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NCT04805203 Clinical Trial

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

Multiple Myeloma Clinical Trial

— Covimmunomm  

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04805203
Other study ID # IFM 2020-08
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 16, 2020
Est. completion date December 31, 2022

Study information
Verified date October 2023
Source Intergroupe Francophone du Myelome
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 139
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• blood sample analyses
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

Locations
Country Name City State
France 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 Centre hospitalier Pierre Oudot Bourgoin-Jallieu
France Hôpital A.Morvan Brest
France CHU de Caen Caen
France CH de Cannes Cannes
France Clinique du Parc Castelnau-le-Lez
France Centre Hospitalier William Morey Chalon Sur Saone
France Centre Hospitalier Métropole de Savoie Chambéry
France Centre Hospitalier Sud Francilien Corbeil-Essonnes
France CHU Henri Mondor Créteil
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 CH de Lens Lens
France Hopital Claude Huriez-CHRU LILLE Lille
France CHU Limoges Limoges
France Centre Hospitalier Lyon sud Lyon
France GHT des Landes Mont-de-Marsan
France CHU saint Eloi Montpellier
France Hôpital E. MULLER Mulhouse
France Hôpitaux de Brabois - CHRU de Nancy Nancy
France CHRU Nantes Nantes
France Hopital Archet 1 Nice
France Hopital Cochin Paris
France Hôpital Necker Enfants Malades Paris
France Hôpital Pitié-Salpêtrière Paris
France Hopital Saint Antoine Paris
France CHU Poitiers Poitiers
France CH René Dubos Pontoise
France CHU de Reims Reims
France Chu Pontchaillou Rennes
France CH Roubaix Roubaix
France Centre Henri Becquerel Rouen
France Centre Hospitalier Yves Le Foll Saint brieuc
France Institut de Cancérologie Lucien Neuwirth Saint-Priest
France Centre Hospitalier Saint-Quentin
France ICANS Strasbourg
France CH Tarbes Tarbes
France CHU Toulouse Toulouse
France CHRU Bretonneau Tours
France CH de valenciennes Valenciennes
France CH Bretagne Atlantique Vannes et Auray-P.Chubert Vannes
France CHV André Mignot Versailles

Sponsors (1)
Lead Sponsor Collaborator
Intergroupe Francophone du Myelome

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Correlation of patient immune function with death or development of protective immunity number of death up to 6 months following COVID-19 diagnosis
Secondary 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
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