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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 139
- Locations
- 53
- Primary Endpoint
- Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
Time Frame: one month following COVID-19 diagnosis
gammaglobulin measurements in g/L
Correlation of patient immune function with death or development of protective immunity
Time Frame: up to 6 months following COVID-19 diagnosis
number of death
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
Time Frame: 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
Time Frame: one month following COVID-19 diagnosis
number of cells B, T, and NK actived and inhibited
Secondary Outcomes
- Number of patient with protective immune response(before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments)