Actively Recruiting
Study of Gammagard Liquid Immune Globulin Infusion, 10 to Prevent Infections in Adults With Multiple Myeloma Receiving BCMAxCD3-Directed Bispecific Antibody Therapy
Led by Takeda · Updated on 2026-05-18
183
Participants Needed
28
Research Sites
N/A
Total Duration
On this page
Sponsors
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Takeda
Lead Sponsor
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Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well Immune Globulin Infusion human, 10 IGI, 10 can prevent infections in adults with multiple myeloma who are receiving B-cell maturation antigen BCMA x cluster of differentiation 3 CD3 directed bispecific antibody therapy. This phase 3 study aims to compare primary infection prevention using IGI, 10 for 12 months with secondary prevention where IGI, 10 is given only after a serious infection occurs. Multiple myeloma is a cancer of the plasma cells in the bone marrow, and infections can be a serious complication during treatment. Participants will be randomly assigned to one of two groups. The primary infection prevention group will receive a 400 mgkg dose of IGI, 10 intravenously every 3 or 4 weeks for 12 months starting within 3 days after randomization. The secondary infection prevention group will receive the same dose and schedule of IGI, 10 only if they develop a serious infection during the 12-month study period. Treatment visits will occur 15 times with a 4-week dosing interval or 19 times with a 3-week dosing interval. During the study, participants will attend up to 19 visits depending on dosing schedule, including a screening period of up to 8 weeks. Researchers will monitor the time to the first serious infection as the primary outcome and track various infection rates, antibiotic use, immune antibody levels, adverse events, hospitalizations, and healthcare visits related to infections. Total participation can last up to 14 months, including screening and treatment. Safety and tolerability of the infusion will also be assessed throughout the study.
CONDITIONS
Brief Title
A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with multiple myeloma according to International Myeloma Working Group guidelines
- Started teclistamab treatment within the first 8 weeks of planned therapy
- Provide written informed consent before any study procedures
- At least 18 years old at consent
- If of childbearing potential, agree to use effective contraception and avoid donating ova from screening until 30 days after last study drug dose
You will not qualify if you...
- Have not achieved at least minimal response to teclistamab within 8 weeks before screening
- Current serious infection or more than one serious infection in past 3 months
- Polyclonal IgG level less than 150 mg/dL before teclistamab start
- Receiving or received immunoglobulin products within 16 weeks before screening
- Received hyperimmune or specialty high-titer immunoglobulin products within 30 days before screening
- Received live viral vaccines within 30 days before screening
- Eastern Cooperative Oncology Group performance status score greater than 2
- Active infection requiring anti-infective treatment within 1 week before enrollment
- Received other BCMAxCD3 bispecific antibody therapy before screening
- Undergoing or scheduled for plasmapheresis during study or within 16 weeks before screening
- At high risk for symptomatic hyperviscosity syndrome
- Major surgery scheduled during study or not fully recovered from recent major surgery
- Active secondary malignancy or medical condition with life expectancy less than 2 years
- History of severe reactions to intravenous immunoglobulin or immune serum globulin
- History or recent thromboembolic events within 6 months before screening
- Moderate to severe renal dysfunction with eGFR ≤ 30 mL/min/1.73 m²
- Positive for hepatitis B surface antigen, hepatitis C PCR, or HIV PCR unless cured hepatitis C
- Primary immunodeficiency requiring IgG replacement
- Persistently elevated liver enzymes >3 times upper limit of normal
- IgA deficiency with antibodies and history of hypersensitivity to IVIG
- Known hypersensitivity to IGI, 10% excipients
- Known substance abuse within 12 months except cannabinoids
- Anemia precluding blood draws
- Medical or physical conditions interfering with study or causing undue risk
- Receiving immunosuppressive treatment other than for multiple myeloma or corticosteroids
- Unable or unwilling to comply with protocol
- Participation in another investigational study within 30 days before screening
- Family member or employee of investigator or site staff
- Pregnant, lactating, or positive pregnancy test at screening or enrollment
Research Team
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Takeda Contact
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