
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at having isatuximab as a drip into your bloodstream (intravenous) or as an injection under your skin (subcutaneous).
It is for people with multiple myeloma that:
Myeloma is a type of cancer that starts in the . Doctors usually treat multiple myeloma with a combination of different types of drugs:
The treatment can work well for some time. But sometimes the cancer can continue to grow despite treatment. This is refractory or relapsed multiple myeloma.
Treatment for refractory or relapsed myeloma depends on a number of things including the type of treatment you have before. A possible treatment is a combination of:
Isatuximab is a type of targeted drug called a monoclonal antibody. You usually have it as a drip into your bloodstream (intravenous or IV) every week. It takes between 30 to 60 minutes each time. This is the .
Doctors think that having isatuximab as an injection under your skin (subcutaneous or SC) works just as well as isatuximab IV. But they want to find out for sure.
Everyone taking part in this trial has one of the following:
The main aims of this trial are to find out:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is a phase 3 trial. The researchers need around 20 people from the UK to take part.
It is a randomised trial. The people taking part are put into 1 of the following groups by a computer:
Neither you nor your doctor will be able to decide which group you are in.
Everyone has treatment in cycles of treatment. This means that you have the 3 drugs and then a rest to allow your body to recover. Each cycle of treatment last 4 weeks.
This is how you have each cycle of treatment. You have:
You then start a new cycle of treatment. This continues for as long as the treatment is working and the side effects aren’t too bad.
Isatuximab SC
Your nurse puts a small needle into your skin which is attached to a pump or device. This device has isatuximab. The device gives the drug slowly over 10 minutes. At the end of the injection, the needle retracts back into the device and this is then removed.
Isatuximab IV
It takes between 30 to 60 minutes to have isatuximab IV each time.
Quality of life questionnaires
Everyone taking part completes quality of life questionnaires. They ask about how you have been feeling and what side effects you have had.
You complete the questionnaires:
Research samples
The researchers will ask to take extra blood tests as part of this trial. Where possible, you have them at the same time as your routine blood tests. They use these blood samples to understand more about how isatuximab is absorbed by the body.
You see a doctor and have some tests before taking part. These tests might include:
You have treatment in the hospital outpatient department. You see the trial doctor at the hospital every week for the first month. You then see the trial team every 4 weeks. You have blood tests and a physical examination before the start of each treatment cycle.
When you finish treatment, you go to hospital for follow up appointments. You see the trial team every one or 3 months until the trial finishes.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Isatuximab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The most common side effects of isatuximab are:
You may have different side effects if you have isatuximab as an injection under your skin. And there may be some side effects the doctors don’t know about yet. Your treatment team will monitor you during and after the injection.
The most common side effects of pomalidomide are:
We have information about the side effects of pomalidomide and dexamethasone.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Mamta Garg
Sanofi
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.