NCT00525447已完成1 期
A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 36
- 试验地点
- 9
- 主要终点
- Adverse events and lab abnormalities.
研究概览
简要总结
This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple myeloma.
- •Received at least one prior systemic therapy other than single-agent corticosteroids.
- •Measurable disease of monoclonal protein greater than or equal to 0.5 gram/dL in plasma or 0.5 gram/24 hr urine collection, or greater than 10 mg/dL free light chain (FLC) in serum as determined by serum FLC assay and provided the serum FLC ratio is abnormal.
排除标准
- •Received an allogenic stem cell transplant.
- •Previous intolerance of lenalidomide or dexamethasone.
- •Primary invasive malignancy (other than multiple myeloma) within the last 3 years.
研究组 & 干预措施
1
Experimental
干预措施: SGN-40 (Drug)
1
Experimental
干预措施: lenalidomide (Drug)
1
Experimental
干预措施: dexamethasone (Drug)
结局指标
主要结局
Adverse events and lab abnormalities.
时间窗: Within 3 weeks of final infusion of SGN-40
次要结局
- Best clinical response, progression-free survival, and overall survival.(Study duration)
- PK profile.(Within 3 weeks of final infusion of SGN-40)
- Anti-drug antibody immune responses.(Within 3 weeks of final infusion of SGN-40)
研究者
研究点 (9)
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