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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04805203
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Intergroupe Francophone du Myelome
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hervé Avet Loiseau, PU-PH
Principal Investigator Affiliation Intergroupe Francophone du Myelome
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Covid19
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Amiens SUD, Amiens, France

Status

Recruiting

Address

CHU Amiens SUD

Amiens, ,

Site Contact

MAROLLEAU Jean-Pierre, MD

a.huguet@myelome.fr

0531156338

CHRU Hôpital du Bocage, Angers, France

Status

Not yet recruiting

Address

CHRU Hôpital du Bocage

Angers, ,

Site Contact

Mamoun DIB, MD

a.huguet@myelome.fr

0531156338

Ch Annecy Genevois, Annecy, France

Status

Not yet recruiting

Address

Ch Annecy Genevois

Annecy, ,

Site Contact

Frédérique ORSINI PIOCELLE, MD

a.huguet@myelome.fr

0531156338

CH Victor Dupouy, Argenteuil, France

Status

Recruiting

Address

CH Victor Dupouy

Argenteuil, ,

Site Contact

Driss CHAOUI

a.huguet@myelome.fr

0531156338

CH d'ARRAS, Arras, France

Status

Not yet recruiting

Address

CH d'ARRAS

Arras, ,

Site Contact

Stéphane DARRE

a.huguet@myelome.fr

0531156338

CH Auch, Auch, France

Status

Not yet recruiting

Address

CH Auch

Auch, ,

Site Contact

willy Vaillant, MD

a.huguet@myelome.fr

0531156338

Centre Hospitalier H.Duffaut, Avignon, France

Status

Recruiting

Address

Centre Hospitalier H.Duffaut

Avignon, ,

Site Contact

Hacene ZERAZHI, MD

a.huguet@myelome.fr

0531156338

Centre Hospitalier Simone Veil de Blois, Blois, France

Status

Not yet recruiting

Address

Centre Hospitalier Simone Veil de Blois

Blois, ,

Site Contact

Abderazzak EL YAMANI, MD

a.huguet@myelome.fr

0531156338

CHU Bordeaux-hopital haut leveque, Bordeaux, France

Status

Recruiting

Address

CHU Bordeaux-hopital haut leveque

Bordeaux, ,

Site Contact

Cyrille HULIN, MD

a.huguet@myelome.fr

0531156338

Centre hospitalier Pierre Oudot, Bourgoin-Jallieu, France

Status

Not yet recruiting

Address

Centre hospitalier Pierre Oudot

Bourgoin-Jallieu, ,

Site Contact

Florence LACHENAL

a.huguet@myelome.fr

0531156338

Hôpital A.Morvan, Brest, France

Status

Not yet recruiting

Address

Hôpital A.Morvan

Brest, ,

Site Contact

Jean-Richard EVEILLARD, MD

a.huguet@myelome.fr

0531156338

CHU de Caen, Caen, France

Status

Recruiting

Address

CHU de Caen

Caen, ,

Site Contact

Margaret MACRO, MD

a.huguet@myelome.fr

0531156338

CH de Cannes, Cannes, France

Status

Not yet recruiting

Address

CH de Cannes

Cannes, ,

Site Contact

Régis KAPHAN

a.huguet@myelome.fr

0531156338

Clinique du Parc, Castelnau-le-Lez, France

Status

Not yet recruiting

Address

Clinique du Parc

Castelnau-le-Lez, ,

Site Contact

Carole EXBRAYAT

a.huguet@myelome.fr

0531156338

Centre Hospitalier William Morey, Chalon Sur Saone, France

Status

Not yet recruiting

Address

Centre Hospitalier William Morey

Chalon Sur Saone, ,

Site Contact

Laurent VOILLAT, MD

a.huguet@myelome.fr

0531156338

Centre Hospitalier Métropole de Savoie, Chambéry, France

Status

Not yet recruiting

Address

Centre Hospitalier Métropole de Savoie

Chambéry, ,

Site Contact

Pierre Faurie

a.huguet@myelome.fr

0531156338

Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France

Status

Not yet recruiting

Address

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, ,

Site Contact

Sophie CEREJA

a.huguet@myelome.fr

0531156338

CHU Henri Mondor, Créteil, France

Status

Not yet recruiting

Address

CHU Henri Mondor

Créteil, ,

Site Contact

Karim BELHADJ

a.huguet@myelome.fr

0531156338

CH de Dax côte d'Argent, Dax, France

Status

Not yet recruiting

Address

CH de Dax côte d'Argent

Dax, ,

Site Contact

François LIFERMANN, MD

a.huguet@myelome.fr

0531156338

CHU François Mitterand, Dijon, France

Status

Recruiting

Address

CHU François Mitterand

Dijon, ,

Site Contact

Denis Caillot, MD

a.huguet@myelome.fr

0531156338

CH de Dunkerque, Dunkerque, France

Status

Withdrawn

Address

CH de Dunkerque

Dunkerque, ,

CHU grenoble, Grenoble, France

Status

Recruiting

Address

CHU grenoble

Grenoble, ,

Site Contact

Clara Mariette, MD

a.huguet@myelome.fr

0531156338

Grenoble, France

Status

Not yet recruiting

Address

Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble

Grenoble, ,

Site Contact

Cécile LEYRONNAS

a.huguet@myelome.fr

0531156338

CH de Lens, Lens, France

Status

Not yet recruiting

Address

CH de Lens

Lens, ,

Site Contact

Daniela ROBU

a.huguet@myelome.fr

0531156338

Hopital Claude Huriez-CHRU LILLE, Lille, France

Status

Not yet recruiting

Address

Hopital Claude Huriez-CHRU LILLE

Lille, ,

Site Contact

Salomon Manier

a.huguet@myelome.fr

0531156338

CHU Limoges, Limoges, France

Status

Not yet recruiting

Address

CHU Limoges

Limoges, ,

Site Contact

Arnaud Jaccard

a.huguet@myelome.fr

0531156338

Centre Hospitalier Lyon sud, Lyon, France

Status

Recruiting

Address

Centre Hospitalier Lyon sud

Lyon, ,

Site Contact

Lionel Karlin, MD

a.huguet@myelome.fr

0531156338

Centre Léon Bérard, Lyon, France

Status

Withdrawn

Address

Centre Léon Bérard

Lyon, ,

Institut Paoli Calmettes, Marseille, France

Status

Withdrawn

Address

Institut Paoli Calmettes

Marseille, ,

GHT des Landes, Mont-de-Marsan, France

Status

Recruiting

Address

GHT des Landes

Mont-de-Marsan, ,

Site Contact

Reza TABRIZI

a.huguet@myelome.fr

0531156338

CHU saint Eloi, Montpellier, France

Status

Recruiting

Address

CHU saint Eloi

Montpellier, ,

Site Contact

Laure Vincent

a.huguet@myelome.fr

0531156338

Hôpital E. MULLER, Mulhouse, France

Status

Not yet recruiting

Address

Hôpital E. MULLER

Mulhouse, ,

Site Contact

Muriel Newinger-Porte

a.huguet@myelome.fr

0531156338

Hôpitaux de Brabois - CHRU de Nancy, Nancy, France

Status

Not yet recruiting

Address

Hôpitaux de Brabois - CHRU de Nancy

Nancy, ,

Site Contact

Pierre FEUGIER

a.huguet@myelome.fr

0531156338

CHRU Nantes, Nantes, France

Status

Recruiting

Address

CHRU Nantes

Nantes, ,

Site Contact

Cyrille TOUZEAU, MD

a.huguet@myelome.fr

0531156338

Hopital Archet 1, Nice, France

Status

Not yet recruiting

Address

Hopital Archet 1

Nice, ,

Site Contact

Valentine RICHEZ, MD

a.huguet@myelome.fr

0531156338

Hopital Cochin, Paris, France

Status

Not yet recruiting

Address

Hopital Cochin

Paris, ,

Site Contact

Marguerite VIGNON

a.huguet@myelome.fr

0531156338

Hopital Saint Antoine, Paris, France

Status

Not yet recruiting

Address

Hopital Saint Antoine

Paris, ,

Site Contact

Mohamad MOHTY

a.huguet@myelome.fr

0531156338

Hôpital Necker Enfants Malades, Paris, France

Status

Recruiting

Address

Hôpital Necker Enfants Malades

Paris, ,

Site Contact

Laurent FRENZEL, MD

a.huguet@myelome.fr

0531156338

Hôpital Pitié-Salpêtrière, Paris, France

Status

Not yet recruiting

Address

Hôpital Pitié-Salpêtrière

Paris, ,

Site Contact

Véronique Morel

a.huguet@myelome.fr

0531156338

CHU Poitiers, Poitiers, France

Status

Recruiting

Address

CHU Poitiers

Poitiers, ,

Site Contact

Xavier LELEU, MD

a.huguet@myelome.fr

0531156338

CH René Dubos, Pontoise, France

Status

Not yet recruiting

Address

CH René Dubos

Pontoise, ,

Site Contact

Riad BENRAMDANE, MD

a.huguet@myelome.fr

0531156338

CHU de Reims, Reims, France

Status

Not yet recruiting

Address

CHU de Reims

Reims, ,

Site Contact

Sophie GODET, MD

a.huguet@myelome.fr

0531156338

Chu Pontchaillou, Rennes, France

Status

Not yet recruiting

Address

Chu Pontchaillou

Rennes, ,

Site Contact

Olivier Decaux, MD

a.huguet@myelome.fr

0531156338

CH Roubaix, Roubaix, France

Status

Not yet recruiting

Address

CH Roubaix

Roubaix, ,

Site Contact

Isabelle DERVITE

a.huguet@myelome.fr

0531156338

Centre Henri Becquerel, Rouen, France

Status

Not yet recruiting

Address

Centre Henri Becquerel

Rouen, ,

Site Contact

Fabrice Jardin, MD

a.huguet@myelome.fr

0531156338

Centre Hospitalier Yves Le Foll, Saint brieuc, France

Status

Not yet recruiting

Address

Centre Hospitalier Yves Le Foll

Saint brieuc, ,

Site Contact

Olivier ALLANGBA, MD

a.huguet@myelome.fr

0531156338

Institut de Cancérologie Lucien Neuwirth, Saint-Priest, France

Status

Recruiting

Address

Institut de Cancérologie Lucien Neuwirth

Saint-Priest, ,

Site Contact

Philippe COLLET

a.huguet@myelome.fr

0531156338

Centre Hospitalier, Saint-Quentin, France

Status

Recruiting

Address

Centre Hospitalier

Saint-Quentin, ,

Site Contact

Reda GARIDI

a.huguet@myelome.fr

0531156338

ICANS, Strasbourg, France

Status

Recruiting

Address

ICANS

Strasbourg, ,

Site Contact

Cecile SONNTAG, MD

a.huguet@myelome.fr

0531156338

CH Tarbes, Tarbes, France

Status

Not yet recruiting

Address

CH Tarbes

Tarbes, ,

Site Contact

Claire DINGREMONT, MD

a.huguet@myelome.fr

0531156338

CHU Toulouse, Toulouse, France

Status

Recruiting

Address

CHU Toulouse

Toulouse, ,

Site Contact

Aurore Perrot, MD

a.huguet@myelome.fr

0531156338

CHRU Bretonneau, Tours, France

Status

Not yet recruiting

Address

CHRU Bretonneau

Tours, ,

Site Contact

Thomas CHALOPIN, MD

a.huguet@myelome.fr

0531156338

CH de valenciennes, Valenciennes, France

Status

Not yet recruiting

Address

CH de valenciennes

Valenciennes, ,

Site Contact

Faiza KEDDAR, MD

a.huguet@myelome.fr

0531156338

Vannes, France

Status

Not yet recruiting

Address

CH Bretagne Atlantique Vannes et Auray-P.Chubert

Vannes, ,

Site Contact

Pascal Godmer, MD

a.huguet@myelome.fr

0531156338

CHV André Mignot, Versailles, France

Status

Recruiting

Address

CHV André Mignot

Versailles, ,

Site Contact

Sophie RIGAUDEAU

a.huguet@myelome.fr

0531156338