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
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:
- Primary infection prevention group: They will receive IGI, 10% for 12 months.
- 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 of up to 8 weeks).
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Takeda Contact
- Phone Number: +1-877-825-3327
- Email: medinfoUS@takeda.com
Study Locations
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New South Wales
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Kogarah, New South Wales, Australia, 2217
- Recruiting
- St George Private Hospital
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Principal Investigator:
- Shir-Jing Ho
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Contact:
- Site Contact
- Phone Number: 0291133425
- Email: shirjing.ho@health.nsw.gov.au
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Queensland
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Douglas, Queensland, Australia, 4814
- Recruiting
- Townsville Hospital
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Contact:
- Site Contact
- Email: hock.lai@health.qld.gov.au
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Principal Investigator:
- Hock-Choong Lai
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Victoria
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St Albans, Victoria, Australia, 3021
- Recruiting
- Western Health - Sunshine Hospital
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Principal Investigator:
- William Renwick
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Contact:
- Site Contact
- Email: william.renwick@wh.org.au
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Recruiting
- Fiona Stanley Hospital
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Contact:
- Site Contact
- Email: Paul.Cannell@health.wa.gov.au
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Principal Investigator:
- Paul Cannell
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Linz, Austria, 4020
- Recruiting
- A O Krankenhaus der Elisabethinen
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Principal Investigator:
- Irene Strassl
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Contact:
- Site Contact
- Email: irene.strassl@ordensklinikum.at
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Sankt Pölten, Austria, 3100
- Recruiting
- Universitaetsklinikum St. Poelten
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Principal Investigator:
- Petra Pichler
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Contact:
- Site Contact
- Phone Number: 43 2742 9004 22181
- Email: petra.pichler@stpoelten.lknoe.at
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Vienna, Austria, 1060
- Recruiting
- Krankenhaus der Barmherzigen Schwestern Wien
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Contact:
- Site Contact
- Email: evamaria.autzinger@bhs.at
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Principal Investigator:
- Eva Maria Autzinger
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Quebec
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Montreal, Quebec, Canada, H2X 0A9
- Recruiting
- Centre Hospitalier de L'Universite de Montreal
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Contact:
- Site Contact
- Email: hugo.chapdelaine.chum@ssss.gouv.qc.ca
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Principal Investigator:
- Hugo Chapdelaine
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Odense, Denmark, 5000
- Recruiting
- Odense Universitetshospital
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Contact:
- Site Contact
- Email: ida.bruun.kristensen@rsyd.dk
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Principal Investigator:
- Ida Bruun Kristensen
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Athens, Greece, 105 57
- Recruiting
- Alexandra General Hospital of Athens
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Contact:
- Site Contact
- Email: mdimop@med.uoa.gr
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Principal Investigator:
- Meletios-Athanasios Dimopoulos
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Kaposvár, Hungary, 7400
- Recruiting
- Somogy Megyei Kaposi Mor Oktato Korhaz
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Contact:
- Site Contact
- Phone Number: 368250341
- Email: rajnicsp@hotmail.com
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Principal Investigator:
- Peter Rajnics
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Torrette, Italy, 60126
- Recruiting
- Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
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Principal Investigator:
- Massimo Offidani
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Contact:
- Site Contact
- Email: massimo.offidani@ospedaliriuniti.marche.it
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Amsterdam, Netherlands, 1019PE
- Recruiting
- Amsterdam University Medical Center (Amsterdam UMC)
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Contact:
- Site Contact
- Email: n.vandedonk@vumc.nl
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Principal Investigator:
- Niels Van de Donk
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Nieuwegein, Netherlands, 3435
- Recruiting
- St. Antonius Ziekenhuis
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Contact:
- Site Contact
- Email: i.nijhof@antoniusziekenhuis.nl
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Principal Investigator:
- Inger Nijhof
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Skorzewo, Poland, 60-185
- Recruiting
- AIDPORT Sp. z o.o.
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Principal Investigator:
- Michal Kwiatek
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Contact:
- Site Contact
- Email: michal.kwiatek@aidport.pl
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Marbella, Spain, 29603
- Recruiting
- Hospital Costa Del Sol
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Principal Investigator:
- Maria Casanova
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Contact:
- Site Contact
- Phone Number: 951976776
- Email: Mariacasanova@yahoo.com
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Palma de Mallorca, Spain, 7120
- Recruiting
- Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD)
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Contact:
- Site Contact
- Phone Number: 65122 34871205000
- Email: albert.perez@ssib.es
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Principal Investigator:
- Albert Perez Montana
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Valencia, Spain, 46026
- Recruiting
- Hospital Universitari i Politecnic La Fe
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Principal Investigator:
- Javier de la Rubia Comos
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Contact:
- Site Contact
- Email: delarubia_jav@gva.es
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Stafford, United Kingdom, ST16 3SA
- Recruiting
- County Hospital (Stafford Hospital)
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Principal Investigator:
- Kamaraj Karunanithi
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Contact:
- Site Contact
- Phone Number: 01782671095
- Email: kamaraj.karunanithi@uhns.nhs.uk
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Gloucestershire
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Gloucester, Gloucestershire, United Kingdom, GL1 3NN
- Recruiting
- Gloucestershire Royal Hospital
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Principal Investigator:
- Asha Johny
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Contact:
- Site Contact
- Phone Number: 03004225246
- Email: asha.johny@nhs.net
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South Glamorgan
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Cardiff, South Glamorgan, United Kingdom, CF14 4XU
- Recruiting
- Cardiff & Vale University Health Board
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Principal Investigator:
- Ceri Bygrave
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Contact:
- Site Contact
- Phone Number: 07538800643
- Email: Ceri.Bygrave@wales.nhs.uk
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Alabama
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Mobile, Alabama, United States, 36604
- Recruiting
- Infirmary Health - Diagnostic & Medical Clinic (DMC)
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Principal Investigator:
- Furhan Yunus
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Contact:
- Site Contact
- Phone Number: 251-435-5710
- Email: furhan.yunus@infirmaryhealth.org
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California
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Orange, California, United States, 92868
- Recruiting
- Chao Family Comprehensive Cancer Center UCI
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Contact:
- Site Contact
- Email: enelson@uci.edu
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Principal Investigator:
- Edward Nelson
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Kansas
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Westwood, Kansas, United States, 66205
- Recruiting
- University of Kansas
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Principal Investigator:
- Jeries Kort
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Contact:
- Site Contact
- Email: jkort@kumc.edu
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Maryland
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Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland | Greenebaum Cancer Center
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Principal Investigator:
- Mehmet Kocoglu
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Contact:
- Site Contact
- Phone Number: 410-328-6842
- Email: mkocoglu@umm.edu
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Michigan
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Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Health System
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Principal Investigator:
- Philip Kuriakose
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Contact:
- Site Contact
- Phone Number: 313-916-2772
- Email: pkuriak1@hfhs.org
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Missouri
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St Louis, Missouri, United States, 63141
- Recruiting
- Washington University School of Medicine
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Contact:
- Site Contact
- Phone Number: 314-454-8304
- Email: markschroeder@wustl.edu
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Principal Investigator:
- Mark Schroeder
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New York
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Albany, New York, United States, 12208
- Recruiting
- New York Oncology Hematology
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Principal Investigator:
- Courtney Marie Bellomo
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Contact:
- Site Contact
- Phone Number: 518-262-6696
- Email: Courtney.bellomo@nyoh.com
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 within the first 8 weeks of their planned treatment schedule and are planned to receive teclistamab for the next 12 months.
- The participant or the participant's legally acceptable representative 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.
Exclusion Criteria:
- The participant has not achieved at least a minimal response to teclistamab within 8 weeks during the screening period.
- 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 any time before 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.
- The participant has moderate to severe renal dysfunction based on an estimated glomerular filtration rate less than or equal to (<=) 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.
- 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.
- The participant has a persistent serum aspartate aminotransferase and alanine aminotransferase >3.0 times the upper limit of normal 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.
- 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.
- Known substance abuse including opiates, psychostimulant agents, or other illicit drugs with the exception of cannabinoids within 12 months of screening.
- 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.
- 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 or the participant's legally designated representative is not willing and able to comply with the protocol requirements.
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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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%, intravenously (IV) every 3 or 4 weeks within 3 days after randomization up to 12 months.
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IGI, 10% IV infusion.
Other Names:
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Active Comparator: Secondary Infection Prophylaxis: IGI, 10%
Participants randomized to secondary infection prophylaxis will receive a 400 mg/kg dose of IGI, 10%, 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.
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IGI, 10% IV infusion.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Time To the First Serious Infection
Time Frame: Up to 12 months
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Up to 12 months
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants With at Least 1 Serious Infection
Time Frame: Up to 12 months
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Up to 12 months
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Annualized Rate of Days on Antibiotics for Treatment of Bacterial Infections
Time Frame: Up to 12 months
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Up to 12 months
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Annualized Rate of Bacterial Infections
Time Frame: Up to 12 months
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Up to 12 months
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Annualized Rate of Serious Infections
Time Frame: Up to 12 months
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Up to 12 months
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Annualized Rate of Acute Serious Bacterial Infections (ASBIs)
Time Frame: Up to 12 months
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Up to 12 months
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Number of Participants With Any Infections
Time Frame: Up to 12 months
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Up to 12 months
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Duration of Infections
Time Frame: Up to 12 months
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Up to 12 months
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Time To Any First Infection
Time Frame: Up to 12 months
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Up to 12 months
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Annualized Rate of Any Infections
Time Frame: Up to 12 months
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Up to 12 months
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Number of Participants With Bacterial/Viral Infection/Fungal Infection
Time Frame: Up to 12 months
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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.
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Up to 12 months
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Annualized Rate of Episodes of Fever due to Infections
Time Frame: Up to 12 months
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Up to 12 months
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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
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3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
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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
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3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
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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
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3-Week dosing: Day 1 up to Day 357; 4-Week dosing: Day 1 up to Day 364
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Number of Participants With Adverse Event (AEs) and Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 12 months
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Up to 12 months
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Number of Participants With TEAEs Related to IGI, 10%
Time Frame: Up to 12 months
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Up to 12 months
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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)
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Within 72 hours of IGI, 10% administration (up to 12 months)
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Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TEAEs Related to IGI, 10%
Time Frame: Up to 12 months
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Up to 12 months
|
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Number of Participants With at Least 1 Hospitalization due to Infection
Time Frame: Up to 12 months
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Up to 12 months
|
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Number of Hospitalizations, Including Intensive Care Unit (ICU) and Non-ICU due to Infection
Time Frame: Up to 12 months
|
Up to 12 months
|
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Number of Participants With Outpatient Visits, Including Emergency Room (ER) Visits due to Infection
Time Frame: Up to 12 months
|
Up to 12 months
|
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Duration of Hospitalizations, Including ICU and Non-ICU due to Infection
Time Frame: Up to 12 months
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Up to 12 months
|
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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
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Study Director, Takeda
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Hemic and Lymphatic Diseases
- Multiple Myeloma
- Immunologic Factors
- Physiological Effects of Drugs
- Immunoglobulins, Intravenous
Other Study ID Numbers
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)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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