The combination of bendamustine, lenalidomide, and dexamethasone (BRd) is safe and efficacious as second-line treatment for patients with relapsed/refractory multiple myeloma, a study published in the British Journal of Haematology has shown.1
Lenalidomide plus dexamethasone is a standard treatment regimen for patients with relapsed/refractory multiple myeloma; however, only a small proportion of patients will achieve high quality responses with this combination.
Bendamustine combined with lenalidomide and dexamethasone has demonstrated efficacy in patients with advanced relapsed/refractory myeloma, but its associated dose-limiting hepatotoxicity has limited its use to patients with heavily pretreated disease.
Therefore, investigators sought to evaluate the efficacy and safety of this 3-drug combination in patients with relapsed/refractory myeloma who have received only 1 prior line of therapy.
The multicenter, phase 2 study enrolled 50 patients who received induction therapy with bendamustine intravenously on days 1 and 2, lenalidomide orally daily for days 1 to 21, and dexamethasone on days 1, 8, 15, and 22, for 6 28-day cycles. Participants then received lenalidomide and dexamethasone alone for 12 cycles.
Results showed that 51% of the 45 evaluable patients achieved a complete response or a very good partial response. Median progression-free survival was 18.6 months (95% CI, 16.5-29.2) and median time to progression was 19.9 months (95% CI, 16.5-not reached).
Median overall survival has not yet been reached (95% CI, 37.7-not reached). Investigators estimated that 76% (95% CI, 64-91) of patients will be alive at 2 years.
Of note, researchers observed grade 4 neutropenia and thrombocytopenia in 34% and 16% of patients, respectively, despite pegfilgrastim support.
Mey UJM, Brugger W, Schwarb H, et al. Bendamustine, lenalidomide and dexamethasone (BRd) has high activity as 2nd-line therapy for relapsed and refractory multiple myeloma – a phase II trial. Br J Haematol. 2016 Dec 16. doi: 10.1111/bjh.14481. [Epub ahead of print]