SWOG 1211: A randomized phase I/II study of optimal induction therapy for newly diagnosed high-risk multiple myeloma (HRMM).

TPS8624 Background: The introduction of immunomodulatory agents and proteasome inhibitors, and advances in high dose therapy administration have made an impact on progression free survival (PFS) and overall survival (OS) for multiple myeloma (MM) patients in general, but patients with HRMM still have a poor long-term prognosis. Therefore, it is imperative to develop novel therapeutic regimens that will extend PFS and OS in this group. The SWOG 1211 is the first national and inter-group study targeting the HRMM population. Methods: Eligibility and Trial Design: A randomized phase I/II trial was designed to evaluate the efficacy of incorporating novel agents into first line therapy for HRMM patients comparing lenalidomide, bortezomib and dexamethasone (RVD) with or without addition of elotuzumab (Elo). Eligible patients must have a documented history of HRMM defined by one or more of the following: Poor risk genomics defined by 70-gene model. Translocation (14;16), translocation (14;20) and/or deletion (17p...