MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 514
- 试验地点
- 40
- 主要终点
- Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells
研究概览
简要总结
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM.
Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries.
Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study.
Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Confirmed newly diagnosed or relapsed/refractory (R/R) Multiple myeloma (MM) who have signed informed consent for the use of their biological material for research purposes.
排除标准
- •Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.
结局指标
主要结局
Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells
时间窗: Up to approximately 2.5 months following last subject last visit
t(11;14) status (positive or negative) of the earliest multiple myeloma (MM) sample collected at initial diagnosis or across lines of therapies, by FISH analysis of bone marrow plasma cells is evaluated.
Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells
时间窗: Up to approximately 2.5 months following last subject last visit
BCL2 status (BCL2 high or not) of the earliest MM sample collected, either at initial diagnosis or across lines of therapies, by qPCR analysis of bone marrow plasma cells is evaluated.
次要结局
- Percentage of Participants Achieving Stability of BCL2 Status(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants Achieving Stability of t(11;14) Status(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants With t(11;14) Status of MM Samples(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants With t(1;14) Status and BCL2 Status(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy(Up to approximately 2.5 months following last subject last visit)
- Percentage of Participants With BCL2 Status of MM Samples(Up to approximately 2.5 months following last subject last visit)