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

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

Drugs

Evaluation	Drug	Modality	Dose	Route
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

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

Summary

Timeline

Drugs

Indications