IMMUNOPHENOTYPE ROLE IN THE EVALUATION OF CLINICAL RESPONSE
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 主要终点
- Overall survival
研究概览
简要总结
The study proposed by SSCVD Allogeneic Stem Cells of this Hospital provides for the collection of a series composed of patients with multiple myeloma undergoing allogeneic stem cell transplants at our center in the period 2000-2011.
This collection is carried out with retrospective investigation , through the review of paper and electronic records and data cards already collected as part of clinical trials conducted by our own Division and approved by the Ethics Committee of Management.
The purpose of data collection is particularly retrospective analysis of the incidence of extramedullary relapse , the response in flow cytometry immunophenotypic and clinical response of the disease , will also be taken into consideration for overall survival ( OS) , event-free survival (EFS) , the cumulative incidence of treatment-related mortality and graft- versus-host disease ( GVHD ), acute and chronic.
The data were processed in a completely anonymous and as provided by law. The results of the study will not result in any diagnostic or therapeutic intervention on patients still alive.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with multiple myeloma undergoing allogeneic stem cell transplantation in the period 2000-2011 at the University Transplant Center of the Division of Hematology.
- •Were taken into account both donor transplants voluntary blood relative.
排除标准
- •Patients who died early after allogeneic transplantation (<3 months) in which has not been evaluated disease status.
- •In the evaluation of the response of immunophenotypic disease were excluded from the analysis of bone marrow aspirate samples with low cellularity.
结局指标
主要结局
Overall survival
时间窗: 5 years
Event free survival
时间窗: 5 years
次要结局
未报告次要终点
研究者
Benedetto Bruno
MD
Azienda Ospedaliera San Giovanni Battista