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The 60th American Society of Hematology (ASH) Annual Meeting was held in San Diego, California, from 1–4 December 2018. On Saturday 1 December 2018, an oral abstract session was held entitled: Clinical Autologous Transplantation: Results: Multiple Myeloma: Upfront Autologous Transplantation, which focused on updates of advanced clinical trials for newly diagnosed multiple myeloma (NDMM).
Laura Rosiñol from the Hospital Clinic, Barcelona, Spain, presented the final results of the GEM05menos65 phase III trial for NDMM patients under 65, around ten years after the last patient was recruited. Patients were randomized (1:1:1) to three arms of induction treatment [combination chemotherapy (CT) (VBMCP-VBAD) and bortezomib (CT+V); thalidomide and dexamethasone (Td); bortezomib, thalidomide, and dexamethasone (VTd)] prior to receiving an autologous stem cell transplant (ASCT). The results of this trial along with those of the GIMEMA-MMY-3006 trial led to the approval of the VTd triplet as an induction treatment prior to an ASCT by the European Medicines Agency in August 2013.
Data are presented as VTd versus (vs) Td vs CT+V
The long-term follow-up of the GEM05menos65 phase III trial confirms that induction with VTd is superior to that of Td or CT+V in terms of PFS and supports the use of VTd as the standard of care for pre-transplant induction in patients with NDMM. Patients who achieved MRD negativity after ASCT treatment had similar PFS and OS, independent of cytogenetic status. Patients with high-risk cytogenetics who remained MRD positive post-transplant had an unfavorable prognosis.
Rosiñol L. et al. VTD (Bortezomib/Thalidomide/Dexamethasone) As Pretransplant Induction Therapy for Multiple Myeloma: Definitive Results of a Randomized Phase 3 Pethema/GEM Study. 2018 Dec 1; Oral Abstract #126: ASH 60th Annual Meeting and Exposition, San Diego, CA.