
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at adding isatuximab to lenalidomide and dexamethasone for myeloma. It is for people who have myeloma without symptoms. This is called smouldering myeloma.
The trial is for people with smouldering myeloma who have a high chance of developing symptoms.
You don’t normally have treatment straight away if you have smouldering myeloma. Doctors keep an eye on you and treat the myeloma if you develop symptoms.
Some people with smouldering myeloma have a higher chance of developing symptoms sooner. Doctors think it might be better to treat this group of people early before they develop symptoms.
Lenalidomide and dexamethasone are a combination of drugs already used to treat myeloma.
Isatuximab is a newer drug. It is a type of called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins.
In this trial, some people have lenalidomide and dexamethasone. And some have lenalidomide, dexamethasone and isatuximab.
The main aims of the 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. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
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 phase 3 trial is taking place worldwide. The team need about 320 people to take part. There are 2 parts to this trial.
Part 1 includes 20 people. In part 1 everyone has lenalidomide, dexamethasone and isatuximab. This is to check how safe this combination of treatment is. When this part is finished then part 2 can begin.
Part 2 is randomised. The team need 300 people to take part. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in.
There are 2 treatment groups. You have one of the following:
Lenalidomide and dexamethasone
Lenalidomide is a capsule. You take it every day for 3 weeks and then you have a week of not taking it. Dexamethasone is a tablet you take once a week. You might have the first dose of dexamethasone as a drip into a vein.
Each 4 week period is called a . You have treatment for up to 2 years. You stop treatment if your myeloma gets worse.
Lenalidomide, dexamethasone and isatuximab
You have lenalidomide and dexamethasone as described above.
You have isatuximab as a drip into a vein. You have treatment in cycles. Each 4 week period is a cycle of treatment. You have isatuximab:
You have isatuximab for up to 3 years. You stop treatment if your smouldering myeloma gets worse.
You also have paracetamol and an a few hours before isatuximab. This is to reduce the chance of having a reaction to it.
Samples for research
The trial team ask you to give some extra blood samples. Where possible you have these at the same time as your routine blood tests. They also ask for samples from the .
The researchers plan to use the samples to:
Quality of life
The trial team ask you to fill out a questionnaire:
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor and have tests before you can take part. These include:
The doctors might also collect your
You have regular check ups during the trial. You have a PET-CT scan and an MRI scan once a year.
Follow up
When you stop treatment you have a check up:
If you stopped treatment because your myeloma got worse, you have a check up every 6 months. The team can let you know how long this will be for.
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.
The most common side effects of isatuximab we know about so far include:
Another possible side effect is called cytokine release syndrome (CRS). Isatuximab can cause the release of a chemical in the body called cytokines. The side effects of the release of these cytokines can be mild to severe. They can include:
You might also develop the following:
The trial doctor will talk to you about all the possible side effects of treatment before you join the trial. You’ll have a chance to ask questions.
We have more information about:
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
"I am glad that taking part in a trial might help others on their own cancer journey.”