Phase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain Amyloidosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Disease-free survival at 2 years (patients with responsive disease)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with multiple myeloma or primary systemic amyloidosis.
详细描述
OBJECTIVES:
- Determine the response rate in patients with multiple myeloma or primary systemic amyloidosis treated with high-dose chemotherapy with autologous hematopoietic stem cell support.
- Determine the toxicity of this regimen in these patients.
- Determine the disease-free survival and overall survival of patients with multiple myeloma treated with this regimen.
OUTLINE: Patients are stratified according to disease response to prior treatment (responsive vs refractory or relapsed) and diagnosis (multiple myeloma vs primary systemic amyloidosis).
Following a course of induction chemotherapy, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until the completion of peripheral blood stem cell (PBSC) harvesting. Patient who do not mobilize sufficient cells undergo bone marrow harvest.
Patients receive melphalan IV over 30 minutes on days -2 and -1. Half of the stored PBSCs and/or bone marrow is reinfused on day 0. Patients receive sargramostim (GM-CSF) daily beginning on day 0 and continuing until blood counts recover. Patients with primary systemic amyloidosis who are not responding to or are unable to tolerate treatment do not proceed to the second course of therapy.
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:
- •Histologically confirmed multiple myeloma OR
- •Primary systemic amyloidosis resulting in significant organ dysfunction and decreased quality of life
- •Complete or partial response after standard chemotherapy
- •Primary refractory or relapsed multiple myeloma after first-line treatment with standard chemotherapy
- •Ineligible for higher priority national or institutional clinical studies
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin less than 2 times normal
- •Creatinine less than 2.5 mg/dL or on stable hemodialysis
- •Cardiovascular:
- •LVEF at least 45%
- •DLCO at least 60% of predicted OR
- •Approval by pulmonologist
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Concurrent participation in gene therapy trials allowed
- •Chemotherapy:
- •See Disease Characteristics
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent steroids as antiemetics during chemotherapy
- •No concurrent anticancer hormonal therapy
- •Radiotherapy:
- •Not specified
- •Not specified
- •No concurrent barbiturates or acetaminophen during chemotherapy
- •Concurrent participation in supportive care trials allowed
排除标准
- 未提供
结局指标
主要结局
Disease-free survival at 2 years (patients with responsive disease)
次要结局
- Duration of hematologic toxicity
- Time to an absolute neutrophil count
- Platelet independence