Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma
This research study is for adults newly diagnosed with multiple myeloma. The main goal is to test a new combination treatment that includes a drug called belantamab mafodotin along with standard therapies (Velcade, Revlimid, and dexamethasone). Researchers want to find out how safe this new combination is, how the body handles the drugs, and if it helps treat the cancer. They are also looking to find the best dose of belantamab mafodotin to use in future studies. Participants will receive a mix of these treatments in cycles, with belantamab mafodotin given at different schedules depending on the group they are in. Eventually, the study will check how well people are doing after treatment ends.
At a glance
What is this study about?
This study is about finding new and better ways to treat multiple myeloma, a type of blood cancer that affects plasma cells. If you've recently been diagnosed with multiple myeloma and need treatment, this study might be relevant to you. Doctors are trying out a new approach that combines a drug called belantamab mafodotin with the standard treatment often used for this condition, which includes Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone. We'll simply call this standard treatment "VRd" for short.
The main aim is to see if adding belantamab mafodotin to VRd is a safe and effective way to treat newly diagnosed multiple myeloma. Safety is always the top priority in these kinds of studies. Researchers will also be looking at how the drugs work in your body and how your cancer responds to the new combination. Importantly, they're trying to figure out the best amount, or "dose," of belantamab mafodotin to give alongside the standard treatments so that it's most helpful with the fewest side effects.
Taking part in this study means you would receive a combination of these medications. The VRd part of the treatment is given in cycles, usually lasting three weeks, for the first eight cycles. After that, the treatment changes slightly to a combination of Revlimid and dexamethasone (called "Rd"), given in four-week cycles. The new drug, belantamab mafodotin, will be added to these cycles on a schedule that depends on which group you're assigned to – sometimes every 3, 6, or 9 weeks initially, and then every 4, 8, or 12 weeks later on. The study will monitor progress throughout and follow up after treatment stops to see how you're doing.
Key takeaways
- This study is for adults newly diagnosed with multiple myeloma.
- It tests a new drug, belantamab mafodotin, with standard treatments (VRd or Rd).
- The main goals are to check safety, effectiveness, and find the right dose.
- Participation involves regular clinic visits for treatment and health checks.
- You must not be suitable for a stem cell transplant to join.
- You can stop participating at any time.
Who may be eligible?
To be able to join this study, you need to be an adult over 18 who has recently been diagnosed with multiple myeloma and requires treatment. Your doctors must confirm your diagnosis using specific international guidelines.
You also need to have measurable signs of your cancer, meaning doctors can clearly see and track the disease with tests. This is important so they can tell if the treatment is working. Another key point is that you should not be suitable for a stem cell transplant, perhaps because of other health conditions like heart or lung problems that might make that treatment too risky for you.
Finally, you'll need to be generally well enough to take part in a study like this. This includes having good overall health, as measured by your doctor (an ECOG score of 0-2), and your major organs like your kidneys, liver, and blood systems, need to be working within certain healthy limits.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult aged 18 or over?
- Have you recently been diagnosed with multiple myeloma and need treatment?
- Do you have measurable signs of your cancer (e.g., in blood or urine tests)?
- Are you not able to have a stem cell transplant due to other health issues?
- Are your major organs (like kidneys, liver, and blood) working within healthy limits?
- Are you generally well enough for a study, as assessed by your doctor?
What does participation involve?
If you decide to take part in this study, you will receive a combination of medications. Initially, for the first eight treatment cycles (each lasting three weeks), you will get the standard VRd treatment along with belantamab mafodotin. The belantamab mafodotin will be given either every 3, 6, or 9 weeks, depending on which group you are in. After these first eight cycles, the treatment will switch to a combination of Revlimid and dexamethasone (Rd), given in four-week cycles, with belantamab mafodotin added either every 4, 8, or 12 weeks.
You will have regular appointments for these treatments and to monitor your health. These visits will involve various tests and assessments to see how you are responding to the medication and to check for any side effects. The study will continue until your doctor decides to stop your treatment, which could be due to your health, side effects, or if the treatment is no longer working as well. Once your treatment ends, you'll have a final visit to check everything, followed by another safety check-up about 70 days later. The total duration of your participation will depend on how you respond to the treatment and for how long your doctor feels it is beneficial.
Potential risks and benefits
Locations (30)
- GSK Investigational SiteVerified postcodeWestwood, United States
- GSK Investigational SiteVerified postcodeCharlotte, United States
- GSK Investigational SiteVerified postcodeMadison, United States
- GSK Investigational SiteVerified postcodeNewcastle, Australia
- GSK Investigational SiteVerified postcodeClayton, Australia
- GSK Investigational SiteVerified postcodeFitzroy, Australia
- GSK Investigational SiteVerified postcodeEdmonton, Canada
- GSK Investigational SiteVerified postcodeLondon, Canada
- GSK Investigational SiteVerified postcodePoitiers, France
- GSK Investigational SiteVerified postcodeDresden, Germany
- GSK Investigational SiteVerified postcodeHamburg, Germany
- GSK Investigational SiteVerified postcodeSchwerin, Germany
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in the plasma cells in your bone marrow.
What is belantamab mafodotin?
It's a medication that targets cancer cells in a specific way, and this study aims to see how it works with other treatments.
Why are they studying this new combination?
Doctors want to find out if combining belantamab mafodotin with standard treatments can be a safer and more effective way to treat newly diagnosed multiple myeloma.
Will I know which treatment schedule I'm on?
Yes, your study doctor will explain which group you are assigned to and the schedule for your medication.
What happens after the treatment finishes?
You'll have a final visit to check your health and then another safety check-up about 70 days later.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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