First‐line therapy with bendamustine/prednisone/bortezomib—A GMMG trial for non‐transplant eligible symptomatic multiple myeloma patients

Objectives The German‐speaking Myeloma Multicenter Group (GMMG) conducted this trial to investigate efficacy and safety of the three‐drug combination bendamustine/prednisone/bortezomib (BPV) as first‐line therapy for elderly patients with multiple myeloma (MM). Methods Elderly MM patients requiring first‐line therapy and not eligible for intensive treatment were enrolled in this phase IIb multicenter study. Patients were treated with BPV regimen for a maximum of nine cycles. Results Forty‐six patients were included in the trial with a median age of 76 years. Nineteen patients had renal impairment at baseline. The ORR was 78.8% for patients treated with 3 and more BPV cycles and 71.1% for all evaluable patients. The median progression‐free survival was 25 months, and overall survival at 24 months was 83.3%. The clinical benefit rate including MR was 91.2%. In patients with renal impairment at baseline, a renal response was observed in 11 pts. with complete recovery of the renal function in six patients. The most frequent CTC grade 3/4 AEs experienced by patients were hematological (17.5%) and infectious (9.8%) complications. No new safety signals were observed for the study drugs under investigation. Conclusions Bendamustine/prednisone/bortezomib may serve as a first‐line regimen for transplant‐ineligible elderly MM patients in particular for patients with renal impairment requiring a fast and durable renal response.