Selinexor Treatment of Refractory Myeloma

NCT02336815 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2023-01-26

Study results available
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Summary

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

Conditions

Interventions

DRUG

Selinexor

Fixed oral dose of 80 mg twice weekly (e.g., Monday and Wednesday or Tuesday and Thursday, etc.)

DRUG

Dexamethasone

20 mg was given with each dose of Selinexor.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-26
Primary Completion
2019-07-26
Completion
2019-07-26

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Greece

Study Locations

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Entities

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 NCT02336815 on ClinicalTrials.gov