A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants With Hematologic Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis.
PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
详细描述
OBJECTIVES:
Primary
- To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone, in terms of toxicity, in patients with primary systemic amyloidosis.
- To determine the hematologic response rate in patients treated with this regimen.
Secondary
- To assess organ response in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of primary systemic amyloidosis
- •PATIENT CHARACTERISTICS:
- •Not pregnant
- •Negative pregnancy test
- •Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day, therapeutic warfarin, or low molecular weight heparin)
- •PRIOR CONCURRENT THERAPY:
- •Recovered from prior therapy
- •Permanent or stable side effects/changes allowed
- •Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed
- •More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or radiotherapy
排除标准
- •No secondary or familial amyloidosis
- •No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions)
- •No prior cumulative doses of oral melphalan > 200 mg
- •No more than one prior course of high-dose melphalan with stem cell transplant
研究组 & 干预措施
Melphalan Revlimid and Dexamethasone
Melphalan Lenalidomide Dexamethasone
干预措施: melphalan (Drug)
Melphalan Revlimid and Dexamethasone
Melphalan Lenalidomide Dexamethasone
干预措施: dexamethasone (Drug)
Melphalan Revlimid and Dexamethasone
Melphalan Lenalidomide Dexamethasone
干预措施: lenalidomide (Drug)
结局指标
主要结局
Number of Participants With Hematologic Response
时间窗: one year
Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay. Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more.
次要结局
- Number of Organs Improved or Stable Based on Description Below:(one year)
- Number of Participants Removed From Study Due to Toxicities(One year)
研究者
Vaishali Sanchorawala
Principal Investigator
Boston Medical Center