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NCT06980480RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
183 (estimated)
First submitted
13 May 2025
Start date
14 Jan 2026
Primary completion date
11 Sept 2028
Lead sponsor
Takeda
NCT number
NCT06980480
EU CT number
2024-518420-80-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 183
  • From 14 Jan 2026 to the primary completion date, 11 Sept 2028
  • 76 sites in 18 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before screening.
  • 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 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 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 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.
  • 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.
  • Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.
  • The participant is receiving immunosuppressive treatment (other than for MM or corticosteroids) at screening or plans to receive immunosuppressive treatment after study enrollment.
  • 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.

Other illness

  • 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 an active secondary (non-MM) malignancy or other medical condition with life-expectancy of less than (\<) 2 years.
  • 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.
  • 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.
  • 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.

Lab values

  • 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 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 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).
  • 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.
  • 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).
  • 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.

Other

  • 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 an Eastern Cooperative Oncology Group performance status score of \>2.
  • The participant is not willing and able to comply with the protocol requirements.
  • The participant is a family member or employee of the investigator or the investigator's site staff.
  • The participant is pregnant or has a positive pregnancy test or is lactating at the time of screening or enrollment.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (76)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ordensklinikum Linz GmbH
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LinzAustriaRecruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH
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ViennaAustriaRecruiting
Royal Adelaide Hospital
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AdelaideAustraliaRecruiting
Townsville Hospital
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DouglasAustraliaRecruiting
Greenslopes Private Hospital
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GreenslopesAustraliaRecruiting
St George Private Hospital
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KogarahAustraliaRecruiting
St Vincents Hospital Melbourne
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MelbourneAustraliaRecruiting
Fiona Stanley Hospital
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MurdochAustraliaRecruiting
Western Health Sunshine Hospital
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St AlbansAustraliaRecruiting
Centro de Hematologia e Oncologia (CHO)
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JoinvilleBrazilRecruiting
Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation
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Porto AlegreBrazilRecruiting
Instituto Oncoclínicas de Ensino
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Rio de JaneiroBrazilRecruiting
Instituto D'Or de Pesquisa e Ensino
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SalvadorBrazilRecruiting
Instituto D'Or de Pesquisa E Ensino - São Paulo
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São PauloBrazilRecruiting
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaRecruiting
Cancer Care Manitoba
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WinnipegCanadaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
University Hospital Cologne AöR
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CologneGermanyNot yet recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyNot yet recruiting
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyNot yet recruiting
Aalborg University Hospital
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AalborgDenmarkRecruiting
Region Midtjylland
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Aarhus NDenmarkRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Odense University Hospital
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Odense CDenmarkRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Costa del Sol
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MarbellaSpainRecruiting
University Hospital Son Espases
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PalmaSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Cardiff & Vale University Health Board
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CardiffUnited KingdomRecruiting
Colchester General Hospital
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ColcesterUnited KingdomRecruiting
Royal Devon and Exeter Hospital
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ExeterUnited KingdomRecruiting
Gloucestershire Royal Hospital
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GloucesterUnited KingdomRecruiting
Milton Keynes University Hospital NHS Foundation Trust
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Milton KeynesUnited KingdomRecruiting
County Hospital (Stafford Hospital)
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StaffordUnited KingdomRecruiting
Alexandra Hospital
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AthensGreeceRecruiting
University General Hospital of Ioannina
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IoanninaGreeceRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
University of Debrecen
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DebrecenHungaryRecruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház
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KaposvárHungaryRecruiting
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
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SzombathelyHungaryRecruiting
Shaare Zedek Medical Center
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JerusalemIsraelRecruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Azienda Sanitaria Locale di Pescara
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PescaraItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Sint Antonius Ziekenhuis Stichting
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NieuwegeinNetherlandsRecruiting
Helse Nord-Trondelag HF
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LevangerNorwayRecruiting
Akershus University Hospital
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LoerenskogNorwayRecruiting
Oslo Universitetssykehus HF
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OsloNorwayRecruiting
St. Olavs hospital HF
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TrondheimNorwayRecruiting
Pratia S.A.
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CracowPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandRecruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandRecruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandRecruiting
Aidport sp z o.o.
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SkorzewoPolandRecruiting
Institutul Clinic Fundeni
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BucharestRomaniaRecruiting
Spitalul Clinic Colțea
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BucharestRomaniaRecruiting
Spitalul Clinic Colentina Bucuresti
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BucharestRomaniaRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaRecruiting
Spitalul Clinic Municipal Filantropia Craiova
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CraiovaRomaniaRecruiting
New York Oncology Hematology
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AlbanyUnited StatesRecruiting
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesRecruiting
Henry Ford Health System
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DetroitUnited StatesRecruiting
Infirmary Health - Diagnostic & Medical Clinic (DMC)
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MobileUnited StatesRecruiting
Chao Family Comprehensive Cancer Center UCI
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OrangeUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
University of Kansas
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WestwoodUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.