Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Patient care and follow up will be performed according to the current clinical practice and the recommendations of HAS.
Study Type
OBSERVATIONAL
Enrollment
102
Gammanorm given per standard of care
Other Subcutaneous Immunoglobulins given per standard of care
CH William Morey Chalon-sur-Saône
Chalon-sur-Saône, France
CHD Vendée
La Roche-sur-Yon, France
CH la Rochelle - Hôpital Saint Louis
La Rochelle, France
CH Orléans
Orléans, France
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment collected as biological data including immunoglobulins (quantitative dosage and electrophoresis), lymphocytes, CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells
Time frame: 12 months
Change in immune system
To analyze the change in the immune system (CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells)
Time frame: 12 months
IgG levels
To analyze the IgG levels with respect to the IgSC treatment
Time frame: 12 months
Lymphocytic Repertoire analyzing the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).
To analyze the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).
Time frame: 12 months
IgSC treatment
To characterize the IgSC treatment duration and the patient management (observance, duration and reason of termination)
Time frame: 12 months
Bacterial Infections
To evaluate the severe and non-severe bacterial infection rates
Time frame: 12 months
Antibiotic Consumption
To evaluate the antibiotics consumption during the study
Time frame: 12 months
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CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque
Pessac, France
CH Saint Malo
St-Malo, France
Hospitalizations due to infections
Evaluate the hospitalization rates due to infections
Time frame: 12 months
Safety of IgSCs to characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment
To characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment
Time frame: 12 months
Predictive Factors of Recurrent Infections
To characterize potential predictive factors or markers of recurrent infections despite of the Ig treatment by collecting information about infections at follow up visits, especially bacterial infections and their respective antibiotherapy
Time frame: 12 months