First‐line therapy with Bendamustine/Prednisone/Bortezomib (BPV) – 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 3-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 9 cycles. RESULTS: 46 patients were included into the trial with a median age of 76 years. 19 patients had renal impairment at baseline. The ORR was 76.5%, the median progression free survival 25 months and overall survival at 24 month 83.3%. The clinical benefit rate (CBR) 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 6 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: BPV 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.