- Evidence of disease progression:
- Symptomatic relapsed or refractory requiring current treatment.
- Previously treated with ≥ 3 prior regimens (lines of therapy) that included at least one of each of the following: alkylating agent, immunomodulatory drug, proteasome inhibitor, and a steroid.
- Must be refractory to most recent anti-cancer regimen.
- Must have measurable disease defined by one of the following:
- Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or for IgA myeloma, by quantitative IgA. If SPEP is felt to be unreliable for routine Mprotein measurement (e.g., for patients with IgA MM), then quantitative Ig levels by nephelometry or turbidometry are acceptable; or
- Urinary M-protein excretion at least 200 mg/24 hours; or
- Serum Free Light Chain (Serum FLC) whereby the involved light chain measures ≥ 10 mg/dL and with an abnormal ratio.
- Eastern Cooperative Oncology Group performance status of ≤ 1.
- Time since the last prior therapy:
- Radiation, chemotherapy, immunotherapy or any other anticancer therapy, including investigational anticancer therapy ≤ 2 weeks prior to Cycle 1 Day 1.
- Palliative steroids for disease related symptoms are allowed up to 3 days prior to Cycle 1 Day 1.
- Active graft versus host disease after allogeneic stem cell transplantation. At least 3 months must have elapsed since completion of allogeneic stem cell transplantation.
- Active central nervous system malignancy. Patients who have only had prophylactic intrathecal or intravenous chemotherapy against central nervous system disease are eligible.
- Patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea that could interfere with the absorption of KPT-8602.
- Prior exposure to XPO1 inhibitors.
- Life expectancy of ≥ 4 months.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|