Study of the Safety, Tolerability and Efficacy of KPT-8602 in Patients With Relapsed/Refractory Multiple Myeloma

Overview

This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in patients with relapsed/refractory multiple myeloma.
SparkCures ID 789
Trial Phase Phase 1/2
Enrollment 116 Patients
Treatments
Tags
Trial Sponsors
  • Karyopharm Therapeutics
NCT Identifier

NCT02649790

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria

  • Evidence of disease progression:
    • Symptomatic relapsed or refractory requiring current treatment.
    • Previously treated with ≥ 3 prior regimens (lines of therapy) that included at least one of each of the following: alkylating agent, immunomodulatory drug, proteasome inhibitor, and a steroid.
    • Must be refractory to most recent anti-cancer regimen.
  • Must have measurable disease defined by one of the following:
    • Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or for IgA myeloma, by quantitative IgA; or
    • Urinary M-protein excretion at least 200 mg/24 hours; or
    • Serum Free Light Chain (Serum FLC) whereby the involved light chain measures ≥ 10 mg/dL and with an abnormal ratio.
  • Eastern Cooperative Oncology Group performance status of ≤ 1.

Exclusion Criteria

  • Time since the last prior therapy:
    • Radiation, chemotherapy, immunotherapy or any other anticancer therapy, including investigational anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1.
    • Palliative steroids for disease related symptoms are allowed up to 3 days prior to Cycle 1 Day 1.
  • Active graft versus host disease after allogeneic stem cell transplantation. At least 3 months must have elapsed since completion of allogeneic stem cell transplantation.
  • Active central nervous system malignancy. Patients who have only had prophylactic intrathecal or intravenous chemotherapy against central nervous system disease are eligible.
  • Patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea that could interfere with the absorption of KPT-8602.
  • Prior exposure to a SINE compound.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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Trial Links

Read the latest news and updates on this trial.