NCT00729118已完成1 期
Vorinostat (SAHA) and Lenalidomide After Autologous Transplant for Patients With Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Safety of patients receiving SAHA and lenalidomide following autologous PBSCT
研究概览
简要总结
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide after autologous stem cell transplant in treating patients with multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To assess the dose-limiting toxicities and safety of vorinostat and lenalidomide after autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
- To evaluate the overall response rate to the combination of Vorinostat (SAHA) and lenalidomide.
Secondary
- To evaluate the effect of this treatment regimen on natural killer cell activity and regulatory T cells in the post-transplant period.
- To determine preliminary clinical activity of this treatment regimen by assessing overall survival and progression-free survival of these patients.
- To obtain pilot data regarding an association between this treatment regimen and patient quality of life and circulating inflammatory cytokines.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lenalidomide + Vorinostat
Experimental
Maintenance post autologous transplant
干预措施: lenalidomide (Drug)
Lenalidomide + Vorinostat
Experimental
Maintenance post autologous transplant
干预措施: vorinostat (Drug)
结局指标
主要结局
Safety of patients receiving SAHA and lenalidomide following autologous PBSCT
时间窗: up to 3 years
Patients will be assessed for Adverse events using the NCI CTCAE version 4.0 criteria
次要结局
- Duration of response(up to 3 years)
- Time to progression (TTP)(up to 3 years)
- Duration of overall response(up to 3 years)
- Overall survival(up to 3 years)
- Response rate(up to 3 years)
- Progression-free survival (PFS)(up to 3 years)
- Time to response(up to 3 years)
研究者
Yvonne Efebera
Principal Investigator
Ohio State University Comprehensive Cancer Center
研究点 (1)
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