Actively Recruiting
A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
Led by Takeda · Updated on 2026-04-06
183
Participants Needed
24
Research Sites
138 weeks
Total Duration
On this page
Sponsors
T
Takeda
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 of up to 8 weeks).
CONDITIONS
Official Title
A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of Multiple Myeloma according to International Myeloma Working Group guidelines before enrollment
- Started teclistamab within the first 8 weeks of planned treatment and planned to receive it for the next 12 months
- Provided signed and dated informed consent before any study procedures
- At least 18 years of age at the time of signing informed consent
- If of childbearing potential, agree to use a highly effective contraceptive method and avoid donating ova from screening until 30 days after last study drug dose
You will not qualify if you...
- Has not achieved at least a minimal response to teclistamab within 8 weeks during screening
- Has a current serious infection or more than one serious infection in the past 3 months before screening
- Polyclonal IgG level less than 150 mg/dL before teclistamab initiation
- Currently receiving or received immunoglobulin products within 16 weeks before screening
- Received hyperimmune or specialty high-titer immunoglobulin product within 30 days before screening
- Received live viral vaccines within 30 days before screening
- Eastern Cooperative Oncology Group performance status score greater than 2
- Active viral or bacterial infection requiring treatment within 1 week before enrollment
- Received other BCMAxCD3-directed bispecific antibody therapy before screening
- Scheduled for plasmapheresis during study or had it within 16 weeks before screening
- High risk for symptomatic hyperviscosity syndrome as judged by investigator
- Major surgery scheduled during study or not fully recovered from recent major surgery
- Active secondary malignancy or medical condition with life expectancy less than 2 years
- History of hypersensitivity or severe reactions to IVIG or immune serum globulin infusions
- History or diagnosis of thromboembolic episodes within 6 months before screening
- Moderate to severe renal dysfunction (eGFR ≤30 mL/min/1.73 m²) at screening
- Positive for hepatitis B surface antigen, hepatitis C virus PCR, or HIV PCR at screening
- Diagnosis of primary immunodeficiency requiring IgG replacement
- Persistent elevated liver enzymes at screening
- IgA deficiency with antibodies to IgA and history of hypersensitivity to IVIG
- Known systemic hypersensitivity to IGI, 10% excipients
- Known substance abuse within 12 months before screening (except cannabinoids)
- Anemia precluding phlebotomy for lab studies
- Medical condition or findings interfering with study completion or causing undue risk
- Receiving or planning immunosuppressive treatment other than for MM or corticosteroids
- Unwilling or unable to comply with protocol requirements
- Participation in another investigational study within 30 days before screening or during study
- Family member or employee of investigator or site staff
- Pregnant, lactating, or positive pregnancy test at screening or enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Infirmary Health - Diagnostic & Medical Clinic (DMC)
Mobile, Alabama, United States, 36604
Actively Recruiting
2
Chao Family Comprehensive Cancer Center UCI
Orange, California, United States, 92868
Actively Recruiting
3
University of Kansas
Westwood, Kansas, United States, 66205
Actively Recruiting
4
University of Maryland | Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
5
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
6
Washington University School of Medicine
St Louis, Missouri, United States, 63141
Actively Recruiting
7
New York Oncology Hematology
Albany, New York, United States, 12208
Actively Recruiting
8
St George Private Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
9
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
10
Universitaetsklinikum St. Poelten
Sankt Pölten, Austria, 3100
Actively Recruiting
11
Krankenhaus der Barmherzigen Schwestern Wien
Vienna, Austria, 1060
Actively Recruiting
12
Odense Universitetshospital
Odense, Denmark, 5000
Actively Recruiting
13
Alexandra General Hospital of Athens
Athens, Greece, 105 57
Actively Recruiting
14
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, Hungary, 7400
Actively Recruiting
15
Azienda Ospedaliero-Universitaria delle Marche; SOD Clinica Medica
Torrette, Italy, 60126
Actively Recruiting
16
Amsterdam University Medical Center (Amsterdam UMC)
Amsterdam, Netherlands, 1019PE
Actively Recruiting
17
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435
Actively Recruiting
18
Aidport sp. z o.o.
Skorzewo, Poland, 60-185
Actively Recruiting
19
Hospital Costa Del Sol
Marbella, Spain, 29603
Actively Recruiting
20
Hospital Universitari Son Espases (HUSE) (Hospital Universitario Son Dureta) (HUSD)
Palma de Mallorca, Spain, 7120
Actively Recruiting
21
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
22
Gloucestershire Royal Hospital
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
Actively Recruiting
23
Cardiff & Vale University Health Board
Cardiff, South Glamorgan, United Kingdom, CF14 4XU
Actively Recruiting
24
County Hospital (Stafford Hospital)
Stafford, United Kingdom, ST16 3SA
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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