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Salvage bortezomib-dexamethasone and high-dose melphalan (HDM) and autologous stem cell support (ASCT) in myeloma patients at first relapse after HDM with ASCT. A phase-2 trial.

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Author

  • P Gimsing
  • Ø Hjertner
  • N Abildgaard
  • N F Andersen
  • T G Dahl
  • H Gregersen
  • T W Klausen
  • U-H Mellqvist
  • O Linder
  • R Lindås
  • N Tøffner Clausen
  • Stig Lenhoff
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Summary, in English

Until recently, only retrospective studies had been published on salvage high-dose melphalan (HDM) with autologous stem cell 'transplantation' (ASCT). In a prospective, nonrandomized phase-2 study, we treated 53 bortezomib-naïve patients with bortezomib-dexamethasone as induction and bortezomib included in the conditioning regimen along with the HDM. Median progression-free survival (PFS), time to next treatment (TNT) and overall survival (OS) after start of reinduction therapy were 21.6, 22.8 and 46.6 months, respectively. For 49 patients who completed salvage bortezomib-HDM(II) with ASCT, there was no significant difference of PFS and TNT after HDM (II) compared with after the initial HDM(I), and thus patients were their own controls (PFS (I: 20.1 vs II: 19.3 months (P=0.8)) or TNT (I: 24.4 vs II: 20.7 months (P=0.8)). No significant differences in the response rates after salvage ASCT compared with the initial ASCT. Bortezomib-HDM conditioning combo was feasible, and toxicity was as expected for patients treated with bortezomib and ASCT. In conclusion, in bortezomib-naïve patients treated at first relapse with salvage ASCT including bortezomib, PSF and TNT did not differ significantly from initial ASCT and median OS was almost 5.5 years with acceptable toxicity. A recent prospective randomized study confirms salvage ASCT to be an effective treatment.Bone Marrow Transplantation advance online publication, 29 June 2015; doi:10.1038/bmt.2015.125.

Publishing year

2015

Language

English

Pages

1306-1311

Publication/Series

Bone Marrow Transplantation

Volume

50

Issue

10

Document type

Journal article

Publisher

Nature Publishing Group

Topic

  • Hematology

Status

Published

ISBN/ISSN/Other

  • ISSN: 1476-5365