NCT00415987Unknown2 期
Hematopoietic Stem Cell Transplantation in Myeloma
Azienda Ospedaliera San Giovanni Battista2 个研究点 分布在 1 个国家开始时间: 2006年12月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
- 主要终点
- Survival Outcomes
研究概览
简要总结
The treatment assignment is based on the presence or absence of an HLA-identical sibling donor (Genetic Randomisation, NOT formal Randomisation). Patients with suitable HLA-identical sibling donors are offered a tandem transplant approach consisting of standard autografting nonmyeloablative radiotherapy and allografting. Patients without HLA-identical siblings are treated with standard double autologous transplantation as per Institutional guidelines or enrolled in other treatment programs approved by local IRBs.This is a multi-center study. The Division of Hematology of University of Torino at the S.G.B. Hospital, Torino, Italy, is the co-ordinating Center.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Durie-Salmon stage IIA-IIIB multiple myeloma;
- •Age > 18 and ≤ 65 years;
- •previously untreated myeloma;
- •presence of a sibling (potential donor);
- •bilirubins < twice normal;ALAT and ASAT < four times normal;
- •left ventricular ejection fraction > 40%;
- •creatinine clearances > 40 mL/min;
- •Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) > 40% and/or need for continuous oxygen supplementation;
- •Karnofsky performance status > 60%;
- •patients must give written informed consent;
排除标准
- •Age > 65 years
- •previously treated myeloma;
- •absence of a sibling (genetic randomisation cannot be applied);
- •Karnofsky performance status score < 60%
- •HIV-infection;
- •pregnancy;
- •Refusal to use contraceptive techniques during and for 12 months following treatment
- •patients unable to give written informed consent
- •PS. Informed consent is obtained from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.
结局指标
主要结局
Survival Outcomes
次要结局
- Response Rate
- Toxicity
研究者
研究点 (2)
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