A Multicenter, Randomized, Controlled, Open-Label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Subjects With Multiple Myeloma Receiving B-Cell Maturation Antigen×CD3-Directed Bispecific Antibody Therapy
EudraCT / EU CT No
2024-518420-80-00
Protocol No
TAK-339-3001
Trial information
Medical condition
MM
Trial phase
Phase 3
Sponsor
Takeda
Start date
13/07/2026
Main objective
To compare primary versus secondary infection prophylaxis with intravenous Gammagard Liquid (IGI, 10%) in multiple myeloma patients receiving BCMA×CD3 bispecific antibody therapy, with time to first serious infection as the primary endpoint.
Locations and Contact points
Greece
Site city
Organisation name
Department name
Name
Email
Telephone number
Ioannina
University General Hospital of Ioannina
Department of Hematology, Clinical Studies Office
Eleftheria Hatzimichael
2651099650
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