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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-25

Study Completion Date

2019-11-22

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.

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Detailed Description

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Conditions

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Secondary Immune Deficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Gammanorm

Patients on Gammanorm per standard of care

Gammanorm

Intervention Type DRUG

Gammanorm given per standard of care

Other Subcutaneous Immunoglobulin

Patients on subcutaneous immunoglobulin treatments other than Gammanorm

Other Subcutaneous Immunoglobulins

Intervention Type DRUG

Other Subcutaneous Immunoglobulins given per standard of care

Interventions

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Gammanorm

Gammanorm given per standard of care

Intervention Type DRUG

Other Subcutaneous Immunoglobulins

Other Subcutaneous Immunoglobulins given per standard of care

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections.
2. 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).
3. Patient having received all the necessary information about the study and signed an informed consent document.

Exclusion Criteria

1. Patient having initiated an IgSC treatment.
2. Patient having received IgSC or IgIV treatment within 6 months prior to inclusion.
3. Incapacity/Inability to attend the follow-up visits.
4. Patient refusing to participate in the study.
5. HIV positive patients.
6. Incapacity to understand the study objective and process, to agree or to give informed consent to participate in the study.
7. Pregnant or breast-feeding women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No