Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Changes in M-protein Levels
研究概览
简要总结
This randomized phase II trial studies how well celecoxib works in preventing multiple myeloma in patients with monoclonal gammopathy or smoldering myeloma. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing multiple myeloma.
详细描述
PRIMARY OJBECTIVES:
I. Determine the efficacy of celecoxib vs placebo in reducing serum levels of M-component in patients with monoclonal gammopathy of undetermined significance or smoldering myeloma.
SECONDARY OBJECTIVES:
I. Determine the effects of this drug on secondary biomarkers as surrogate endpoints in these patients.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
Arm I (celecoxib)
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
干预措施: celecoxib (Drug)
Arm I (celecoxib)
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
干预措施: laboratory biomarker analysis (Other)
Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
干预措施: placebo (Drug)
Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Changes in M-protein Levels
时间窗: Baseline and 6 months
For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.
次要结局
未报告次要终点