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

August 6, 2026 updated by: Takeda

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

183

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Melbourne, Australia, 3065
        • Recruiting
        • St Vincents Hospital Melbourne
        • Principal Investigator:
          • Hang Quach
        • Contact:
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • St George Private Hospital
        • Principal Investigator:
          • Shir-Jing Ho
        • Contact:
    • Queensland
      • Douglas, Queensland, Australia, 4814
    • Victoria
      • St Albans, Victoria, Australia, 3021
        • Recruiting
        • Western Health - Sunshine Hospital
        • Principal Investigator:
          • William Renwick
        • Contact:
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • Austria
      • Linz, Austria, 4020
      • Sankt Pölten, Austria, 3100
        • Recruiting
        • Universitaetsklinikum St. Poelten
        • Principal Investigator:
          • Petra Pichler
        • Contact:
      • Vienna, Austria, 1060
        • Recruiting
        • Krankenhaus der Barmherzigen Schwestern Wien
        • Contact:
        • Principal Investigator:
          • Eva Maria Autzinger
  • Brazil
      • Porto Alegre, Brazil, 90110-270
        • Recruiting
        • Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation
        • Principal Investigator:
          • Marcelo Capra
        • Contact:
      • São Paulo, Brazil, 01401-002
        • Recruiting
        • Instituto D'Or de Pesquisa e Ensino - Sao Paulo
        • Contact:
        • Principal Investigator:
          • Abel Neto
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
  • Czechia
      • Ostrava, Czechia, 70800
        • Recruiting
        • Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika
        • Principal Investigator:
          • Roman Hajek
        • Contact:
  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Aalborg Hospital
        • Contact:
        • Principal Investigator:
          • Henrik Gregersen
      • Aarhus, Denmark, DK-820
        • Recruiting
        • Aarhus Universitetshospital
        • Contact:
        • Principal Investigator:
          • Maja Vase
      • Copenhagen, Denmark, 2100
      • Odense, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital
        • Contact:
        • Principal Investigator:
          • Ida Bruun Kristensen
  • Greece
      • Athens, Greece, 105 57
        • Recruiting
        • Alexandra General Hospital of Athens
        • Contact:
        • Principal Investigator:
          • Meletios-Athanasios Dimopoulos
      • Ioannina, Greece, 45500
        • Recruiting
        • University General Hospital of Ioannina
        • Principal Investigator:
          • Eleftheria Hatzimichael
        • Contact:
  • Hungary
      • Kaposvár, Hungary, 7400
        • Recruiting
        • Somogy Megyei Kaposi Mor Oktato Korhaz
        • Contact:
        • Principal Investigator:
          • Peter Rajnics
      • Szombathely, Hungary, 9700
        • Recruiting
        • Markusovszky Egyetemi Oktatokorhaz
        • Principal Investigator:
          • Mark Plander
        • Contact:
  • Italy
      • Catania, Italy, 95124
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco
        • Principal Investigator:
          • Francesco Di Raimondo
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo di Pavia
        • Principal Investigator:
          • Silvia Mangiacavalli
        • Contact:
      • Pescara, Italy, 65125
        • Recruiting
        • Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo
        • Contact:
        • Principal Investigator:
          • Carmine Liberatore
      • Roma, Italy, 161
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
        • Contact:
        • Principal Investigator:
          • Maria Petrucci
      • Torrette, Italy, 60126
  • Netherlands
      • Amsterdam, Netherlands, 1019PE
        • Recruiting
        • Amsterdam University Medical Center (Amsterdam UMC)
        • Contact:
        • Principal Investigator:
          • Niels Van de Donk
      • Nieuwegein, Netherlands, 3435
  • Poland
      • Gdansk, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne - Ul. Smoluchowskiego 17
        • Principal Investigator:
          • Agata Tyczynska
        • Contact:
      • Skorzewo, Poland, 60-185
        • Recruiting
        • Aidport Sp. z o.o.
        • Principal Investigator:
          • Michal Kwiatek
        • Contact:
  • Romania
      • Bucharest, Romania, 020125
        • Recruiting
        • Colentina Clinical Hospital
        • Principal Investigator:
          • Mihaela Andreescu
        • Contact:
  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Ana Lopez de la Guia
        • Contact:
      • Madrid, Spain, 28041
        • Recruiting
        • Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)
        • Principal Investigator:
          • Joaquin Martinez Lopez
        • Contact:
      • Marbella, Spain, 29603
        • Recruiting
        • Hospital Costa del Sol
        • Principal Investigator:
          • Maria Casanova
        • Contact:
      • Palma de Mallorca, Spain, 07120
        • Recruiting
        • Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD)
        • Principal Investigator:
          • Albert Perez Montana
        • Contact:
      • Salamanca, Spain, 37007
        • Recruiting
        • Complejo Asistencial Universitario de Salamanca - H. Clinico
        • Principal Investigator:
          • Maria Victoria Mateos Manteca
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Principal Investigator:
          • Javier de la Rubia Comos
        • Contact:
  • United Kingdom
      • Milton Keynes, United Kingdom, MK6 5LD
        • Recruiting
        • Milton Keynes University Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Kunaal Kaushik
      • Stafford, United Kingdom, ST16 3SA
        • Recruiting
        • County Hospital (Stafford Hospital)
        • Principal Investigator:
          • Kamaraj Karunanithi
        • Contact:
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DH
        • Recruiting
        • Royal Devon and Exeter Hospital
        • Principal Investigator:
          • Loretta Ngu
        • Contact:
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Recruiting
        • Gloucestershire Royal Hospital
        • Principal Investigator:
          • Asha Johny
        • Contact:
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 4XU
        • Recruiting
        • Cardiff & Vale University Health Board
        • Principal Investigator:
          • Ceri Bygrave
        • Contact:
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • Infirmary Health - Diagnostic & Medical Clinic (DMC)
        • Principal Investigator:
          • Furhan Yunus
        • Contact:
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Chao Family Comprehensive Cancer Center UCI
        • Contact:
        • Principal Investigator:
          • Edward Nelson
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas
        • Principal Investigator:
          • Jeries Kort
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland | Greenebaum Cancer Center
        • Principal Investigator:
          • Mehmet Kocoglu
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Principal Investigator:
          • Philip Kuriakose
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Mark Schroeder
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • New York Oncology Hematology
        • Principal Investigator:
          • Courtney Marie Bellomo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other Names:
  • Gammagard Liquid
  • KIOVIG
  • TAK-339
Active Comparator: 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.
Other Names:
  • Gammagard Liquid
  • KIOVIG
  • TAK-339

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time To the First Serious Infection
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least 1 Serious Infection
Time Frame: Up to 12 months
Up to 12 months
Annualized Rate of Days on Antibiotics for Treatment of Bacterial Infections
Time Frame: Up to 12 months
Up to 12 months
Annualized Rate of Bacterial Infections
Time Frame: Up to 12 months
Up to 12 months
Annualized Rate of Serious Infections
Time Frame: Up to 12 months
Up to 12 months
Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
Time Frame: Up to 12 months
Up to 12 months
Number of Participants With Any Infections
Time Frame: Up to 12 months
Up to 12 months
Duration of Infections
Time Frame: Up to 12 months
Up to 12 months
Time To Any First Infection
Time Frame: Up to 12 months
Up to 12 months
Annualized Rate of Any Infections
Time Frame: Up to 12 months
Up to 12 months
Number of Participants With Bacterial/Viral Infection/Fungal Infection
Time Frame: Up to 12 months
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.
Up to 12 months
Annualized Rate of Episodes of Fever due to Infections
Time Frame: Up to 12 months
Up to 12 months
Total Immunoglobulin G (IgG) Levels in Serum
Time Frame: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
IgG Subclasses (IgG1, IgG2, IgG3, and IgG4) Levels in Serum
Time Frame: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
Antigen-specific Antibody Levels in Serum
Time Frame: 3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
Number of Participants With Adverse Event (AEs) and Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 12 months
Up to 12 months
Number of Participants With TEAEs Related to IGI, 10%
Time Frame: Up to 12 months
Up to 12 months
Number of Participants With TEAEs Temporally Associated to the IGI, 10% Within 72 hours of Administration
Time Frame: Within 72 hours of IGI, 10% administration (up to 12 months)
Within 72 hours of IGI, 10% administration (up to 12 months)
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TEAEs Related to IGI, 10%
Time Frame: Up to 12 months
Up to 12 months
Number of Participants With at Least 1 Hospitalization due to Infection
Time Frame: Up to 12 months
Up to 12 months
Number of Hospitalizations, Including Intensive Care Unit (ICU) and Non-ICU due to Infection
Time Frame: Up to 12 months
Up to 12 months
Number of Participants With Outpatient Visits, Including Emergency Room (ER) Visits due to Infection
Time Frame: Up to 12 months
Up to 12 months
Duration of Hospitalizations, Including ICU and Non-ICU due to Infection
Time Frame: Up to 12 months
Up to 12 months
Number of Days of Hospitalization per Participant-year, Including ICU and Non-ICU due to Infection or Other Reasons
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Collaborators

Takeda Development Center Americas, Inc.
Baxalta Innovations GmbH, now part of Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

September 11, 2028

Study Completion (Estimated)

September 11, 2028

Study Registration Dates

First Submitted

May 13, 2025

First Submitted That Met QC Criteria

May 13, 2025

First Posted (Actual)

May 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-339-3001
  • 2024-518420-80-00 (Ctis: EU CTIS Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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