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临床试验/NCT04492371
NCT04492371已完成不适用

COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY

Stichting European Myeloma Network8 个研究点 分布在 8 个国家目标入组 1,054 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,054
试验地点
8
主要终点
Costs related to COVID-19

研究概览

简要总结

Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.

详细描述

Coronavirus Disease 2019 (COVID-19), caused by a novel coronavirus (SARS-CoV-2), is a highly contagious disease that appeared in Wuhan, Hubei province of China in December 2019. It has now spread to multiple countries through infected persons travelling mainly by air. Most of the infected patients have mild symptoms including fever, fatigue and cough. But in severe cases, patients can progress rapidly and develop the acute respiratory distress syndrome, septic shock, metabolic acidosis and coagulopathy including a disseminated intravascular coagulation (DIC).

Multiple myeloma (MM) is a mature B-cell malignancy largely affecting the older patient with a median age at presentation of 70 years. The general performance status (PS) and the presence of comorbidity can identify a group of patients with poor tolerance to treatment, as well as risks of both bacterial and viral infection. MM patients have benefited significantly from therapeutic developments, however, the host response biology of the older person, coupled with a distinct disease biology overlay induces immune dysfunction. For example, the impact of aging on the human immune system is well documented. In MM it has long-since been understood that there is a spectrum of immune dysregulation, an important host factor considered in the "Hallmarks of cancer" theory. In addition, the delivery of anti-MM therapy includes immune modulating agents such as steroids, proteasome inhibitors and CD38-directed therapy though not all immune modulation is necessarily detrimental.

As such, myeloma patients are considered a higher risk in the current pandemic with SARS-COVID19. However, it is not clear whether this is actually the case, and the risk may not be different to population in general. Equally it may be sub-groups of patients who are at risk e.g. on treatment versus stable response (plateau), frailty. AS such, this proposal aims to collect in an observational study, the outcomes of COVID19 infection in MM patients across Europe.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Multiple Myeloma patients
  • COVID-19 infection

排除标准

  • 未提供

结局指标

主要结局

Costs related to COVID-19

时间窗: 1 years

Costs related to Covid in terms of health resource needs.

Laboratory values collected at hospitalization

时间窗: 1 years

Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.

Nature of COVID19

时间窗: 1 years

The duration of infection.

COVID-19 infection in myeloma patient subgroups

时间窗: 1 years

Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.

Systemic anti-cancer therapy subgroup

时间窗: 1 years

Number of infection recovery for each systemic anti-cancer subgroup.

Incidence of COVID-19 infection in frail patients

时间窗: 1 years

Number of frail patients with COVID-19 infection and resolution of it.

Infection outcome in different countries

时间窗: 1 years

Number of infection and outcome per country.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (8)

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