🏛️ Verified NIH Record • Updated 2026-08-06

A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma (NCT06980480)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Takeda

🩺 Plain-English Summary (8th-Grade Level)

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 approximately 8 weeks).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (30 items).

Location: Infirmary Health - Diagnostic & Medical Clinic (DMC) — Mobile, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • The participant has not achieved at least a minimal response to teclistamab during the screening period after signing the ICF and within 8 weeks of the first step-up dose of teclistamab.
  • The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before screening.
  • 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.
  • The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
  • 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.
  • The participant has received live viral vaccines within 30 days before screening.
  • The participant has an Eastern Cooperative Oncology Group performance status score of \>2.
  • 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.
  • The participant has received other B Cell Maturation Antigen (BCMA)\*Cluster of Differentiation (CD3)-directed Bispecific Antibody therapy (BsAb), BCMA-targeted chimeric antigen receptor T-cell (CAR T-cell), or BCMA-targeted antibody drug conjugate (ADC) therapy within 1 year prior to screening.
  • The participant is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening.
  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (48 Sites)

  • Infirmary Health - Diagnostic & Medical Clinic (DMC) — Mobile, Alabama
  • Chao Family Comprehensive Cancer Center UCI — Orange, California
  • University of Kansas — Westwood, Kansas
  • University of Maryland | Greenebaum Cancer Center — Baltimore, Maryland
  • Henry Ford Health System — Detroit, Michigan
  • Washington University School of Medicine — St Louis, Missouri
  • New York Oncology Hematology — Albany, New York
  • St George Private Hospital — Kogarah, New South Wales
  • Townsville Hospital — Douglas, Queensland
  • Western Health - Sunshine Hospital — St Albans, Victoria
  • Fiona Stanley Hospital — Murdoch, Western Australia
  • St Vincents Hospital Melbourne — Melbourne,
  • A O Krankenhaus der Elisabethinen — Linz,
  • Universitaetsklinikum St. Poelten — Sankt Pölten,
  • Krankenhaus der Barmherzigen Schwestern Wien — Vienna,
  • Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation — Porto Alegre,
  • Instituto D'Or de Pesquisa e Ensino - Sao Paulo — São Paulo,
  • Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec
  • Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika — Ostrava,
  • Aalborg Hospital — Aalborg,
  • Aarhus Universitetshospital — Aarhus,
  • Copenhagen University Hospital — Copenhagen,
  • Odense Universitetshospital — Odense,
  • Alexandra General Hospital of Athens — Athens,
  • University General Hospital of Ioannina — Ioannina,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗