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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified July 2026 by Takeda
Sponsor
Takeda
Information Provided by (Responsible Party)
Takeda
Clinicaltrials.gov Identifier
NCT06980480
Other Study ID Numbers:
TAK-339-3001
First Submitted
May 12, 2025
First Posted
May 19, 2025
Last Update Posted
August 6, 2026
Last Verified
July 2026

ClinicalTrials.gov processed this data on August 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Multiple MyelomaSecondary Immunodeficiency
Biological: IGI, 10%Biological: IGI, 10%

Study Design

Study TypeInterventional
Actual Enrollment183 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposePrevention
Official TitleA 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
Study Start DateJanuary 13, 2026
Actual Primary Completion Date2yrs 2w from now
Actual Study Completion Date2yrs 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Primary Infection Prophylaxis: IGI, 10%
Participants randomized to primary infection prophylaxis will receive a 400 milligrams per kilogram (mg/kg) dose of IGI, 10% in accordance with the standard of care (SOC), intravenously (IV) every 3 or 4 weeks within 3 days after randomization up to 12 months.
Biological: IGI, 10%
IGI, 10% IV infusion.
Secondary Infection Prophylaxis: IGI, 10%
Participants randomized to secondary infection prophylaxis will receive a 400 mg/kg dose of IGI, 10% in accordance with the SOC, 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.
Biological: IGI, 10%
IGI, 10% IV infusion.

Outcome Measures

Primary Outcome Measures
  1. Time To the First Serious Infection
Secondary Outcome Measures
  1. Number of Participants With at Least 1 Serious Infection
  2. Annualized Rate of Days on Antibiotics for Treatment of Bacterial Infections
  3. Annualized Rate of Bacterial Infections
  4. Annualized Rate of Serious Infections
  5. Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
  6. Number of Participants With Any Infections
  7. Duration of Infections
  8. Time To Any First Infection
  9. Annualized Rate of Any Infections
  10. Number of Participants With Bacterial/Viral Infection/Fungal Infection
    Number of participants with bacterial/viral infection, including covid/fungal infection diagnosed clinically and via microbiology (culture, polymerase chain reaction \[PCR\], other imaging will be reported.
  11. Annualized Rate of Episodes of Fever due to Infections
  12. Total Immunoglobulin G (IgG) Levels in Serum
  13. IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Levels in Serum
  14. Antigen-specific Antibody Levels in Serum
  15. Number of Participants With Adverse Event (AEs) and Treatment-Emergent Adverse Events (TEAEs)
  16. Number of Participants With TEAEs Related to IGI, 10%
  17. Number of Participants With TEAEs Temporally Associated to the IGI, 10% Within 72 hours of Administration
  18. Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TEAEs Related to IGI, 10%
  19. Number of Participants With at Least 1 Hospitalization due to Infection
  20. Number of Hospitalizations, Including Intensive Care Unit (ICU) and Non-ICU due to Infection
  21. Number of Participants With Outpatient Visits, Including Emergency Room (ER) Visits due to Infection
  22. Duration of Hospitalizations, Including ICU and Non-ICU due to Infection
  23. Number of Days of Hospitalization per Participant-year, Including ICU and Non-ICU due to Infection or Other Reasons

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsTakeda
Locations
Infirmary Health - Diagnostic & Medical Clinic (DMC) | Mobile Alabama, United States, 36604Chao Family Comprehensive Cancer Center UCI | Orange California, United States, 92868University of Kansas | Westwood Kansas, United States, 66205University of Maryland | Greenebaum Cancer Center | Baltimore Maryland, United States, 21201Henry Ford Health System | Detroit Michigan, United States, 48202Washington University School of Medicine | St Louis Missouri, United States, 63141New York Oncology Hematology | Albany New York, United States, 12208St George Private Hospital | Kogarah New South Wales, Australia, 2217Townsville Hospital | Douglas Queensland, Australia, 4814Western Health - Sunshine Hospital | St Albans Victoria, Australia, 3021Fiona Stanley Hospital | Murdoch Western Australia, Australia, 6150St Vincents Hospital Melbourne | Melbourne , Australia, 3065A O Krankenhaus der Elisabethinen | Linz , Austria, 4020Universitaetsklinikum St. Poelten | Sankt Pölten , Austria, 3100Krankenhaus der Barmherzigen Schwestern Wien | Vienna , Austria, 1060Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation | Porto Alegre , Brazil, 90110-270Instituto D'Or de Pesquisa e Ensino - Sao Paulo | São Paulo , Brazil, 01401-002Centre Hospitalier de l'Universite de Montreal | Montreal Quebec, Canada, H2X 0A9Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika | Ostrava , Czechia, 70800Aalborg Hospital | Aalborg , Denmark, 9000Aarhus Universitetshospital | Aarhus , Denmark, DK-820Copenhagen University Hospital | Copenhagen , Denmark, 2100Odense Universitetshospital | Odense , Denmark, 5000Alexandra General Hospital of Athens | Athens , Greece, 105 57University General Hospital of Ioannina | Ioannina , Greece, 45500Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvár , Hungary, 7400Markusovszky Egyetemi Oktatokorhaz | Szombathely , Hungary, 9700Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco | Catania , Italy, 95124Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia , Italy, 27100Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo | Pescara , Italy, 65125Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza | Roma , Italy, 161Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica | Torrette , Italy, 60126Amsterdam University Medical Center (Amsterdam UMC) | Amsterdam , Netherlands, 1019PESt. Antonius Ziekenhuis | Nieuwegein , Netherlands, 3435Uniwersyteckie Centrum Kliniczne - Ul. Smoluchowskiego 17 | Gdansk , Poland, 80-214Aidport sp. z o.o. | Skorzewo , Poland, 60-185Colentina Clinical Hospital | Bucharest , Romania, 020125Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O) | Madrid , Spain, 28041Hospital Universitario La Paz | Madrid , Spain, 28046Hospital Costa Del Sol | Marbella , Spain, 29603Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD) | Palma de Mallorca , Spain, 07120Complejo Asistencial Universitario de Salamanca - H. Clinico | Salamanca , Spain, 37007Hospital Universitari i Politecnic La Fe | Valencia , Spain, 46026Royal Devon And Exeter Hospital | Exeter Devon, United Kingdom, EX2 5DHGloucestershire Royal Hospital | Gloucester Gloucestershire, United Kingdom, GL1 3NNCardiff & Vale University Health Board | Cardiff South Glamorgan, United Kingdom, CF14 4XUMilton Keynes University Hospital NHS Foundation Trust | Milton Keynes , United Kingdom, MK6 5LDCounty Hospital (Stafford Hospital) | Stafford , United Kingdom, ST16 3SA
Investigators
Study Director: Study Director, Takeda