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NCT06980480PHASE3Recruiting

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

Takeda

Start Date

1/14/2026

Completion Date

9/11/2028

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. 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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

BIOLOGICAL

IGI, 10%

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Conditions

Multiple MyelomaSecondary Immunodeficiency

Locations

Infirmary Health - Diagnostic & Medical Clinic (DMC)

Mobile, Alabama 36604

United States

Chao Family Comprehensive Cancer Center UCI

Orange, California 92868

United States

University of Kansas

Westwood, Kansas 66205

United States

University of Maryland | Greenebaum Cancer Center

Baltimore, Maryland 21201

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Washington University School of Medicine

St Louis, Missouri 63141

United States

New York Oncology Hematology

Albany, New York 12208

United States

St George Private Hospital

Kogarah, New South Wales 2217

Australia

Townsville Hospital

Douglas, Queensland 4814

Australia

Western Health - Sunshine Hospital

St Albans, Victoria 3021

Australia

Fiona Stanley Hospital

Murdoch, Western Australia 6150

Australia

St Vincents Hospital Melbourne

Melbourne, 3065

Australia

A O Krankenhaus der Elisabethinen

Linz, 4020

Austria

Universitaetsklinikum St. Poelten

Sankt Pölten, 3100

Austria

Krankenhaus der Barmherzigen Schwestern Wien

Vienna, 1060

Austria

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec H2X 0A9

Canada

Fakultni Nemocnice Ostrava (FNO) - Neurologicke klinika

Ostrava, 70800

Czechia

Aalborg Hospital

Aalborg, 9000

Denmark

Aarhus Universitetshospital

Aarhus, DK-820

Denmark

Copenhagen University Hospital

Copenhagen, 2100

Denmark

Odense Universitetshospital

Odense, 5000

Denmark

Alexandra General Hospital of Athens

Athens, 105 57

Greece

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, 7400

Hungary

Markusovszky Egyetemi Oktatokorhaz

Szombathely, 9700

Hungary

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100

Italy

Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo

Pescara, 65125

Italy

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

Roma, 161

Italy

Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica

Torrette, 60126

Italy

Amsterdam University Medical Center (Amsterdam UMC)

Amsterdam, 1019PE

Netherlands

St. Antonius Ziekenhuis

Nieuwegein, 3435

Netherlands

Uniwersyteckie Centrum Kliniczne - Ul. Smoluchowskiego 17

Gdansk, 80-214

Poland

Aidport sp. z o.o.

Skorzewo, 60-185

Poland

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

Madrid, 28041

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Costa Del Sol

Marbella, 29603

Spain

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

Palma de Mallorca, 07120

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Royal Devon And Exeter Hospital

Exeter, Devon EX2 5DH

United Kingdom

Gloucestershire Royal Hospital

Gloucester, Gloucestershire GL1 3NN

United Kingdom

Cardiff & Vale University Health Board

Cardiff, South Glamorgan CF14 4XU

United Kingdom

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes, MK6 5LD

United Kingdom

County Hospital (Stafford Hospital)

Stafford, ST16 3SA

United Kingdom