IGI, 10%
BiologicalIGI, 10% IV infusion.
Other names: TAK-339, Gammagard Liquid, KIOVIG
NCT Number: NCT06980480
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
St George Private Hospital, Kogarah, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IGI, 10% IV infusion.
Other names: TAK-339, Gammagard Liquid, KIOVIG
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Number of participants with bacterial/viral infection, including covid/fungal infection diagnosed clinically and via microbiology (culture, polymerase chain reaction [PCR], other imaging will be reported.
Time frame: Up to 12 months
Time frame: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
Time frame: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
Time frame: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Within 72 hours of IGI, 10% administration (up to 12 months)
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Time frame: Up to 12 months
Contact information is provided by the study sponsor or research team.
Takeda
Industry
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 AntigenxCD3-Directed Bispecific Antibody Therapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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