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

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 NahiRoald Lindas, Niels Frost Andersen, Ingemar Turesson, Anders Waage, Jan Westin

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskriftPeer review

Sammanfattning

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.
Originalspråkengelska
Sidor (från-till)4647-4654
TidskriftBlood
Volym121
Nummer23
DOI
StatusPublished - 2013

Ämnesklassifikation (UKÄ)

  • Hematologi

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