Gammagard Liquid for Primary vs Secondary Infection Prophylaxis in Adults with Multiple Myeloma
Research type
Research Study
Full title
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.
IRAS ID
1011936
Contact name
Filiz Seeborg
Contact email
Sponsor organisation
Takeda Development Center Americas Inc.
Eudract number
2024-518420-80
Clinicaltrials.gov Identifier
Research summary
This is a clinical research study for Intravenous Gammagard Liquid (GGL) (Immune Globulin Infusion, 10%), Study Drug, for patients
with Multiple Myeloma (MM), who are being treated or plan to be treated with teclistamab. GGL provides antibodies to people with a
weakened immune system. Myeloma is a common blood cancer where the immune system is weakened, teclistamab is a licensed drug used to treat myeloma.
This study will include a maximum of 183 people, all 18 years and older. The study will take place in about 65 sites/hospitals in at
least 9 different countries. Participants will complete a screening period of up to 8 weeks, where tests will be done to check it is safe for them to take part and they are eligible.
This is an open-label study. Adults who meet the study rules will be placed into one of two study groups by chance: Treatment Arm 1 for primary prophylaxis or Treatment Arm 2 for secondary prophylaxis. Out of 3 participants, 2 will be placed in Treatment Arm 1 and 1 in Treatment Arm 2. Participants in Treatment Arm 1 will start IGI, 10% treatment immediately. Participants placed in Treatment Arm 2 will start IGI, 10% treatment after they have experienced at least 1 serious infection. Participants can receive IGI, 10% for up to 12 months and will remain in the study for 14 months. During the study, participants will also stay on teclistamab.
The study aims to answer the following questions:
1. To see how well IGI, 10% works for primary infection prevention compared to secondary infection prevention.
2. To check the effect of IGI, 10% treatment on serious infections and other infection-related problems.
3. To check the effect of IGI, 10% treatment on all infections and infection-related problems.
4. To check if IGI, 10% is safe and can be tolerated for preventing infections.
5. To check the effect of IGI, 10% treatment on now often and how long participants must stay in hospital due to infection.REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0458
Date of REC Opinion
12 Aug 2025
REC opinion
Further Information Favourable Opinion