NCT02780609

Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Selinexor	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.
DRUG	Melphalan	Melphalan 100 mg/m\^2 IV over 30-45 minutes.
DRUG	Dexamethasone	Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
PROCEDURE	Autologous Hematopoietic Cell Transplantation (HCT)	Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
DRUG	Fosaprepitant	Fosaprepitant at 150 mg IV on days -3 and -2.

Timeline

• Start date: 2017-07-20
• Primary completion: 2021-02-20
• Completion: 2021-02-23
• First posted: 2016-05-23
• Last updated: 2022-11-04
• Results posted: 2022-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study