drugset / Trial / NCT03117361
Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide
NaSingle-groupOpen-labelTreatment
Summary
This is a multi-center, open-label, single arm, non-comparative phase II trial, designed to evaluate the efficacy of plitidepsin in combination with bortezomib and dexamethasone in patients with Multiple Myeloma (MM) double refractory to bortezomib and lenalidomide.
Timeline
- Start
- 2017-05-08
- Primary completion
- 2018-07-30
- Completion
- 2018-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plitidepsin | Peptide | 5 mg/m2 | Intravenous |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |