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

NCT03850704 | Unknown

• 1 other identifier: 2019EX023
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma

Keywords

MM

Interventions

Selinexor DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

selinexor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Erica Warlick, MD

  Division of Hematology, Oncology and Transplantation, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 22, 2019
• Last Updated: February 22, 2019

Record last verified: 2019-02