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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gammanorm | Patients on Gammanorm per standard of care |
| |
| Other Subcutaneous Immunoglobulin | Patients on subcutaneous immunoglobulin treatments other than Gammanorm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gammanorm | Drug | Gammanorm given per standard of care |
| |
| Other Subcutaneous Immunoglobulins |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in immune system | To analyze the change in the immune system (CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells) | 12 months |
| IgG levels | To analyze the IgG levels with respect to the IgSC treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Every eligible patient for the selection criteria will be consecutively included in the study to avoid any selection bias.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH William Morey Chalon-sur-Saône | Chalon-sur-Saône | 71100 | France | |||
| CHD Vendée |
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| Drug |
Other Subcutaneous Immunoglobulins given per standard of care |
|
| 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). | 12 months |
| IgSC treatment | To characterize the IgSC treatment duration and the patient management (observance, duration and reason of termination) | 12 months |
| Bacterial Infections | To evaluate the severe and non-severe bacterial infection rates | 12 months |
| Antibiotic Consumption | To evaluate the antibiotics consumption during the study | 12 months |
| Hospitalizations due to infections | Evaluate the hospitalization rates due to infections | 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 | 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 | 12 months |
| La Roche-sur-Yon |
| 85000 |
| France |
| CH la Rochelle - Hôpital Saint Louis | La Rochelle | 17000 | France |
| CH Orléans | Orléans | 45100 | France |
| CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque | Pessac | 33604 | France |
| CH Saint Malo | St-Malo | 35400 | France |