Advanced

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

Mellqvist, Ulf-Henrik; Gimsing, Peter; Hjertner, Oyvind; Lenhoff, Stig LU ; Laane, Edward; Remes, Kari; Steingrimsdottir, Hlif; Abildgaard, Niels; Ahlberg, Lucia and Blimark, Cecilie, et al. (2013) In Blood 121(23). p.4647-4654
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... (More)
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. (Less)
Please use this url to cite or link to this publication:
author
, et al. (More)
(Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Blood
volume
121
issue
23
pages
4647 - 4654
publisher
American Society of Hematology
external identifiers
  • wos:000321895700008
  • scopus:84881035760
ISSN
1528-0020
DOI
10.1182/blood-2012-11-464503
language
English
LU publication?
yes
id
2a02bd7c-2f3a-4e13-99b8-394c86a11999 (old id 4043201)
date added to LUP
2013-10-01 15:16:41
date last changed
2019-02-24 03:00:41
@article{2a02bd7c-2f3a-4e13-99b8-394c86a11999,
  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.},
  author       = {Mellqvist, Ulf-Henrik and Gimsing, Peter and Hjertner, Oyvind and Lenhoff, Stig and Laane, Edward and Remes, Kari and Steingrimsdottir, Hlif and Abildgaard, Niels and Ahlberg, Lucia and Blimark, Cecilie and Dahl, Inger Marie and Forsberg, Karin and Gedde-Dahl, Tobias and Gregersen, Henrik and Gruber, Astrid and Guldbrandsen, Nina and Haukas, Einar and Carlson, Kristina and Kvam, Ann Kristin and Nahi, Hareth and Lindas, Roald and Andersen, Niels Frost and Turesson, Ingemar and Waage, Anders and Westin, Jan},
  issn         = {1528-0020},
  language     = {eng},
  number       = {23},
  pages        = {4647--4654},
  publisher    = {American Society of Hematology},
  series       = {Blood},
  title        = {Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial},
  url          = {http://dx.doi.org/10.1182/blood-2012-11-464503},
  volume       = {121},
  year         = {2013},
}