The main goal of this study is to show that people with certain immune problems (from Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma) get fewer serious infections when they receive Gamunex C through an IV once every 4 weeks, along with their usual medical care, for one year. All participants will receive Gamunex-C 500 mg/kg once every 4 weeks (total 13 doses) starting Day 1 (Week 1) through Week 48 (end of Treatment Phase).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Sterile solution
Study Site 102
St. Petersburg, Florida, United States
NOT_YET_RECRUITINGStudy Site 101
Fort Wayne, Indiana, United States
RECRUITINGStudy Site 105
Westbrook, Maine, United States
NOT_YET_RECRUITINGStudy Site 104
Columbus, Ohio, United States
NOT_YET_RECRUITINGStudy Site 103
Tacoma, Washington, United States
NOT_YET_RECRUITINGserious bacterial infection (SBI) rate per-participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first
Time to first onset of SBI
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first
Time to first onset of severe bacterial infection
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Proportion of participants who experience at least one severe bacterial infection.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of severe bacterial infections per participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of all bacterial infections per participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Time to first onset of non-severe bacterial infection.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The proportion of participants who experience at least one bacterial infection.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of infections of any kind (bacterial/viral/fungal, irrespective of severity or seriousness) per participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Time to first onset of any kind of infection (bacterial/viral/fungal).
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The proportion of participants who experience a validated infection
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of validated (as defined above) infections per participant per year
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Number of days on prophylactic antibiotics (including oral, parenteral, oral plus parenteral).
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The number of days on prophylactic antibiotics per participant per year
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Number of days on therapeutic antibiotics (including oral, parenteral, oral plus parenteral).
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The number of days on therapeutic antibiotics per participant per year
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Number of hospitalizations due to any infections
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Total duration of hospitalizations due to any infections
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
The rate of hospitalizations per participant per year due to any infections.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
Rate of infections requiring IV administration of an antibiotic or antiviral/anti infective per-participant per year.
Time frame: During treatment (1year) and up to 28 days after the last dose of study treatment or until the intake of any IgRT, other than Gamunex-C, whichever occurs first.
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