Clinical trial NCT04805203: Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Myeloma
Covid19
Keywords: Multiple Myeloma
Covid19
Lead sponsor: Intergroupe Francophone du Myelome
Sponsor class: NETWORK
First posted: 2021-03-18
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
timeFrame: up to one month following COVID-19 diagnosis
measure: Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
timeFrame: one month following COVID-19 diagnosis
measure: Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
timeFrame: up to one month following COVID-19 diagnosis
measure: Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
timeFrame: one month following COVID-19 diagnosis
measure: Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
timeFrame: up to one month following COVID-19 diagnosis
measure: Characterize the immune laboratory parameters of Multiple Myeloma patientsat the cure of COVID-19
timeFrame: one month following COVID-19 diagnosis
measure: Correlation of patient immune function with death or development of protective immunity
timeFrame: up to 6 months following COVID-19 diagnosis
Secondary outcomes:
measure: Number of patient with protective immune response
timeFrame: before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens SUD
city: Angers
country: France
facility: CHRU Hôpital du Bocage
city: Annecy
country: France
facility: Ch Annecy Genevois
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Arras
country: France
facility: CH d'ARRAS
city: Auch
country: France
facility: CH Auch
city: Avignon
country: France
facility: Centre Hospitalier H.Duffaut
city: Besançon
country: France
facility: CHRU Besançon
city: Blois
country: France
facility: Centre Hospitalier Simone Veil de Blois
city: Bordeaux
country: France
facility: CHU Bordeaux-hopital haut leveque
city: Bourgoin-Jallieu
country: France
facility: Centre hospitalier Pierre Oudot
city: Brest
country: France
facility: Hôpital A.Morvan
city: Caen
country: France
facility: CHU de Caen
city: Cannes
country: France
facility: CH de Cannes
city: Castelnau-le-Lez
country: France
facility: Clinique du Parc
city: Chalon Sur Saone
country: France
facility: Centre Hospitalier William Morey
city: Chambéry
country: France
facility: Centre Hospitalier Métropole de Savoie
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Créteil
country: France
facility: CHU Henri Mondor
city: Dax
country: France
facility: CH de Dax côte d'Argent
city: Dijon
country: France
facility: CHU François Mitterand
city: Grenoble
country: France
facility: CHU grenoble
city: Grenoble
country: France
facility: Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
city: Lens
country: France
facility: CH de Lens
city: Lille
country: France
facility: Hopital Claude Huriez-CHRU LILLE
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Centre Hospitalier Lyon sud
city: Mont-de-Marsan
country: France
facility: GHT des Landes
city: Montpellier
country: France
facility: CHU saint Eloi
city: Mulhouse
country: France
facility: Hôpital E. MULLER
city: Nancy
country: France
facility: Hôpitaux de Brabois - CHRU de Nancy
city: Nantes
country: France
facility: CHRU Nantes
city: Nice
country: France
facility: Hopital Archet 1
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Poitiers
country: France
facility: CHU Poitiers
city: Pontoise
country: France
facility: CH René Dubos
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: Chu Pontchaillou
city: Roubaix
country: France
facility: CH Roubaix
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint brieuc
country: France
facility: Centre Hospitalier Yves Le Foll
city: Saint-Priest
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Saint-Quentin
country: France
facility: Centre Hospitalier
city: Strasbourg
country: France
facility: ICANS
city: Tarbes
country: France
facility: CH Tarbes
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHRU Bretonneau
city: Valenciennes
country: France
facility: CH de valenciennes
city: Vannes
country: France
facility: CH Bretagne Atlantique Vannes et Auray-P.Chubert
city: Versailles
country: France
facility: CHV André Mignot
Study officials:
affiliation: Intergroupe Francophone du Myelome
name: Hervé Avet Loiseau, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: