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RecruitingInterventionalPhase 3

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

NCT ID: NCT06980480Sponsor: TakedaLast updated: 2026-05-18

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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment. 2. Participant who recently started teclistamab within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months. 3. The participant or the participant's legally acceptable representative has provided informed consent (that is, in writing, documented via a signed and dated Informed Consent Form \[ICF\]) and any required privacy authorization before the initiation of any study procedures. 4. The participant is at least 18 years of age at the time of signing the ICF. 5. If a person of childbearing potential engages in sexual relations that carry risk of pregnancy, they agree to the following for the period from screening until 30 days after the last dose of study drug: 1. To use a highly effective contraceptive method. 2. To avoid donating ova. Exclusion Criteria: 1. The participant has not achieved at least a minimal response to teclistamab within 8 weeks during the screening period. 2. The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before screening. 3. The participant has a documented polyclonal IgG level less than (\<) 150 milligrams per deciliter (mg/dL) at the most recent assessment before teclistamab initiation (within 4 weeks) as assessed by the investigator according to the site's standard practice. 4. The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening. 5. The participant has received a hyperimmune or specialty high-titer immunoglobulin product (example, cytomegalovirus immune globulin, varicella-zoster immune globulin, hepatitis B immune globulin) within 30 days before screening. 6. The participant has received live viral vaccines within 30 days before screening. 7. The participant has an Eastern Cooperative Oncology Group performance status score of \>2. 8. The participant has an active viral or bacterial infection or symptoms/signs of such an infection requiring treatment with anti-infectives within 1 week before enrollment. 9. The participant has received other B Cell Maturation Antigen (BCMA)\*Cluster of Differentiation (CD3)-directed Bispecific Antibody therapy any time before screening. 10. The participant is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening. 11. The participant may be excluded from the study if, in the opinion of the investigator, the participant is at high risk for symptomatic hyperviscosity syndrome. 12. The participant has major surgery scheduled during the study, or the participant has not fully recovered from a recent major surgery (as judged by the investigator) during screening (participants with planned surgical procedures to be conducted under local anesthesia may participate). 13. The participant has an active secondary (non-MM) malignancy or other medical condition with life-expectancy of less than (\<) 2 years. 14. The participant has a known history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) after Intravenous Immunoglobulin (IVIG) and/or immune serum globulin infusions. 15. The participant has a known history or current diagnosis of thromboembolic episodes such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease within 6 months before screening. 16. The participant has moderate to severe renal dysfunction based on an estimated glomerular filtration rate less than or equal to (\<=) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2), as defined by kidney disease: Improving Global Outcomes Clinical Practice Guideline for the Management of Glomerular Diseases, 2021 at the time of screening. 17. The participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen, Polymerase Chain Reaction (PCR) for hepatitis C virus, PCR for Human Immunodeficiency Virus (HIV) Type 1 and Type 2. Cured participants with a history of hepatitis C infection who have a negative PCR test at screening are eligible. 18. The participant has a documented diagnosis of a form of primary immunodeficiency (PID) involving a defect in antibody formation and requiring IgG replacement, as defined according to the International Union of Immunological Societies Committee. 19. The participant has a persistent serum aspartate aminotransferase and alanine aminotransferase \>3.0 times the upper limit of normal at screening (may be repeated once to determine if it is persistent). 20. The participant has an immunoglobulin A (IgA) deficiency (\<0.07 grams per liter \[g/L\]) with antibodies to IgA and a history of hypersensitivity reaction to IVIG. 21. Participant with a known systemic hypersensitivity to any of the excipients of IGI, 10% in accordance with the investigator's brochure/package insert/Summary of Product Characteristics. 22. Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening. 23. The participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator (may be repeated once to determine if it has resolved). 24. The participant has a medical condition, laboratory finding, or physical examination finding that precludes participation or with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with the successful completion of the study or place the participant at undue medical risk. 25. The participant is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment. 26. The participant or the participant's legally designated representative is not willing and able to comply with the protocol requirements. 27. The participant has participated or is scheduled to participate in another clinical study involving an investigational product (IP) or investigational device within 30 days before screening and during the course of the study. 28. The participant is a family member or employee of the investigator or the investigator's site staff. 29. The participant is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.

Study locations (7)

Infirmary Health - Diagnostic & Medical Clinic (DMC)

Mobile, Alabama, 36604

Recruiting
Furhan Yunus · Principal Investigator

Chao Family Comprehensive Cancer Center UCI

Orange, California, 92868

Recruiting
Site Contact · Contact
Edward Nelson · Principal Investigator

University of Kansas

Westwood, Kansas, 66205

Recruiting
Site Contact · Contact
Jeries Kort · Principal Investigator

University of Maryland | Greenebaum Cancer Center

Baltimore, Maryland, 21201

Recruiting
Site Contact · Contact
Mehmet Kocoglu · Principal Investigator

Henry Ford Health System

Detroit, Michigan, 48202

Recruiting
Site Contact · Contact
Philip Kuriakose · Principal Investigator

Washington University School of Medicine

St Louis, Missouri, 63141

Recruiting
Mark Schroeder · Principal Investigator

New York Oncology Hematology

Albany, New York, 12208

Recruiting
Courtney Marie Bellomo · Principal Investigator