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

October 18, 2023 updated by: Intergroupe Francophone du Myelome

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • CHU Amiens Sud
      • Angers, France
        • CHRU Hopital du bocage
      • Annecy, France
        • Ch Annecy Genevois
      • Argenteuil, France
        • CH Victor Dupouy
      • Arras, France
        • CH d'Arras
      • Auch, France
        • CH Auch
      • Avignon, France
        • Centre Hospitalier H.Duffaut
      • Besançon, France
        • CHRU Besançon
      • Blois, France
        • Centre Hospitalier Simone Veil de Blois
      • Bordeaux, France
        • CHU Bordeaux-hopital haut leveque
      • Bourgoin-Jallieu, France
        • Centre hospitalier Pierre Oudot
      • Brest, France
        • Hôpital A.Morvan
      • Caen, France
        • CHU de Caen
      • Cannes, France
        • CH de Cannes
      • Castelnau-le-Lez, France
        • Clinique du Parc
      • Chalon Sur Saone, France
        • Centre Hospitalier William Morey
      • Chambéry, France
        • Centre Hospitalier Métropole de Savoie
      • Corbeil-Essonnes, France
        • Centre Hospitalier Sud Francilien
      • Créteil, France
        • CHU Henri Mondor
      • Dax, France
        • CH de Dax côte d'Argent
      • Dijon, France
        • CHU François Mitterand
      • Grenoble, France
        • CHU Grenoble
      • Grenoble, France
        • Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
      • Lens, France
        • CH de Lens
      • Lille, France
        • Hopital Claude Huriez-CHRU LILLE
      • Limoges, France
        • CHU Limoges
      • Lyon, France
        • Centre Hospitalier Lyon Sud
      • Mont-de-Marsan, France
        • GHT des Landes
      • Montpellier, France
        • CHU Saint Eloi
      • Mulhouse, France
        • Hôpital E. Muller
      • Nancy, France
        • Hôpitaux de Brabois - CHRU de Nancy
      • Nantes, France
        • CHRU Nantes
      • Nice, France
        • Hôpital Archet 1
      • Paris, France
        • Hôpital Pitié-Salpétrière
      • Paris, France
        • Hôpital Necker Enfants Malades
      • Paris, France
        • Hopital Saint Antoine
      • Paris, France
        • Hopital Cochin
      • Poitiers, France
        • CHU Poitiers
      • Pontoise, France
        • CH René Dubos
      • Reims, France
        • CHU de Reims
      • Rennes, France
        • CHU Pontchaillou
      • Roubaix, France
        • CH Roubaix
      • Rouen, France
        • Centre Henri Becquerel
      • Saint brieuc, France
        • Centre Hospitalier Yves Le Foll
      • Saint-Priest, France
        • Institut de Cancérologie Lucien Neuwirth
      • Saint-Quentin, France
        • Centre Hospitalier
      • Strasbourg, France
        • ICANS
      • Tarbes, France
        • CH Tarbes
      • Toulouse, France
        • CHU Toulouse
      • Tours, France
        • CHRU Bretonneau
      • Valenciennes, France
        • CH de Valenciennes
      • Vannes, France
        • CH Bretagne Atlantique Vannes et Auray-P.Chubert
      • Versailles, France
        • CHV André Mignot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
Time Frame: up to one month following COVID-19 diagnosis
gammaglobulin measurements in g/L
up to one month following COVID-19 diagnosis
Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
Time Frame: one month following COVID-19 diagnosis
gammaglobulin measurements in g/L
one month following COVID-19 diagnosis
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
Time Frame: up to one month following COVID-19 diagnosis
lymphocytes counts in g/l
up to one month following COVID-19 diagnosis
Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
Time Frame: one month following COVID-19 diagnosis
lymphocytes counts in g/l
one month following COVID-19 diagnosis
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
Time Frame: up to one month following COVID-19 diagnosis
number of cells B, T, and NK actived and inhibited
up to one month following COVID-19 diagnosis
Characterize the immune laboratory parameters of Multiple Myeloma patientsat the cure of COVID-19
Time Frame: one month following COVID-19 diagnosis
number of cells B, T, and NK actived and inhibited
one month following COVID-19 diagnosis
Correlation of patient immune function with death or development of protective immunity
Time Frame: up to 6 months following COVID-19 diagnosis
number of death
up to 6 months following COVID-19 diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patient with protective immune response
Time Frame: 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
before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone du Myelome

Investigators

  • Principal Investigator: Hervé Avet Loiseau, PU-PH, Intergroupe Francophone du Myelome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFM 2020-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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