drugset / Trial / NCT01897714
Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients
Non-randomizedSequentialOpen-labelTreatment
Summary
The study will explore escalating doses of melflufen in combination with dexamethasone in small groups of patients to find the maximum tolerated dose of melflufen. That dose will then be used to determine the efficacy and safety profile of melflufen in combination with dexamethasone in a larger group of patients.
Timeline
- Start
- 2013-07
- Primary completion
- 2017-12
- Completion
- 2020-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan flufenamide | Peptide | 15 mg | Intravenous |
| Subject | Melphalan flufenamide | Peptide | 25 mg | Intravenous |
| Subject | Melphalan flufenamide | Peptide | 40 mg | Intravenous |
| Subject | Melphalan flufenamide | Peptide | 55 mg | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |