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

NCT06980480 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: TAK-339-30012024-518420-80-00
• Study Type: interventional
• Target: 183
• Locations: 12 countries
• Sites: 39

Brief 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. 1.Primary infection prevention group: They will receive IGI, 10% for 12 months.
2. 2.Secondary infection prevention group: They will only receive IGI, 10% if they develop a serious infection during the 12 months study period.

Conditions

Multiple Myeloma; Secondary Immunodeficiency

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Time To the First Serious Infection

  Up to 12 months

Secondary Outcomes (23)

• Number of Participants With at Least 1 Serious Infection

  Up to 12 months

• Annualized Rate of Days on Antibiotics for Treatment of Bacterial Infections

  Up to 12 months

• Annualized Rate of Bacterial Infections

  Up to 12 months

• Annualized Rate of Serious Infections

  Up to 12 months

• Annualized Rate of Acute Serious Bacterial Infections (ASBIs)

  Up to 12 months

Study Arms (2)

Primary Infection Prophylaxis: IGI, 10%

EXPERIMENTAL

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%

Secondary Infection Prophylaxis: IGI, 10%

ACTIVE COMPARATOR

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%

Interventions

IGI, 10% BIOLOGICAL

IGI, 10% IV infusion.

Also known as: TAK-339, Gammagard Liquid, KIOVIG

Primary Infection Prophylaxis: IGI, 10%; Secondary Infection Prophylaxis: IGI, 10%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the International Myeloma Working Group (IMWG) before enrollment.
• 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.
• 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.
• The participant is at least 18 years of age at the time of signing the ICF.
• 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:
• To use a highly effective contraceptive method.
• To avoid donating ova.

You may not qualify if:

• 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.
• The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before screening.
• 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.
• The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16 weeks before screening.
• 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.
• The participant has received live viral vaccines within 30 days before screening.
• The participant has an Eastern Cooperative Oncology Group performance status score of \>2.
• 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.
• 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.
• The participant is scheduled to undergo plasmapheresis during the course of study or has undergone plasmapheresis in the last 16 weeks before screening.
• 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.
• 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).
• The participant has an active secondary (non-MM) malignancy or other medical condition with life-expectancy of less than (\<) 2 years.
• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator
• Baxalta Innovations GmbH, now part of Takeda: collaborator

Study Sites (42)

Infirmary Health - Diagnostic & Medical Clinic (DMC)

Mobile, Alabama, 36604, United States

RECRUITING

Chao Family Comprehensive Cancer Center UCI

Orange, California, 92868, United States

RECRUITING

University of Kansas

Westwood, Kansas, 66205, United States

RECRUITING

University of Maryland | Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63141, United States

RECRUITING

New York Oncology Hematology

Albany, New York, 12208, United States

RECRUITING

St George Private Hospital

Kogarah, New South Wales, 2217, Australia

RECRUITING

Townsville Hospital

Douglas, Queensland, 4814, Australia

RECRUITING

Western Health - Sunshine Hospital

St Albans, Victoria, 3021, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

St Vincents Hospital Melbourne

Melbourne, 3065, Australia

RECRUITING

A O Krankenhaus der Elisabethinen

Linz, 4020, Austria

RECRUITING

Universitaetsklinikum St. Poelten

Sankt Pölten, 3100, Austria

RECRUITING

Krankenhaus der Barmherzigen Schwestern Wien

Vienna, 1060, Austria

RECRUITING

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika

Ostrava, 70800, Czechia

RECRUITING

Aalborg Hospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus Universitetshospital

Aarhus, DK-820, Denmark

RECRUITING

Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

Odense Universitetshospital

Odense, 5000, Denmark

RECRUITING

Alexandra General Hospital of Athens

Athens, 105 57, Greece

RECRUITING

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400, Hungary

RECRUITING

Markusovszky Egyetemi Oktatokorhaz

Szombathely, 9700, Hungary

RECRUITING

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100, Italy

RECRUITING

Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo

Pescara, 65125, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

Roma, 161, Italy

RECRUITING

Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica

Torrette, 60126, Italy

RECRUITING

Amsterdam University Medical Center (Amsterdam UMC)

Amsterdam, 1019PE, Netherlands

RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, 3435, Netherlands

RECRUITING

Uniwersyteckie Centrum Kliniczne - Ul. Smoluchowskiego 17

Gdansk, 80-214, Poland

RECRUITING

Aidport sp. z o.o.

Skorzewo, 60-185, Poland

RECRUITING

Universidad Complutense de Madrid (UCM)-Hospital Universitario 12 de Octubre (H12O)

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Costa Del Sol

Marbella, 29603, Spain

RECRUITING

Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD)

Palma de Mallorca, 07120, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Royal Devon And Exeter Hospital

Exeter, Devon, EX2 5DH, United Kingdom

RECRUITING

Gloucestershire Royal Hospital

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

RECRUITING

Cardiff & Vale University Health Board

Cardiff, South Glamorgan, CF14 4XU, United Kingdom

RECRUITING

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes, MK6 5LD, United Kingdom

RECRUITING

County Hospital (Stafford Hospital)

Stafford, ST16 3SA, United Kingdom

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): September 11, 2028
• Study Completion (Estimated): September 11, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

US (7); GB (5); PL (2); AU (5); NL (2); HU (2); DK (4); CA (1); GR (1); ES (5); IT (4); CZ (1)