Gamunex-C for Cancer
(SIGMA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Gamunex-C, an immune globulin therapy administered intravenously every four weeks, can help individuals with certain cancer-related immune issues avoid serious infections. It targets those with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma. Suitable candidates have low IgG levels and one of these conditions. Participants will receive the treatment alongside their usual medical care for one year. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that Gamunex-C is likely to be safe for humans?
Research has shown that Gamunex-C is generally well-tolerated by patients. One study found the average number of side effects per treatment was 0.33, indicating that most people do not experience many issues. However, some serious side effects have been reported. For instance, there is a risk of kidney damage, especially when combined with certain other medications. Blood clots have occurred in up to 15% of patients using similar treatments. These factors are important for anyone considering participation in a trial with Gamunex-C.12345
Why do researchers think this study treatment might be promising?
Gamunex-C is unique because it is derived from human plasma and is administered via intravenous infusion every four weeks. Unlike traditional cancer treatments that might involve chemotherapy or targeted therapies, Gamunex-C offers a novel approach by utilizing immunoglobulins to potentially modulate the immune system. Researchers are excited about this treatment because it may offer a different mechanism of action that could enhance the body's ability to fight cancer, potentially leading to improved outcomes for patients.
What evidence suggests that Gamunex-C might be an effective treatment for reducing serious infections in cancer patients?
Studies have shown that Gamunex-C, an antibody treatment administered through an IV, can enhance the immune system in patients with certain conditions. This treatment has significantly improved muscle strength and is used to manage various immune system disorders. For patients with multiple myeloma, research found that treatments like Gamunex-C led to better response rates and longer-lasting effects compared to standard care. Additionally, Gamunex-C has effectively managed nerve and muscle issues in cancer patients. These findings suggest that Gamunex-C may help reduce serious infections in people with immune problems related to certain cancers. Participants in this trial will receive Gamunex-C via IV every four weeks to evaluate its effectiveness in cancer-related immune issues.56789
Are You a Good Fit for This Trial?
This trial is for adults with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma who have immune system problems. Participants should be able to receive IV treatments and follow the study schedule.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Gamunex-C 500 mg/kg via IV once every 4 weeks for a total of 13 doses over 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gamunex-C
Trial Overview
The study tests if regular infusions of Gamunex-C (an antibody-rich solution) every 4 weeks for a year can reduce serious infections in people with these blood cancers. All participants get the same treatment along with their usual care.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Grifols Biologicals, LLC
Lead Sponsor
Citations
Intravenous immunoglobulin is safe and effective in controlling ...
Intravenous immunoglobulin is safe and effective in controlling pre-existing paraneoplastic neuromuscular diseases in cancer patients treated ...
The Impact of Diagnosis
If you take GAMUNEX-C or a similar immune globulin product intravenously, you could experience serious kidney disease and death. You may have ...
Gamunex-C
Treatment with Gamunex-C resulted in significant improvements in grip strength (both dominant and nondominant hands), Medical Research Council ( ...
Malignancy in neuromuscular patients on chronic IVIG
In the MG group, cancer incidence was 12 / 75 (16%) among IVIG-treated patients compared to 87/350 (25%) in the MG-non-IVIG group (p = 0.09).
Gamunex-C - Clinical Review
In general, the systemic adverse event (AE) rate of SC infusions is lower than that of IG administered IV, without compromising efficacy. 2.
Gamunex-C: Uses, Dosage & Side Effects
Immune globulin can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant ...
Gamunex-C Safety and Utilization Review
This memorandum documents the Food and Drug Administration's (FDA's) complete evaluation, including review of adverse event (AE) reports in passive surveillance ...
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gamunex-c.com
gamunex-c.com/documents/648456/5516391/Gamunex-C+Prescribing+Information.pdf/28391fe7-086f-b112-0bd4-9738108cd159?t=1688982731791highlights of prescribing information
The mean number of adverse reactions per infusion that occurred during or within 72 hours of the end of product infusion was 0.33 for the GAMUNEX-C and 0.39 for ...
Gamunex-C IVIG Infusion: Uses & Side Effects
This solution is a mix of immune globulins (antibodies) used for patients suffering from immunodeficiencies and neurological conditions.
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