drugset / Trial / NCT02899052
Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
NaSingle-groupOpen-labelTreatment
Summary
A Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed or refractory MM and have received 1 to 3 prior lines of therapy. Part 4 of this study is currently enrolling.
Timeline
- Start
- 2017-01-19
- Primary completion
- 2027-06
- Completion
- 2027-06
Publications
- Badawi MA, Engelhardt B, Dobkowska E, Deng R, Kaufman JL, Menon R, Salem AH. Exposure-response relationships of venetoclax in combination with carfilzomib and dexamethasone in relapsed/refractory t(11;14) multiple myeloma patients. Invest New Drugs. 2024 Dec;42(6):635-643. doi: 10.1007/s10637-024-01471-x. Epub 2024 Oct 10.
- Costa LJ, Davies FE, Monohan GP, Kovacsovics T, Burwick N, Jakubowiak A, Kaufman JL, Hong WJ, Dail M, Salem AH, Yang X, Masud AA, Munasinghe W, Ross JA, Bueno OF, Kumar SK, Stadtmauer EA. Phase 2 study of venetoclax plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma. Blood Adv. 2021 Oct 12;5(19):3748-3759. doi: 10.1182/bloodadvances.2020004146.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 27 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 70 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Subject | Venetoclax | Small molecule | 800 mg | Oral |