A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma (NCT06980480)
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
🩺 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: Review the eligibility criteria below.
Location: Infirmary Health - Diagnostic & Medical Clinic (DMC) — Mobile, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 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,
📞 Contact the Study Coordinator
Phone: (877) 825-3327
Email: medinfoUS@takeda.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Multiple Myeloma
- Ixazomib + Pomalidomide + Dexamethasone In MM — Boston, Massachusetts
- A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma — Birmingham, Alabama
- Multiple Myeloma Outcomes Based on Maintenance Therapy Post Autologous Stem Cell Transplant — Tampa, Florida
- MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb — Beverly Hills, California
- A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma — Phoenix, Arizona
- A Study of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma — Hackensack, New Jersey
Explore by condition: All Multiple Myeloma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.