NCT00618345已完成2 期
Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 35
- 主要终点
- Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To assess the response rate in patients with relapsed or refractory multiple myeloma treated with everolimus.
Secondary
- To evaluate the toxicity of everolimus in patients with multiple myeloma.
- To study the tumor cells and blood from patients entering this trial for laboratory correlates.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of multiple myeloma, meeting 1 of the following criteria:
- •Monoclonal protein in the serum of ≥ 1 g/dL
- •Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours
- •Measurable light chains by free light chain assay of ≥ 10 mg/dL
- •Measurable plasmacytoma
- •Must have received prior therapy and have relapsed or refractory disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •ANC ≥ 1,000/mm³
- •Platelet count ≥ 75,000/mm³
- •Hemoglobin ≥ 8.0 g/dL
- •Total bilirubin ≤ 2.0 mg/dL (if total bilirubin is elevated, direct bilirubin must be normal)
- •AST ≤ 3 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •Calcium < 11 mg/dL
- •No uncontrolled infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No HIV positivity
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 3 weeks since prior cytotoxic chemotherapy
- •At least 2 weeks since prior biologic therapy or radiotherapy
- •At least 2 weeks since prior corticosteroids
- •Concurrent chronic corticosteroids allowed for treatment of disorders other than myeloma
- •No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
排除标准
- 未提供
结局指标
主要结局
Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein
次要结局
- Toxicity
研究者
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