drugset / Trial / NCT00431990
A Phase I/II Trial of Romidepsin (Depsipeptide) and Bortezomib in Patients With Relapsed Myeloma
Phase 1/2
Unknown
40 enrolled
Peter MacCallum Cancer Centre, Australia
Celgene Corporation · collabJanssen-Cilag Ltd. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of the first phase of the study is to determine whether, and at what dose, depsipeptide, bortezomib and dexamethasone can be safely administered to patients with Multiple Myeloma. The second phase of the study will establish whether depsipeptide, bortezomib and dexamethasone is effective in the treatment of patients with multiple myeloma. The study will also examine the role of maintenance therapy with depsipeptide.
Timeline
- Start
- 2006-11
- Primary completion
- 2011-12
- Completion
- 2012-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Romidepsin | Peptide | 10 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 12 mg/m2 | Intravenous |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Bortezomib | Small molecule | 3.5 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | — |