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

Official 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).

Eligibility Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 183 participants

Study Arms

• Primary Infection Prophylaxis: IGI, 10% (EXPERIMENTAL)
  Participants randomized to primary infection prophylaxis will receive a 400 milligrams per kilogram (mg/kg) dose of IGI, 10%, intravenously (IV) every 3 or 4 weeks within 3 days after randomization up to 12 months.
• Secondary Infection Prophylaxis: IGI, 10% (ACTIVE_COMPARATOR)
  Participants randomized to secondary infection prophylaxis will receive a 400 mg/kg dose of IGI, 10%, IV every 3 or 4 weeks only after experiencing at least one serious infection, as determined by the investigator, for the remainder of the 12 months observational period.

Interventions

• BIOLOGICAL: IGI, 10% — IGI, 10% IV infusion.

Primary Outcomes

• Time To the First Serious Infection (Up to 12 months)

Secondary Outcomes

• Number of Participants With at Least 1 Serious Infection (Up to 12 months)
• Annualized Rate of Days on Antibiotics for Treatment of Bacterial Infections (Up to 12 months)
• Annualized Rate of Bacterial Infections (Up to 12 months)
• Annualized Rate of Serious Infections (Up to 12 months)
• Annualized Rate of Acute Serious Bacterial Infections (ASBIs) (Up to 12 months)

Eligibility Criteria

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 a

Trial Locations

• 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
• ...and 10 more locations

Contact Information

• Takeda Contact — CONTACT
  Phone: +1-877-825-3327
  Email: medinfoUS@takeda.com

Study Officials

• Study Director — STUDY_DIRECTOR
  Takeda

More Multiple Myeloma Trials

View all Multiple Myeloma clinical trials