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 (drug), Belantamab mafodotin (drug), Pomalidomide (drug), Dexamethasone (drug)
- How long the study runs
- Study runs about 62 months (dates as stated)
- About the drug or intervention
- Belantamab — drug: Belantamab will be administered. · Belantamab mafodotin — drug: Belantamab mafodotin will be administered. · Pomalidomide — drug: Pomalidomide will be administered. · Dexamethasone — drug: Dexamethasone will be administered.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether a drug called belantamab is safe and works well for people with multiple myeloma, a cancer of the blood. It is given both on its own and together with other treatments. The study is run by GlaxoSmithKline and has three parts with different groups of patients.
Who can take part
- Adults aged 18 or over (or the legal age of consent where the study takes place) with confirmed multiple myeloma that got worse after their last treatment
- Parts 1 and 2: people who have already had at least 3 previous treatments, including certain types of anti-myeloma drugs (an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 monoclonal antibody)
- Part 3: people who have had at least 1 previous treatment including lenalidomide
- People who have had a stem cell transplant using their own cells can take part if it was more than 100 days ago and they have no active infection
- Being well enough for everyday activity (performance status score of 0 to 2)
- Having measurable disease, shown by tests of protein levels in blood or urine
- Adequate organ function shown by blood tests, and side effects from earlier treatments mostly settled
- Women who could become pregnant, and men, must follow strict rules about contraception during and after the study
Who may not be able to
- People with certain related conditions, such as AL amyloidosis, POEMS syndrome, or primary plasma cell leukaemia
- People whose myeloma has spread to the brain or spinal cord covering
- Part 2: people with current corneal (surface of the eye) disease, apart from one mild type
- People with serious liver disease such as cirrhosis, or certain heart problems (for example recent heart attack, severe heart failure, or uncontrolled high blood pressure)
- People who have had another cancer in the last 2 years, with some exceptions
- People allergic to belantamab or similar drugs, or with a history of severe allergic reactions to monoclonal antibodies
- People with an active infection needing treatment, HIV (unless specific criteria are met), or hepatitis B or C (unless specific criteria are met)
- People needing dialysis or with an active kidney problem (protein in the urine caused by myeloma is allowed)
- People who have had a stem cell transplant from a donor, or CAR T-cell therapy (a treatment using altered immune cells) with chemotherapy within 3 months
- People who had radiotherapy in the last 2 weeks, major surgery in the last 2 weeks, plasmapheresis in the last 7 days, or certain recent treatments including a recent monoclonal antibody or other anti-cancer drug
- Part 1: people whose myeloma did not respond to belantamab mafodotin; Part 2: any prior belantamab mafodotin; Part 3: prior belantamab, belantamab mafodotin, or pomalidomide
- Part 3: people with blood clots in the last 3 months or who cannot take blood-thinning prevention treatment
- People who have had live vaccines in the last 30 days or during treatment (and for 70 days after the last dose)
- People taking other anti-cancer treatments or other experimental drugs during the study
What taking part involves
- • Belantamab on its own or in combination with other treatments; the combinations allowed include pomalidomide and dexamethasone (a steroid)
- • Part 3 involves pomalidomide and dexamethasone as part of the treatment
- • Other anti-cancer treatments are not allowed during the study
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, 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
- 123
- Started
- 2023-06-14
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for multiple myeloma
- • Phase1/Phase2 - 123 participants
- • The study consists of three parts: * Part 1: The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with multiple myeloma
Where?
- • Leicester - GSK Investigational Site
- • Oxford - GSK Investigational Site
- • Plymouth - GSK Investigational Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The study consists of three parts: * Part 1: The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). * Part 2: The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different doses of belantamab in combination with a fixed dose of Belantamab mafodotin (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+). * Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the belantamab in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.
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:
- ✓ of treatment anti-myeloma treatments
- ✓ to use contraception
- ✓ anti-thrombotic prophylaxis
- ✓ other anti- B-cell maturation antigen (BCMA) directed agents is allowed
What the study is looking for
- ✓Inclusion criteria
- ✓Participants at the time of signing the agreement to take part Form (ICF) are at least 18 years old or are of the legal...
- ✓Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided...
- ✓transplant was greater than (\>)100 days prior to screening.
- ✓No active bacterial, viral, or fungal infection(s) present
See the full criteria
Where Is This Study? (3 UK sites)
GSK Investigational Site
Leicester LE1 5WW, United Kingdom
GSK Investigational Site
Oxford OX3 7LE, United Kingdom
GSK Investigational Site
Plymouth PL6 8DH, United Kingdom
How to Get in Touch
US GSK Clinical Trials Call Center
Sponsor contactCONTACT
EU GSK Clinical Trials Call Center
Sponsor contactCONTACT
