Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)

Phase 1 Completed 31 enrolled Merck Sharp & Dohme LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this Phase I study of vorinostat in combination with lenalidomide and dexamethasone in participants with relapsed or refractory multiple myeloma is to determine the maximum tolerated dose (MTD) as estimated by the incidence of dose-limiting toxicities (DLTs) and recommended Phase 2 dose (RP2D) as estimated by the incidence of drug-related adverse events (AEs).

Timeline

Start: 2008-02-13
Primary completion: 2012-09-03
Completion: 2013-08-20

Publications

Results Siegel DS, Richardson P, Dimopoulos M, Moreau P, Mitsiades C, Weber D, Houp J, Gause C, Vuocolo S, Eid J, Graef T, Anderson KC. Vorinostat in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood Cancer J. 2014 Feb 21;4(2):e182. doi: 10.1038/bcj.2014.1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	40 mg	Oral
Subject	Lenalidomide	Other / unclassified	10 mg	Oral
Subject	Lenalidomide	Other / unclassified	15 mg	Oral
Subject	Lenalidomide	Other / unclassified	20 mg	Oral
Subject	Lenalidomide	Other / unclassified	25 mg	Oral
Subject	Vorinostat	Small molecule	300 mg	Oral
Subject	Vorinostat	Small molecule	400 mg	Oral

Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)

Summary

Timeline

Publications

Drugs

Indications