Multiple Myeloma
Conditions
Keywords
MM
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.
Interventions
DRUGSelinexor
Sponsors
Masonic Cancer Center, University of Minnesota
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Outcome results
None listed