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

Not Applicable

Terminated

• Conditions: Covid19; Multiple Myeloma

• Registration Number: NCT04805203
• Lead Sponsor: Intergroupe Francophone du Myelome

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 Timeline

• Study First Submitted: 2020-12-15
• Study Start: 2020-12-16
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-18
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19	one month following COVID-19 diagnosis	lymphocytes counts in g/l
Correlation of patient immune function with death or development of protective immunity	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	up to one month following COVID-19 diagnosis	number of cells B, T, and NK actived and inhibited
Characterize the immune laboratory parameters of Multiple Myeloma patientsat the cure of COVID-19	one month following COVID-19 diagnosis	number of cells B, T, and NK actived and inhibited

Secondary Outcome Measures

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

Trial Locations

Locations (53)

CHU Amiens SUD; 🇫🇷 Amiens, France

CHRU Hôpital du Bocage; 🇫🇷 Angers, France

Ch Annecy Genevois; 🇫🇷 Annecy, France

CH Victor Dupouy; 🇫🇷 Argenteuil, France

CH d'ARRAS; 🇫🇷 Arras, France

CH Auch; 🇫🇷 Auch, France

Centre Hospitalier H.Duffaut; 🇫🇷 Avignon, France

CHRU Besançon; 🇫🇷 Besançon, France

Centre Hospitalier Simone Veil de Blois; 🇫🇷 Blois, France

CHU Bordeaux-hopital haut leveque; 🇫🇷 Bordeaux, France

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