NCT00702247Unknown2 期
Allogeneic Stem Cell Transplantation for Multiple Myeloma: a Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low-Dose TBI
Azienda Ospedaliera San Giovanni Battista2 个研究点 分布在 1 个国家开始时间: 1999年7月1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
- overall survival
研究概览
简要总结
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
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
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
overall survival
时间窗: yearly
次要结局
- event free survival(yearly)
研究者
研究点 (2)
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