A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Transplant Ineligible
Summary
This is a phase 1/2, open label, study designed to assess the safety and clinical activity of different belantamab mafodotin doses in combination with daratumumab, lenalidomide and dexamethasone. The study will evaluate different doses of belantamab mafodotin in combination with daratumumab, lenalidomide and dexamethasone in 2 cohorts and will determine the recommended phase 2 dose (RP2D) to be further evaluated for safety and clinical activity in the dose expansion cohort. The RP2D dose will be used for future studies in the transplant ineligible newly diagnosed multiple myeloma setting. Overall, approximately 36 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is randomized. The estimated accrual period will be 12 months corresponding to an approximate total study duration of 4 years.
Timeline
- Start
- 2022-04-13
- Primary completion
- 2026-03-15
- Completion
- 2026-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belantamab mafodotin | Monoclonal antibody | 1.4 mg/kg | Intravenous |
| Subject | Belantamab mafodotin | Monoclonal antibody | 1.9 mg/kg | Intravenous |
| Background | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Background | Dexamethasone | Small molecule | 20 mg | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |