A Phase 4 interventional study of Biological samples in Kidney Transplant, Myeloma and Cancer, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Centre Hospitalier Régional d'Orléans · Phase 4, Interventional, and Other
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Among 47 studies in Neoplasms, Plasma Cell with a site in France — 7 open to participants now, 10 under way, 2 of them phase 3. Neoplasms, Plasma Cell · France.
Among the 47 studies in Neoplasms, Plasma Cell with a site in France, this one is the 13th largest by enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2021, is the only one in phase 4, and was the 37th registered.
710 studies on the registry are indexed under Neoplasms, Plasma Cell; 79 are open to participants now.
Browse Neoplasms, Plasma Cell studies →7 of the 47 studies in Neoplasms, Plasma Cell with a site in France are open now. Recruiting first, the newest first:
University Hospital, Angers · Sites in France
Ages 18+ · Healthy volunteers
Pfizer · Sites in France, United States, Argentina and 24 more countries
Ages 18+
K36 Therapeutics, Inc. · Sites in France, United States, Canada and 1 more country
Ages 18+
University Hospital, Clermont-Ferrand · Sites in France
Ages 18+
Nantes University Hospital · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 58 Neoplasms, Plasma Cell studies recruiting now, 34 (59%) set no upper age limit and 12 (21%) stop at 75 or younger; 4 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 12 · Phase 3 12 · Phase 4 1
First in 1997; this study’s year is marked. 4 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 196 is above the median of 40 across 527 interventional studies indexed under Neoplasms, Plasma Cell.
Median enrollment 120 across the 37 interventional studies, 137 across the 10 observational. Of the 30 that completed or were terminated, 5 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 47 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Régional d'Orléans is the lead sponsor of 132 studies on the registry; 32 are open to participants now.
Centre Hospitalier Régional d'Orléans has 1 study filed under Neoplasms, Plasma Cell — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 47 studies in Neoplasms, Plasma Cell with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons, in comparison to healthy subject. Secondary objectives are to evaluate the humoral response in the nasal mucosa, and the capacity of antibodies to neutralize emerging variants of concerns and to prevent COVID-19.
The serious, even fatal, forms of COVID-19 preferentially affect elderly and fragile subjects. Among these populations at risk, people who are immunocompromised (either by a disease and / or its treatment) have a theoretical risk of responding less well to a preventive vaccination.
The main objective of this study aims to compare the vaccine response of immunocompromised people with healthy subjects (non-immunocompromised), i.e. to assess the serum humoral response (titre and neutralizing capacity of the antibodies induced) following vaccination with ComirnatyTM (i.e. BNT162b2, an anti-SARS-CoV-2 vaccine from Pfizer BioNTech) in immunocompromised persons in comparison to healthy subjects (non-immunocompromised).
Secondary objectives are as follows:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult volunteers to be vaccinated with the ComirnatyTM vaccine and to participate in the study, belonging to one of the following groups:
Group of (15 participants per immunosuppression subgroup):
Group of non-immunocompromised subjects (controls, n = 75)
Exclusion Criteria:
Note: a history of COVID-19 (> at 3 months) is not a contraindication to vaccination and is therefore not a criterion for non-inclusion in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunocompromised subjects and healthy subjects groups will have collection of biological samples (blood with/without nasopharyngeal swabs) at Month-0, -1, -2, -3, -6, with associated data for the study of the kinetics of antibodies anti COVID-19. Biological samples : * Serum and plasma from each participant for the purpose of performing the SARS-CoV-2 serologic tests * Nasopharyngeal samples (not mandatory) Associated data : * Demographic data * Description of clinical manifestations related to vaccination * Description of clinical manifestations related to SARS-CoV-2 infection, if any Blood Fractioning * Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C)
Biological: Biological samples
Immunocompromised subjects and healthy subjects groups will have collection of biological samples (blood with/without nasopharyngeal swabs) at Month-0, -1, -2, -3, -6, with associated data for the study of the kinetics of antibodies anti COVID-19. Biological samples : * Serum and plasma from each participant for the purpose of performing the SARS-CoV-2 serologic tests * Nasopharyngeal samples (not mandatory) Associated data : * Demographic data * Description of clinical manifestations related to vaccination * Description of clinical manifestations related to SARS-CoV-2 infection, if any Blood Fractioning * Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C)
Protective humoral response after vaccination
Proportion of immunocompromised persons with neutralizing activity against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Time frame: Month 2
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Time frame: Month 0
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 one month after the second dose of the vaccine, compared to the proportion obtained in healthy subjects.
Time frame: Month 1
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Time frame: Month 2
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Time frame: Month 3
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Time frame: Month 6
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Time frame: Month 0
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Time frame: Month 1
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Time frame: Month 2
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Time frame: Month 3
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Time frame: Month 6
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Time frame: Month 0
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Time frame: Month 1
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Time frame: Month 2
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Time frame: Month 3
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Time frame: Month 6
Plan to share: No
Ran from Mar 2021 to primary completion in Feb 2022, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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