Overview
This is a single-arm, open-label phase II study with a safety lead-in phase.
Description
The study hypothesis is that the isatuximab plus bortezomib, cyclophosphamide and dexamethasone (VCD) combination is safe and highly effective even in those with renal insufficiency (RI) from myeloma. In this study, we seek to improve the efficacy of VCD by adding isatuximab in newly diagnosed multiple myeloma patients undergoing autologous stem cell transplant (ASCT) irrespective of renal function.
The primary objective is to determine if the addition of isatuximab to VCD will increase the proportion of subjects achieving very good partial response (VGPR), as defined by the International Myeloma Working Group (IMWG) criteria and by the time of completion of post-ASCT consolidation treatment.