A Phase 1 Study of belantamab mafodotin Plus Standard of care in Newly Diagnosed Multiple Myeloma DREAMM9
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What's the purpose of this trial?

This goal of this Phase 1 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 (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 that also has anti-cancer activity.
  • 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 144 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 trial patients will need to have additional eye exams and screenings and are not allowed to wear contact lenses (except for bandage contact lenses if indicated). Patients will need to give themselves eye drops (artificial tears) each day as long as they are receiving belantamab mafodotin.

This trial will look at how patients 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 patients in the trial different doses of belantamab mafodotin.  The other three drugs will be given at the doses allowed in the country where you are located.  The effects of the study drugs, both good and bad, will be studied.

There may be up to eight planned dose levels 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.

If you have stopped study treatment and your multiple myeloma has not gotten worse, you will have one further follow up visit and will then stop the trial and receive another treatment prescribed by your study doctor.   You may choose to stop participating in this trial at any time. If your myeloma gets worse, or you develop bad side effects, researchers may remove you from the trial.


Additional Trial Information

Phase 1

Enrollment: 144 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

All Trial Locations

View all clinical trial locations sorted by state.

Kansas

University of Kansas Cancer Center

Kansas City, KS

Open and Accepting

Louisiana

Ochsner Medical Center

Jefferson, LA

Not Yet Accepting

North Carolina

Levine Cancer Institute Atrium Health

Charlotte, NC

Open and Accepting

Wisconsin

UW Carbone Cancer Center University of Wisconsin Health

Madison, WI

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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