Abstract
Efficacy and safety of bortezomib-based consolidation following ASCT were investigated in newly diagnosed multiple myeloma patients from Australia, Korea, and China. Patients received three cycles of bortezomib-cyclophosphamide-dexamethasone induction followed by high-dose therapy/ASCT, then were randomized (1:1) to consolidation with TP (thalidomide 100 mg/d for ≤12 months/until disease progression; prednisolone 50 mg on alternate days indefinitely/until disease progression; n = 100) or VTP (subcutaneous bortezomib 1.3 mg/m2 every 2 weeks for 32 weeks, plus TP; n = 103). The hypothesized difference in CR + VGPR rate (after ≤12 months consolidation therapy) was not met. The rate of CR + VGPR was numerically higher with VTP versus TP; however, this was not statistically significant (85.7% versus 77.1%; rate difference 8.6%; 95% confidence interval −2.3%–19.5%; p = .122). Secondary efficacy outcomes were similar between treatment arms. Addition of bortezomib to TP consolidation was associated with limited additional toxicity but did not significantly improve efficacy versus TP.
Trial registration: ClinicalTrials.gov identifier: NCT01539083.
Acknowledgments
The authors would like to thank all patients and their families, and investigators at all study sites for their valuable contributions to the study.
Potential conflict of interest:
Disclosure forms provided by the authors are available with the full text of this article online at https://doi.org/10.1080/10428194.2019.1579322.
Noemi Horvath: Advisory board, funding for home chemotherapy and clinical trial support from Janssen Pharmaceutica. Andrew Spencer: Honorarium and research funding from Janssen and Celgene.