NCT00089167已完成2 期
Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Overall progression-free survival at 2 years
研究概览
简要总结
RATIONALE: Drugs such as melphalan, thalidomide, and dexamethasone may be effective in treating patients with primary systemic amyloidosis.
PURPOSE: This phase II trial is studying how well giving melphalan together with thalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
详细描述
OBJECTIVES:
Primary
- Determine the 2-year and overall progression-free survival of patients with newly diagnosed, previously untreated primary systemic (AL) amyloidosis treated with risk-adapted melphalan followed by thalidomide and dexamethasone.
Secondary
- Determine plasma cell disease response in these patients at 3, 12, and 24 months after treatment with this regimen.
- Determine amyloid-related disease response in these patients at 12 and 24 months after treatment with this regimen.
- Determine the prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL plasma cell clones in patients treated with this regimen.
- Determine whether there is molecular minimal residual disease at 12 and 24 months in patients achieving a complete hematologic response after treatment with this regimen.
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 primary systemic (AL) amyloidosis within the past 12 months
- •High- or low-risk disease, determined by the extent of systemic organ involvement with disease and patient age
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No New York Heart Association class III or IV congestive heart failure
- •No restrictive cardiomyopathy requiring oxygen
- •No myocardial infarction within the past 6 months
- •No symptomatic cardiac arrhythmia within the past 60 days
- •No other active malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I cancer in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for AL amyloidosis
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •No other prior or concurrent therapy for AL amyloidosis
排除标准
- 未提供
结局指标
主要结局
Overall progression-free survival at 2 years
次要结局
- Amyloid-related disease response at 12 and 24 months after treatment
- Plasma cell disease response at 3, 12, and 24 months after treatment
- Prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL cell clones
- Molecular minimal residual disease at 12 and 24 months
研究者
研究点 (1)
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