Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma – a Nordic Myeloma Study Group randomized phase 3 trial - UTU Research Portal

A1 Refereed original research article in a scientific journal

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

Subtitle: a Nordic Myeloma Study Group randomized phase 3 trial

Authors: Mellqvist UH, Gimsing P, Hjertner O, Lenhoff S, Laane E, Remes K, Steingrimsdottir H, Abildgaard N, Ahlberg L, Blimark C, Dahl IM, Forsberg K, Gedde-Dahl T, Gregersen H, Gruber A, Guldbrandsen N, Haukas E, Carlson K, Kvam AK, Nahi H, Lindas R, Andersen NF, Turesson I, Waage A, Westin J, for the Nordic Myeloma Study Group

Publisher: AMER SOC HEMATOLOGY

Publication year: 2013

Journal: Blood

Journal name in source: BLOOD

Journal acronym: BLOOD

Number in series: 23

Volume: 121

Issue: 23

First page : 4647

Last page: 4654

Number of pages: 8

ISSN: 0006-4971

DOI: https://doi.org/10.1182/blood-2012-11-464503

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.