Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial
Open Access
- 6 June 2013
- journal article
- research article
- Published by American Society of Hematology in Blood
- Vol. 121 (23), 4647-4654
- 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.This publication has 31 references indexed in Scilit:
- The role of maintenance thalidomide therapy in multiple myeloma: MRC Myeloma IX results and meta-analysisBlood, 2012
- Practical management of adverse events in multiple myeloma: Can therapy be attenuated in older patients?Blood Reviews, 2011
- Current Trends in Autologous Stem-Cell Transplantation for Myeloma in the Era of Novel TherapiesJournal of Clinical Oncology, 2011
- Cyclophosphamide plus dexamethasone is an efficient initial treatment before high‐dose melphalan and autologous stem cell transplantation in patients with newly diagnosed multiple myelomaCancer, 2007
- International uniform response criteria for multiple myelomaLeukemia, 2006
- Bortezomib or High-Dose Dexamethasone for Relapsed Multiple MyelomaThe New England Journal of Medicine, 2005
- A phase 2 study of two doses of bortezomib in relapsed or refractory myelomaBritish Journal of Haematology, 2004
- CRITERIA FOR EVALUATING DISEASE RESPONSE AND PROGRESSION IN PATIENTS WITH MULTIPLE MYELOMA TREATED BY HIGH‐DOSE THERAPY AND HAEMOPOIETIC STEM CELL TRANSPLANTATIONBritish Journal of Haematology, 1998
- The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in OncologyJNCI Journal of the National Cancer Institute, 1993