NL-OMON34526已完成不适用
Vaccination of Multiple Myeloma patients with RNA electroporated mature dendritic cells expressing multiple tumor antigens. - RNA-DC vaccination in multiple myeloma
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •· Age 18-70 years
- •· Patients with stage II and III MM
- •· Complete remission (CR) or partial response (PR) following intensive therapy, including high dose melphalan and autologous stem cell transplantation
- •· Measurable minimal residual disease by M-component (complete of light chain) or molecular disease by BM ig heavy chain rearrangement (ASO-PCR)
- •·Myeloma cells expressing 2-3 of the 3 TAA used for vaccination, each in >20% of CD138+CD38++ plasma cells
- •· Interval of >6 months after completion of intensive chemotherapy.
- •· Life expectancy >6 months
- •· Expected adequacy for follow-up including bone marrow evaluation
- •· Written Informed consent
排除标准
- •· Progressive disease (increase in M-component of >25% in the last 3 months)
- •· Patients on immunosuppressive drugs
- •· Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute therapy must have been completed within 14 days prior to study treatment.
- •· Patients with known allergy to shell fish (contains KLH).
- •· Patients with pregnancy or lactation
- •· WHO performance status 4
- •· Allogeneic stem cell transplantation
研究者
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