OncoMatch/Clinical Trials/NCT06980480
A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
Is NCT06980480 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies IGI, 10% for multiple myeloma.
Treatment: IGI, 10% — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: bispecific antibody (teclistamab) — recently started (within first 8 weeks of planned schedule), planned to continue for next 12 months
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
Cannot have received: immunoglobulin products
currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening
Cannot have received: hyperimmune or specialty high-titer immunoglobulin product (cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin)
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
Cannot have received: live viral vaccine
received live viral vaccines within 30 days before screening
Cannot have received: BCMA/CD3-directed bispecific antibody
received other B Cell Maturation Antigen (BCMA)*Cluster of Differentiation (CD3)-directed Bispecific Antibody therapy any time before screening
Cannot have received: plasmapheresis
scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening
Cannot have received: investigational product/device
participated or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device within 30 days before screening and during the course of the study
Lab requirements
Kidney function
moderate to severe renal dysfunction based on an estimated glomerular filtration rate <= 30 mL/min/1.73 m^2
Liver function
persistent serum aspartate aminotransferase and alanine aminotransferase >3.0 times the upper limit of normal at screening (may be repeated once to determine if it is persistent)
persistent serum aspartate aminotransferase and alanine aminotransferase >3.0 times the upper limit of normal at screening; moderate to severe renal dysfunction based on an estimated glomerular filtration rate <= 30 mL/min/1.73 m^2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Infirmary Health - Diagnostic & Medical Clinic (DMC) · Mobile, Alabama
- Chao Family Comprehensive Cancer Center UCI · Orange, California
- University of Kansas · Westwood, Kansas
- University of Maryland | Greenebaum Cancer Center · Baltimore, Maryland
- Henry Ford Health System · Detroit, Michigan
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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