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Blood Cancer J. 2014 Feb 21;4:e182. doi: 10.1038/bcj.2014.1.

Vorinostat in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma.

Author information

1
Myeloma Division, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.
2
Dana-Farber Cancer Institute, Boston, MA, USA.
3
Department of Clinical Therapeutics, University of Athens, Athens, Greece.
4
University Hospital, Nantes, France.
5
MD Anderson Cancer Center, Houston, TX, USA.
6
Merck & Co. Inc., Whitehouse Station, NJ, USA.
7
Pharmacyclics Inc., Sunnyvale, CA, USA.

Abstract

The addition of vorinostat to lenalidomide/dexamethasone represents a novel combination therapy in multiple myeloma (MM), informed by laboratory studies suggesting synergy. This was a phase I, multicenter, open-label, non-randomized, dose-escalating study in patients with relapsed or relapsed and refractory MM. Clinical evaluation, electrocardiogram, laboratory studies and adverse events were obtained and assessed. The maximum-tolerated dose was not reached owing to a non-occurrence of two dose-limiting toxicities per six patients tested at any of the dosing levels. Patients tolerated the highest dose tested (Level 5) and this was considered the maximum administered dose: at 400 mg vorinostat on days 1-7 and 15-21, 25 mg lenalidomide on days 1-21 and 40 mg dexamethasone on days 1, 8, 15 and 22, per 28-day cycle. Drug-related adverse events were reported in 90% of patients serious adverse experiences were reported in 45% of the patients and 22% of all patients had adverse experiences considered, possibly related to study drug by the investigators. A confirmed partial response or better was reported for 14/30 patients (47%) evaluable for efficacy, including 31% of patients previously treated with lenalidomide. Vorinostat in combination with lenalidomide and dexamethasone proved tolerable with appropriate supportive care, with encouraging activity observed.

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