A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
This study is for adults with a type of blood cancer called multiple myeloma. People with multiple myeloma often have a weaker immune system, which can make them more likely to get infections. We are looking at a medicine called Immune Globulin Infusion (IGI, 10%), to see if it can help prevent these infections. Some participants will receive IGI for 12 months, while others will only get it if they develop a serious infection during the study. The study wants to understand how well IGI works to keep people with multiple myeloma healthy and reduce their risk of getting sick from infections. Your participation could help improve care for others.
At a glance
What is this study about?
Multiple myeloma is a type of cancer that affects special white blood cells called plasma cells in the bone marrow. These cells are part of your immune system, which normally helps your body fight off infections. When you have multiple myeloma, these plasma cells don't work properly, and this can make your immune system weaker, leading to a higher risk of getting infections.
This study is looking at a treatment called Immune Globulin Infusion (human), which we'll call IGI. IGI is made from human blood and contains antibodies that can help your immune system fight off germs. The main goal of this study is to see how well IGI can prevent infections in adults who have multiple myeloma and are also receiving another specific cancer treatment.
Participants in this study will be split into two groups by chance. One group will receive IGI for 12 months to help prevent infections from the start. The other group will only receive IGI if they get a serious infection during the 12-month study period. By comparing these two groups, doctors hope to learn if giving IGI regularly can reduce the number and seriousness of infections for people with multiple myeloma.
Key takeaways
- The study tests if a medicine called IGI can prevent infections in people with multiple myeloma.
- Participants will be randomly assigned to receive IGI either regularly or only if they get a serious infection.
- It involves regular clinic visits over a period of up to 14 months.
- The findings could help improve treatments for people with multiple myeloma.
- Your doctor can help determine if this study is right for you.
Who may be eligible?
To be part of this study, you must be an adult aged 18 or over and have a confirmed diagnosis of multiple myeloma following specific medical guidelines. You should have recently started a particular multiple myeloma treatment called teclistamab, within the last 8 weeks, and plan to continue it for the next 12 months. Everyone joining the study must also provide written agreement (informed consent).
There are also some reasons why you might not be able to join. For example, if your multiple myeloma hasn't shown at least a small improvement from your current teclistamab treatment within the first 8 weeks, or if you have a current serious infection. You also won't be able to join if you've already had more than one serious infection in the last three months, or if you've recently received similar blood products or certain vaccines that interact with the study medicine. The study will also check specific blood test results related to your immune system.
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.
- Are you 18 years old or older?
- Do you have a diagnosis of multiple myeloma?
- Have you recently started teclistamab treatment (within the last 8 weeks) and expect to continue it?
- Do you currently have a serious infection, or have you had more than one serious infection in the past 3 months?
- Have you received any similar immune system treatments or certain vaccines recently?
What does participation involve?
If you decide to join this study, your participation will last for up to 14 months, which includes an initial checking period of up to 8 weeks. During the study, you will need to visit the study clinic either 15 times (if you receive the study medicine every 4 weeks) or 19 times (if you receive it every 3 weeks). These visits are important so the study team can monitor your health, give you the study medicine (IGI), and check how you are responding to it. You will also have various tests and assessments during these visits.
Potential risks and benefits
Locations (28)
- Infirmary Health - Diagnostic & Medical Clinic (DMC)Verified postcodeMobile, United States· Recruiting
- Chao Family Comprehensive Cancer Center UCIVerified postcodeOrange, United States· Recruiting
- University of KansasVerified postcodeWestwood, United States· Recruiting
- University of Maryland | Greenebaum Cancer CenterVerified postcodeBaltimore, United States· Recruiting
- Henry Ford Health SystemVerified postcodeDetroit, United States· Recruiting
- Washington University School of MedicineVerified postcodeSt Louis, United States· Recruiting
- New York Oncology HematologyVerified postcodeAlbany, United States· Recruiting
- St George Private HospitalVerified postcodeKogarah, Australia· Recruiting
- Townsville HospitalVerified postcodeDouglas, Australia· Recruiting
- Western Health - Sunshine HospitalVerified postcodeSt Albans, Australia· Recruiting
- Fiona Stanley HospitalVerified postcodeMurdoch, Australia· Recruiting
- A O Krankenhaus der ElisabethinenVerified postcodeLinz, Austria· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects special white blood cells called plasma cells found in your bone marrow.
What is IGI?
IGI stands for Immune Globulin Infusion. It's a medicine made from human blood containing antibodies that help your immune system fight infections.
Why is this study being done?
This study aims to see if IGI can help prevent infections in people with multiple myeloma who are receiving a specific anti-cancer treatment.
Who can join the study?
Adults aged 18 or over with a confirmed diagnosis of multiple myeloma who have recently started a specific treatment (teclistamab) might be able to join.
How long will I be in the study?
Your participation could last up to 14 months, including an initial screening period.
How to find out more
Takeda Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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