Phase II study of bortezomib, cyclophosphamide and dexamethasone as induction therapy in multiple myeloma: DSMM XI trial. (29th September 2017)

• Record Type: Journal Article
• Authors: Einsele, Hermann; Engelhardt, Monika; Tapprich, Christoph; Müller, Jürgen; Liebisch, Peter; Langer, Christian; Kropff, Martin; Mügge, Lars O.; Jung, Wolfram; Wolf, Hans‐Heinrich; Metzner, Bernd; Hart, Christina; Gramatzki, Martin; Hertenstein, Bernd; Pfreundschuh, Michael; Rösler, Wolf; Fischer, Thomas; Maschmeyer, Georg; Kanz, Lothar; Hess, Georg; Jäger, Elke; Bentz, Martin; Dürk, Heinz A.; Salwender, Hans; Hebart, Holger; Straka, Christian; Knop, Stefan
• Is Part Of: British journal of haematology. Volume 179:Number 4(2017)
• Page Start: 586
• Page End: 597
• Publication Date: 2017-09-29
• Subjects: multiple myeloma -- bortezomib -- cyclophosphamide -- dexamethasone -- induction therapy; Hematology -- Periodicals; Blood -- Diseases -- Periodicals; 616.15
• DOI: 10.1111/bjh.14920
• Languages: English
• ISSNs: 0007-1048

Abstract

Summary: We assessed the safety and efficacy of bortezomib, cyclophosphamide and dexamethasone (VCD) induction therapy in previously untreated multiple myeloma patients. A total of 414 patients received three 21‐day cycles of VCD prior to autologous stem‐cell transplantation (ASCT). Most common grade ≥3 adverse events were leucopenia (31·4%) and thrombocytopenia (6·8%). The overall response rate (ORR) by investigator‐based assessment was 85·4%. Most patients (74%) underwent successful central laboratory‐based molecular cytogenetic analysis. No clinically relevant differences in ORR post‐induction were seen between patients with or without high‐risk cytogenetic abnormalities (86·2% vs. 84·3%). Further follow‐up data are available for 113 patients receiving ASCT who were included in a prospective consolidation trial (median follow‐up, 55·5 months); median progression‐free survival (PFS) was 35·3 months and median overall survival (OS) was not reached. In patients with high‐risk versus standard‐risk cytogenetics, median PFS was 19·9 vs. 43·6 months ( P < 0·0001), and median OS was 54·7 months versus not reached ( P = 0·0022). VCD is an effective and tolerable induction regimen; results suggest that VCD induces high response rates independently of cytogenetic risk status, but after long‐term follow‐up, cytogenetic high risk is associated with markedly reduced PFS and OS post‐ASCT.