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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02780609
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 20, 2017
Status verified
Nov 2022
Primary completion
Feb 20, 2021
Completion
Feb 23, 2021

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor Plus HDM HCT
    The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.

Primary Outcome Measure

Phase I: Recommended Phase II Dose (RPh2D) [ Time Frame: Up to 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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