EUCTR2014-002444-40-NL进行中（未招募）1 期
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. - SVd
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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).
研究者
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