Clincosm LogoSign in Get a demo

Single Patient Use of Selinexor and Dexamethasone for a Patient With Multiple Myeloma

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
No longer available
CT.gov ID
NCT03850704
Collaborator
(none)

Study Details

Study Description

Brief Summary

This is an individual patient, expanded access protocol using Selinexor and dexamethasone ("Sd") for the treatment of Relapsed, Refractory multiple myeloma in a 64 year old male, "19023-UMN-01" weighing 105.7 kg. 19023-UMN-01 has IgG kappa myeloma that has relapsed after numerous treatments.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Selinexor is an oral, first in class, slowly reversible, potent and Selective Inhibitor of Nuclear Export (SINE) compound that specifically blocks Exportin 1 (XPO1). It is one of the most promising investigational drugs available for this patient with clear risk and benefit assessment favoring potential benefit.

Study Design

Study Type:
Expanded Access

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Patients having relapsed/refractory multiple myeloma and neuropathy (or who are otherwise unable to tolerate bortezomib)

    • Aged 18 years and older

    • Patient able to provide written, informed consent to participate in and follow the KEAP Treatment Plan

    Exclusion Criteria:

    • Known hypersensitivity to selinexor or any excipients.

    • Patient receiving any other investigational agent.

    • Any concurrent uncontrolled and active medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.).

    • Known intolerance, hypersensitivity, or contraindication to glucocorticoids.

    • Active graft versus host disease (after allogeneic stem cell transplantation).

    • Active, unstable cardiovascular function:

    • Symptomatic ischemia, or uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics)

    • Congestive heart failure of New York Heart Association Class ≥ 3 or known leftventricular ejection fraction < 40%, or

    • Myocardial infarction within 3 months prior to C1D1.

    • Significant renal impairment with ongoing dialysis treatment

    • Active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could, in the treating physician's opinion, interfere with absorption of treatment.

    • Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota

    Investigators

    • Principal Investigator: Erica Warlick, MD, Division of Hematology, Oncology and Transplantation, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT03850704
    Other Study ID Numbers:
    • 2019EX023
    First Posted:
    Feb 22, 2019
    Last Update Posted:
    Feb 22, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Masonic Cancer Center, University of Minnesota
    MM
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Feb 22, 2019