Wolfgang Knauf1, Gerrit Dingeldein2, Rudolf Schlag3, Manfred Welslau4, Thomas Moehler5, Tobias Terzer6, Sarah Walter7, Christina Habermehl6, Christina Kunz6, Hartmut Goldschmidt8,9, Marc-Steffen Raab8. 1. Centrum Haematologie & Onkologie Bethanien, Frankfurt, Germany. 2. Onkologische Schwerpunktpraxis, Darmstadt, Germany. 3. Hämatologisch-Onkologische Schwerpunktpraxis, Würzburg, Germany. 4. Onkologische Praxis, Aschaffenburg, Germany. 5. IQVIA, Frankfurt, Germany. 6. Department of Biostatistics, German Cancer Research Center, Heidelberg, Germany. 7. Koordinierungszentrum für klinische Studien Heidelberg, FRG, Heidelberg, Germany. 8. Department of Medicine V, University of Heidelberg, Heidelberg, Germany. 9. National Center for Tumor Diseases (NCT), Heidelberg, Germany.
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.
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 MMpatients 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 MMpatients in particular for patients with renal impairment requiring a fast and durable renal response.
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