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 Haukås, Kristina Carlson, Ann Kristin Kvam, Hareth Nahi, Roald Lindås, Niels Frost Andersen, Ingemar Turesson, Anders Waage, Jan Westin, Nordic Myeloma Study Group, Henrik Gregersen, Niels Frost Andersen, Peter Gimsing, Nilsaage Toffner-Clausen, Niels Abildgaard, Edward Laane, Raija Silvennoinen, Kari Remes, Hlif Steingrimsdottir, Roald Lindås, Tobias Gedde-Dahl, Nina Guldbrandsen, Ann Kristin Kvam, Einar Haukås, Inger Marie Dahl, Oyvind Hjertner, Anders Waage, Cecilie Blimark, Ulf-Henrik Mellqvist, Jan Westin, Lucia Ahlberg, Stig Lenhoff, Ingemar Turesson, Olle Linder, Astrid Gruber, Hareth Nahi, Karin Forsberg, Kristina Carlson, 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 Haukås, Kristina Carlson, Ann Kristin Kvam, Hareth Nahi, Roald Lindås, Niels Frost Andersen, Ingemar Turesson, Anders Waage, Jan Westin, Nordic Myeloma Study Group, Henrik Gregersen, Niels Frost Andersen, Peter Gimsing, Nilsaage Toffner-Clausen, Niels Abildgaard, Edward Laane, Raija Silvennoinen, Kari Remes, Hlif Steingrimsdottir, Roald Lindås, Tobias Gedde-Dahl, Nina Guldbrandsen, Ann Kristin Kvam, Einar Haukås, Inger Marie Dahl, Oyvind Hjertner, Anders Waage, Cecilie Blimark, Ulf-Henrik Mellqvist, Jan Westin, Lucia Ahlberg, Stig Lenhoff, Ingemar Turesson, Olle Linder, Astrid Gruber, Hareth Nahi, Karin Forsberg, Kristina Carlson
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. This trial was registered at www.clinicaltrials.gov as #NCT00417911.
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Source: PubMed