A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)
This research study is for adults with multiple myeloma, a type of blood cancer, that has either returned after previous treatment or isn't getting better with current medicines. The main aim is to test a new approach using a drug called belantamab mafodotin. We want to see if giving this drug less frequently, alongside standard cancer treatments, can still be effective at fighting the cancer. A key focus is to check if this new schedule can reduce side effects, especially those affecting the eyes. The study will also carefully monitor how well the treatment works overall, including its impact on the cancer, and make sure it is safe for the people taking part.
At a glance
What is this study about?
This study is looking for better ways to treat multiple myeloma, which is a type of blood cancer. Sometimes, even after treatment, the cancer can come back or stop responding to the medicines. When this happens, it's called 'relapsed-refractory multiple myeloma'.
The main medicine we're looking at in this study is called belantamab mafodotin. It's already used to treat multiple myeloma. However, it can sometimes cause side effects, particularly with the eyes. In this study, we're trying a new schedule where belantamab mafodotin is given less often, but still combined with other standard cancer drugs like Dexamethasone, Pomalidomide, Bortezomib, or Carfilzomib. The idea is that giving the medicine less often might make it easier to tolerate and reduce some of those side effects, especially eye problems, while still being effective against the cancer.
We will be carefully checking how well this new treatment plan works against the cancer and how safe it is for the people taking part. The aim is to find a way for patients to get the benefits of the treatment with potentially fewer discomforts, making their treatment journey a bit smoother.
Key takeaways
- This study explores a new way to give an existing multiple myeloma drug.
- The goal is to reduce eye-related side effects by giving the drug less often.
- It's for adults with multiple myeloma that has come back or isn't responding to prior treatments.
- You'll receive the study drug along with other standard cancer medicines.
- Safety and effectiveness will be closely monitored throughout.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
This study is for adults, aged 18 or older, who have been diagnosed with multiple myeloma. Your cancer must have previously been treated with one or two different types of therapy, but it either came back or didn't get better after those treatments. You also need to be generally well enough to take part in a study, as assessed by your doctor.
To join, your multiple myeloma must still be 'measurable', meaning doctors can track its progress through certain blood or urine tests. If you've had a stem cell transplant in the past, that's okay, but it must have been more than 100 days ago and you shouldn't have any active infections. Any side effects from your previous treatments must also have mostly cleared up, or only be very mild, except for hair loss.
There are also requirements concerning organ function, which will be checked by blood tests, and strict contraception rules for both men and women to prevent pregnancy during the study.
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?
- Have you been diagnosed with multiple myeloma that has come back or isn't responding to past treatments?
- Have you had 1 or 2 types of multiple myeloma treatment before?
- Are you generally well enough for a study, as assessed by your doctor?
- Can your multiple myeloma be measured by blood or urine tests?
What does participation involve?
If you join this study, you'll receive the study treatment, which involves belantamab mafodotin given less often alongside other standard cancer medicines. You will have regular visits to the clinic for medical examinations, blood tests, and other assessments to check your health, how the treatment is working, and if you are experiencing any side effects. You'll also need to follow strict contraception rules throughout the study period. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be monitored closely throughout.
Potential risks and benefits
Locations (27)
- GSK Investigational SiteVerified postcodeLos Alamitos, United States· Recruiting
- GSK Investigational SiteVerified postcodeTorrance, United States· Recruiting
- GSK Investigational SiteVerified postcodeWhittier, United States· Recruiting
- GSK Investigational SiteVerified postcodeFort Myers, United States· Recruiting
- GSK Investigational SiteVerified postcodeMacon, United States· Recruiting
- GSK Investigational SiteVerified postcodeBethesda, United States· Recruiting
- GSK Investigational SiteVerified postcodeBridgeton, United States· Recruiting
- GSK Investigational SiteVerified postcodeSpringfield, United States· Recruiting
- GSK Investigational SiteVerified postcodeFarmington, United States· Recruiting
- GSK Investigational SiteVerified postcodeParis, France· Recruiting
- GSK Investigational SiteVerified postcodeParis, France· Recruiting
- GSK Investigational SiteVerified postcodeKoblenz, Germany· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in your bone marrow.
What does 'relapsed-refractory' mean?
This means your multiple myeloma has either come back after previous treatment, or it isn't responding well to the treatments you've had so far.
What is belantamab mafodotin?
It's a medicine already used to treat multiple myeloma. This study is exploring if giving it less often can reduce side effects, especially eye problems.
Will I still receive my other cancer medicines?
Yes, belantamab mafodotin will be given alongside other standard cancer medicines you might already be familiar with.
How long will I be in the study?
The length of time you'll be in the study can vary. It depends on how you respond to the treatment and what your study doctor decides.
How to find out more
US GSK Clinical Trials Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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