DREAMM5
Platform Study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)
What will happen during the trial?
This trial is randomized, which means that you will be randomly placed into different groups, and this will determine which study drugs you receive.
This trial is open label, which means that both you and the researchers running the study will know which group you are placed in, and which drugs you will be receiving.
This trial is organized into a series of sub-studies. Each individual sub-study will be testing the combination of Belantamab Mafodotin and one of the other anti-cancer therapies being used. Participants will be randomized in this study, which means that neither the patients nor the clinical trial team will be able to choose which sub-study, dose-level, or phase they participate in. Each individual sub-study will be conducted in two phases:
- Phase 1: Dose Exploration – this phase will look to find the safest doses of Belantamab Mafodotin in combination with other anticancer treatments.
- Phase 2: Cohort Expansion – this phase will use the best and safest doses of Belantamab Mafodotin and the anticancer treatments determined by Phase 1 of the study. These doses will be given to a larger number of patients so that researchers can gather more information about how well the combinations work in treating multiple myeloma. Some patients in this part of the study will receive Belantamab Mafodotin alone (not in combination with another anti-cancer treatment).
Treatments in this trial are organized in 21 day cycles, with patients receiving Belantamab Mafodotin and the other anticancer treatments on day 1 of each cycle as intravenous infusions. In some sub-studies, the second anti-cancer treatment may be in the form of tablets for patients to take both at the hospital and at home between hospital visits. Patients can continue to receive experimental treatments until their myeloma gets worse, or they develop bad side effects.
During the first four cycles of this trial, patients must also visit an opthalmologist for eye exams every three weeks. During the entire time patients are a part of this trial, they may not wear contact lenses.
More Information
- Trial Status
- Active, Not Recruiting
- Trial Phase
- Phase 2
- Enrollment
- 464 patients (estimated)
- Sponsors
- GlaxoSmithKline
- Tags
- Antibody Drug Conjugate (ADC), Gamma-Secretase Inhibitor, B-Cell Maturation Antigen (BCMA)
- Trial Type
- Treatment
- Last Update
- 2 weeks ago
- SparkCures ID
- 1061
- NCT Identifier
- NCT04126200
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