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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
183
IGI, 10% IV infusion.
Infirmary Health - Diagnostic & Medical Clinic (DMC)
Mobile, Alabama, United States
RECRUITINGChao Family Comprehensive Cancer Center UCI
Orange, California, United States
RECRUITINGUniversity of Kansas
Westwood, Kansas, United States
RECRUITINGUniversity of Maryland | Greenebaum Cancer Center
Baltimore, Maryland, United States
RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGNew York Oncology Hematology
Albany, New York, United States
RECRUITINGEast Carolina University
Greenville, North Carolina, United States
NOT_YET_RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
NOT_YET_RECRUITINGRoyal Devon And Exeter Hospital
Exeter, Devon, United Kingdom
NOT_YET_RECRUITING...and 6 more locations
Time To the First Serious Infection
Time frame: Up to 12 months
Number of Participants With at Least 1 Serious Infection
Time frame: Up to 12 months
Annualized Rate of Days on Antibiotics for Treatment of Bacterial Infections
Time frame: Up to 12 months
Annualized Rate of Bacterial Infections
Time frame: Up to 12 months
Annualized Rate of Serious Infections
Time frame: Up to 12 months
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
Time frame: Up to 12 months
Number of Participants With Any Infections
Time frame: Up to 12 months
Duration of Infections
Time frame: Up to 12 months
Time To Any First Infection
Time frame: Up to 12 months
Annualized Rate of Any Infections
Time frame: Up to 12 months
Number of Participants With Bacterial/Viral Infection/Fungal Infection
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
Annualized Rate of Episodes of Fever due to Infections
Time frame: Up to 12 months
Total Immunoglobulin G (IgG) Levels in Serum
Time frame: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Levels in Serum
Time frame: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
Antigen-specific Antibody Levels in Serum
Time frame: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
Number of Participants With Adverse Event (AEs) and Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 12 months
Number of Participants With TEAEs Related to IGI, 10%
Time frame: Up to 12 months
Number of Participants With TEAEs Temporally Associated to the IGI, 10% Within 72 hours of Administration
Time frame: Within 72 hours of IGI, 10% administration (up to 12 months)
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TEAEs Related to IGI, 10%
Time frame: Up to 12 months
Number of Participants With at Least 1 Hospitalization due to Infection
Time frame: Up to 12 months
Number of Hospitalizations, Including Intensive Care Unit (ICU) and Non-ICU due to Infection
Time frame: Up to 12 months
Number of Participants With Outpatient Visits, Including Emergency Room (ER) Visits due to Infection
Time frame: Up to 12 months
Duration of Hospitalizations, Including ICU and Non-ICU due to Infection
Time frame: Up to 12 months
Number of Days of Hospitalization per Participant-year, Including ICU and Non-ICU due to Infection or Other Reasons
Time frame: Up to 12 months
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