Gammagard Liquid (10% immune globulin) to prevent infections in adults with multiple myeloma
Official title: 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
Run by Takeda · NCT06980480 · Data updated 2026-11-12
This will try regular Gammagard Liquid (10% immune globulin) infusions to prevent infections in adults with multiple myeloma who are receiving BCMA×CD3 bispecific antibody therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 183 (estimated) |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | teclistamab, CAR T, chimeric antigen receptor |
| Locations | 65 sites (Mobile, Alabama and 64 other locations) |
| Status | Recruiting |
| Started | January 14, 2026 |
| Main results expected | September 11, 2028 |
| Study ends | September 11, 2028 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT06980480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with a documented diagnosis of multiple myeloma who have started teclistamab within the first 8 weeks and plan to continue it for the next 12 months are ideal candidates.
✕Probably not a fit
Patients not receiving BCMA×CD3 bispecific therapy, those with contraindications to immune globulin, or those unlikely to complete the 12-month treatment schedule may not receive benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized Phase 3 trial enrolls adults with multiple myeloma who recently started teclistamab (a BCMA×CD3 bispecific antibody) to test whether regular IGI 10% infusions reduce infections. Participants are randomly assigned to receive IGI every 3–4 weeks for 12 months (primary prevention) or to receive IGI only if they develop a serious infection during the 12-month study period (secondary prevention). Study visits total 15 (4-week dosing) or 19 (3-week dosing) and overall participation is up to 14 months including screening. The trial will compare infection rates and related healthcare use between the two strategies.
Why it matters
Potential benefit: If successful, regular IGI infusions could lower the number and severity of infections in multiple myeloma patients receiving BCMA×CD3 bispecific therapy.
How similar studies have gone: Immune globulin is used to prevent infections in people with secondary immunodeficiency and some myeloma patients, but its specific use alongside BCMA×CD3 bispecific antibody therapy has limited prior data.
Who can join: the full rules
Show full inclusion / exclusion 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 monotherapy within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months. 3. The participant 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 during the screening period after signing the ICF and within 8 weeks of the first step-up dose of teclistamab. 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 (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. 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 (\<) 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 (ULN) 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 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.
Where it's running
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Infirmary Health - Diagnostic & Medical Clinic (DMC)
Mobile, Alabama, United States Recruiting -
Chao Family Comprehensive Cancer Center UCI
Orange, California, United States Recruiting -
University of Kansas
Westwood, Kansas, United States Recruiting -
University of Maryland | Greenebaum Cancer Center
Baltimore, Maryland, United States Recruiting -
Henry Ford Health System
Detroit, Michigan, United States Recruiting -
Washington University School of Medicine
St Louis, Missouri, United States Recruiting
Show 44 more locations
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New York Oncology Hematology
Albany, New York, United States Recruiting -
St George Private Hospital
Kogarah, New South Wales, Australia Recruiting -
Townsville Hospital
Douglas, Queensland, Australia Recruiting -
Greenslopes Private Hospital
Greenslopes, Queensland, Australia Recruiting -
Royal Adelaide Hospital
Adelaide, South Australia, Australia Recruiting -
Western Health - Sunshine Hospital
St Albans, Victoria, Australia Recruiting -
Fiona Stanley Hospital
Murdoch, Western Australia, Australia Recruiting -
St Vincents Hospital Melbourne
Melbourne, Australia Recruiting -
A O Krankenhaus der Elisabethinen
Linz, Austria Recruiting -
Universitaetsklinikum St. Poelten
Sankt Pölten, Austria Recruiting -
Krankenhaus der Barmherzigen Schwestern Wien
Vienna, Austria Recruiting -
Centro de Hematologia e Oncologia (CHO)
Joinville, Santa Catarina, Brazil Recruiting -
Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation
Porto Alegre, Brazil Recruiting -
Instituto Oncoclínicas de Ensino
Rio de Janeiro, Brazil Recruiting -
Instituto D'Or de Pesquisa e Ensino
Salvador, Brazil Recruiting -
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
São Paulo, Brazil Recruiting -
Cancer Care Manitoba
Winnipeg, Manitoba, Canada Recruiting -
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada Recruiting -
Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika
Ostrava, Czechia Recruiting -
Aalborg Hospital
Aalborg, Denmark Recruiting -
Aarhus Universitetshospital
Aarhus, Denmark Recruiting -
Copenhagen University Hospital
Copenhagen, Denmark Recruiting -
Odense Universitetshospital
Odense, Denmark Recruiting -
Alexandra General Hospital of Athens
Athens, Greece Recruiting -
University General Hospital of Ioannina
Ioannina, Greece Recruiting -
University of Debrecen DEOEC
Debrecen, Hungary Recruiting -
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, Hungary Recruiting -
Markusovszky Egyetemi Oktatokorhaz
Szombathely, Hungary Recruiting -
Shaare Zedek Medical Center
Jerusalem, Israel Recruiting -
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco
Catania, Italy Recruiting -
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Italy Recruiting -
Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo
Pescara, Italy Recruiting -
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, Italy Recruiting -
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
Torrette, Italy Recruiting -
Amsterdam University Medical Center (Amsterdam UMC)
Amsterdam, Netherlands Recruiting -
St. Antonius Ziekenhuis
Nieuwegein, Netherlands Recruiting -
Helse Nord-Troendelag Thrust
Levanger, Norway Recruiting -
Akershus University Hospital
Lorenskog, Norway Recruiting -
St.Olavs Hospital
Trondheim, Norway Recruiting -
Uniwersyteckie Centrum Kliniczne - Ul. Smoluchowskiego 17
Gdansk, Poland Recruiting -
Aidport sp. z o.o.
Skorzewo, Poland Recruiting -
Colentina Clinical Hospital
Bucharest, Romania Recruiting -
Institutul Clinic Fundeni
Bucharest, Romania Recruiting -
Coltea Clinical Hospital
Bucharest, Romania Recruiting
+15 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.