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

NCT ID: NCT04805203

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-16

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

blood sample analyses

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intergroupe Francophone du Myelome

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hervé Avet Loiseau, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Intergroupe Francophone du Myelome

Locations

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CHU Amiens SUD

Amiens, , France

Site Status

CHRU Hôpital du Bocage

Angers, , France

Site Status

Ch Annecy Genevois

Annecy, , France

Site Status

CH Victor Dupouy

Argenteuil, , France

Site Status

CH d'ARRAS

Arras, , France

Site Status

CH Auch

Auch, , France

Site Status

Centre Hospitalier H.Duffaut

Avignon, , France

Site Status

CHRU Besançon

Besançon, , France

Site Status

Centre Hospitalier Simone Veil de Blois

Blois, , France

Site Status

CHU Bordeaux-hopital haut leveque

Bordeaux, , France

Site Status

Centre hospitalier Pierre Oudot

Bourgoin, , France

Site Status

Hôpital A.Morvan

Brest, , France

Site Status

CHU de Caen

Caen, , France

Site Status

CH de Cannes

Cannes, , France

Site Status

Clinique du Parc

Castelnau-le-Lez, , France

Site Status

Centre Hospitalier William Morey

Chalon-sur-Saône, , France

Site Status

Centre Hospitalier Métropole de Savoie

Chambéry, , France

Site Status

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

CHU Henri Mondor

Créteil, , France

Site Status

CH de Dax côte d'Argent

Dax, , France

Site Status

CHU François Mitterand

Dijon, , France

Site Status

CHU grenoble

Grenoble, , France

Site Status

Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble

Grenoble, , France

Site Status

CH de Lens

Lens, , France

Site Status

Hopital Claude Huriez-CHRU LILLE

Lille, , France

Site Status

CHU Limoges

Limoges, , France

Site Status

Centre Hospitalier Lyon sud

Lyon, , France

Site Status

GHT des Landes

Mont-de-Marsan, , France

Site Status

CHU saint Eloi

Montpellier, , France

Site Status

Hôpital E. MULLER

Mulhouse, , France

Site Status

Hôpitaux de Brabois - CHRU de Nancy

Nancy, , France

Site Status

CHRU Nantes

Nantes, , France

Site Status

Hopital Archet 1

Nice, , France

Site Status

Hopital Cochin

Paris, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Hôpital Necker Enfants Malades

Paris, , France

Site Status

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

CHU Poitiers

Poitiers, , France

Site Status

CH René Dubos

Pontoise, , France

Site Status

CHU de Reims

Reims, , France

Site Status

Chu Pontchaillou

Rennes, , France

Site Status

CH Roubaix

Roubaix, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Centre Hospitalier Yves Le Foll

Saint-Brieuc, , France

Site Status

Institut de Cancérologie Lucien Neuwirth

Saint-Priest, , France

Site Status

Centre Hospitalier

Saint-Quentin, , France

Site Status

ICANS

Strasbourg, , France

Site Status

CH Tarbes

Tarbes, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

CHRU Bretonneau

Tours, , France

Site Status

CH de valenciennes

Valenciennes, , France

Site Status

CH Bretagne Atlantique Vannes et Auray-P.Chubert

Vannes, , France

Site Status

CHV André Mignot

Versailles, , France

Site Status

Countries

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France

Other Identifiers

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IFM 2020-08

Identifier Type: -

Identifier Source: org_study_id

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