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

Not Applicable

Terminated

• Conditions: Covid19; Multiple 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.

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

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Exclusion Criteria

• Patients without multiple myeloma
• Patients without COVID19
• Patients under juridical protection guardianship, or tutelage measure

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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