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Phase II study of bortezomib, cyclophosphamide and dexamethasone as induction therapy in multiple myeloma: DSMM XI trial
Author(s) -
Einsele Hermann,
Engelhardt Monika,
Tapprich Christoph,
Müller Jürgen,
Liebisch Peter,
Langer Christian,
Kropff Martin,
Mügge Lars O.,
Jung Wolfram,
Wolf HansHeinrich,
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
Publication year - 2017
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.14920
Subject(s) - medicine , multiple myeloma , cyclophosphamide , bortezomib , dexamethasone , regimen , oncology , gastroenterology , autologous stem cell transplantation , adverse effect , surgery , chemotherapy
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 .