NCT00988312已完成1 期
Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma
University Hospital Carl Gustav Carus1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2002年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Specific T-cell proliferation/cytokine secretion
研究概览
简要总结
Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in order to slow down or cure the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •multiple myeloma
- •stage I (Salmon & Durie)
- •no cytoreductive pre-treatment
排除标准
- •myeloma stages II-III
- •asecretory disease
研究组 & 干预措施
s.c. vaccination
Experimental
vaccine given subcutaneously
干预措施: autologous idiotype-protein pulsed dendritic cells (Biological)
i.v. vaccination
Experimental
vaccines are given intravenously
干预措施: autologous idiotype-protein pulsed dendritic cells (Biological)
结局指标
主要结局
Specific T-cell proliferation/cytokine secretion
次要结局
- plasmacells in bone marrow(pre and post vaccination)
- monoclonal protein(pre and post vaccination)
- vital signs(pre and post vaccination)
- number of T cells(pre and post vaccination)
研究者
研究点 (1)
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