NCT00800059招募中1 期
A Dose Escalation Study of Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) for the Treatment of Relapsed or Refractory Multiple Myeloma (MM)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma
研究概览
简要总结
The investigators hypothesize that conformal radiation will allow the administration of higher doses of external beam radiation to marrow based malignancies than total body irradiation (TBI)without increasing the toxicity to normal tissues beyond that induced by TBI. Further,the investigators hypothesize that this will result in an improvement in disease response and disease control for patients with multiple myeloma. This is a dose escalation study of TMI with the primary objective of determining the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •A subject must meet all of the following criteria to be eligible for the study. These will be evaluated within the four weeks prior to enrolment.
- •Subject must have primary refractory or relapsed multiple myeloma.
- •Subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse.
- •Subject must meet institutional guidelines for autologous HSCT with adequate renal, cardiac, pulmonary and hepatic function.
- •An autologous hematopoietic stem cell graft containing more than 2.5 x 106 CD34+ cells/kg must be cryopreserved and available for transplantation.
- •Subject must be of age more than 18 and less than 60 years.
- •Subject must have an ECOG performance score of 0,1, or
- •Subject must have the ability to comply with the protocol visit schedule and other protocol requirements.
排除标准
- •A subject meeting any of the following criteria is not eligible for participation in the study:
- •Subject with non-secretory multiple myeloma or any plasma cell disorders other that MM.
- •Subjects that have not received previous therapy with adequate intense corticosteroids for multiple myeloma.
- •Subjects with a severely limited life expectancy by concomitant illness, defined as a life-expectancy of less than 6 months.
- •Subjects who have previously received radiation treatments or other neoplastic disorders.
- •Subjects with a history of non-compliance in other studies.
- •Pregnant or lactating female subjects.
结局指标
主要结局
To determine the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma
时间窗: 30 days from the time of aSCT
次要结局
- The intermediate morbidity and mortality associated with TMI and aHSCT(100 days from aHSCT)
- The late morbidity of TMI(Beyond 6 months after transplantaton)
- The early morbidity and mortality associated with TMI and aHSCT(30 days from aHSCT)
- The frequency and timing of engraftment following TMI and aHSCT(within 30 days of aHSCT)
研究者
研究点 (2)
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