A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants Wi… (NCT07582432) | Clinical Trial Compass
RecruitingPhase 3
A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
United States49 participantsStarted 2026-04-23
Plain-language 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
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treatment (i.e., prior immune globulin replacement therapy) within 6 months before the Screening Visit.
* Participants with any active infections at the time of Screening Visit. Participants with active secondary malignancies.
* Participants with known PID.
* Participants with a life expectancy less than 1.5 years.
* Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the participant at undue medical risk.
* Participants who have had known serious treatment related adverse events to immunoglobulin or any anaphylactic reaction to blood or any blood-derived prod…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring how often serious bacterial infections happen each year in people with CLL, myeloma, or non-Hodgkin lymphoma who receive Gamunex — given that my specific diagnosis is one of those, how likely am I to benefit from this kind of immune support based on where I am in my treatment?
2Since this is a Phase 3 trial, there should already be some safety data from earlier phases — can you walk me through what is known about the safety profile of Gamunex so I understand what risks I'd be taking on if I enrolled?
3How does participating in this trial compare to receiving standard intravenous immunoglobulin therapy outside of a trial, and is there a reason you'd recommend one path over the other for my situation?
4This trial tracks serious bacterial infection rates over time, which means I'd likely need regular monitoring and follow-up visits — what would that commitment actually look like in my day-to-day life, and is that realistic given my current treatment schedule?
5Are there patients with my specific diagnosis — whether CLL, multiple myeloma, or non-Hodgkin lymphoma — for whom you would NOT recommend looking into this trial, and do any of those reasons apply to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
serious bacterial infection (SBI) rate per-participant per year.
Timeframe: 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