Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT03850704
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.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03850704
Study Brief:
Protocol Section:
NCT03850704