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
- Diseases
- Multiple myeloma
- 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
Sites (76)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Noe LGA Gesundheit Region Mitte GmbH Coordinator of this site? Confirm its status | St. Poelten | Austria | Recruiting |
| Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Townsville Hospital Coordinator of this site? Confirm its status | Douglas | Australia | Recruiting |
| Greenslopes Private Hospital Coordinator of this site? Confirm its status | Greenslopes | Australia | Recruiting |
| St George Private Hospital Coordinator of this site? Confirm its status | Kogarah | Australia | Recruiting |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| Western Health Sunshine Hospital Coordinator of this site? Confirm its status | St Albans | Australia | Recruiting |
| Centro de Hematologia e Oncologia (CHO) Coordinator of this site? Confirm its status | Joinville | Brazil | Recruiting |
| Sao Jose do Rio Preto Regional Faculty of Medicine FoundationSao Jose do Rio Preto Regional Faculty of Medicine Foundation Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Instituto Oncoclínicas de Ensino Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Instituto D'Or de Pesquisa e Ensino Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Instituto D'Or de Pesquisa E Ensino - São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Cancer Care Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Costa del Sol Coordinator of this site? Confirm its status | Marbella | Spain | Recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Cardiff & Vale University Health Board Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Recruiting |
| Colchester General Hospital Coordinator of this site? Confirm its status | Colcester | United Kingdom | Recruiting |
| Royal Devon and Exeter Hospital Coordinator of this site? Confirm its status | Exeter | United Kingdom | Recruiting |
| Gloucestershire Royal Hospital Coordinator of this site? Confirm its status | Gloucester | United Kingdom | Recruiting |
| Milton Keynes University Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Milton Keynes | United Kingdom | Recruiting |
| County Hospital (Stafford Hospital) Coordinator of this site? Confirm its status | Stafford | United Kingdom | Recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Somogy Vármegyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Recruiting |
| Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Szombathely | Hungary | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Sanitaria Locale di Pescara Coordinator of this site? Confirm its status | Pescara | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Sint Antonius Ziekenhuis Stichting Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Helse Nord-Trondelag HF Coordinator of this site? Confirm its status | Levanger | Norway | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Recruiting |
| Oslo Universitetssykehus HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Institutul Clinic Fundeni Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colțea Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colentina Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic Municipal Filantropia Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| New York Oncology Hematology Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| University of Maryland/Greenebaum Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Infirmary Health - Diagnostic & Medical Clinic (DMC) Coordinator of this site? Confirm its status | Mobile | United States | Recruiting |
| Chao Family Comprehensive Cancer Center UCI Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| University of Kansas Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.