A trial of selinexor, cyclophosphamide and prednisolone for myeloma (MUK twelve)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is for people whose myeloma has come back or treatment has stopped working.
More about this trial
You might have cyclophosphamide (a chemotherapy drug) and the steroid drug prednisolone to treat myeloma. You might have these 2 drugs on their own or alongside 1 of the following:
Doctors are looking for ways to improve treatment. In this trial, they are looking at adding a drug called selinexor to cyclophosphamide and prednisolone.
Selinexor is a type of targeted drug. It works by blocking the action of a protein within myeloma cells. This causes them to die.
The aims of the trial are to:
- find out how well selinexor works in combination with cyclophosphamide and prednisolone
- 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.
Who can take part
You may be able to join this trial if all of the following apply.
You:
- have myeloma that has come back or treatment has stopped working after at least 2 treatments that included lenalidomide and a drug such as bortezomib
- have myeloma that shows up in urine and blood tests
- are suitable to have cyclophosphamide and prednisolone only
- are well enough to be up and about for at least half the day (performance status 0,1 or 2)
- are willing to use reliable contraception during treatment and for 12 months afterwards if there is any chance you or your partner could become pregnant
- have satisfactory blood test results
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
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 leukaemia
- have had selinexor or a similar drug in the past
- have had any treatment for myeloma including experimental treatments in the last 28 days
- have a condition called graft versus host disease
- have had radiotherapy for pain control in the last 7 days or radiotherapy to treat your myeloma in the last 14 days
- have myeloma in the brain or spinal cord
Medical conditions
You:
- have heart problems such as a heart attack in the last 6 months or angina that isn’t well controlled
- have an infection that is causing symptoms
- are taking prednisolone (you may be able to take part if your doctor is happy for you to stop this before the trial treatment starts)
- can’t swallow tablets or you have had problems with your digestive system that might interfere with how well you absorb the trial drug
- have a herpes infection of the eye
- have had major surgery in the 14 days before being put into a treatment group
- have HIV
- have hepatitis A, hepatitis B or hepatitis C
- have any other serious medical condition or mental health problem that the trial team think could affect you taking part
Other
You:
- are pregnant or breastfeeding
- are allergic or sensitive to any of the drugs in the trial
Trial design
This is a phase 2 trial. It is taking place in the UK. Researchers need 60 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.
You have 1 of the following:
- cyclophosphamide and prednisolone (CP)
- selinexor, cyclophosphamide and prednisolone (SCP)
1 out of 4 people will have cyclophosphamide and prednisolone. And 3 out of every 4 people will have selinexor, cyclophosphamide and prednisolone.
Cyclophosphamide and prednisolone (CP)
Cyclophosphamide and prednisolone are tablets.
You have:
- cyclophosphamide once a day, every day
- prednisolone once every other day
You take the tablets at home. You have a diary card to record when you take your tablets.
Selinexor, cyclophosphamide and prednisolone (SCP)
Cyclophosphamide, prednisolone and selinexor are tablets.
You have:
- selinexor once a week
- cyclophosphamide once a day, every day
- prednisolone once every other day
You take the tablets at home. You have a diary card to record when you take your tablets.
For both groups, you have treatment for as long as it is working and the side effects aren’t too bad.
You stop treatment if the myeloma gets worse. Your doctor will talk to you about other treatment options. Some people who had cyclophosphamide and prednisolone might go on to have SCP as part of the trial.
Samples for research
You give some extra blood samples during treatment. Where possible you have them at the same time as your routine blood tests.
You also give a bone marrow sample. They plan to use the samples to:
- see how well the treatment is working
- learn more about myeloma
Hospital visits
You see a doctor and have some tests before you can take part. These include:
- physical examination
- blood tests
- urine tests
- bone marrow test
- heart trace (ECG)
You go to the hospital once a month for:
- a check up
- blood and urine samples
In the first month of treatment you have an extra hospital visit 2 weeks after starting treatment. This is to give another blood sample.
You stop treatment if your myeloma gets worse. Your doctor will discuss other treatment options with you.
You see the trial doctor for a check up:
- a month later
- every month after that
Side effects
This is the first time people are having selinexor in combination with cyclophosphamide and prednisolone. So, there may be some side effects we don’t know about yet.
The trial team will monitor you during the time you have treatment and you have a phone number to call if you are worried about anything.
Some common side effects of selinexor include:
- feeling or being sick
- diarrhoea or constipation
- loss of appetite, taste changes and weight loss
- tiredness (fatigue)
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- low levels of salt in the blood
- blurred eyesight or worsening of cataracts if you already have them
- dizziness
- kidney problems
- shortness of breath
- confusion or memory problems (cognitive disorder)
We have more information about the side effects of:
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Martin Kaiser
Supported by
University of Leeds
Myeloma UK
Karyopharm Therapeutics
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
