1-8 (21 days each)
    • Belantamab Mafodotin will be given by intravenous infusion. Doses will be given as either a single (Day 1) or split dose (Day 1, 8)
    • Bortezomib will be given as a subcutaneous injection on days 1,4, 8, and 11.
    • Lenalidomide will be taken by mouth on days 1-14.
    • Dexamethasone will be taken by mouth on days 1, 2, 4, 5, 8, 9, 11 and 12.
  • Cycles 9 onwards (28 days each)
    • Belantamab Mafodotin will be given by intravenous infusion. Doses will be given as either a single (Day 1) or split dose (Day 1, 8)
    • Lenalidomide will be taken by mouth on days 1-21.
    • Dexamethasone will be taken by mouth on days 1, 8, 15, and 22.

Part 2 will use the best dose from Part 1 and study the safety and effectiveness of Belantamab Mafodotin combined with Bortezomib, Lenalidomide and Dexamethasone in a larger group of patients. Patients participating in Part 2 will be randomly separated into two groups, or arms. Arm A will receive Belantamab Mafodotin, Bortezomib, Lenalidomide and Dexamethasone. Arm B will receive Bortezomib, Lenalidomide and Dexamethasone. Researchers will then compare data from the two different groups to see if Belantamab Mafodotin can help to improve your multiple myeloma.

  • Arm A
    • Cycles 1-8 (21 days each)
      • Belantamab Mafodotin will be given by intravenous infusion. Doses will be given as either a single (Day 1) or split dose (Day 1, 8)
      • Bortezomib will be given as a subcutaneous injection on days 1,4, 8, and 11.
      • Lenalidomide will be taken by mouth on days 1-14.
      • Dexamethasone will be taken by mouth on days 1, 2, 4, 5, 8, 9, 11 and 12.
    • Cycles 9 onwards (28 days each)
      • Belantamab Mafodotin will be given by intravenous infusion. Doses will be given as either a single (Day 1) or split dose (Day 1, 8)
      • Lenalidomide will be taken by mouth on days 1-21.
      • Dexamethasone will be taken by mouth on days 1, 8, 15, and 22. 
  • ARM B
    • Cycles 1-8 (21 days each)
      • Bortezomib will be given as a subcutaneous injection on days 1,4, 8, and 11.
      • Lenalidomide will be taken by mouth on days 1-14.
      • Dexamethasone will be taken by mouth on days 1, 2, 4, 5, 8, 9, 11 and 12
    • Cycles 9 onwards (28 days each)
      • Lenalidomide will be taken by mouth on days 1-21.
      • Dexamethasone will be taken by mouth on days 1, 8, 15 and 22

If you have stopped study treatment and your multiple myeloma has not gotten worse, you may have follow-up visits. If you are in Part 1, you will have one final visit 45 days after you have stopped taking the study drug. If you are in Part 2 and you have stopped taking study drug, you will be followed for overall survival up to 5 years. You may choose to stop participating in this study at any time. If your myeloma gets worse, or you develop bad side effects, researchers may remove you from the study.


Additional Trial Information

Phase 3

Enrollment: 810 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 newly diagnosed multiple myeloma, with no prior treatment.
  • Patients must have adequate bone marrow, liver, kidney, and cardiac functions.
  • Patients must not be eligible for an autologous stem cell transplant.
  • Patients must be willing to adhere to contraceptive requirements.
View Additional Criteria

Trial Locations

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View all clinical trial locations sorted by state.

Kansas

University of Kansas Cancer Center

Kansas City, KS

Upcoming Center

Louisiana

Ochsner Medical Center

Jefferson, LA

Upcoming Center

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Accepting

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

Upcoming Center
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