NCT02780609 - Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 20, 2017

Primary Completion Date

February 20, 2021

Study Completion Date

February 23, 2021

Conditions

Multiple Myeloma

Interventions

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.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa