Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study

Abstract

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\u2009mg/d for ≤12 months/until disease progression; prednisolone 50\u2009mg on alternate days indefinitely/until disease progression; n\u2009=\u2009100) or VTP (subcutaneous bortezomib 1.3\u2009mg/m2 every 2 weeks for 32 weeks, plus TP; n\u2009=\u2009103). The hypothesized difference in CR\u2009+\u2009VGPR rate (after ≤12 months consolidation therapy) was not met. The rate of CR\u2009+\u2009VGPR 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\u2009=\u2009.122). 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.