NCT00599495已完成2 期
Allogeneic Stem Cell Transplantation From Unrelated Donors After Dose-reduced Intensity Conditioning Regimen for Patients With Multiple Myeloma and Relapse After Autologous Stem Cell Transplantation: A Phase II-study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Engraftment, chimerism, toxicity, non-relapse mortality
研究概览
简要总结
The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.
详细描述
The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Myeloma stage II or III acc. to Salmon and Durie (chemosensitive or refractory) and relapse or progression after high dose chemotherapy with autologous stem cell support
- •Age 18-60 years
- •ECOG-performance status 0-1
- •Availability of a HLA-compatible unrelated donor (HLA-A, -B, -DRB1, -DQB1)
排除标准
- •Serious concomitant medical disease that would limit life span or ability to tolerate chemotherapy
- •Severe cardiac failure (ejection fraction < 40%)
- •Severe impairment of renal function (Creatinine clearance < 50ml/min)
- •Severe impairment of liver function (bilirubine > 2 fold of upper limits of normal)
- •Pregnant or lactating women
- •Other major organ or system dysfunctions(GI, neurological, psychiatric dysfunctions that would impair tolerance of chemotherapy or prolonged haematological recovery)
- •Positivity for HIV
结局指标
主要结局
Engraftment, chimerism, toxicity, non-relapse mortality
时间窗: Follow-up until day +1095
次要结局
- Evaluation of response/GvHD/ infectious complications/ disease-free survival, Prognostic impact of cytogenetic, Evaluation of incidence and prognostic impact of molecular remission in patients with clinically complete remission.(Follow-up until day +1095)
研究者
研究点 (2)
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