Phase Ii Mmrc Trial Of Extended Treatment With Carfilzomib (Cfz), Lenalidomide (Len), And Dexamethasone (Dex) Plus Autologous Stem Cell Transplantation (Asct) In Newly Diagnosed Multiple Myeloma (Ndmm).

8510 Background: In a phase I/II study of combination treatment with CFZ, LEN, and DEX (KRd) without ASCT, KRd provided a high rate of sCR (55%) in NDMM patients (pts) and 3-year progression-free survival and OS rates of 79% and 96% (Jakubowiak et al. Blood 2012;120:1801-9; Jasielec et al. Blood 2013;122:3220). To further improve response and outcomes, we designed a phase II study to assess activity of extended treatment with KRd and ASCT. Methods: Pts received 28-day (d) cycles of CFZ 20/36 mg/m2IV (d1, 2, 8, 9, 15, 16), LEN 25mg PO (d1–21), and DEX 40/20 mg PO wkly (cycles1–4 induction/5–8 consolidation) with ASCT after cycle 4. For cycles 8–18, KRd was given with a modified CFZ schedule (d1, 2, 15, 16) and then LEN alone after cycle 18. Response was assessed by IMWG plus nCR. The primary endpoint is the rate of stringent complete response (sCR) at the end of cycle 8, with statistical hypothesis that the improvement of sCR from 30% (KRd without ASCT) to u003e50% will represent added benefit of ASCT. Results...