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.
A trial of plitidepsin with dexamethasone for myeloma that has come back or is no longer responding to treatment (ADMYRE)
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.
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 (
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
- See if plitidepsin and dexamethasone help people with relapsed or refractory myeloma more than dexamethasone alone
- Learn more about the side effects
Who can enter
You can enter this trial if you
- Have been diagnosed with myeloma that has got worse despite having between 3 and 6 other types of treatment
- Have already had the drugs bortezomib and lenalidomide (thalidomide if lenalidomide was not available) unless you were not able to tolerate them
- Have satisfactory blood test results
- Have recovered from the side effects of any other treatment (apart from hair loss) unless they are very mild
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have high levels of calcium in your blood (hypercalcaemia) that cannot be controlled
- Have had any other treatment in the last 2 weeks that could affect your myeloma, or in the last 6 weeks if treatment included one of a group of drugs called
- Are known to be sensitive to either of the drugs in this trial
- Have had chemotherapy that has damaged your
bone marrowso that it is not producing enough healthy blood cells
- Have muscle weakness (myopathy)
- Have had a heart attack or have any other heart problems that are a cause for concern (the trial doctors can advise you on this)
- Have had a peptic ulcer or any bleeding from the upper part of your
digestive systemin the last year or that was related to taking steroids
- Have an infection that cannot be controlled with medication or any other medical condition that the trial doctors think could make it unsafe for you to take part
- Had mood changes when you took steroids in the past
- Are known to be HIV positive or have hepatitis B or C
- Are pregnant or breastfeeding
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
- Physical examination
- Blood and urine tests
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
- CT scan or MRI scan
- Bone marrow test
- X-rays of your bones
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
- Muscle cramps or muscle pain
- Tiredness (fatigue)
- Loss of appetite
- Feeling or being sick
- Changes to the way your liver works
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.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Amin Rahemtulla