drugset
drugset / Trial / NCT03639610

PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function

NCT03639610 ↗

Phase 2 Terminated 35 enrolled Oncopeptides AB
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This was a multicenter study of the pharmacokinetics (PK) of melphalan during treatment with melflufen and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) and impaired renal function.

Timeline

Start
2018-08-28
Primary completion
2021-12-22
Completion
2021-12-22

Outcome

Outcome not reported

Stopped: “The sponsor decided to terminate the study following an FDA request of a partial clinical hold.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan flufenamide Peptide 20 mg Intravenous
Subject Melphalan flufenamide Peptide 30 mg Intravenous
Subject Melphalan flufenamide Peptide 40 mg Intravenous
Background Dexamethasone Small molecule 20 mg Oral
Background Dexamethasone Small molecule 40 mg Oral

Indications

impaired renal function disease plasma cell myeloma