Selinexor combined bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma with extramedullary disease: a multicenter study

Abstract Objective: We aimed to explored the efficacy and safety of XVRD protocol in newly diagnosed multiple myeloma with extramedullary disease. Methods: This is a single-arm, open, observational clinical study. For induction/consolidation(21-day cycles), patients (pts) received 8 cycles of XVRd (Selinexor 60 mg PO weekly, Bortezomib 1.3 mg/m² SC days1, 4, 8, 11, Lenalidomide 25 mg PO days 1-14, and Dexamethasone 40 mg PO weekly). In maintenance (28-day cycles), pts received XR (Selinexor+Lenalidomide) at least 2 years until disease progression, death or withdrawal. The primary endpoint was overall response rates and minimal residual disease negative rates. Results: The median age of the 10 pts was 62 (range 55-81) years. R-ISS stage 3 was present in 2 (20%) pts. 3 pts had high risk cytogenetic and 1 patient with plasma cell leukocyte. According to IMWG criteria, the ORR of 10 pts with NDMM was 100%, including 2 stringent complete response (sCR), 2 complete remission (CR), 4 very good partial response (VGPR) and 2 partial response (PR). Median progression-free survival and overall survival were not achieved. The most common grade 3-4 treatment-emergent adverse events (occurring in 10% of pts) were thrombocytopenia. The most common non-hematological adverse events were grade 1 or 2, including nausea (30%), fatigue (40%), and anorexia (20%). Overall, the severe toxicities are manageable. Conclusion: The XVRd regimen has good efficacy and tolerance in newly diagnosed multiple myeloma with extramedullary disease.