MYeloma Resistance And Clonal Evolution
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 2
- 主要终点
- Describe the mechanisms of resistance of myeloma cells.
研究概览
简要总结
Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.
详细描述
The MYRACLE cohort study aims at including all patients (>18 years old) who are diagnosed with MM in any stage of the disease and treated in specialized oncology centers in 2 public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up until refusal to participate in the study, emigration or death. The MYRACLE follow-up is continuous and collects data on socio-economic status, medical status, MM therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.
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
- •Patient consulting due to the discovery or recurrence of MM according to international diagnostic criteria (IMWG 2014)
- •Patient having consented to participate in the study and his/her biocollection
- •Patient affiliated to or benefiting from a social security scheme or similar
排除标准
- •Major under guardianship or curatorship
- •Protected persons.
- •Pregnant or breast-feeding women
- •Persons benefiting from the AME
结局指标
主要结局
Describe the mechanisms of resistance of myeloma cells.
时间窗: 15 years
Number of resistance.
次要结局
未报告次要终点