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🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2026-08-07)

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

🟢 Recruiting Phase 3 💊 Investigational Drug / Biologic Sponsor: Takeda

🩺 Protocol 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 approximately 8 weeks).

Primary Research Facility: Infirmary Health - Diagnostic & Medical Clinic (DMC) (Mobile, Alabama)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

📍 Primary Site Map

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

📍 All Participating Trial Locations (48 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Infirmary Health - Diagnostic & Medical Clinic (DMC) — Mobile, Alabama • Contact: (251) 435-5710
2. Chao Family Comprehensive Cancer Center UCI — Orange, California
3. University of Kansas — Westwood, Kansas
4. University of Maryland | Greenebaum Cancer Center — Baltimore, Maryland • Contact: (410) 328-6842
5. Henry Ford Health System — Detroit, Michigan • Contact: (313) 916-2772
6. Washington University School of Medicine — St Louis, Missouri • Contact: (314) 454-8304
7. New York Oncology Hematology — Albany, New York • Contact: (518) 262-6696
8. St George Private Hospital — Kogarah, New South Wales • Contact: (029) 113-3425
9. Townsville Hospital — Douglas, Queensland
10. Western Health - Sunshine Hospital — St Albans, Victoria
11. Fiona Stanley Hospital — Murdoch, Western Australia
12. St Vincents Hospital Melbourne — United States
13. A O Krankenhaus der Elisabethinen — United States
14. Universitaetsklinikum St. Poelten — United States • Contact: 43 2742 9004 22181
15. Krankenhaus der Barmherzigen Schwestern Wien — United States
16. Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation — United States
17. Instituto D'Or de Pesquisa e Ensino - Sao Paulo — United States
18. Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec
19. Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika — United States
20. Aalborg Hospital — United States
21. Aarhus Universitetshospital — United States
22. Copenhagen University Hospital — United States
23. Odense Universitetshospital — United States
24. Alexandra General Hospital of Athens — United States
25. University General Hospital of Ioannina — United States

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💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06980480 • Last Synced: 2026-08-07
View on ClinicalTrials.gov ↗
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