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

NCT02780609 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-11-04

Study results available
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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

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.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Taiga Nishihori, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2021-02-20
Completion
2021-02-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02780609 on ClinicalTrials.gov