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A Phase I/II Study of Carfilzomib, Lenalidomide, Dexamethasone and the Anti-B-Cell Maturation Antigen (BCMA) Antibody Drug Conjugate Belantamab Mafodotin in Multiple Myeloma
This research study is being done to learn if the study drug belantamab mafodotin, in combination with other standard medications, can improve multiple myeloma. This study will also help determine what effects, good and/or bad, this combination of study drugs have on subjects and their cancer, and to evaluate the overall response to this study treatment combination.
Details
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 70 |
| Start date | 2021-05-19 |
| Completion | 2032-11 |
Conditions
- Multiple Myeloma
Interventions
- Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin
Primary outcomes
- Establish Maximum Tolerated Dose (MTD) — time to complete Cycle 1 (28 days)
DLTs will be determined for each subject enrolled in Phase I as a binary variable indicating whether the subject experienced a DLT during Cycle 1 of belantamab mafodotin-containing protocol directed induction therapy. - Evaluate Complete Response (CR) — up to 5 years
CR will be determined for each subject as a binary variable indicating whether the achieved a best overall response to induction therapy of CR or better.
Countries
United States