1. Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial.
- Author
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Mellqvist, Ulf-Henrik, Gimsing, Peter, Hjertner, Oyvind, Lenhoff, Stig, Laane, Edward, Remes, Kari, Steingrimsdottir, Hlif, Abildgaard, Niels, Ahlberg, Lucia, Blimark, Cecilie, Dahl, Inger Marie, Forsberg, Karin, Gedde-Dahl, Tobias, Gregersen, Henrik, Gruber, Astrid, Guldbrandsen, Nina, Haukås, Einar, Carlson, Kristina, Kvam, Ann Kristin, and Nahi, Hareth
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PROTEASOME inhibitors , *STEM cell transplantation , *MULTIPLE myeloma , *FATIGUE (Physiology) , *RANDOMIZED controlled trials , *RANDOMIZATION (Statistics) - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2013
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