
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at dexamethasone and plitidepsin for myeloma that is not responding to treatment or has come back after other types of treatment. You may hear this called refractory or relapsed myeloma.
Doctors can treat myeloma with chemotherapy, biological therapy and steroids. Some people have intensive treatment and a stem cell transplant.
If myeloma comes back after treatment, doctors may suggest different combinations of drugs. But if you have had a number of different types of treatment, it becomes more difficult to treat myeloma. You may have steroids, but researchers are looking for other treatments to help people in this situation.
In this trial, they are looking at a new drug called plitidepsin (also known as Aplidin). Like other types of chemotherapy plitidepsin damages cells as they divide, which can lead to the death of myeloma cells.
But plitidepsin also seems to have an effect on a growth factor called vascular endothelial growth factor (). Cancer cells need their own blood supply to grow and VEGF helps new blood vessels develop. Blocking the development of new blood vessels can stop myeloma cells growing.
Everybody taking part in this trial will have the steroid drug dexamethasone. Some people will also have plitidepsin. The aims of the study are to
You can enter this trial if you
You cannot enter this trial if you
This is an international phase 3 trial that will recruit about 250 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everybody taking part has 4 week cycles of treatment.
People in group A have dexamethasone once a week and plitidepsin once every 2 weeks. Dexamethasone is a steroid tablet that you swallow. Plitidepsin is a drug you have through a drip into a vein. It takes about 3 hours each time. You must have the dexamethasone at least an hour before the plitidepsin.
People in group B just take the dexamethasone tablets once a week.
There will be twice as many people in group A as in group B. So 2 out of 3 people entering this trial will get the trial drug.
As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it controls your disease. If you are in group B and your myeloma has got worse 8 weeks after starting this treatment, the trial doctor may ask you to change to group A.
You will see the doctors and have some tests before you start treatment. The tests may include
You see the trial doctors at the beginning of each treatment cycle and have more blood and urine tests. You have an ECG every 2 weeks and an echocardiogram or MUGA scan every 12 weeks. You may need to have more scans and X-rays.
In the first 2 treatment cycles, some people in group A will have a number of extra blood tests before and after they have plitidepsin. This is to learn more about what happens to drug in the body ().
After you finish treatment, you see the trial team again about a month later (or earlier than this if you are going to start another type of cancer treatment). You have more blood and urine tests, an ECG and an echo or MUGA scan. You may also have another bone marrow test and another scan or X-ray.
You will then have follow up hospital appointments once a month until your myeloma gets worse or you start another type of treatment. After that, you will see the trial team every 3 months until the trial has completely finished.
As plitidepsin is still quite a new drug, there may be some side effects we don’t know about yet. From earlier studies, doctors know the possible side effects include
If you are having plitidepsin, you will have other medicines to try to reduce the risk of sickness and of having an allergic reaction to the drug.
There is more information about the possible side effects of dexamethasone on CancerHelp UK.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Amin Rahemtulla
Pharma Mar
Hammersmith Hospital
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.