A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
Summary
The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.
Arms & interventions
- DrugXembify
SC infusion pump
- DrugPlacebo
SC infusion pump
Outcome measures
Primary
Annual Rate of Major Bacterial Infections per Year
Time frame: Up to Week 51
Secondary
Time to First Onset of Major Bacterial Infection
Time frame: Up to Week 51
Percentage of Participants who Experience Major Bacterial Infections
Time frame: Up to Week 51
Rate of all Bacterial Infections Determined by the Investigator
Time frame: Up to Week 51
Percentage of Participants who Experience Bacterial Infections
Time frame: Up to Week 51
Time to First Onset of Non-Major Bacterial Infections
Time frame: Up to Week 51
Number of Days on Which Participants Were on Antibiotics
Time frame: Up to Week 51
Number of Hospitalizations due to any Infections
Time frame: Up to Week 51
Duration of Hospitalizations due to any Infections
Time frame: Up to Week 51
Number of Hospitalizations due to Major Bacterial Infections
Time frame: Up to Week 51
Duration of Hospitalizations due to Major Bacterial Infections
Time frame: Up to Week 51
Rate of all Infections as Determined by the Investigator
Time frame: Up to Week 51
Number of Participants with Validated Infections
Time frame: Up to Week 51
Time to First Onset of any Infection
Time frame: Up to Week 51
Eligibility criteria
Study locations (7)
GC2202 Study Site 115
Huntington Park, California, 90255
GC2202 Study Site 103
St. Petersburg, Florida, 33701
GC2202 Study Site 111
Bethesda, Maryland, 20889
GC2202 Study Site 109
Greenville, North Carolina, 27843
GC2202 Decentralized Study Site 114
Morrisville, North Carolina, 27560
GC2202 Study Site 105
Canton, Ohio, 44718
GC2202 Study Site 110
Rockville, South Carolina, 29732