RecruitingChronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Grifols Biologicals, LLC
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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 product.
- ✕ Participants who have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral PI which have decreased IgA in addition to decreased IgG requiring IgG replacement).
Where it's recruiting
Source: ClinicalTrials.gov · NCT07582432 · last updated 2026-05-12