Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805203
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone du Myelome

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Covid19 Other: blood sample analyses Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805203


Contacts
Layout table for location contacts
Contact: amandine huguet 0531156338 ext +33 a.huguet@myelome.fr
Contact: Chanaz Louni c.louni@myelome.fr

Locations
Show Show 55 study locations
Sponsors and Collaborators
Intergroupe Francophone du Myelome
Investigators
Layout table for investigator information
Principal Investigator: Hervé Avet Loiseau, PU-PH Intergroupe Francophone du Myelome
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Intergroupe Francophone du Myelome
ClinicalTrials.gov Identifier: NCT04805203    
Other Study ID Numbers: IFM 2020-08
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intergroupe Francophone du Myelome:
Multiple Myeloma
Covid19
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Multiple Myeloma
Neoplasms, Plasma Cell
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases