Actively Recruiting
A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
Led by Grifols Biologicals, LLC · Updated on 2026-05-12
49
Participants Needed
5
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with B-cell Chronic Lymphocytic Leukemia (CLL) with intermediate or high Rai stage
- Diagnosed with Multiple Myeloma (MM) at International Staging System stage II or III
- Diagnosed with B-cell Non-Hodgkin Lymphoma (NHL) at Stage III or higher
- Documented low IgG levels below 5 g/L at screening
You will not qualify if you...
- Received allogeneic stem cell transplant within 6 months before screening
- Currently receiving or have received immunoglobulin replacement therapy within 6 months before screening
- Have any active infections or active secondary malignancies at screening
- Diagnosed with primary immunodeficiency (PID)
- Life expectancy less than 1.5 years
- Significant acute or chronic diseases that may interfere with study completion
- History of serious treatment-related adverse reactions to immunoglobulin or anaphylaxis to blood products
- Known selective IgA deficiency
- Pregnant, breastfeeding, or unwilling to use effective contraception if of childbearing potential
- Severe kidney disease with eGFR below 30 mL/min/1.73 m2
- Liver enzyme levels greater than 3 times normal at screening
- History of thromboembolic events within last year or multiple lifetime episodes
- Known hyperviscosity syndrome or hypercoagulable state
- Signs or symptoms of hepatitis B or C infection
- Uncontrolled high blood pressure or heart rate over 100 bpm
- Substance or prescription drug abuse within 12 months before screening
- Participation in another clinical trial within 30 days before screening (except certain observational or interventional studies)
- Unwillingness or inability to comply with study protocol
- Investigator judgment of likely non-compliance or medical risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Study Site 102
St. Petersburg, Florida, United States, 33709
Not Yet Recruiting
2
Study Site 101
Fort Wayne, Indiana, United States, 46894
Actively Recruiting
3
Study Site 105
Westbrook, Maine, United States, 04092
Not Yet Recruiting
4
Study Site 104
Columbus, Ohio, United States, 43210
Not Yet Recruiting
5
Study Site 103
Tacoma, Washington, United States, 98405
Not Yet Recruiting
Research Team
J
Judith Wessels-Kranz
CONTACT
M
Marina Acosta Enslen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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