Send to

Choose Destination
See comment in PubMed Commons below
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

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


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.

PubMed Commons home

PubMed Commons

How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Nature Publishing Group Icon for PubMed Central
    Loading ...
    Support Center