A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Particip
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 wi
| Condition(s) | Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | Inclusion Criteria: Participants with documented and confirmed diagnosis of any of the diseases below: * B-cell CLL according to iwCLL criteria and Rai staging of intermediate (1 and 2) or high (3 and 4); or * MM according to the International Myeloma Working Group criteria (IMWG), R ISS stage II or, III; or * Histologically confirmed diagnosis of B-cell NHL, Stage III or above (IV, Progressive/refractory, or recurrent/relapsed stage) according to the Lugano Classification. Participants with HGG with IgG levels \<5g/L at screening. Exclusion Criteria: * Participants with documented history of allogeneic hematopoietic stem cell transplant within 6 months before Screening Visit. * Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement trea |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Grifols Biologicals, LLC |
| Locations | St. Petersburg, Florida, United States; Fort Wayne, Indiana, United States; Westbrook, Maine, United States; Columbus, Ohio, United States; Tacoma, Washington, United States |
| Start date | 2026-04-23 |
| NCT ID | NCT07582432 |
| Official listing | https://clinicaltrials.gov/study/NCT07582432 |