A Phase 2, Randomized, Parallel, Open-Label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-Agent Belantamab Mafodotin (GSK2857916) in Participants with Relapsed or Refractory Multiple Myeloma (DREAMM-14)
This study is investigating a new medication, belantamab mafodotin, for people in the UK living with multiple myeloma. This is a type of blood cancer that affects plasma cells. The study focuses on participants whose multiple myeloma has returned after previous treatments or has not responded to other medicines. Scientists want to understand how safe the new medication is, especially checking for any effects on the eyes. They'll also be looking at how well the medication works to shrink or control the cancer, and how the body handles the medicine. This is a Phase 2 study, which means it builds on earlier research to gather more information on safety and effectiveness in a larger group of people.
At a glance
What is this study about?
This study is for adults with multiple myeloma, a type of blood cancer, whose disease has either returned after treatment or hasn't responded to other medicines. Researchers are testing a new drug called belantamab mafodotin (you might hear it called GSK2857916) to see if it's a safe and effective treatment option. The study is particularly interested in understanding how different doses of this medicine affect people, and especially how it might impact their eyes.
Because this medicine can sometimes cause changes to the eyes, a big part of the study focuses on carefully monitoring eye health. Doctors will be checking for any eye problems and how often they occur, as well as how severe they might be. This information is really important for making sure the medicine can be given as safely as possible in the future.
Beyond eye safety, the study will also measure how well the medicine works against the cancer. This includes looking at whether the cancer shrinks or stops growing, how long these effects last, and how long people live after starting the treatment. They'll also find out how the body processes the medicine, which helps them understand the best way to give it.
Key takeaways
- This study tests a new treatment for relapsed or refractory multiple myeloma.
- It's a Phase 2 study, focused on safety (especially eye effects) and effectiveness.
- Adults aged 18+ with specific types of multiple myeloma may be eligible.
- Participation involves regular medical check-ups and detailed eye assessments.
- No placebo is used; all participants will receive the active study medicine.
Who may be eligible?
To join this study, you must be an adult aged 18 years or older with multiple myeloma. Your multiple myeloma needs to be considered 'relapsed' (meaning it has come back after previous treatment) or 'refractory' (meaning it has not responded to other treatments given in the past).
There might be other specific health requirements or conditions that would make someone suitable or unsuitable for the study. These are put in place to ensure the safety of everyone taking part and to make sure the study results are clear.
Both men and women are welcome to participate. Your medical team will review all the detailed criteria to see if this study could be a good option for you.
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 18 years old or older?
- Do you have multiple myeloma?
- Has your multiple myeloma come back after previous treatment?
- Has your multiple myeloma not responded to other treatments you've tried?
What does participation involve?
If you decide to take part, you'll receive the study medicine, belantamab mafodotin, according to one of the dosing plans being tested. You will have regular visits to the clinic for medical check-ups, blood tests, and detailed eye examinations. These eye checks are very important because the study is closely monitoring for any changes to your eyes. You'll likely have these checks before, during, and after receiving the treatment.
Your study doctor and nurses will guide you through all the necessary appointments, explain any procedures, and monitor your health closely throughout the study. The total duration of your participation will depend on how you respond to the treatment and the study’s protocol, but there will be ongoing follow-up to track your health and any long-term effects.
Potential risks and benefits
Locations (7)
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- —UnverifiedGreece
- —UnverifiedFrance
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in the plasma cells in your bone marrow, which are a type of white blood cell.
What does 'relapsed or refractory' mean?
It means the cancer has either come back after previous treatment or didn't respond to the treatments you've had so far.
What is a Phase 2 study?
Phase 2 studies focus on understanding how safe a new medicine is and how well it works for a specific condition, in a slightly larger group of people than earlier studies.
What are 'corneal events'?
These are changes or problems with the cornea, which is the clear, outer layer at the front of your eye. The study will monitor these very carefully.
Will I know if I'm getting the active drug?
This study is 'open-label', meaning both you and your study team will know you are receiving the active drug, belantamab mafodotin. There is no placebo group.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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