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Clinical Trial
. 2013 Jun 6;121(23):4647-54.
doi: 10.1182/blood-2012-11-464503. Epub 2013 Apr 24.

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

Ulf-Henrik Mellqvist  1 , 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
Collaborators, Affiliations
Clinical Trial

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

Ulf-Henrik Mellqvist et al. Blood. .

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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Figures

Figure 1
Figure 1
Flow diagram of 403 patients included in the Nordic Myeloma Study Group bortezomib consolidation study.
Figure 2
Figure 2
Analysis of outcome from start of consolidation therapy. Kaplan-Meier estimates of PFS for bortezomib-treated patients vs controls (A), PFS for patients achieving ≥VGPR vs patients achieving <VGPR (B), PFS for patients in the <VGPR category at randomization (C), PFS for patients in the ≥VGPR category at randomization (D), and OS for bortezomib-treated patients vs controls (E).
Figure 3
Figure 3
Neurologic toxicity. Number of patients experiencing neuropathic pain (A) and peripheral sensory neuropathy (B) by treatment arm.
Figure 4
Figure 4
Hematologic toxicity. Mean neutrophil (A) and platelet (B) count for patients randomized to bortezomib during the consolidation period. ANC, absolute neutrophil count.
Figure 5
Figure 5
Quality of life. Score for fatigue by treatment arm.
See this image and copyright information in PMC

References

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