A Phase I Study of Belantamab Mafodotin in Multiple Myeloma Participants with Normal and Impaired Hepatic Function DREAMM13
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What's the purpose of this trial?

This is a phase 1 study evaluating the safety, dosage and tolerability of belantamab mafodotin in participants with relapsed or refractory multiple myeloma with both normal and impaired liver function.

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).

What will happen during the trial?

This trial plans to enroll approximately 24 participants and will be conducted in two different parts:

PART 1 (ACCEPTING)

  • Part 1 will test the safety and determine the best dose of belantamab mafodotin to use in Part 2 and will enroll participants into one of two groups:
    • Group 1 (Normal Liver Function)
    • Group 2 (Moderate Liver Impairment)

PART 2 (NOT YET ACCEPTING)

  • Part 2 will be conducted with participants who have severe liver impairment and will be enroll into one group:
    • Group 3 (Severe Liver Impairment)

This trial is organized into 21 day cycles. Participants will receive belantamab mafodotin intravenously on day 1 of each cycle.

Patients may not wear contact lenses while participating in this trial.

All participants in this study 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 before each dose for the next four cycles. If you don’t develop eye side effects, eye exam frequency may be reduced to every 6 months at the discretion of the eye specialist.


Additional Trial Information

Phase 1

Enrollment: 24 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 diagnosis of multiple myeloma.
  • Patients must have failed at least two prior lines of therapy, including an immunomodulatory drug (e.g.,lenalidomide or pomalidomide), proteasome inhibitor (e.g., bortezomib, ixazomib or carfilzomib)
  • Patients must have undergone an autologous stem cell transplant (or not be eligible to receive a transplant).
  • Patients must have adequate bone marrow, kidney and cardiac function as described by the study parameters.
  • Patients must not have had a prior allogeneic stem cell transplant.
  • Patients must not have previously received belantamab mafodotin.
  • Patients must not have evidence of active internal bleeding.
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Arizona

University of Arizona Comprehensive Cancer Center

Tucson, AZ

Not Yet Accepting

California

Beverly Hills Cancer Center

Beverly Hills, CA

Not Yet Accepting

Florida

Cancer Specialists of North Florida

Fleming Island, FL

Not Yet Accepting

Boca Raton Clinical Research (BRCR) Medical Center

Plantation, FL

Open and Accepting

Illinois

Northwestern University Feinberg School of Medicine

Chicago, IL

Not Yet Accepting

Loyola University Medical Center Cardinal Bernardin Cancer Center

Maywood, IL

Not Yet Accepting

Kansas

Cancer Center of Kansas (Wichita)

Wichita, KS

Not Yet Accepting

Maryland

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Not Yet Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Not Yet Accepting

Pennsylvania

Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Not Yet Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Not Yet Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Not Yet Accepting

Joe Arrington Cancer Research and Treatment Center CovenantHealth

Lubbock, TX

Not Yet Accepting

Renovation Clinical

The Woodlands, TX

Open and Accepting

Wisconsin

Aurora Saint Luke's Medical Center

Milwaukee, WI

Not Yet Accepting
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