drugset / Trial / NCT01897714

Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients

NCT01897714

Phase 1/2 Terminated 75 enrolled Oncopeptides AB
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

EvaluationDrugModalityDoseRoute
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