The combination of bendamustine, bortezomib, and dexamethasone is efficacious and tolerable as first-line therapy for patients with multiple myeloma ineligible to receive high-dose therapy, a study published in the British Journal of Haematology has shown.1
An interim analysis of a phase 2 study evaluating bendamustine 80 mg/m2 on days 1 and 4 with bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11, and dexamethasone 40 mg on days 1 to 4 in patients with multiple myeloma showed that this regimen was efficacious but relatively toxic.
Therefore, researchers modified the study to evaluate bendamustine 80 mg/m2 on days 1 and 2 plus bortezomib 1.3 mg/m2 on days 1, 8, and 15, and dexamethasone 20 mg on days 1, 2, 8, 9, 15, and 16 every 28 days for up to 8 cycles, followed by maintenance bortezomib intravenously every 2 weeks.
For the study, investigators enrolled 59 patients with newly diagnosed myeloma who were not candidates for high-dose therapy/autologous hematopoietic cell transplantation to receive frontline treatment with the 3-drug regimen. Researchers assigned 18 patients to the original schema and 41 to the modified schema.
The original schema was given for a median of 7 cycles and the modified schema was given for a median of 8 cycles during induction.
Results showed that 91% of patients achieved an overall response, including 9% who had a complete response. Only patients who received the modified schema achieved a complete response.
At a median follow-up of 19.1 months, researchers found that median progression-free survival was 11.1 months with original chemotherapy regimen and 18.9 months with the modified regimen, suggesting that modifications to decrease intensity while increasing duration improved outcomes.
The common adverse events were neuropathy, fatigue, anemia, constipation, and thrombocytopenia. The most frequently reported grade 3 to 4 adverse events were fatigue and neuropathy. Most adverse events were more prevalent with the original regimen.
1. Berdeja JG, Bauer T, Arrowsmith E, et al. Phase II study of bendamustine, bortezomib and dexamethasone (BBD) in the first-line treatment of patients with multiple myeloma who are not candidates for high dose chemotherapy. Br J Haematol. 2017 Feb 7. doi: 10.1111/bjh.14536 [Epub ahead of print]