Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase III trial
Mené sur 370 patients atteints d'un myélome multiple, cet essai de phase III évalue, du point de vue de la survie sans progression et de la qualité de vie, le bortezomib en traitement de consolidation trois mois après une greffe autologue de cellules souches
The Nordic Myeloma Study Group (NMSG) conducted an open randomized trial to compare bortezomib as consolidation therapy given after high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) to no consolidation in bortezomib naïve patients with newly diagnosed multiple myeloma. Overall, 370 patients were centrally randomly assigned three 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 randomisation was 27 months for the bortezomib group compared to 20 months for the control group (p=0.05). Fifty-one out of 90 patients in the treatment group compared to 32 out of 90 controls improved their response after randomisation (p=0.007). 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 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 ≥ VGPR at randomisation. Consolidation with bortezomib after ASCT in bortezomib naïve patients improves PFS without interfering with QoL. (This study was registered at www.clinicaltrials.gov as #NCT00417911.)