NCT01272466已完成1 期
Vaccination With Peptides Derived From Anti-apoptotic Proteins From the Bcl-2 Family, Administered in Combination With Montanide ISA-51 in Relation to Treatment With Proteasome Inhibitors in Patients With Relapsed Multiple Myeloma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to proteasome inhibition present exogene antigens better than unexposed dendritic cells. Patients with relapse of multiple myeloma will be offered vaccination with peptides derived from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory adjuvant. The vaccination will be given in relation to treatment with the proteasome inhibitor bortezomib.
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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of multiple myeloma
- •tissue type of HLA-A1, HLA-A2 or HLA-A3
- •Performance status < 2
- •Adequate bone marrow - renal and liver function
- •written informed concent
排除标准
- •candidate for bone marrow transplantation
- •other malignancies than multiple myeloma
- •other significant medical disease (heart-, lung or liver disease or diabetes)
- •active autoimmune disease
- •treatment with immunosuppressive drugs
- •treatment with other experimental drugs
- •uncontrolled hypercalcemia
研究组 & 干预措施
peptides from antiapoptotic proteins
Experimental
干预措施: peptides derived from antiapoptotic proteins (Biological)
结局指标
主要结局
Number of participants with adverse events
时间窗: 15 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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