NCT00802568已完成2 期
Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma
Institut Paoli-Calmettes2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Mortality rate at 1 year
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying the side effects of giving fludarabine together with busulfan and antithymocyte globulin followed by donor stem cell transplant and to see how well it works in treating patients with multiple myeloma that has not responded to treatment.
详细描述
OBJECTIVES:
Primary
- To study the toxicity of reduced intensity conditioning comprising fludarabine phosphate, busulfan, and anti-thymocyte globulin followed by allogeneic hematopoietic stem cell transplantation in patients with refractory or relapsed multiple myeloma.
Secondary
- To study the tumor response in these patients.
- To study the incidence of acute or chronic graft-versus-host disease in these patients.
- To study the incidence of infectious complications in these patients.
- To study relapse- or progression-free and overall survival of these patients.
- To study the biological mechanisms (i.e., taking graft, immunological recovery, antitumor activity, and chimerism).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（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:
- •Stage I disease with a bone lesion
- •Stage II or III disease meeting any of the following criteria:
- •Elevated beta-2 microglobulin
- •Deletion of chromosome 13
- •Refractory or relapsed disease
- •Presence of an evaluable monoclonal component
- •Must have achieved reduction of primary tumor after receiving prior intensified chemotherapy with high-dose melphalan and cyclosporine with autologous transplantation
- •HLA identical family donor available
- •Bone marrow transplantation is allowed in case hematopoietic stem cell collection fails
- •PATIENT CHARACTERISTICS:
- •Karnofsky 70-100%
- •No contraindications to allogeneic transplantation
- •No contraindications to drugs used in conditioning regimen
- •No psychiatric illness
- •No other cancer within the past 5 years except basal cell skin cancer or epithelioma in situ of the cervix
- •No serious and uncontrolled infection
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 1 month since participation in another prior clinical trial
排除标准
- 未提供
结局指标
主要结局
Mortality rate at 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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