Study of Gamunex-C with Standard Treatment to Prevent Infections in Adults with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the use of Gamunex-C, an intravenous immunoglobulin treatment, in people with certain immune problems caused by Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma. The study aims to show that these participants experience fewer serious infections when they receive Gamunex-C along with their usual medical care. This is an open-label, single-arm clinical trial sponsored by Grifols Biologicals, LLC, focusing on safety, effectiveness, and how the drug moves through the body. Participants receive Gamunex-C at a dose of 500 mgkg through an IV every 4 weeks, totaling 13 doses over one year. The treatment phase starts on Day 1 Week 1 and continues through Week 48. There are no placebo or comparison groups since all participants get the study treatment in addition to their standard care. During the study, participants will be monitored for serious bacterial infections and other types of infections while receiving treatment and for 28 days after the last dose, or until they start any other immunoglobulin replacement therapy. Researchers will track infection rates, time to infection onset, hospitalizations due to infections, and antibiotic use. The total duration of participation is about one year, including treatment and follow-up for safety and effectiveness.

A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma