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
- Belantamab mafodotin (drug), Lenalidomide (drug), Dexamethasone (drug), Daratumumab (drug)
- How long the study runs
- Study runs about 76 months (dates as stated)
- About the drug or intervention
- Belantamab mafodotin — drug: Belantamab mafodotin will be administered. · Lenalidomide — drug: Lenalidomide will be administered. · Dexamethasone — drug: Dexamethasone will be administered. · Daratumumab — drug: Daratumumab will be administered.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at two treatment combinations for people newly diagnosed with multiple myeloma, a cancer of the blood, who cannot have a stem cell transplant using their own cells. One group will receive belantamab mafodotin with lenalidomide and dexamethasone, while the other group will receive daratumumab with lenalidomide and dexamethasone. The study is funded by GlaxoSmithKline.
Who can take part
- Adults aged 18 or over (or the legal age of consent where the study takes place) who can give informed consent.
- Newly diagnosed multiple myeloma that needs treatment, with at least one sign of measurable disease found in blood or urine tests.
- Not able to have high-dose chemotherapy with a stem cell transplant using their own cells, either because of age limits where they live or because of other health problems.
- Able to carry out day-to-day activities at least some of the time (performance status score of 0 to 2).
- Good enough organ function based on blood tests.
- Men must follow rules about using contraception and not donating sperm during treatment and for at least 6 months after the last dose.
- Women must not be pregnant or breastfeeding, and women who could become pregnant must use highly effective contraception during treatment and for 4 months after the last dose, and not donate eggs.
Who may not be able to
- Certain related conditions, such as systemic AL amyloidosis, Waldenstrom's disease, POEMS syndrome, or primary plasma cell leukaemia.
- Any previous whole-body treatment for multiple myeloma or smouldering multiple myeloma.
- Signs that the myeloma has spread to the brain or spinal cord coverings.
- Major surgery in the 2 weeks before the first dose, or not fully recovered from surgery.
- Serious or unstable medical or mental health problems that could affect safety or taking part.
- Current liver or bile disease (with some exceptions, such as Gilbert's syndrome or symptom-free gallstones).
- Other cancers, unless stable for at least 2 years and agreed with the study's medical monitor.
- Certain heart problems, such as untreated abnormal heart rhythms, a recent heart attack or heart procedure (within 3 months), or severe heart failure.
- HIV infection, unless strict conditions are met.
- Hepatitis B or C, unless strict conditions are met.
- Current disease of the surface of the eye (the cornea), apart from a mild form.
- Cannot tolerate medicines used to prevent viral infections or blood clots.
- Allergy or bad reaction to belantamab mafodotin or similar drugs.
- Plasma exchange treatment within 7 days before the first dose.
- Live or live-attenuated vaccines within 30 days before the first dose of belantamab mafodotin.
What taking part involves
- • Taking one of two drug combinations: either belantamab mafodotin with lenalidomide and dexamethasone, or daratumumab with lenalidomide and dexamethasone. Not stated — ask the trial team for details on how each drug is given.
- • Not stated — ask the trial team for details about tests, scans and other procedures.
Time commitment: Not stated — ask the trial team about how long the study lasts, how often visits happen, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 520
- Started
- 2024-12-16
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for multiple myeloma
- • Phase3 - 520 participants
- • The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with multiple myeloma
Where?
- • Leicester - GSK Investigational Site
- • Middlesbrough - GSK Investigational Site
- • Oxford - GSK Investigational Site
- • Plymouth - GSK Investigational Site
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.
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:
- ✓ 2 negative highly sensitive serum pregnancy tests
Treatments you must NOT have had:
- ✗ or concurrent malignancies other than multiple myeloma
- ✗ a live or live-attenuated vaccine
What the study is looking for
- ✓Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of...
- ✓Capable of giving signed agreement to take part, which includes compliance with the requirements and restrictions listed...
- ✓NDMM with a requirement for treatment as documented per IMWG criteria.
- ✓Must have at least 1 aspect of cancer that can be measured on scans, as assessed by the central laboratory, defined as 1 of the following:
- ✓Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or
Who cannot take part
- ✗Prior treatment that goes through your whole body for multiple myeloma, or smoldering multiple myeloma.
- ✗Signs of meningeal or central nervous system involvement with multiple myeloma.
- ✗Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery....
- ✗Current active liver or biliary disease (except for Gilbert's syndrome or not causing symptoms gallstones, or otherwise...
- ✗Evidence of cardiovascular risk including any of the following:
See the full criteria
Where Is This Study? (5 UK sites)
GSK Investigational Site
Leicester LE1 5WW, United Kingdom
GSK Investigational Site
Middlesbrough TS4 3BW, United Kingdom
GSK Investigational Site
Oxford OX3 7LE, United Kingdom
GSK Investigational Site
Plymouth PL6 8DH, United Kingdom
GSK Investigational Site
Wolverhampton WV10 0QP, United Kingdom
How to Get in Touch
US GSK Clinical Trials Call Center
Sponsor contactCONTACT
EU GSK Clinical Trials Call Center
Sponsor contactCONTACT
