An Open-label, Multi-Center, Single-arm Prospective Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex®-C plus Standard Medical Treatment to Prevent Infections in Participants with Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma (Sigma).

Condition studied

Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

SBI rate per-participant per year.

Endpoint detail

Time to first onset of SBI., Time to first onset of severe bacterial infection., Proportion of participants who experience at least one severe bacterial infection., The rate of severe bacterial infections per participant per year, The rate of all bacterial infections per participant per year, Time to first onset of non-severe bacterial infection, The proportion of participants who experience at least one bacterial infection, The rate of infections of any kind (bacterial/viral/fungal, irrespective of severity or seriousness) per participant per year, Time to first onset of any kind of infection (bacterial/viral/fungal)., The proportion of participants who experience a validated infection., The rate of validated (as defined above) infections per participant per year, Number of days on prophylactic antibiotics (including oral, parenteral, oral plus parenteral)., The number of days on prophylactic antibiotics per participant per year, Number of days on therapeutic antibiotics (including oral, parenteral, oral plus parenteral)., The number of days on therapeutic antibiotics per participant per year, Number of hospitalizations and total duration of hospitalizations due to any infections., The rate of hospitalizations per participant per year due to any infections, Rate of infections requiring IV administration of an antibiotic or antiviral/anti-infective per-participant per year.