Status:
NO_LONGER_AVAILABLE
Single Patient Use of Selinexor and Dexamethasone for a Patient With Multiple Myeloma
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
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" weighi...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03850704
Last Update
February 22 2019
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