P170 | A MULTICENTER REAL-WORLD STUDY ON THE COMBINATION OF SELINEXOR WITH BORTEZOMIB AND DEXAMETHASONE (SVD) FOR THE TREATMENT OF RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS

Selinexor, the first-in-class selective inhibitor of exportin 1, represents a novel therapeutic option for relapsed/refractory multiple myeloma (RRMM) patients (pts). It has been recently approved by AIFA either in combination with bortezomib and dexamethasone (SVd), for lenalidomide-refractory pts treated with at least one prior therapy, or with dexamethasone for pts with a more advanced disease. Data on the efficacy and safety of the SVd regimen mainly comes from clinical trials, which however are not representative of the current real-world pt population: in the phase III BOSTON trial, only 38% of pts had been exposed to lenalidomide and 6% to daratumumab, while most pts in this setting are now refractory to both lenalidomide and daratumumab. Additionally, real-world data are scarce. To expand the available evidence on the use of SVd in a real-world setting, a national, non-profit, multicentre observational study has been designed, involving approximately 30 academic and community practice centres. The study was sponsored by the Gruppo Italiano Malattie EMatologiche dell’Adulto (GIMEMA) Multiple Myeloma Working Group. Key inclusion and exclusion criteria aim to enrol pts who have received 1–3 prior lines of therapy and are eligible for SVd outside of clinical trials. Specifically, pts must be aged 18 years or older and have measurable MM, as per IMWG criteria, with documented progressive disease on or after their most recent therapy and be lenalidomide- but not bortezomib-refractory. The main objective is to assess the efficacy of SVd in terms of progression-free survival. Secondary objectives include additional efficacy outcomes (e.g., haematological response rates, time to progression) as well as the characterization of the safety and tolerability profile of the regimen. All objectives will also be evaluated in relevant sub-populations identified by number of prior lines and therapy type, cytogenetic risk, early progression status, modification of SVd schedule and strategies for managing gastrointestinal toxicity. The study aims to enrol at least 159 pts, both prospectively and retrospectively. A web-based system will be used to register pts in a database. Enrolment is expected to begin in May 2025 across all participating centres. Data collection and preliminary analysis of the retrospective cohort will enable the presentation of initial findings at the upcoming congress, providing early insights into the real-world use of SVd.