Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: Selinexor (KPT 330): Oral dose of KPT 330 (100 mg tablet)
Control Intervention1: NIL: NIL
Sponsors
Karyopharm Therapeutics Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed MM with measurable disease per IMWG guidelines as defined by at least 1 of the following: a. Serum M-protein >= 0.5 g/dL ( > 5 g/L) by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative serum IgA levels; or b. Urinary M-protein excretion at least 200 mg/24 hours; or c. Serum FLC >= 100 mg/L, provided that the serum FLC ratio is abnormal (normal FLC ratio: 0.26 to 1.65). 2. Had at least 1 prior anti-MM regimen and no more than 3 prior anti-MM regimens.
Exclusion criteria
Exclusion criteria: 1. Prior exposure to a SINE compound, including selinexor. 2. Prior malignancy that required treatment, or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to randomization. Cancer treated with curative intent for > 5 years previously and without evidence of recurrence will be allowed. 3. Has any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures. 4. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1. Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable. 5. Active plasma cell leukemia. 6. Documented systemic light chain amyloidosis. 7. MM involving the central nervous system. 8. Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome. 9. Spinal cord compression. 10. Greater than Grade 2 peripheral neuropathy or Grade >= 2 peripheral neuropathy with pain at baseline, regardless of whether or not the patient is currently receiving medication. 11. Known intolerance, hypersensitivity, or contraindication to glucocorticoids. 12. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy (including investigational therapies) 13. Prior autologous stem cell transplantation 14. Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1. 15. Pregnant or breastfeeding females. 16. BSA 17. Life expectancy of 18. Major surgery within 4 weeks prior to C1D1. 19. Active, unstable cardiovascular function: a. Symptomatic ischemia, or b. Uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with first-degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded), or c. Congestive heart failure of New York Heart Association Class >= 3 or known left ventricular ejection fraction d. Myocardial infarction within 3 months prior to C1D1. 20. Known active human immunodeficiency virus (HIV) infection or HIV seropositivity. 21. Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus ribonucleic acid (RNA) or hepatitis B virus surface antigen. 22. Any active gastrointestinal dysfunction interfering with the patientâ??s ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment. 23. Any active, serious psychiatric, medical, or other conditions/situ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To compare progression free survival(PFS) based on the Independent review committee (IRCs) disease outcome assessments in patients randomized to the SVd Arm versus the Vd Arm 2.To compare the Overall Response Rate (â?¥ PR) based on the IRCâ??s response outcome assessments, in patients randomized to the SVd Arm versus the Vd ArmTimepoint: 1. After 30% PFS events or 33 months (whichever is earlier) 2. After 12-15 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the incidence of any Grade â?¥ 2 peripheral neuropathy events (total Grade â?¥ 2 and separately for Grades 2, 3, and 4) in patients randomized to the SVd Arm versus patients randomized to the Vd Arm. 2.To compare the number of patients with response â?¥ VGPR, â?¥ CR, â?¥ sCR, or minimal residual disease (MRD) negative (for patients who achieve CR or sCR) in patients randomized to the SVd Arm versus the Vd ArmTimepoint: After 12-15 months | — |
Countries
Austria, Belgium, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, India, Israel, Italy, Romania, Russian Federation, Spain, Ukraine, United Kingdom, United States of America
Contacts
Public ContactVikrant Pratap Singh
Excel Life Sciences Pvt. Ltd.
Outcome results
None listed