Phase II study of bortezomib, cyclophosphamide and dexamethasone as induction therapy in multiple myeloma: DSMM XI trial

Einsele, Hermann and Engelhardt, Monika and Tapprich, Christoph and Mueller, Juergen and Liebisch, Peter and Langer, Christian and Kropff, Martin and Muegge, Lars O. and Jung, Wolfram and Wolf, Hans-Heinrich and Metzner, Bernd and Hart, Christina and Gramatzki, Martin and Hertenstein, Bernd and Pfreundschuh, Michael and Roesler, Wolf and Fischer, Thomas and Maschmeyer, Georg and Kanz, Lothar and Hess, Georg and Jaeger, Elke and Bentz, Martin and Duerk, Heinz A. and Salwender, Hans and Hebart, Holger and Straka, Christian and Knop, Stefan (2017) Phase II study of bortezomib, cyclophosphamide and dexamethasone as induction therapy in multiple myeloma: DSMM XI trial. BRITISH JOURNAL OF HAEMATOLOGY, 179 (4). pp. 586-597. ISSN 0007-1048, 1365-2141

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Abstract

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.

Item Type: Article
Uncontrolled Keywords: STEM-CELL TRANSPLANTATION; MINIMAL RESIDUAL DISEASE; MULTIPARAMETER FLOW-CYTOMETRY; INDUCED PERIPHERAL NEUROPATHY; NEWLY-DIAGNOSED PATIENTS; HIGH-RISK CYTOGENETICS; HIGH-DOSE THERAPY; PLUS DEXAMETHASONE; HOVON-65/GMMG-HD4 TRIAL; CHROMOSOMAL-ABERRATIONS; multiple myeloma; bortezomib; cyclophosphamide; dexamethasone; induction therapy
Subjects: 600 Technology > 610 Medical sciences Medicine
Depositing User: Dr. Gernot Deinzer
Date Deposited: 14 Dec 2018 13:19
Last Modified: 13 Feb 2019 13:01
URI: https://pred.uni-regensburg.de/id/eprint/1891

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