Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma
- Conditions
- Covid19Multiple Myeloma
- Interventions
- Other: blood sample analyses
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 139
- 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
- Patients without multiple myeloma
- Patients without COVID19
- Patients under juridical protection guardianship, or tutelage measure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description blood samples blood sample analyses 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.
- 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)
ICANS
🇫🇷Strasbourg, France
Clinique du Parc
🇫🇷Castelnau-le-Lez, France
CHU Henri Mondor
🇫🇷Créteil, France
CHU Poitiers
🇫🇷Poitiers, France
CHRU Bretonneau
🇫🇷Tours, France
CHU Amiens SUD
🇫🇷Amiens, France
CHRU Hôpital du Bocage
🇫🇷Angers, France
CH Auch
🇫🇷Auch, France
Ch Annecy Genevois
🇫🇷Annecy, France
CH d'ARRAS
🇫🇷Arras, France
CH Victor Dupouy
🇫🇷Argenteuil, France
Centre Hospitalier H.Duffaut
🇫🇷Avignon, France
Centre Hospitalier Simone Veil de Blois
🇫🇷Blois, France
CHRU Besançon
🇫🇷Besançon, France
CHU Bordeaux-hopital haut leveque
🇫🇷Bordeaux, France
Centre hospitalier Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
Hôpital A.Morvan
🇫🇷Brest, France
CH de Cannes
🇫🇷Cannes, France
CHU de Caen
🇫🇷Caen, France
Centre Hospitalier William Morey
🇫🇷Chalon Sur Saone, France
Centre Hospitalier Métropole de Savoie
🇫🇷Chambéry, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-Essonnes, France
CH de Dax côte d'Argent
🇫🇷Dax, France
CHU François Mitterand
🇫🇷Dijon, France
CHU grenoble
🇫🇷Grenoble, France
Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
🇫🇷Grenoble, France
Hopital Claude Huriez-CHRU LILLE
🇫🇷Lille, France
CHU Limoges
🇫🇷Limoges, France
CH de Lens
🇫🇷Lens, France
Centre Hospitalier Lyon sud
🇫🇷Lyon, France
CHU saint Eloi
🇫🇷Montpellier, France
Hôpital E. MULLER
🇫🇷Mulhouse, France
GHT des Landes
🇫🇷Mont-de-Marsan, France
CHRU Nantes
🇫🇷Nantes, France
Hôpitaux de Brabois - CHRU de Nancy
🇫🇷Nancy, France
Hopital Archet 1
🇫🇷Nice, France
Hopital Cochin
🇫🇷Paris, France
Hopital Saint Antoine
🇫🇷Paris, France
Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
Hôpital Necker Enfants Malades
🇫🇷Paris, France
CH René Dubos
🇫🇷Pontoise, France
Chu Pontchaillou
🇫🇷Rennes, France
CHU de Reims
🇫🇷Reims, France
Centre Henri Becquerel
🇫🇷Rouen, France
CH Roubaix
🇫🇷Roubaix, France
Centre Hospitalier Yves Le Foll
🇫🇷Saint brieuc, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷Saint-Priest, France
Centre Hospitalier
🇫🇷Saint-Quentin, France
CH Tarbes
🇫🇷Tarbes, France
CHU Toulouse
🇫🇷Toulouse, France
CH de valenciennes
🇫🇷Valenciennes, France
CH Bretagne Atlantique Vannes et Auray-P.Chubert
🇫🇷Vannes, France
CHV André Mignot
🇫🇷Versailles, France