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RECRUITING
NCT06980480
PHASE3

A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma

Sponsor: Takeda

View on ClinicalTrials.gov

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 of up to 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

2026-04-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

IGI, 10%

IGI, 10% IV infusion.

Locations (24)

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

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Universitaetsklinikum St. Poelten

Sankt Pölten, Austria

Krankenhaus der Barmherzigen Schwestern Wien

Vienna, Austria

Odense Universitetshospital

Odense, Denmark

Alexandra General Hospital of Athens

Athens, Greece

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, Hungary

Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica

Torrette, Italy

Amsterdam University Medical Center (Amsterdam UMC)

Amsterdam, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Aidport sp. z o.o.

Skorzewo, Poland

Hospital Costa Del Sol

Marbella, Spain

Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD)

Palma de Mallorca, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Gloucestershire Royal Hospital

Gloucester, Gloucestershire, United Kingdom

Cardiff & Vale University Health Board

Cardiff, South Glamorgan, United Kingdom

County Hospital (Stafford Hospital)

Stafford, United Kingdom