Study on the Effectiveness and Safety of Gamunex for Patients with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma
Sponsor: Grifols Biologicals, LLC
ClinicalTrials ID:NCT07582432
This clinical trial is testing whether Gamunex, given through an IV every four weeks, can help reduce serious infections in patients with certain blood cancers, alongside their regular treatment for one year.
Patient Parameters
| Parameter | Options |
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Program Overview
The main aim of this study is to see if Gamunex, when given through an IV every four weeks, can help people with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma have fewer serious infections. Participants will receive Gamunex-C at a dose of 500 mg/kg once every four weeks for a total of 13 doses over the course of one year, starting from the first week of the study.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of one of the following:
- B-cell Chronic Lymphocytic Leukemia (CLL) at intermediate or high stages.
- Multiple Myeloma (MM) at stage II or III.
- B-cell Non-Hodgkin Lymphoma (NHL) at stage III or higher.
- Have low levels of a specific antibody (IgG) in the blood.
Exclusion Criteria
- Have had a stem cell transplant in the last 6 months.
- Currently receiving or have recently received immunoglobulin replacement therapy.
- Have active infections or other cancers at the time of screening.
- Have a known primary immune deficiency.
- Have a life expectancy of less than 1.5 years.
- Have significant health issues that could interfere with the study.
- Have had serious reactions to immunoglobulin or blood products.
- Have a specific type of antibody deficiency (Selective IgA Deficiency).
- Women who are pregnant, breastfeeding, or not using effective birth control.
- Have severe kidney disease or high liver enzyme levels.
- Have a history of blood clots or certain heart conditions.
- Have conditions that affect blood thickness or clotting.
- Have active hepatitis B or C infections.
- Have uncontrolled high blood pressure or a high heart rate.
- Have a history of substance abuse.
- Have participated in another clinical trial recently.
- Are unable or unwilling to follow the study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Study Site 102 | 33709 | St. Petersburg | Florida |
| Study Site 101 | 46894 | Fort Wayne | Indiana |
| Study Site 105 | 04092 | Westbrook | Maine |
| Study Site 104 | 43210 | Columbus | Ohio |
| Study Site 103 | 98405 | Tacoma | Washington |
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