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

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

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 Overview

• Status: Completed
• Conditions: Secondary Immune Deficiency
• Intervention / Treatment: Drug: Gammanorm; Drug: Other Subcutaneous Immunoglobulins

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• France
  • Chalon-sur-Saône, France, 71100
    • CH William Morey Chalon-sur-Saône
  • La Roche-sur-Yon, France, 85000
    • CHD Vendee
  • La Rochelle, France, 17000
    • CH la Rochelle - Hôpital Saint Louis
  • Orléans, France, 45100
    • CH Orleans
  • Pessac, France, 33604
    • CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque
  • Saint-Malo, France, 35400
    • CH Saint Malo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Every eligible patient for the selection criteria will be consecutively included in the study to avoid any selection bias.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gammanorm; Patients on Gammanorm per standard of care	Drug: Gammanorm; Gammanorm given per standard of care
Other Subcutaneous Immunoglobulin; Patients on subcutaneous immunoglobulin treatments other than Gammanorm	Drug: Other Subcutaneous Immunoglobulins; Other Subcutaneous Immunoglobulins given per standard of care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Octapharma

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Immunologic Deficiency Syndromes; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: Optinorm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No