Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial comparing giving carfilzomib once a week with giving it twice a week for myeloma (ARROW)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is open to people with myeloma that has come back after treatment (relapsed) or stopped responding to treatment (refractory).
More about this trial
Carfilzomib is a type of biological therapy called a proteasome inhibitor. It works by stopping the breakdown of abnormal proteins in the cancer cell. This causes the cancer cell to die.
We know from research that carfilzomib can help people with myeloma. Currently doctors give carfilzomib twice in one week. In this trial half the people will get carfilzomib twice a week and the other half will get it once a week.
The aim of the trial is to find out if having carfilzomib once a week is just as good as having it twice a week.
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 may be able to join this trial if all of the following apply
- You have myeloma that has come back after treatment or didn’t respond to treatment
- You have had at least 2 and no more than 3 previous treatments for your myeloma
- Your myeloma had responded well enough (a
partial response) to at least one of the treatments
- You have had a type of treatment that changes how the
immune systemresponds to myeloma (an immunmodulator)
- You have already had treatment with another
- Your doctor was able to measure the M protein in a blood sample or urine sample within the past 21 days
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Your heart works well enough
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for at least 1 month afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply. You
- Have myeloma with the immunoglobulin M (IIgM)
- Have a
- Have a syndrome called POEMS that affects your nerves and many body organs
- Have had another cancer in the past 5 years apart from some
early cancersthat were successfully treated
- Have or had
- Have had chemotherapy in the past 28 days
- Have had treatment that stimulates the immune system (immunotherapy) in the past 21 days
- Have had a total dose of more than 160mg dexamethasone or 1000mg (1 gram) prednisolone within the 14 days before been randomised for this trial
- Have had radiotherapy to a small area in the past 7 days
- Have had radiotherapy to a large area in the past 21 days
- Have already had carfilzomib or a similar drug called oprozomib
- Are allergic to carfilzomib or any of its ingredients
- Have certain heart problems
- Have had an infection in the past 2 weeks that needed to be treated with antibiotics
- Have fluid between the sheets of skin covering the lungs (pleural effusion) that needed to be drained within 2 weeks of been randomised for this trial
- Have fluid in the abdomen (ascites) that needed to be drained within the 2 weeks of been randomised into this trial
- Have ongoing problems with graft versus host disease (GVHD) after a bone marrow transplant from a donor
- Have high blood pressure or diabetes that isn’t controlled by medication
- Have moderate to severe damage to the nerves (neuropathy) caused by other treatments within 2 weeks of been randomised into this trial
- Have a liver disease called cirrhosis
- Have HIV, hepatitis B or hepatitis C
- Have taken an experimental drug or used a device as part of another clinical trial in the past month
- Have had major surgery in the past month
- Have any other medical condition or mental health problem that the trial team think could affect you taking part in the trial
- Are pregnant or breastfeeding
It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- People in one group have carfilzomib once a week and dexamethasone
- People in the other group have carfilzomib twice a week and dexamethasone
You have dexamethasone as a drip into a vein or as a tablet once a week for 4 weeks. You have this for 9 cycles of treatment. From cycle 10 you have dexamethasone once a week for 3 weeks.
You continue having treatment as long as it is helping you and the side effects aren’t too bad.
The researchers will ask your permission to take some extra blood samples. They will use these to find out what happens to carfilzomib in the body and how it affects the body. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
The trial team will ask you to fill out a questionnaire
- before you start treatment
- every 8 weeks during treatment
- at the end of treatment
- then every 12 weeks afterwards
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor to have some tests before taking part. These include
- A physical examination
- Blood tests
- Heart scan (
- Heart trace (
During treatment you see the doctor regularly for a physical examination and blood tests.
You see the doctor at the end of treatment to see how you are. You then see the doctor every 3 months. Or a member of the trial team will phone you to see how you are.
The most common side effects of carfilzomib are
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Change in the way your heart, liver, lung and kidneys work
- Shortness of breath
- Blurred vision, cataracts
- Diarrhoea or constipation
- Feeling or being sick
- Tummy (stomach) pain
- Tiredness (fatigue)
- High temperature (fever)
- Feeling hot
- Swelling of hands, feet or ankles
- Pain, swelling, irritation or discomfort of the vein at the drip site
- Loss of appetite
- Back or joint pain
- Pain in the arms, legs, hands or feet
- Numbness, tingling or loss of feeling in the hands or feet
- Difficulty sleeping
- Change to the amount of potassium, sugar and creatinine in your blood
- High blood pressure
We have information about the side effects of dexamethasone.
The trial team will talk to you about the side effects of carfilzomib and dexamethasone before you agree to take part.
How to join a clinical trial
Dr Catherine Williams
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer