drugset / Trial / NCT00765102
Trial of Romidepsin and Bortezomib for Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one of two strata, bortezomib-resistant or bortezomib non-resistant.
Timeline
- Start
- 2008-09-01
- Primary completion
- 2010-03-01
- Completion
- 2010-03-01
Publications
- Background Berenson J, et al. A phase II study of a 1-hour infusion of romidepsin combined with bortezomib for multiple myeloma (MM) patients with relapsed or refractory disease. Presented at 2009 ASCO Annual Meeting, May 29-June 2, 2009, Orlando FL. Abstract No. e10908. J Clin Oncol 2009;27(15s)
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 8 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 10 mg/m2 | Intravenous |