The combination of vorinostat, lenalidomide, and dexamethasone is active in heavily pretreated patients with multiple myeloma refractory to lenalidomide, a study published in the British Journal of Haematology has shown.1
In this single-center, open-label, phase 2b trial, researchers enrolled 25 patients with multiple myeloma refractory to lenalidomide. Patients were considered lenalidomide-refractory if they had no clinical response on a previous lenalidomide-containing regimen or if they experienced disease progression on or within 60 days of discontinuing a previous lenalidomide-containing regimen.
All participants received vorinostat 400 mg orally on days 1 to 7 and 15 to 21, lenalidomide 25 mg orally daily on days 1 to 21, and dexamethasone 40 mg on days 1, 8, 15, and 22 of each 28-day cycle.
Results showed that 24% of patients achieved an objective response, all of which were partial responses. Eighty percent of patients achieved stable disease or better.
Median time to a partial response was 1.9 months and median duration of response was 3.3 months. Researchers also found that median progression-free survival was 5.3 months.
The most frequently reported grade 3 to 4 adverse events were neutropenia, thrombocytopenia, anemia, and gastrointestinal toxicities.
Although these findings suggest that this regimen is active in lenalidomide-refractory patients, further evaluation is warranted to evaluate the efficacy and safety in a large, randomized controlled trial.
1. Sanchez L, Vesole DH, Richter JR, et al. A phase IIb trial of vorinostat in combination with lenalidomide and dexamethasone in patients with multiple myeloma refractory to previous lenalidomide-containing regimens. Br J Haematol. 2016 Nov 18. doi: 10.1111/bjh.14429. [Epub ahead of print]