drugset / Trial / NCT01979276
Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma
Phase 1/2
Terminated
4 enrolled
Weill Medical College of Cornell University
Celgene Corporation · collab
NaSingle-groupOpen-labelTreatment
Summary
This clinical trial is for subjects with multiple myeloma that has returned after treatment (relapsed) or did not respond to prior treatment (refractory). The study is in two parts, Phase I and Phase II. Phase I will determine the maximum tolerated dose of romidepsin in combination with pomalidomide and dexamethasone. The purpose of Phase II is to evaluate the effectiveness of combining romidepsin with pomalidomide and dexamethasone. The hypothesis is that overall response in a cohort of patients treated with romidepsin + pomalidomide + dexamethasone will be 60 percent.
Timeline
- Start
- 2013-11
- Primary completion
- 2016-10
- Completion
- 2016-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |
| Subject | Romidepsin | Peptide | 9 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 12 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 15 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 18 mg/m2 | Intravenous |