The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.

Conditions
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Secondary Immune Deficiency

Intervention / Treatment
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* Drug: Gammanorm
* Drug: Other Subcutaneous Immunoglobulins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections. Patients with indication for IgSC treatment but who have not started the treatment yet. Prior IgSC or IgIV treatment 6 months before inclusion is accepted (with a washout period of 6 months minimum). Patient having received all the necessary information about the study and signed an informed consent document. Exclusion Criteria: Patient having initiated an IgSC treatment. Patient having received IgSC or IgIV treatment within 6 months prior to inclusion. Incapacity/Inability to attend the follow-up visits. Patient refusing to participate in the study. HIV positive patients. Incapacity to understand the study objective and process, to agree or to give informed consent to participate in the study. Pregnant or breast-feeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gammanorm<br>Patients on Gammanorm per standard of care | Drug: Gammanorm<br>* Gammanorm given per standard of care<br>|
| Other Subcutaneous Immunoglobulin<br>Patients on subcutaneous immunoglobulin treatments other than Gammanorm | Drug: Other Subcutaneous Immunoglobulins<br>* Other Subcutaneous Immunoglobulins given per standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |