At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- IGI, 10% (biological)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- IGI, 10% — biological: IGI, 10% IV infusion.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 183
- Started
- 2026-01-14
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for multiple myeloma
- • Phase3 - 183 participants
- • Multiple myeloma is a cancer of the plasma cells in the bone marrow
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with multiple myeloma
Where?
- • Exeter - Royal Devon And Exeter Hospital
- • Colcester - Colchester General Hospital
- • Gloucester - Gloucestershire Royal Hospital
- • Cardiff - Cardiff & Vale University Health Board
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ privacy authorization
What the study is looking for
- ✓The participants must have a documented diagnosis of Multiple Myeloma (MM) according to the guidelines by the...
- ✓Participant who recently started teclistamab monotherapy within the first 8 weeks of their planned treatment...
- ✓The participant is at least 18 years of age at the time of signing the ICF.
- ✓To use a highly effective contraceptive method.
- ✓To avoid donating ova.
Who cannot take part
- ✗The participant has not achieved at least a minimal response to teclistamab during the screening period after...
- ✗The participant has a current serious infection or greater than (\>) 1 serious infection in the past 3 months before...
- ✗The participant is currently receiving immunoglobulin products or has received immunoglobulin products within 16...
- ✗The participant has received live viral vaccines within 30 days before screening.
- ✗The participant has an activity scale performance status score of \>2.
See the full criteria
Where Is This Study? (6 UK sites)
Royal Devon And Exeter Hospital
Exeter EX2 5DH, United Kingdom
Colchester General Hospital
Colcester CO4 5JL, United Kingdom
Gloucestershire Royal Hospital
Gloucester GL1 3NN, United Kingdom
Cardiff & Vale University Health Board
Cardiff 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
How to Get in Touch
Takeda Contact
Sponsor contactCONTACT
