Covimmunomm: Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: blood samples 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. |
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
|
Outcome Measures
Primary Outcome Measures
- 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]
gammaglobulin measurements in g/L
- Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19 [one month following COVID-19 diagnosis]
gammaglobulin measurements in g/L
- 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]
lymphocytes counts in g/l
- 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
- 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
- Correlation of patient immune function with death or development of protective immunity [up to 6 months following COVID-19 diagnosis]
number of death
Secondary Outcome Measures
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Amiens SUD | Amiens | France | ||
| 2 | CHRU Hôpital du Bocage | Angers | France | ||
| 3 | Ch Annecy Genevois | Annecy | France | ||
| 4 | CH Victor Dupouy | Argenteuil | France | ||
| 5 | CH d'ARRAS | Arras | France | ||
| 6 | CH Auch | Auch | France | ||
| 7 | Centre Hospitalier H.Duffaut | Avignon | France | ||
| 8 | Centre Hospitalier Simone Veil de Blois | Blois | France | ||
| 9 | CHU Bordeaux-hopital haut leveque | Bordeaux | France | ||
| 10 | Centre hospitalier Pierre Oudot | Bourgoin-Jallieu | France | ||
| 11 | Hôpital A.Morvan | Brest | France | ||
| 12 | CHU de Caen | Caen | France | ||
| 13 | CH de Cannes | Cannes | France | ||
| 14 | Clinique du Parc | Castelnau-le-Lez | France | ||
| 15 | Centre Hospitalier William Morey | Chalon Sur Saone | France | ||
| 16 | Centre Hospitalier Métropole de Savoie | Chambéry | France | ||
| 17 | Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | ||
| 18 | CHU Henri Mondor | Créteil | France | ||
| 19 | CH de Dax côte d'Argent | Dax | France | ||
| 20 | CHU François Mitterand | Dijon | France | ||
| 21 | CH de Dunkerque | Dunkerque | France | ||
| 22 | CHU grenoble | Grenoble | France | ||
| 23 | Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble | Grenoble | France | ||
| 24 | CH de Lens | Lens | France | ||
| 25 | Hopital Claude Huriez-CHRU LILLE | Lille | France | ||
| 26 | CHU Limoges | Limoges | France | ||
| 27 | Centre Hospitalier Lyon sud | Lyon | France | ||
| 28 | Centre Léon Bérard | Lyon | France | ||
| 29 | Institut Paoli Calmettes | Marseille | France | ||
| 30 | GHT des Landes | Mont-de-Marsan | France | ||
| 31 | CHU saint Eloi | Montpellier | France | ||
| 32 | Hôpital E. MULLER | Mulhouse | France | ||
| 33 | Hôpitaux de Brabois - CHRU de Nancy | Nancy | France | ||
| 34 | CHRU Nantes | Nantes | France | ||
| 35 | Hopital Archet 1 | Nice | France | ||
| 36 | Hopital Cochin | Paris | France | ||
| 37 | Hopital Saint Antoine | Paris | France | ||
| 38 | Hôpital Necker Enfants Malades | Paris | France | ||
| 39 | Hôpital Pitié-Salpêtrière | Paris | France | ||
| 40 | CHU Poitiers | Poitiers | France | ||
| 41 | CH René Dubos | Pontoise | France | ||
| 42 | CHU de Reims | Reims | France | ||
| 43 | Chu Pontchaillou | Rennes | France | ||
| 44 | CH Roubaix | Roubaix | France | ||
| 45 | Centre Henri Becquerel | Rouen | France | ||
| 46 | Centre Hospitalier Yves Le Foll | Saint brieuc | France | ||
| 47 | Institut de Cancérologie Lucien Neuwirth | Saint-Priest | France | ||
| 48 | Centre Hospitalier | Saint-Quentin | France | ||
| 49 | ICANS | Strasbourg | France | ||
| 50 | CH Tarbes | Tarbes | France | ||
| 51 | CHU Toulouse | Toulouse | France | ||
| 52 | CHRU Bretonneau | Tours | France | ||
| 53 | CH de valenciennes | Valenciennes | France | ||
| 54 | CH Bretagne Atlantique Vannes et Auray-P.Chubert | Vannes | France | ||
| 55 | CHV André Mignot | Versailles | France |
Sponsors and Collaborators
- Intergroupe Francophone du Myelome
Investigators
- Principal Investigator: Hervé Avet Loiseau, PU-PH, Intergroupe Francophone du Myelome
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IFM 2020-08