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

NCT ID: NCT03850704

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

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.

Conditions

Multiple Myeloma

Interventions

Selinexor

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erica Warlick, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Hematology, Oncology and Transplantation, University of Minnesota

Other Identifiers

2019EX023

Identifier Type: -

Identifier Source: org_study_id