UARK 99-016, A Phase II Trial of Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide in Patients With Multiple Myeloma and Poor Hematopoietic Stem Cell Reserve
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate the effectiveness of combination treatment with Thalidomide and Pamidronate in patients with refractory myeloma and poor hematopoietic stem cell reserve. Effectiveness will be based on the estimate of the objective response rate (CR + PR).
研究概览
简要总结
The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate is in controlling multiple myeloma and to study any side effects that may be experienced.
详细描述
Recently, laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size, tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called "anti-angiogenesis". It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a diagnosis of Multiple myeloma with poor hematopoietic reserve (platelet count <100,000 OR inability to collect adequate PBSC to support autologous transplant (4X106 CD34+cells/kg OR WBC <2,000)
- •Patients must not be eligible for UARK 98-035
- •Patients must be at least 6 weeks beyond previous chemotherapy
- •All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines
排除标准
- •Prior bisphosphonate therapy within 30 days prior to study entry
- •Serum creatinine > 5 mg/dl, ascites, or serum direct bilirubin > 2.5 mg/dl
- •Prior plicamycin or calcitonin within 2 weeks of study entry
- •Severe cardiac disease, unstable thyroid disease, or epilepsy
结局指标
主要结局
To evaluate the effectiveness of combination treatment with Thalidomide and Pamidronate in patients with refractory myeloma and poor hematopoietic stem cell reserve. Effectiveness will be based on the estimate of the objective response rate (CR + PR).
次要结局
- To compare the effect of these agents on disease parameters, specifically on time to disease progression and overall survival.