Pomalidomide in Relapsed and Refractory Multiple Myeloma (RRMM)
This study is investigating a treatment for multiple myeloma, a type of blood cancer, that has come back after previous treatments or isn't responding (relapsed or refractory multiple myeloma). Researchers are comparing two treatment approaches. One group will receive a combination of pomalidomide and dexamethasone. The other group will get these two drugs plus an additional drug called cyclophosphamide. The main goal is to see if adding cyclophosphamide helps people live longer without their cancer progressing. The study will also look at whether certain markers in their body can predict how well people respond to pomalidomide, which could help guide future treatment decisions in the UK.
At a glance
What is this study about?
Multiple myeloma is a type of blood cancer that affects plasma cells in the bone marrow. When multiple myeloma comes back after treatment or stops responding to available medicines, it can be very challenging to treat. Currently, there aren't many options for these patients, and the disease can progress quickly. Standard treatments in the UK for multiple myeloma that has relapsed often include combinations of drugs like bortezomib, lenalidomide, dexamethasone, and a type of drug called an alkylating agent (like cyclophosphamide). Adding cyclophosphamide has previously shown to improve treatment results for some patients and is generally well-tolerated.
This study is building on previous research that suggested combining pomalidomide, dexamethasone, and cyclophosphamide might be safe and helpful. The main purpose is to determine if adding cyclophosphamide to the pomalidomide and dexamethasone combination helps people with relapsed or refractory multiple myeloma live longer without their disease getting worse. This is known as "progression-free survival."
Beyond simply looking at how long people live without their disease progressing, the study also aims to identify features in a patient's body that might predict who will respond best to pomalidomide. This information is really important because it could help doctors make more informed decisions about treatment and assist organisations like NICE (the National Institute for Health and Care Excellence) in deciding how best to use pomalidomide to benefit patients in the UK.
Key takeaways
- This study is for people with multiple myeloma that has returned or isn't responding to previous treatments.
- It compares a two-drug combination (pomalidomide and dexamethasone) with a three-drug combination (adding cyclophosphamide).
- The main aim is to see if adding cyclophosphamide helps patients live longer without their cancer progressing.
- The study also hopes to find out who might best respond to pomalidomide treatment.
- Participation involves being randomly assigned to a treatment group and regular medical check-ups.
Who may be eligible?
To be able to take part in this study, you would need to have been diagnosed with multiple myeloma that is causing symptoms and can be measured. Your cancer must have either come back or not responded to previous treatments, and you must need new therapy. You should have already received at least two lines of treatment for your multiple myeloma. For example, if you had initial treatment followed by a stem cell transplant and then further treatment, this would count as one line of therapy.
It's important that you've also previously been treated with both lenalidomide and a proteasome inhibitor (another type of drug) and that these treatments haven't worked well enough. This could mean your disease got worse during or soon after taking them, or you didn't have a good enough response after several cycles, or you couldn't tolerate the medicines. You also need to have received enough of an "alkylator" type of drug, such as during a stem cell transplant or a few cycles of treatment.
Beyond your cancer history, you would need to be generally well enough to participate, with a life expectancy of at least 3 months and a good general fitness level (as assessed by your doctor). Your blood tests, specifically your neutrophil and platelet counts, would also need to be within a certain range. The study is open to both men and women, aged 18 and over.
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.
- Do I have symptomatic multiple myeloma that can be measured?
- Has my multiple myeloma come back or stopped responding to previous treatments?
- Have I had at least two lines of treatment for my multiple myeloma already?
- Have I previously been treated with both lenalidomide and a proteasome inhibitor, and these treatments didn't work well enough?
- Am I generally well enough to participate, with good blood counts?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will receive a combination of pomalidomide, dexamethasone, and cyclophosphamide. The other group will receive pomalidomide and dexamethasone. You or your doctor won't be able to choose which group you are in. You will continue to receive the assigned treatment until your disease starts to get worse or if you experience side effects that are too difficult to manage.
Taking part will involve regular visits to the hospital for assessments, blood tests, and to receive your medication. The specific schedule and duration of these visits will be explained in detail by the study team. You will be closely monitored throughout the study to track your progress and any side effects. The total duration of your participation will depend on how your disease responds to treatment and whether you experience any unacceptable side effects.
Potential risks and benefits
Locations (21)
- Belfast Health & Social Care TrustVerified postcodeBelfast, United Kingdom
- University of Birmingham NHS Foundation TrustVerified postcodeBirmingham, United Kingdom
- Birmingham Heartlands HospitalVerified postcodeBirmingham, United Kingdom
- Royal Sussex County HospitalVerified postcodeBrighton, United Kingdom
- Queens HospitalVerified postcodeBurton-on-Trent, United Kingdom
- University Hospital of Wales NHS TrustVerified postcodeCardiff, United Kingdom
- Ninewells HospitalVerified postcodeDundee, United Kingdom
- Beatson Oncology CentreVerified postcodeGlasgow, United Kingdom
- St James's HopsitalVerified postcodeLeeds, United Kingdom
- University Hospital of Leicester NHS TrustVerified postcodeLeicester, United Kingdom
- St Bartholomew HospitalVerified postcodeLondon, United Kingdom
- University College London HospitalVerified postcodeLondon, United Kingdom
Common questions
What is multiple myeloma?
Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. It can affect your bones, kidneys, and immune system.
What does 'relapsed and refractory' mean?
Relapsed means the cancer has come back after treatment. Refractory means the cancer isn't responding to past or current treatments.
What are pomalidomide, dexamethasone, and cyclophosphamide?
These are different types of medications used to treat multiple myeloma. Pomalidomide and dexamethasone are common treatments, and cyclophosphamide is an older chemotherapy drug that can be added to improve results.
What is 'progression-free survival'?
This is the length of time a patient lives without their disease getting worse or progressing. It's an important measure in cancer studies.
Will I know which treatment I'm getting?
No, you will be randomly assigned to a treatment group, and neither you nor your doctor will get to choose which one you receive. This helps ensure the study results are fair.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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