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 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.
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 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.
Additional Trial Information
Phase 1
Enrollment: 28 patients (estimated)
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