Study Stopped
Recruitment delay due to difficulties to involve patient at Covid diagnosis in hematology departments Abandoned study
Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma
Covimmunomm
1 other identifier
interventional
139
1 country
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-myeloma
Started Dec 2020
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2020
CompletedStudy Start
First participant enrolled
December 16, 2020
CompletedFirst Posted
Study publicly available on registry
March 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedOctober 19, 2023
October 1, 2023
2 years
December 15, 2020
October 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
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
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
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
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
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
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
number of death
up to 6 months following COVID-19 diagnosis
Secondary Outcomes (1)
Number of patient with protective immune response
before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments
Study Arms (1)
blood samples
OTHER4 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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients without multiple myeloma
- Patients without COVID19
- Patients under juridical protection guardianship, or tutelage measure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
CHU Amiens SUD
Amiens, France
CHRU Hôpital du Bocage
Angers, France
Ch Annecy Genevois
Annecy, France
CH Victor Dupouy
Argenteuil, France
CH d'ARRAS
Arras, France
CH Auch
Auch, France
Centre Hospitalier H.Duffaut
Avignon, France
CHRU Besançon
Besançon, France
Centre Hospitalier Simone Veil de Blois
Blois, France
CHU Bordeaux-hopital haut leveque
Bordeaux, France
Centre hospitalier Pierre Oudot
Bourgoin, France
Hôpital A.Morvan
Brest, France
CHU de Caen
Caen, France
CH de Cannes
Cannes, France
Clinique du Parc
Castelnau-le-Lez, France
Centre Hospitalier William Morey
Chalon-sur-Saône, France
Centre Hospitalier Métropole de Savoie
Chambéry, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
CHU Henri Mondor
Créteil, France
CH de Dax côte d'Argent
Dax, France
CHU François Mitterand
Dijon, France
CHU grenoble
Grenoble, France
Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
CH de Lens
Lens, France
Hopital Claude Huriez-CHRU LILLE
Lille, France
CHU Limoges
Limoges, France
Centre Hospitalier Lyon sud
Lyon, France
GHT des Landes
Mont-de-Marsan, France
CHU saint Eloi
Montpellier, France
Hôpital E. MULLER
Mulhouse, France
Hôpitaux de Brabois - CHRU de Nancy
Nancy, France
CHRU Nantes
Nantes, France
Hopital Archet 1
Nice, France
Hopital Cochin
Paris, France
Hopital Saint Antoine
Paris, France
Hôpital Necker Enfants Malades
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
CHU Poitiers
Poitiers, France
CH René Dubos
Pontoise, France
CHU de Reims
Reims, France
Chu Pontchaillou
Rennes, France
CH Roubaix
Roubaix, France
Centre Henri Becquerel
Rouen, France
Centre Hospitalier Yves Le Foll
Saint-Brieuc, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest, France
Centre Hospitalier
Saint-Quentin, France
ICANS
Strasbourg, France
CH Tarbes
Tarbes, France
CHU Toulouse
Toulouse, France
CHRU Bretonneau
Tours, France
CH de valenciennes
Valenciennes, France
CH Bretagne Atlantique Vannes et Auray-P.Chubert
Vannes, France
CHV André Mignot
Versailles, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hervé Avet Loiseau, PU-PH
Intergroupe Francophone du Myelome
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2020
First Posted
March 18, 2021
Study Start
December 16, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
October 19, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share