
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
This trial is for people who might not be able to have the full dose of treatment because they have other illnesses or are not fit enough. It is looking at changing the dose of ixazomib, lenalidomide and dexamethasone to see if these people are better able to cope with treatment.
The trial is for people who can’t have a stem cell transplant.
It is also looking at whether taking ixazomib with lenalidomide after the initial treatment works better than lenalidomide on its own. This is to keep myeloma under control.
Cancer Research UK supports this trial.
Treatment for people with newly diagnosed myeloma who can’t have a can include:
These treatments work for people who are otherwise fit and healthy. But for people who aren’t as fit and have other illnesses the outcomes are not so good. Researchers are looking for ways to help these people.
In this trial researchers are looking at 3 drugs that you might have as part of your treatment for myeloma. These are:
There are 2 parts to this trial.
Part 1 is about initial treatment to control or have no signs of myeloma (complete recovery). This is induction treatment.
Part 2 is about continuing treatment to make sure it does not get any worse. This is maintenance treatment.
Induction treatment
In part 1 everyone has lenalidomide, ixazomib and dexamethasone. Doctors look at:
This a scoring system of frailty. It is to see how fit you are. The doctor works out your frailty score before you start treatment.
There are 2 groups in this part of the trial.
In the 1st group you have the standard treatment. During your treatment the dose can change considering how bad your side effects are. So your dose of treatment might change through your treatment. This can include stopping treatment.
In the 2nd group the doctor can change your dose of lenalidomide and dexamethasone. They can reduce it if you are having side effects. Or they can increase it if it is work well and you have no side effects. And changes to the standard dose of treatment reflect this. You continue to have the same dose through your treatment.
The aim in this part of the trial is to find out whether using the scoring system before the start of treatment helps:
Maintenance treatment
In part 2 researchers are comparing:
The aim of this part of the trial is to find out:
The following bullet points list 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.
There are 2 parts to this trial.
Part 1
Who can take part
You may be able to join part 1 of this trial if all of the following apply. You:
Part 2
Who can take part
You may be able to join part 2 of 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. You have:
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. There are 2 parts to this trial.
Part 1
In part 1 the trial team need 740 people to take part.
This part is a randomised trial. You go into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The groups are:
In the reduced dose group the doctor works out your dose according to:
Ixazomib, lenalidomide and dexamethasone are tablets. Your doctor tells you how many to take. You have treatment in cycles each is 4 weeks.
You take ixazomib once a week for 3 weeks and then have a week of not taking it.
You take lenalidomide once a day for 3 weeks and then have a week of not taking it.
You take dexamethasone once a week for 4 weeks.
You have 12 cycles of treatment as long as it is working and the side effects are not too bad.
After the 12 cycles of treatment your doctor will talk to you about how well the treatment has worked. You can go into part 2 if the treatment has worked well enough.
Part 2
In part 2 the team need 478 people to join.
This part is a double blinded randomised trial. You go into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. Neither you nor your doctor will know which group you are in. The 2 groups are:
You take lenalidomide once a day for 3 weeks and then have a week of not taking it.
You take ixazomib or the dummy drug once a week for 3 weeks and then have a week of not taking it.
You continue treatment as long as it is helping you and the side effects are not too bad.
Quality of life
You fill in questionnaires:
The questions ask about:
These are quality of life questionnaires.
Research samples
When you have a to diagnose myeloma the team take an extra sample of bone marrow. You also give an extra blood sample.
You can agree to either:
Researchers can use these samples to find out:
You see the doctor to have some tests before joining the trial. These tests include:
Your doctor will also look at:
This is the scoring system for frailty. The information is to work out how fit you are. And whether you should have a reduced dose of lenalidomide and dexamethasone with ixazomib in the 1st part of the trial.
Part 1
During treatment you see the doctor every 4 weeks for blood tests and to see how you are.
At the end of treatment you see the doctor to see how well treatment has worked. You can go into part 2 if the treatment has worked well enough.
Part 2
Before going into a treatment group you see the doctor for:
During treatment you see the doctor every 4 weeks to see how you are and for blood tests.
Follow up
After you finish treatment in either part 1 or part 2 your doctor will tell you how often they want to see you.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Gordon Cook
Professor Graham Jackson
Cancer Research UK
University of Leeds
Myeloma Research Alliance (UK-MRA)
Takeda
Celgene
This is Cancer Research UK trial number CRUK/16/019.
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”