Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Myeloma, Covid19

Intervention / Treatment
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* Other: blood sample analyses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients without multiple myeloma Patients without COVID19 Patients under juridical protection guardianship, or tutelage measure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: blood samples<br>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. | Other: blood sample analyses<br>* maximum 4 blood samples analyses per patient. At diagnosis of covid 19, in intensif care (if applicable), at covid19 recovery and 6 months after recovery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19 | gammaglobulin measurements in g/L | up to one month following COVID-19 diagnosis | 
| Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19 | gammaglobulin measurements in g/L | one month following COVID-19 diagnosis | 
| Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19 | lymphocytes counts in g/l | up to one month following COVID-19 diagnosis | 
| Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19 | lymphocytes counts in g/l | one month following COVID-19 diagnosis | 
| Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19 | number of cells B, T, and NK actived and inhibited | up to one month following COVID-19 diagnosis | 
| Characterize the immune laboratory parameters of Multiple Myeloma patientsat the cure of COVID-19 | number of cells B, T, and NK actived and inhibited | one month following COVID-19 diagnosis | 
| Correlation of patient immune function with death or development of protective immunity | number of death | up to 6 months following COVID-19 diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with protective immune response | T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies | before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Covid19