A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With … (NCT06980480) | Clinical Trial Compass
RecruitingPhase 3
A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
United States, Australia, Austria183 participantsStarted 2026-01-14
Plain-language summary
Multiple myeloma is a cancer of the plasma cells in the bone marrow.
The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of differentiation 3 (CD3) directed bispecific antibody therapy.
Participants will be randomly assigned to one of two groups:
1. Primary infection prevention group: They will receive IGI, 10% for 12 months.
2. Secondary infection prevention group: They will only receive IGI, 10% if they develop a serious infection during the 12 months study period.
During the study, participants will visit their study clinic 15 times (for 4-week dosing interval) or 19 times (for 3-week dosing interval) and their total participation duration will be up to 14 months (including screening period of up to 8 weeks).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment.
. Participant who recently started teclistamab within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.
. The participant or the participant's legally acceptable representative has provided informed consent (that is, in writing, documented via a signed and dated Informed Consent Form \[ICF\]) and any required privacy authorization before the initiation of any study procedures.
. The participant is at least 18 years of age at the time of signing the ICF.
. If a person of childbearing potential engages in sexual relations that carry risk of pregnancy, they agree to the following for the period from screening until 30 days after the last dose of study drug:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial testing Gammagard Liquid specifically to prevent serious infections in multiple myeloma patients with weakened immune systems, could this be relevant for me given my current infection history or immune status?
2The trial's main goal is to measure how long it takes before a first serious infection occurs — what counts as a 'serious infection' in this context, and how does my personal infection risk compare to the kinds of patients this study is designed for?
3Gammagard Liquid is already an approved immune globulin therapy used in other conditions — does that mean more is already known about its safety profile compared to a brand-new experimental drug, and what side effects should I still be aware of?
4Would joining this trial mean I'd be delaying or replacing any standard myeloma treatments I might otherwise receive, or would it run alongside my existing care plan?
5If I'm not a good fit for this trial, are there other standard-of-care options for managing secondary immunodeficiency and infection risk that we should be considering right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The participant has not achieved at least a minimal response to teclistamab within 8 weeks during the screening period.
. The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before screening.
. The participant has a documented polyclonal IgG level less than (\<) 150 milligrams per deciliter (mg/dL) at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site's standard practice.
. The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
. The participant has received a hyperimmune or specialty high-titer immunoglobulin product (example, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening.
. The participant has received live viral vaccines within 30 days before screening.
. The participant has an Eastern Cooperative Oncology Group performance status score of \>2.
. The participant has an active viral or bacterial infection or symptoms/signs of such an infection requiring treatment with anti-infectives within 1 week before enrollment.