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A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma

StatusRecruiting
PhasePhase 3
SponsorTakeda
Started2026-01-14
View on ClinicalTrials.gov ↗
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 approximately 8 weeks).

Amendment history 4 changes detected by DataLookout

2026-08-08
minor
Trial sites expanded: 42 → 48 locations
2026-07-19
minor
Trial sites expanded: 28 → 42 locations
2026-05-19
minor
Trial sites expanded: 24 → 28 locations
2026-04-07
minor
Trial sites expanded: 16 → 24 locations
Trial Details
NCT Number NCT06980480
Lead Sponsor Takeda
Collaborators: Takeda Development Center Americas, Inc., Baxalta Innovations GmbH, now part of Takeda
Conditions Multiple Myeloma, Secondary Immunodeficiency
Enrollment 183 participants
Start Date 2026-01-14
Primary Completion 2028-09-11 (estimated)
Study Completion 2028-09-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-07