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临床试验/NCT04805203
NCT04805203终止不适用

Analysis of the Immune Parameters Involved in the Onset and Fate of SARS-CoV-2 Infection in Patients With Multiple Myeloma (COVIMMUNOMM) COVID-19 and Multiple Myeloma

Intergroupe Francophone du Myelome53 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2020年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
139
试验地点
53
主要终点
Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19

研究概览

简要总结

Among all MM patients included in the cohort at the time of diagnosis of SARS-CoV-2 infection, blood samples will be collected at inclusion, at time of the infection acute phase in the most severe cases (when admitted in intensive care units), and at recovery. The following immune function tests will be evaluated, gammaglobulin measurements, lymphocytes counts, B, T, and NK cells analyses by cytometry, including exhaustion analyses. In addition, T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies, will be evaluated at recovery and 6 months after MM treatment re-initiation.

详细描述

MM is a hematological malignancy, supposed mainly not curable, except for some exceptional patients, despite the availability of numerous new drugs. The patients are highly susceptible to infections, both bacterial and viral, due to a defect immune status, both at the antibody level (hypogammaglobulinemia) and the cellular level. This immunosuppression is further worsened by the treatments, and especially high dose glucocorticoids used at each phase of the disease. Consequently, MM patients are highly susceptible to contract COVID19, and to develop a severe form. This has been confirmed in a first study in Spring, showing a mortality rate of 37%. Among all MM patients included in the cohort at the time of diagnosis of SARS-CoV-2 infection, blood samples will be collected at inclusion, at time of the infection acute phase in the most severe cases (when admitted in intensive care units), and at recovery. The following immune function tests will be evaluated, gammaglobulin measurements, lymphocytes counts, B, T, and NK cells analyses by cytometry, including exhaustion analyses. In addition, T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies, will be evaluated at recovery and 6 months after MM treatment re-initiation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with a multiple myeloma and a documented COVID19 (by RT-PCR, thoracic TDM, and/or antigenix test).
  • •Patients having received the information to participate in the research and having expressed their non-opposition
  • •Patients with social security insurance or equivalent

排除标准

  • •Patients without multiple myeloma
  • •Patients without COVID19
  • •Patients under juridical protection guardianship, or tutelage measure

研究组 & 干预措施

blood samples

Other

4 blood samples per patient maximum (at diagnosis of covid19, during intensive care if applicable, at revecory of covid 19 and 6 months after recovery.

干预措施: blood sample analyses (Other)

结局指标

主要结局

Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19

时间窗: one month following COVID-19 diagnosis

gammaglobulin measurements in g/L

Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19

时间窗: up to one month following COVID-19 diagnosis

gammaglobulin measurements in g/L

Characterize the immune laboratory parameters of Multiple Myeloma patientsat the cure of COVID-19

时间窗: one month following COVID-19 diagnosis

number of cells B, T, and NK actived and inhibited

Correlation of patient immune function with death or development of protective immunity

时间窗: up to 6 months following COVID-19 diagnosis

number of death

次要结局

  • Number of patient with protective immune response(before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (53)

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