Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Rate of HLA-DR on medullary T-lymphocytes
研究概览
简要总结
The myeloma microenvironment is the target of many drugs in development, and it is unclear how they can be combined with reference treatments such as lenalidomide. This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.
This study will provide rational guidance for future combination therapies with lenalidomide.
详细描述
With the significant increase in the number of therapeutic combinations targeting the tumour microenvironment, it is crucial to better understand the effect of reference myeloma treatments on the different immune populations present in the tumour in order to rationally optimise the combination with new strategies under development. In addition, the identification of biomarkers in the circulating blood that can predict/monitor the impact of new therapies on the immune response is a major challenge.
This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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 with newly diagnosed multiple myeloma;
- •Patient not eligible for intensive treatment;
- •Patient for whom first-line treatment with Lenalidomide-Dexamethasone will be initiated;
- •Patient accepting the performance of an additional myelogram at the end of the 1st treatment cycle.
- •Patient aged 18 years or older;
- •Patient who has given free, informed and written consent;
- •Patient affiliated to a social security scheme
- •For women of childbearing age, use of effective contraception
排除标准
- •Patient with relapsed multiple myeloma;
- •Patient eligible for intensive treatment;
- •Patient for whom chemotherapy involves treatment other than Lenalidomide-Dexamethasone;
- •Patient with a contraindication to lenalidomide treatment
- •Pregnant or breastfeeding woman;
- •Person subject to legal protection (safeguard of justice, curatorship,guardianship) or person deprived of liberty.
结局指标
主要结局
Rate of HLA-DR on medullary T-lymphocytes
时间窗: 1 month
Changed expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.
次要结局
- Activation status of biological markers(1 month)