A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction and consolidation for patients with progressive or refractory Multiple Myeloma.
- Conditions
- A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction and consolidation for patients with progressive or refractory Multiple Myeloma.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002444-40-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 37
•Documented diagnosis of multiple myeloma and measurable disease (serum M-protein = 5 g/L or urine M-protein = 200 mg/24 hours or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/L);
•Documented progression as per the IMWG uniform response criteria (Durie, 2006) during or after the anti-myeloma regimen; or never achieved a response better than PD after at least 2 cycles of their previous anti-myeloma regimen.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Prior resistance/refractory disease to bortezomib
•Systemic AL amyloidosis
•Non secretory myeloma
•Known CNS involvement
•Absolute neutrophil count (ANC) <1.0 x 109/L, unless related to MM.
•Platelet count < 50 x 109/L.
•Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L).
•Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method