DREAMM13
A Phase I Study of Belantamab Mafodotin in Multiple Myeloma Participants with Normal and Impaired Hepatic Function
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.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 1
- Enrollment
- 28 patients (estimated)
- Sponsors
- GlaxoSmithKline
- Tags
- Antibody Drug Conjugate (ADC), B-Cell Maturation Antigen (BCMA)
- Trial Type
- Treatment
- Last Update
- 2 months ago
- SparkCures ID
- 1105
- NCT Identifier
- NCT04398680
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