drugset
drugset / Trial / NCT03481556

Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM

NCT03481556 ↗

Phase 1/2 Terminated 56 enrolled Oncopeptides AB
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma to combination regimens of melflufen with currently approved agents. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab.

Timeline

Start
2018-04-12
Primary completion
2022-02-02
Completion
2022-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Subject Daratumumab Monoclonal antibody 16 mg/kg Intravenous
Subject Dexamethasone Small molecule 12 mg Oral
Subject Dexamethasone Small molecule 20 mg Oral
Subject Dexamethasone Small molecule 40 mg Oral
Subject Melphalan flufenamide Peptide 20 mg Intravenous
Subject Melphalan flufenamide Peptide 30 mg Intravenous
Subject Melphalan flufenamide Peptide 40 mg Intravenous

Indications

plasma cell myeloma