NCT00142129已完成2 期
Phase II Study of Velcade in Waldenstrom's Macroglobulinemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
研究概览
简要总结
The purpose of this study is to evaluate how tumors in patients with Waldenstrom's macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects (good and bad) it has on the cancer.
详细描述
- Patients will receive bortezomib intravenously twice weekly for 2 weeks on days 1,4,8 and 11 of each cycle. A 10-day rest period (days 12-21) will follow the 2 weeks of treatment. The treatment cycle is repeated up to eight times depending upon the disease response and if the patient is tolerating the drugs.
- The following procedures will be conducted as part of the treatment monitoring: DAY 1 VISIT (of each treatment cycle): evaluation of disease-related symptoms, vital signs and weight and blood tests. DAY 4 VISIT (of each treatment cycle): vital signs and blood work. DAY 8 VISIT (of each treatment cycle): vital signs and blood work. DAY 11 VISIT(of each treatment cycle): vital signs, blood work, and possible CT Scan.
- Treatment will be discontinued if any of the following occur: Disease gets worse, severe side-effects or the patient requires other anti-cancer therapy.
- At the end of the treatment (30 days after the last dose of study drug) the patient will have a physical exam, vital signs, evaluation of disease-related symptoms, blood work and CT scan for tumor measurements.
- Long term follow-up consists of every 3 month clinical visits until disease progression or up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Clinicopathological diagnosis of Waldenstrom's macroglobulinemia who have failed one first line therapy
- •Measurable disease, defined as presence of immunoglobulin M (Ig M) paraprotein with a minimum IgM level of >2 times ULN
- •Karnofsky performance status of >60
- •Life expectancy of > 3 months
- •Baseline platelet count >50,000,000,000/L and ANC of 750,000,000/L
- •AST and ALT < 3 x ULN
- •Total bilirubin < 2 x ULN
- •Calculated or measured creatinine clearance > 30mL/minute
- •Serum sodium > 130 mmol/L
排除标准
- •Greater than or equal to Grade 2 peripheral neuropathy
- •Hypersensitivity to bortezomib, boron or mannitol
- •Prior therapy with Velcade
- •Pregnant or lactating women
结局指标
主要结局
To determine response rate along with attainment of stable disease following treatment with bortezomib in patients with Waldenstrom's macroglobulinemia.
次要结局
- To assess the safety and tolerability of bortezomib in this patient population.
研究者
研究点 (4)
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