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A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
Sponsor: Takeda
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).
Official 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 AntigenxCD3-Directed Bispecific Antibody Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
183
Start Date
2026-01-14
Completion Date
2028-09-11
Last Updated
2026-08-07
Healthy Volunteers
No
Interventions
IGI, 10%
IGI, 10% IV infusion.
Locations (48)
Infirmary Health - Diagnostic & Medical Clinic (DMC)
Mobile, Alabama, United States
Chao Family Comprehensive Cancer Center UCI
Orange, California, United States
University of Kansas
Westwood, Kansas, United States
University of Maryland | Greenebaum Cancer Center
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
New York Oncology Hematology
Albany, New York, United States
St George Private Hospital
Kogarah, New South Wales, Australia
Townsville Hospital
Douglas, Queensland, Australia
Western Health - Sunshine Hospital
St Albans, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
St Vincents Hospital Melbourne
Melbourne, Australia
A O Krankenhaus der Elisabethinen
Linz, Austria
Universitaetsklinikum St. Poelten
Sankt Pölten, Austria
Krankenhaus der Barmherzigen Schwestern Wien
Vienna, Austria
Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation
Porto Alegre, Brazil
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
São Paulo, Brazil
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika
Ostrava, Czechia
Aalborg Hospital
Aalborg, Denmark
Aarhus Universitetshospital
Aarhus, Denmark
Copenhagen University Hospital
Copenhagen, Denmark
Odense Universitetshospital
Odense, Denmark
Alexandra General Hospital of Athens
Athens, Greece
University General Hospital of Ioannina
Ioannina, Greece
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, Hungary
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco
Catania, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Italy
Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo
Pescara, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, Italy
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
Torrette, Italy
Amsterdam University Medical Center (Amsterdam UMC)
Amsterdam, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Uniwersyteckie Centrum Kliniczne - Ul. Smoluchowskiego 17
Gdansk, Poland
Aidport sp. z o.o.
Skorzewo, Poland
Colentina Clinical Hospital
Bucharest, Romania
Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Costa Del Sol
Marbella, Spain
Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD)
Palma de Mallorca, Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Royal Devon And Exeter Hospital
Exeter, Devon, United Kingdom
Gloucestershire Royal Hospital
Gloucester, Gloucestershire, United Kingdom
Cardiff & Vale University Health Board
Cardiff, South Glamorgan, United Kingdom
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes, United Kingdom
County Hospital (Stafford Hospital)
Stafford, United Kingdom