Multiple MyelomaCovimmunommNCT04805203
Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma
A study testing blood sample analyses in people with Multiple Myeloma and Covid19, run by Intergroupe Francophone du Myelome at 53 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Multiple Myeloma, Covid19
- What is being tested?
- blood sample analyses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 53 sitesFrance
- Study dates
- 16 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients without multiple myeloma
- Patients without COVID19
- Patients under juridical protection guardianship, or tutelage measure
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
France53 sites
CHU Amiens SUD
Amiens
CHRU Hôpital du Bocage
Angers
Ch Annecy Genevois
Annecy
CH Victor Dupouy
Argenteuil
CH d'ARRAS
Arras
CH Auch
Auch
Centre Hospitalier H.Duffaut
Avignon
CHRU Besançon
Besançon
Centre Hospitalier Simone Veil de Blois
Blois
CHU Bordeaux-hopital haut leveque
Bordeaux
Centre hospitalier Pierre Oudot
Bourgoin
Hôpital A.Morvan
Brest
CHU de Caen
Caen
CH de Cannes
Cannes
Clinique du Parc
Castelnau-le-Lez
Centre Hospitalier William Morey
Chalon-sur-Saône
Centre Hospitalier Métropole de Savoie
Chambéry
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
CHU Henri Mondor
Créteil
CH de Dax côte d'Argent
Dax
CHU François Mitterand
Dijon
CHU grenoble
Grenoble
Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
Grenoble
CH de Lens
Lens
Hopital Claude Huriez-CHRU LILLE
Lille
CHU Limoges
Limoges
Centre Hospitalier Lyon sud
Lyon
GHT des Landes
Mont-de-Marsan
CHU saint Eloi
Montpellier
Hôpital E. MULLER
Mulhouse
Hôpitaux de Brabois - CHRU de Nancy
Nancy
CHRU Nantes
Nantes
Hopital Archet 1
Nice
Hopital Cochin
Paris
Hopital Saint Antoine
Paris
Hôpital Necker Enfants Malades
Paris
Hôpital Pitié-Salpêtrière
Paris
CHU Poitiers
Poitiers
CH René Dubos
Pontoise
CHU de Reims
Reims
Chu Pontchaillou
Rennes
CH Roubaix
Roubaix
Centre Henri Becquerel
Rouen
Centre Hospitalier Yves Le Foll
Saint-Brieuc
Institut de Cancérologie Lucien Neuwirth
Saint-Priest
Centre Hospitalier
Saint-Quentin
ICANS
Strasbourg
CH Tarbes
Tarbes
CHU Toulouse
Toulouse
CHRU Bretonneau
Tours
CH de valenciennes
Valenciennes
CH Bretagne Atlantique Vannes et Auray-P.Chubert
Vannes
CHV André Mignot
Versailles
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma, Covid19
- Being tested
- blood sample analyses
- Keywords
- Multiple Myeloma, Covid19
- Medical subject headings
- Multiple Myeloma, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample analysesOther
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
| Study group | Role | What they receive |
|---|---|---|
| blood samples | Other | 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. Receives: Other: blood sample analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the immune laboratory parameters of Multiple Myeloma patients at the start of infection with COVID-19
gammaglobulin measurements in g/L
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one month following COVID-19 diagnosis
Correlation of patient immune function with death or development of protective immunity
number of death
Measured: up to 6 months following COVID-19 diagnosis
Secondary outcomes (1)
Number of patient with protective immune response
T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies
Measured: before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start16 Dec 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Recruitment delay due to difficulties to involve patient at Covid diagnosis in hematology departments Abandoned study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone du Myelome
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hervé Avet Loiseau, PU-PH, Principal investigator, Intergroupe Francophone du Myelome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805203
- Sponsor's protocol ID
- IFM 2020-08
- Acronym
- Covimmunomm
- Status last verified
- Oct 2023
- First submitted
- 15 Dec 2020
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04805203
- Acronym / sponsor ID
- Covimmunomm / IFM 2020-08
- Conditions
- Multiple Myeloma, Covid19
- Keywords
- Multiple Myeloma, Covid19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment delay due to difficulties to involve patient at Covid diagnosis in hematology departments Abandoned study
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Intergroupe Francophone du MyelomeResearch network
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood samples | Other | Other: blood sample analyses4 blood samples per patient maximum (at diagnosis of covid19, during intensive care if applicable, at revecory of covid 19 and 6 months after recovery. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients without multiple myeloma
- Patients without COVID19
- Patients under juridical protection guardianship, or tutelage measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample analysesmaximum 4 blood samples analyses per patient. At diagnosis of covid 19, in intensif care (if applicable), at covid19 recovery and 6 months after recovery | Other | blood samples |
Primary outcome
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
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
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
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
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
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
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
1 secondary outcome
Number of patient with protective immune response
Time frame: before the reintroduction of MM treatments, and 6 months later to evaluate if those treatments
Results and safety
The study was stopped early (reason given: Recruitment delay due to difficulties to involve patient at Covid diagnosis in hematology departments Abandoned study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé Avet Loiseau, PU-PH principal investigator
Intergroupe Francophone du Myelome
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample analyses in people with Multiple Myeloma and Covid19, run by Intergroupe Francophone du Myelome at 53 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment delay due to difficulties to involve patient at Covid diagnosis in hematology departments Abandoned study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.