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Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial

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Author

  • Ulf-Henrik Mellqvist
  • Peter Gimsing
  • Oyvind Hjertner
  • Stig Lenhoff
  • Edward Laane
  • Kari Remes
  • Hlif Steingrimsdottir
  • Niels Abildgaard
  • Lucia Ahlberg
  • Cecilie Blimark
  • Inger Marie Dahl
  • Karin Forsberg
  • Tobias Gedde-Dahl
  • Henrik Gregersen
  • Astrid Gruber
  • Nina Guldbrandsen
  • Einar Haukas
  • Kristina Carlson
  • Ann Kristin Kvam
  • Hareth Nahi
  • Roald Lindas
  • Niels Frost Andersen
  • Ingemar Turesson
  • Anders Waage
  • Jan Westin
Show all

Summary, in English

The Nordic Myeloma Study Group conducted an open randomized trial to compare bortezomib as consolidation therapy given after high-dose therapy and autologous stem cell transplantation (ASCT) with no consolidation in bortezomib-naive patients with newly diagnosed multiple myeloma. Overall, 370 patients were centrally randomly assigned 3 months after ASCT to receive 20 doses of bortezomib given during 21 weeks or no consolidation. The hypothesis was that consolidation therapy would prolong progression-free survival (PFS). The PFS after randomization was 27 months for the bortezomib group compared with 20 months for the control group (P = .05). Fifty-one of 90 patients in the treatment group compared with 32 of 90 controls improved their response after randomization (P = .007). No difference in overall survival was seen. Fatigue was reported more commonly by the bortezomib-treated patients in self-reported quality-of-life (QOL) questionnaires, whereas no other major differences in QOL were recorded between the groups. Consolidation therapy seemed to be beneficial for patients not achieving at least a very good partial response (VGPR) but not for patients in the >= VGPR category at randomization. Consolidation with bortezomib after ASCT in bortezomib-naive patients improves PFS without interfering with QOL. This trial was registered at www.clinicaltrials.gov as #NCT00417911.

Publishing year

2013

Language

English

Pages

4647-4654

Publication/Series

Blood

Volume

121

Issue

23

Document type

Journal article

Publisher

American Society of Hematology

Topic

  • Hematology

Status

Published

ISBN/ISSN/Other

  • ISSN: 1528-0020