"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of cyclophosphamide, dexamethasone and ixazomib for myeloma (MUK 8)
This trial is for people whose myeloma has come back or treatment has stopped working.
More about this trial
Cyclophosphamide and the steroid drug dexamethasone are often used to treat myeloma. You might have these 2 drugs on their own or alongside 1 of the following
- bortezomib (Velcade)
But if the myeloma comes back or doesn’t go away afterwards, it can be more difficult to treat.
In this trial researchers are looking at a new drug called ixazomib alongside cyclophosphamide and dexamethasone.
Ixazomib is a type of
The aims of the trial are to
- find out if ixazomib helps people with myeloma
- learn more about the side effects
Who can enter
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.
You might be able to join this trial if all of the following apply. You
- Have myeloma that has stopped responding to treatment or got worse after the last treatment
- Have myeloma that shows up in blood test and urine tests
- Have had thalidomide, lenalidomide and bortezomib in the past
- Your doctor thinks cyclophosphamide and dexamethasone is a suitable treatment for you
- Are well enough to be up and about for at least half the day (performance status 0,1 or 2)
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception during treatment and for a minimum of a month and a half afterwards if there is any chance that you or your partner could become pregnant
You cannot join this trial if any of these apply.
- You have a collection of white blood cells called plasma cells (a plasmacytoma) growing outside your bones and you have no other symptoms of myeloma or you have plasma cell leukeamia
- You have myeloma in the brain or spinal cord
- You have already had ixazomib
- Your kidneys aren’t working properly
- You have problems with your heart, such as a heart attack in the last 6 months, high blood pressure that is not well controlled, angina that is not well controlled, an abnormal rhythm of your heart, congestive heart failure that is causing symptoms (fluid around you heart)
- You have had a
stem cell transplantwith somebody else’s cells in the last 12 months
- You have a condition called a
graft versus host disease
- You are known to be sensitive or allergic to ixazomib
- You can’t swallow tablets or you have had problems with your
digestive systemthat might interfere with how you absorb the trial drug
- You have had moderate to severe numbness or tingling in your hands and feet (peripheral neuropathy)
- You have had radiotherapy for pain control in the 7 days before joining the trial
- You have had major surgery in the 2 weeks before joining the trial
- You have taken any medication that blocks an enzyme called CYP3A4 or medications such as ciprofloxacin in the 7 days before joining this trial
- You are known to be HIV positive
- You have an active infection including hepatitis A, hepatitis B or hepatitis C
- You have had any other cancer in the past unless it was successfully treated with surgery and there hasn’t been any sign of it since
- You have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
- You are pregnant or breast feeding
This is a phase 2 trial. The researchers need 250 people to take part.
It is a randomised trial. You are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- one group have cyclophosphamide and dexamethasone
- the other group have ixazomib, cyclophosphamide and dexamethasone
Dexamethasone, cyclophosphamide and ixazomib are tablets. You have treatment as follows in 4 week cycles (28 days).
Cyclophosphamide and dexamethasone (CD)
- cyclophosphamide once a week for the first 3 weeks
- dexamethasone tablets on 4 days a week for the first 2 weeks
Ixazomib, cyclophosphamide and dexamethasone (ICD)
- ixazomib and cyclophosphamide once a week for the first 3 weeks
- dexamethasone tablets on 4 days a week for the first 2 weeks
You have treatment for as long it is helping you and the side effects aren’t too bad.
You stop treatment if your myeloma gets worse. If you were having ICD, your doctor will talk to you about other treatment options. If you are having cyclophosphamide and dexamethasone, you might then be suitable to have ixazomib, cyclophosphamide and dexamethasone (ICD). But the trial doctor can tell you more about this.
The researchers will ask for a sample of your bone marrow which will be removed when you have your bone marrow test. The researchers will also ask to take extra blood tests as part of this trial. Where possible you have these at the same time as your routine blood tests. The aim of these tests is to understand more about myeloma and how to treat it.
You don’t have to give these extra samples if you don’t want to. You can still take part in the trial.
Quality of life
The trial team will ask everybody taking part to complete some questionnaires before treatment starts and then regularly throughout treatment. These are called quality of life questionnaires. They look at how the treatment affects you physically and emotionally.
You will see the trial doctors and have some tests before you start treatment. These include
- A physical examination
- Blood and urine tests
- Bone marrow test
While you are having treatment you go to hospital
- once a week for the first 3 months
- at least once a month after that
You might have more hospital visits than you had during your previous treatments. You see the doctors regularly for a physical examination and blood and urine tests.
If you stop treatment, and start another treatment, you are monitored by your doctor at follow up visits every 2 months. If your myeloma get worse again, you stop this treatment. Your doctor will then discuss further treatment options with you.
Your doctor might decide to stop your treatment if you have bad side effects. If this applies to you, you go to hospital every month for a check up.
As ixazomib is a new drug, there might be side effects that we don’t know about yet. The trial team will monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything.
The most common side effects so far include
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- skin rash
- tiredness (fatigue)
- feeling or being sick
- diarrhoea or constipation
- numbness, tingling or pain feelings in hands or feet (peripheral neuropathy)
- fever and chills
- taste changes and loss of appetite
- kidney problems
- lung infections
- shortness of breath and cough
- tummy (abdomen) or back pain
- swelling or fluid build up in the arms or legs
- muscle, joint or bone aches and pains
- feeling dizzy and low blood pressure
You mustn’t take certain drugs while taking part in this trial. These include St John’s Wort and ginkoba. The trial team will give you more information about this.
We have information about
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.
Professor Gordon Cook
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Leeds