Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 1/2 Completed 40 enrolled Washington University School of Medicine

Non-randomizedSequentialOpen-labelTreatment

Summary

The aim of this phase I/II trial is to determine the maximal tolerated dose (MTD) of carfilzomib together with pegylated liposomal doxorubicin hydrochloride (PLD) with or without dexamethasone, and then to establish the efficacy and safety of this novel combination in patients with relapsed or refractory multiple myeloma

Timeline

Start: 2012-05-14
Primary completion: 2017-12-28
Completion: 2018-03-23

Publications

Schroeder MA, Fiala MA, Huselton E, Cardone MH, Jaeger S, Jean SR, Shea K, Ghobadi A, Wildes T, Stockerl-Goldstein KE, Vij R. A Phase I/II Trial of Carfilzomib, Pegylated Liposomal Doxorubicin, and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2019 Jul 1;25(13):3776-3783. doi: 10.1158/1078-0432.CCR-18-1909. Epub 2019 Apr 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carfilzomib	Other / unclassified	27 mg/m2	Intravenous
Subject	Carfilzomib	Other / unclassified	36 mg/m2	Intravenous
Subject	Carfilzomib	Other / unclassified	45 mg/m2	Intravenous
Subject	Carfilzomib	Other / unclassified	56 mg/m2	Intravenous
Subject	Dexamethasone	Small molecule	20 mg	Intravenous
Subject	Doxorubicin	Other / unclassified	30 mg/m2	Intravenous

Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications