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
Development of novel therapeutic agents such as proteasome inhibitors and immunomodulatory drugs (IMiDs), and the combination of these agents with existing therapies, has significantly improved response rates and survival outcomes for patients with multiple myeloma (MM) in recent years [1–3]. High-dose therapy (HDT) plus autologous stem cell transplant (ASCT) represents a standard of care among eligible patients with newly diagnosed MM (NDMM); patients typically receive triplet induction therapy prior to ASCT, followed by consolidation and/or maintenance therapy [4,5]. Several studies have shown that achievement of complete response (CR) or very good partial response (VGPR) before and after ASCT is strongly associated with improved clinical outcomes [6–8], thus supporting the concept of post-ASCT consolidation treatment. In Australia, to date, the standard of care post-ASCT has been 12 months of thalidomide combined with indefinite prednisolone (TP). This is based on the demonstrated superiority of TP over prednisolone alone for both progression-free survival (PFS) and overall survival (OS) [9,10]. In light of these results, post-ASCT TP has been routinely used in Australia and elsewhere . The use of bortezomib-based consolidation therapy post-ASCT has been shown to deepen responses and prolong PFS [12–14].