A Pilot, Phase-I Trial of Rabbit Anti-Thymocyte Globulin (rATG, Thymoglobulin™) in Combination With Rapamycin in Relapsed Multiple Myeloma (MM)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity and maximum tolerated dose
研究概览
简要总结
RATIONALE: Biological therapies, such as antithymocyte globulin may stimulate the immune system in different ways and stop cancer cells from growing. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It may also prevent or reduce the side effects of antithymocyte globulin. Giving antithymocyte globulin together with sirolimus may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of antithymocyte globulin when given together with sirolimus in treating patients with relapsed multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability, in terms of clinical and laboratory toxicity, of anti-thymocyte globulin (ATG) combined with sirolimus in patients with relapsed multiple myeloma.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Determine the maximum tolerated dose of ATG when administered with sirolimus in these patients.
Secondary
- Determine the clinical activity of this regimen, in terms of measurability of improvement in clinical benefits, in these patients.
- Assess patients for sensitivity of CD 138^-positive myeloma cells to ATG prior to treatment.
- Determine the pharmacokinetics, in terms of ATG levels in blood and bone marrow, in these patients.
- Assess the binding capability of ATG to bone marrow resident myeloma cells.
- Determine if an ATG-resistant clone emerges after treatment.
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
结局指标
主要结局
Dose-limiting toxicity and maximum tolerated dose
时间窗: Duration of the study
次要结局
- Relapse rates as measured by standard response criteria(Duration of the study)
- Laboratory correlative studies(During treatment)
研究者
JJ Ifthikharuddin
Principal Investigator
University of Rochester