Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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 approximately 8 weeks).
Protocol Amendment History 3 changes
notable Trial sites expanded: 28 -> 42 locations 2026-07-19
notable Trial sites expanded: 24 -> 28 locations 2026-05-19
notable Trial sites expanded: 16 -> 24 locations 2026-04-07
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 2026-07-17