At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 with histologically confirmed multiple myeloma
- ✓Achieved partial response (PR) or very good partial response (VGPR) with systemic chemotherapy
- ✓Received fewer than 4 lines of prior anti-myeloma therapy
- ✓Adequate pulmonary, cardiac, hepatic, and renal function
- ✕Non-secretory multiple myeloma
- ✕Achieved complete response (CR) prior to autologous HCT
- ✕Central nervous system (CNS) involvement
- ✕Uncontrolled bacterial, viral, or fungal infections
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Selinexor, Melphalan, and 3 other interventions for Multiple Myeloma. Completed, enrolled 22 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.
Melphalan 100 mg/m\^2 IV over 30-45 minutes.
Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant at 150 mg IV on days -3 and -2.