Κλινικές Μελέτες

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