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Phase 1/2 Investigator Sponsored Study of Selinexor in Combination with High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
Phase I: The primary purpose of this study phase is to determine the best dose also referred to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant. Phase II: The primary purpose of this study phase is to assess the complete response (CR) conversion rate.
1. The Primary Objective of the phase 1 study is to determine the RPh2D/MTD of conditioning regimen of selinexor plus high-dose melphalan. 2. The Primary Objective of the phase 2 study is to assess complete response (CR) conversion rate at 3 months post HCT. Secondary Objectives: Secondary objectives are to estimate overall response rate (ORR) at 3 months post HCT and to estimate progression-free survival (PFS) and overall survival (OS).
Alkeran (Melphalan); Dexamethasone (); KPT-330 (Selinexor); Melphalan (); Selinexor ()