
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is looking at to help work out the best treatment for myeloma. It is also looking at measuring small amounts of myeloma cells that may be present after initial treatment. This is called
.
It is for people who:
Cancer Research UK supports this trial.
Lenalidomide, bortezomib, dexamethasone and cyclophosphamide are all standard treatments for myeloma. They are not yet available on the NHS in the particular combinations you have in this trial. You might also have a stem cell transplant as part of your routine care.
Isatuximab is a newer treatment. Some people have it for myeloma that has come back. It isn’t yet a treatment for newly diagnosed myeloma. Isatuximab is an immunotherapy. It helps the to find and kill cancer cells. Doctors aren’t sure how well it will work for newly diagnosed myeloma.
In this trial, researchers are looking at different combinations of treatment to improve outcomes for people with myeloma. The treatment you have depends on:
To work this out doctors examine and blood tests.
Those who have certain gene changes have high risk myeloma. Sometimes treatment doesn’t work as well for this group of people. Those who don’t have these changes have standard risk myeloma.
The main aims of the trial are to find out:
Please note, there are several treatment groups so the entry conditions for this trial are complex. Each group has specific entry conditions and we haven’t listed them all.
The trial team check if you are suitable to join the trial and which group you might join. They can tell you more about this.
The group you join depends on a number of factors such as:
The following bullet points summarise some of the main entry conditions. 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:
As well as the above there are specific entry conditions and exclusion criteria for each treatment group. Speak to your doctor or research nurse if you want to find out more about the entry conditions for this trial. |
This phase 2/3 trial is taking place in the UK. The team are aiming for 1,400 people to take part.
The trial involves:
The treatment you have includes:
You also have melphalan chemotherapy when you have your .
The schedule of drugs is different for each part of the trial. The trial team will tell you exactly which drugs you have, when you have each drug and for how long.
Some parts of the trial are randomised. You are put into a treatment group at random. Neither you nor your doctor can decide which group you are in.
Initial Treatment
You have a bone marrow test to check to see if you have certain gene changes in your myeloma cells. People with these gene changes have high risk myeloma. People without these changes have standard risk myeloma.
Everyone then has lenalidomide, cyclophosphamide, bortezomib and dexamethasone for the first . Each cycle is 3 weeks.
Everyone then has 3 more cycles of treatment with the above drugs. Those who have high risk myeloma also have isatuximab.
You then have melphalan chemotherapy and a stem cell transplant. This is part of your routine care. Your doctor can tell you more about this treatment. They can also tell you how long you’ll be in hospital for and how long it will take to recover from the stem cell transplant.
Minimal residual disease (MRD) test
3 months after the stem cell transplant you have a bone marrow test and blood tests to see how well treatment worked. The team check if you have any myeloma cells left in your bone marrow. This is called Minimal Residual Disease or MRD.
To have further treatment, the team need to know if you:
Further treatment
The treatment you have next depends on whether you:
Standard risk groups
Standard risk MRD negative group (R1)
To begin with you have 12 cycles of isatuximab. Each cycle is 4 weeks. This takes about a year in total. You then have another MRD test. Those who are MRD positive continue to have isatuximab. Those who are still MRD negative are put into a treatment group at .
There are 2 treatment groups. You have one of the following:
The aim is to see if no further treatment with isatuximab works just as well as continuing to have treatment with this drug.
Standard risk MRD positive group (R2)
You are put into a treatment group at random. There are 4 groups. You have one of the following:
You stop treatment if your myeloma gets worse. The aim is to see which treatment works best.
High risk group
In the high risk group everyone has lenalidomide, bortezomib, isatuximab and dexamethasone. You have 4 cycles of treatment. Each cycle is 3 weeks. You then have long term lenalidomide and isatuximab. You have this for as long as treatment is working and the side effects aren’t too bad.
Quality of life
The trial team ask you to fill out questionnaires:
The questionnaires ask about side effects and how you’ve been feeling. This is called a quality of life study.
Samples for research
The researchers will ask to take some extra fluid when you have a bone marrow test. They will also ask to take some extra blood and urine samples. Where possible, you have the blood samples at the same time as your routine blood tests.
They plan to use the samples to:
You need to agree to give most of the samples to take part in the trial. The team may ask to use the samples for future research. You can say no to this. It won’t affect you taking part in the rest of the trial.
You see the doctor and have tests before you can take part. These include:
You see the doctor for regular check ups, blood tests and bone marrow tests. How often you have these depends on which part of the trial you are in. The trial team can tell you more about this.
Treatment and how you have it
You have bortezomib as an injection under your skin. You have this at the hospital on the day care ward. It might be possible for a healthcare professional to give you the injection at home. Or you might be able to do the injection yourself. You can ask your healthcare team about this.
Lenalidomide is a capsule.
Cyclophosphamide is a tablet or capsule.
Dexamethasone is a tablet.
You have isatuximab as a drip into a vein. You have this at the hospital on the day care ward.
How often you have the above treatments depends on which part of the trial you are in. The trial team can tell you more about this.
Follow up
The team follow you up every 2 months when you finish treatment. You might see them at a routine hospital appointment or they may call you to see how you are getting on.
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 These side effects could happen during treatment or 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. |
Isatuximab is a newer treatment so there might be side effects we don’t know about yet. Below are the most common side effects that people reported. It isn’t known if they are all caused by isatuximab. The side effects include:
Your doctor will talk to you about all the possible side effects of treatment. You’ll have a chance to ask any questions you may have.
We have more information about the following treatments and their side effects:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Kwee Yong
Dr Karthik Ramasamy
Cancer Research UK
Celgene
Sanofi
University of Leeds
This is Cancer Research UK trial number CRUK/17/012.
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.”