drugset / Trial / NCT01496118
Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma
Phase 1/2
Completed
80 enrolled
SCRI Development Innovations, LLC
Novartis · collabOnyx Therapeutics, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
Relapsed/refractory Multiple Myeloma (MM) is an incurable disorder with a poor prognosis. Carfilzomib is a novel proteasome inhibitor with activity in this setting. Panobinostat is a pan-deacetylase inhibitor which has shown synergistic cytotoxicity in vitro and in vivo with proteasome inhibitors. The combination should enhance the activity of both agents against myeloma cells. In Phase I, the optimal doses of the combination of carfilzomib and panobinostat will be determined. Assuming this combination is feasible, the Phase II portion will proceed using the doses determined in Phase I.
Timeline
- Start
- 2011-12
- Primary completion
- 2020-12
- Completion
- 2020-12
Publications
- Berdeja JG, Gregory TK, Faber EA, Hart LL, Mace JR, Arrowsmith ER, Flinn IW, Matous JV. A phase I/II study of the combination of panobinostat and carfilzomib in patients with relapsed or relapsed/refractory multiple myeloma: Final analysis of second dose-expansion cohort. Am J Hematol. 2021 Apr 1;96(4):428-435. doi: 10.1002/ajh.26088. Epub 2021 Jan 28.
- Berdeja JG, Hart LL, Mace JR, Arrowsmith ER, Essell JH, Owera RS, Hainsworth JD, Flinn IW. Phase I/II study of the combination of panobinostat and carfilzomib in patients with relapsed/refractory multiple myeloma. Haematologica. 2015 May;100(5):670-6. doi: 10.3324/haematol.2014.119735. Epub 2015 Feb 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 27 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 36 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 45 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | Intravenous |
| Subject | Panobinostat | Small molecule | 20 mg | — |
| Subject | Panobinostat | Small molecule | 30 mg | — |