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

This is an expanded access trial for Multiple Myeloma focused on measuring MM Read More

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.