UARK 98-003, A Phase II Pilot Study of Anti-Angiogenesis Therapy Using Thalidomide in Patients With Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma
研究概览
简要总结
The purpose of this research is to study how helpful thalidomide is in controlling the myeloma disease and to study any side effect resulting from thalidomide.
详细描述
Patients will receive thalidomide in the oral form (by mouth). Then the dose of thalidomide will be increased each week until week 7 as long as there are no significant side effects. After week 7, patients will continue to receive thalidomide as long as there is no toxicity requiring the treatment to be stopped and as long as there is no evidence of rapid tumor growth during the treatment with thalidomide.
Routine physical examinations and blood tests will be done to monitor the effect of treatment and the toxicities encountered, if any, and provide the available treatments for side effects accordingly. Blood tests will be done once a month for the first six months of receiving thalidomide.
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
- •All patients must have a confirmed diagnosis of previously treated, active multiple myeloma
- •Myeloma protein should be evident from which to evaluate response
- •Must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
- •Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug
- •Patients must have a total white blood cell count of 2,000 K/microliters. Patients may be anemic or thrombocytopenic provided this is felt to be due to extensive marrow involvement with myeloma
- •Patients must have adequate liver function as demonstrated by a direct bilirubin of < or = 2.0 mg/dL.
排除标准
- •Patients must not have an active infection requiring parenteral antibiotics
- •No other concurrent therapy for myeloma is permitted while on Thalidomide
结局指标
主要结局
To determine tumor response, overall and progression free survival following thalidomide therapy in patients with multiple myeloma
次要结局
- To determine toxicities associated with thalidomide in patients with multiple myeloma