First‐line therapy with bendamustine/prednisone/bortezomib—A GMMG trial for non‐transplant eligible symptomatic multiple myeloma patients. (26th May 2020)

• Record Type: Journal Article
• Authors: Knauf, Wolfgang; Dingeldein, Gerrit; Schlag, Rudolf; Welslau, Manfred; Moehler, Thomas; Terzer, Tobias; Walter, Sarah; Habermehl, Christina; Kunz, Christina; Goldschmidt, Hartmut; Raab, Marc‐Steffen
• Is Part Of: European journal of haematology. Volume 105:Number 2(2020)
• Page Start: 116
• Page End: 125
• Publication Date: 2020-05-26
• Subjects: clinical trials -- multiple myeloma -- non‐Hodgkin's lymphoma -- plasma cell neoplasms; Hematology -- Periodicals; Blood -- Diseases -- Periodicals; Blood -- Periodicals; 616.15005
• DOI: 10.1111/ejh.13409
• Languages: English
• ISSNs: 0902-4441

Abstract

Abstract: 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.