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临床试验/NCT01272466
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

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年2月最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lene Meldgaard Knudsen

M.D

Herlev Hospital

研究点 (2)

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