Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-25 @ 5:03 PM
Study NCT ID:
NCT04805203
Status:
TERMINATED
Last Update Posted:
2023-10-19
First Post:
2020-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'whyStopped': 'Recruitment delay due to difficulties to involve patient at Covid diagnosis in hematology departments Abandoned study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'gammaglobulin measurements in g/L'}, {'measure': 'Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19', 'timeFrame': 'one month following COVID-19 diagnosis', 'description': 'gammaglobulin measurements in g/L'}, {'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', 'description': 'lymphocytes counts in g/l'}, {'measure': 'Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19', 'timeFrame': 'one month following COVID-19 diagnosis', 'description': 'lymphocytes counts in g/l'}, {'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', 'description': 'number of cells B, T, and NK actived and inhibited'}, {'measure': 'Characterize the immune laboratory parameters of Multiple Myeloma patientsat the cure of COVID-19', 'timeFrame': 'one month following COVID-19 diagnosis', 'description': 'number of cells B, T, and NK actived and inhibited'}, {'measure': 'Correlation of patient immune function with death or development of protective immunity', 'timeFrame': 'up to 6 months following COVID-19 diagnosis', 'description': 'number of death'}], 'secondaryOutcomes': [{'measure': 'Number of patient with protective immune response', 'timeFrame': 'before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments', 'description': 'T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Covid19'], 'conditions': ['Multiple Myeloma', 'Covid19']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a multiple myeloma and a documented COVID19 (by RT-PCR, thoracic TDM, and/or antigenix test).\n* Patients having received the information to participate in the research and having expressed their non-opposition\n* Patients with social security insurance or equivalent\n\nExclusion Criteria:\n\n* Patients without multiple myeloma\n* Patients without COVID19\n* Patients under juridical protection guardianship, or tutelage measure'}, 'identificationModule': {'nctId': 'NCT04805203', 'acronym': 'Covimmunomm', 'briefTitle': 'Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma', 'organization': {'class': 'NETWORK', 'fullName': 'Intergroupe Francophone du Myelome'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IFM 2020-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'blood samples', 'description': '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.', 'interventionNames': ['Other: blood sample analyses']}], 'interventions': [{'name': 'blood sample analyses', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['blood samples']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens SUD', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Angers', 'country': 'France', 'facility': 'CHRU Hôpital du Bocage', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Annecy', 'country': 'France', 'facility': 'Ch Annecy Genevois', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Argenteuil', 'country': 'France', 'facility': 'CH Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'city': 'Arras', 'country': 'France', 'facility': "CH d'ARRAS", 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'city': 'Auch', 'country': 'France', 'facility': 'CH Auch', 'geoPoint': {'lat': 43.64561, 'lon': 0.58856}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Centre Hospitalier H.Duffaut', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Besançon', 'country': 'France', 'facility': 'CHRU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Blois', 'country': 'France', 'facility': 'Centre Hospitalier Simone Veil de Blois', 'geoPoint': {'lat': 47.59432, 'lon': 1.32912}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Bordeaux-hopital haut leveque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bourgoin', 'country': 'France', 'facility': 'Centre hospitalier Pierre Oudot', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'city': 'Brest', 'country': 'France', 'facility': 'Hôpital A.Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Cannes', 'country': 'France', 'facility': 'CH de Cannes', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'city': 'Castelnau-le-Lez', 'country': 'France', 'facility': 'Clinique du Parc', 'geoPoint': {'lat': 43.63605, 'lon': 3.90137}}, {'city': 'Chalon-sur-Saône', 'country': 'France', 'facility': 'Centre Hospitalier William Morey', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'city': 'Chambéry', 'country': 'France', 'facility': 'Centre Hospitalier Métropole de Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'city': 'Créteil', 'country': 'France', 'facility': 'CHU Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dax', 'country': 'France', 'facility': "CH de Dax côte d'Argent", 'geoPoint': {'lat': 43.71032, 'lon': -1.05366}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CHU François Mitterand', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lens', 'country': 'France', 'facility': 'CH de Lens', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hopital Claude Huriez-CHRU LILLE', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Centre Hospitalier Lyon sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Mont-de-Marsan', 'country': 'France', 'facility': 'GHT des Landes', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Mulhouse', 'country': 'France', 'facility': 'Hôpital E. MULLER', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'city': 'Nancy', 'country': 'France', 'facility': 'Hôpitaux de Brabois - CHRU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHRU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'Hopital Archet 1', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Pontoise', 'country': 'France', 'facility': 'CH René Dubos', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'city': 'Reims', 'country': 'France', 'facility': 'CHU de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Chu Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Roubaix', 'country': 'France', 'facility': 'CH Roubaix', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Centre Hospitalier Yves Le Foll', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'Saint-Priest', 'country': 'France', 'facility': 'Institut de Cancérologie Lucien Neuwirth', 'geoPoint': {'lat': 45.69651, 'lon': 4.94385}}, {'city': 'Saint-Quentin', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'ICANS', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Tarbes', 'country': 'France', 'facility': 'CH Tarbes', 'geoPoint': {'lat': 43.23407, 'lon': 0.07139}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHRU Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Valenciennes', 'country': 'France', 'facility': 'CH de valenciennes', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'city': 'Vannes', 'country': 'France', 'facility': 'CH Bretagne Atlantique Vannes et Auray-P.Chubert', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}, {'city': 'Versailles', 'country': 'France', 'facility': 'CHV André Mignot', 'geoPoint': {'lat': 48.80359, 'lon': 2.13424}}], 'overallOfficials': [{'name': 'Hervé Avet Loiseau, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intergroupe Francophone du Myelome'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intergroupe Francophone du Myelome', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}