An Open-label, Multi-Center, Single-arm Prospective Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex®-C plus Standard Medical Treatment to Prevent Infections in Participants with Secondary Antibody Deficiency Associated with Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma (Sigma).
Some blood cancers—such as chronic lymphocytic leukaemia, multiple myeloma, and non-Hodgkin lymphoma—can weaken your immune system. They do this by lowering your body's levels of antibodies, which are proteins that fight off illness. This problem is known as secondary antibody deficiency, and it makes people prone to frequent and severe bacterial infections. This Phase 3 trial is testing a medicine called Gamunex-C. Gamunex-C provides healthy antibodies collected from blood donors directly into your bloodstream through a drip. Doctors want to see whether adding Gamunex-C to regular cancer care can lower the number of serious infections participants get, reduce their need for antibiotics, and prevent hospital stays. Because this is an open-label trial, all participants will receive the study treatment alongside their usual standard care. Doctors will closely track health, infections, and safety throughout.
At a glance
What is this study about?
When you have a blood cancer like chronic lymphocytic leukaemia, multiple myeloma, or non-Hodgkin lymphoma, both the condition itself and the treatments used to manage it can damage your immune system. In particular, your body may stop making enough antibodies. Antibodies are vital protective proteins that find and destroy bacteria and viruses. Without enough of them, even everyday germs can lead to severe chest infections, blood poisoning, or other dangerous illnesses.
Gamunex-C is an antibody therapy made from healthy donor plasma. It is designed to act like an extra shield for your immune system by replacing the missing antibodies. This trial, known as the Sigma study, is exploring whether regular infusions of Gamunex-C can safely protect patients from serious bacterial infections when added to their regular cancer treatment.
Researchers are measuring how often participants develop severe infections, how many days they need antibiotics, and whether they need treatment in hospital. They are also checking how the body processes the medicine to find the most effective and safe approach for people living with weakened immune systems.
Key takeaways
- Tests Gamunex-C antibody drips to prevent serious bacterial infections.
- Open to adults with CLL, multiple myeloma, or non-Hodgkin lymphoma and low antibody levels.
- All participants receive the study medicine alongside their usual cancer care.
- The main goal is reducing infection rates, antibiotic use, and hospital stays.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with chronic lymphocytic leukaemia, multiple myeloma, or non-Hodgkin lymphoma. To be considered, participants must also have secondary antibody deficiency, meaning their blood tests show low levels of protective antibodies and they are at higher risk of catching infections.
Both men and women can join. However, this study may not be suitable for people who have had severe allergic reactions to antibody products in the past, or those with specific medical complications that make immunoglobulin infusions unsafe. The trial team will carry out detailed health checks to make sure taking part is appropriate and safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with chronic lymphocytic leukaemia, multiple myeloma, or non-Hodgkin lymphoma.
- My doctor has told me I have low antibody levels (secondary antibody deficiency).
- I get frequent infections or have been told I am at high risk of them.
- I am willing and able to attend regular hospital appointments for infusions and tests.
What does participation involve?
If you take part, you will receive Gamunex-C as an infusion (a slow drip into a vein) at regular clinic visits. These appointments will take place at a hospital or specialist clinic alongside your standard cancer care. During each visit, the medical team will check your temperature, blood pressure, and general health, and you will have routine blood tests to measure your antibody levels.
You will be asked to keep a simple record of any symptoms, infections, or antibiotic medicines you take between visits. The study team will monitor your progress closely throughout the treatment period. The overall length of your participation will be explained by the study doctor, and you can ask questions at every stage.
Potential risks and benefits
Locations (5)
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedCzechia
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
Will I receive a dummy drug (placebo)?
No. This is an open-label, single-arm trial, which means every person who joins will receive the actual study medicine, Gamunex-C.
How is the medicine given?
Gamunex-C is given as a liquid infusion through a small needle or tube into a vein, usually in your arm.
Do I have to stop my current cancer treatment?
No. Gamunex-C is given alongside your standard medical treatment, not instead of it.
How will the doctors know if the treatment is working?
They will track the number and severity of any infections you experience, check your blood antibody levels, and record how often you need antibiotics.
What happens if I change my mind during the study?
You can leave the study at any point without giving a reason. Your doctors will continue to provide your normal care and treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.