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

Primary Purpose

Multiple Myeloma, Covid19

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample analyses
Sponsored by
Intergroupe Francophone du Myelome
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring Multiple Myeloma, Covid19

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens SUD
  • CHRU Hôpital du Bocage
  • Ch Annecy Genevois
  • CH Victor Dupouy
  • CH d'ARRAS
  • CH Auch
  • Centre Hospitalier H.Duffaut
  • CHRU Besançon
  • Centre Hospitalier Simone Veil de Blois
  • CHU Bordeaux-hopital haut leveque
  • Centre hospitalier Pierre Oudot
  • Hôpital A.Morvan
  • CHU de Caen
  • CH de Cannes
  • Clinique du Parc
  • Centre Hospitalier William Morey
  • Centre Hospitalier Métropole de Savoie
  • Centre Hospitalier Sud Francilien
  • CHU Henri Mondor
  • CH de Dax côte d'Argent
  • CHU François Mitterand
  • CHU grenoble
  • Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
  • CH de Lens
  • Hopital Claude Huriez-CHRU LILLE
  • CHU Limoges
  • Centre Hospitalier Lyon sud
  • GHT des Landes
  • CHU saint Eloi
  • Hôpital E. MULLER
  • Hôpitaux de Brabois - CHRU de Nancy
  • CHRU Nantes
  • Hopital Archet 1
  • Hopital Cochin
  • Hopital Saint Antoine
  • Hôpital Necker Enfants Malades
  • Hôpital Pitié-Salpêtrière
  • CHU Poitiers
  • CH René Dubos
  • CHU de Reims
  • Chu Pontchaillou
  • CH Roubaix
  • Centre Henri Becquerel
  • Centre Hospitalier Yves Le Foll
  • Institut de Cancérologie Lucien Neuwirth
  • Centre Hospitalier
  • ICANS
  • CH Tarbes
  • CHU Toulouse
  • CHRU Bretonneau
  • CH de valenciennes
  • CH Bretagne Atlantique Vannes et Auray-P.Chubert
  • CHV André Mignot

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

blood samples

Arm 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.

Outcomes

Primary Outcome Measures

Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
gammaglobulin measurements in g/L
Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
gammaglobulin measurements in g/L
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
lymphocytes counts in g/l
Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
lymphocytes counts in g/l
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
number of cells B, T, and NK actived and inhibited
Characterize the immune laboratory parameters of Multiple Myeloma patientsat the cure of COVID-19
number of cells B, T, and NK actived and inhibited
Correlation of patient immune function with death or development of protective immunity
number of death

Secondary Outcome Measures

Number of patient with protective immune response
T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies

Full Information

First Posted
December 15, 2020
Last Updated
October 18, 2023
Sponsor
Intergroupe Francophone du Myelome
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1. Study Identification

Unique Protocol Identification Number
NCT04805203
Brief Title
Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma
Acronym
Covimmunomm
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment delay due to difficulties to involve patient at Covid diagnosis in hematology departments Abandoned study
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intergroupe Francophone du Myelome

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Covid19
Keywords
Multiple Myeloma, Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
blood samples
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
blood sample analyses
Intervention 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
Primary Outcome Measure Information:
Title
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
Description
gammaglobulin measurements in g/L
Time Frame
up to one month following COVID-19 diagnosis
Title
Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
Description
gammaglobulin measurements in g/L
Time Frame
one month following COVID-19 diagnosis
Title
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
Description
lymphocytes counts in g/l
Time Frame
up to one month following COVID-19 diagnosis
Title
Characterize the immune laboratory parameters of Multiple Myeloma patients at the cure of COVID-19
Description
lymphocytes counts in g/l
Time Frame
one month following COVID-19 diagnosis
Title
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
Description
number of cells B, T, and NK actived and inhibited
Time Frame
up to one month following COVID-19 diagnosis
Title
Characterize the immune laboratory parameters of Multiple Myeloma patientsat the cure of COVID-19
Description
number of cells B, T, and NK actived and inhibited
Time Frame
one month following COVID-19 diagnosis
Title
Correlation of patient immune function with death or development of protective immunity
Description
number of death
Time Frame
up to 6 months following COVID-19 diagnosis
Secondary Outcome Measure Information:
Title
Number of patient with protective immune response
Description
T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies
Time Frame
before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé Avet Loiseau, PU-PH
Organizational Affiliation
Intergroupe Francophone du Myelome
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens SUD
City
Amiens
Country
France
Facility Name
CHRU Hôpital du Bocage
City
Angers
Country
France
Facility Name
Ch Annecy Genevois
City
Annecy
Country
France
Facility Name
CH Victor Dupouy
City
Argenteuil
Country
France
Facility Name
CH d'ARRAS
City
Arras
Country
France
Facility Name
CH Auch
City
Auch
Country
France
Facility Name
Centre Hospitalier H.Duffaut
City
Avignon
Country
France
Facility Name
CHRU Besançon
City
Besançon
Country
France
Facility Name
Centre Hospitalier Simone Veil de Blois
City
Blois
Country
France
Facility Name
CHU Bordeaux-hopital haut leveque
City
Bordeaux
Country
France
Facility Name
Centre hospitalier Pierre Oudot
City
Bourgoin-Jallieu
Country
France
Facility Name
Hôpital A.Morvan
City
Brest
Country
France
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Name
CH de Cannes
City
Cannes
Country
France
Facility Name
Clinique du Parc
City
Castelnau-le-Lez
Country
France
Facility Name
Centre Hospitalier William Morey
City
Chalon Sur Saone
Country
France
Facility Name
Centre Hospitalier Métropole de Savoie
City
Chambéry
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
Country
France
Facility Name
CHU Henri Mondor
City
Créteil
Country
France
Facility Name
CH de Dax côte d'Argent
City
Dax
Country
France
Facility Name
CHU François Mitterand
City
Dijon
Country
France
Facility Name
CHU grenoble
City
Grenoble
Country
France
Facility Name
Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
City
Grenoble
Country
France
Facility Name
CH de Lens
City
Lens
Country
France
Facility Name
Hopital Claude Huriez-CHRU LILLE
City
Lille
Country
France
Facility Name
CHU Limoges
City
Limoges
Country
France
Facility Name
Centre Hospitalier Lyon sud
City
Lyon
Country
France
Facility Name
GHT des Landes
City
Mont-de-Marsan
Country
France
Facility Name
CHU saint Eloi
City
Montpellier
Country
France
Facility Name
Hôpital E. MULLER
City
Mulhouse
Country
France
Facility Name
Hôpitaux de Brabois - CHRU de Nancy
City
Nancy
Country
France
Facility Name
CHRU Nantes
City
Nantes
Country
France
Facility Name
Hopital Archet 1
City
Nice
Country
France
Facility Name
Hopital Cochin
City
Paris
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
Country
France
Facility Name
Hôpital Necker Enfants Malades
City
Paris
Country
France
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
Country
France
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Facility Name
CH René Dubos
City
Pontoise
Country
France
Facility Name
CHU de Reims
City
Reims
Country
France
Facility Name
Chu Pontchaillou
City
Rennes
Country
France
Facility Name
CH Roubaix
City
Roubaix
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Centre Hospitalier Yves Le Foll
City
Saint brieuc
Country
France
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint-Priest
Country
France
Facility Name
Centre Hospitalier
City
Saint-Quentin
Country
France
Facility Name
ICANS
City
Strasbourg
Country
France
Facility Name
CH Tarbes
City
Tarbes
Country
France
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Facility Name
CHRU Bretonneau
City
Tours
Country
France
Facility Name
CH de valenciennes
City
Valenciennes
Country
France
Facility Name
CH Bretagne Atlantique Vannes et Auray-P.Chubert
City
Vannes
Country
France
Facility Name
CHV André Mignot
City
Versailles
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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