NCT00777998已完成2 期
Autologous-Allogeneic Tandem Stem Cell Transplantation and Maintenance Therapy With Thalidomide/ DLI for Patients With Multiple Myeloma (MM) and Age < _60 Years: A Phase II-study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 40
- 主要终点
- Event-free survival 4 years after auto-allo/ auto-auto Tandem-SCT. Any of the following will be considered an endpoint event: recurrence or progression of primary disease, disease related mortality, or treatment related mortality.
研究概览
简要总结
The present study will be a multicenter, prospective phase II-study investigating safety and efficacy of the combination of auto-allo tandem stem cell transplantation in patients with multiple myeloma and age of >_60 years, followed by maintenance therapy with low-dose Thalidomide and Donor Lymphocyte Infusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient's age 18-60 years
- •Patient's written informed consent
- •Women and men capable of reproduction must agree to use adequate contraceptive measures (condom, IUD, oral contraceptives) until three months after termination of treatment
- •a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD)
排除标准
- •More than eight chemotherapy cycles prior to registration
- •severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- •total bilirubin, SGPT or SGOT > 3 times upper the normal level
- •Left ventricular ejection fraction < 30 %
- •Creatinine Clearance < 30 ml/min
- •DLCO < 35 % and/or receiving supplementary continuous oxygen
- •Positive serology for HIV
- •Pregnant or lactating women
- •Participation in another trial at the time of registration
- •Preceding autologous stem cell transplantation
- •age > 61 years
结局指标
主要结局
Event-free survival 4 years after auto-allo/ auto-auto Tandem-SCT. Any of the following will be considered an endpoint event: recurrence or progression of primary disease, disease related mortality, or treatment related mortality.
时间窗: four years after Tandem stem cell transplantation
次要结局
- Incidence of acute GvHD(day +100 after allogeneic stem cell transplantation)
- Treatment related mortality(four years after allogeneic stem cell transplantation)
- cumulative incidence of relapse(four years after Tandem stem cell transplantation)
- Toxicity of conditioning regimen and of maintenance therapy(Throughout conditioning regimen and maintenance therapy)
- Incidence of chronic GvHD(at one year and at two years after allogeneic stem cell transplantation)
- Disease related mortality(four years after allogeneic stem cell transplantation)
- overall survival(four years after allogeneic stem cell transplantation)
研究者
研究点 (40)
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