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
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).
Arms & interventions
- BiologicalIGI, 10%
IGI, 10% IV infusion.
Outcome measures
Primary
Time To the First Serious Infection
Time frame: Up to 12 months
Secondary
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
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
Eligibility criteria
Study locations (7)
Infirmary Health - Diagnostic & Medical Clinic (DMC)
Mobile, Alabama, 36604
Chao Family Comprehensive Cancer Center UCI
Orange, California, 92868
University of Kansas
Westwood, Kansas, 66205
University of Maryland | Greenebaum Cancer Center
Baltimore, Maryland, 21201
Henry Ford Health System
Detroit, Michigan, 48202
Washington University School of Medicine
St Louis, Missouri, 63141
New York Oncology Hematology
Albany, New York, 12208