A trial of vorinostat, bortezomib and dexamethasone for myeloma that has come back (MUK four)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
The trial is looking at the drugs vorinostat, bortezomib and dexamethasone for myeloma that has come back.
Doctors can treat myeloma with a drug called bortezomib. You often have bortezomib with a steroid drug called dexamethasone. Adding another drug called vorinostat may improve the treatment. And it may make myeloma less likely to become 
to bortezomib.
Vorinostat is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
The people taking part in this trial have myeloma that is not responding to treatment or has come back. The aims of the trial are to
- See if vorinostat, bortezomib and dexamethasone helps people in this situation
- Learn more about the side effects of this drug combination
Who can enter
You may be able to enter this trial if you
- Have myeloma
- Have had between 1 and 3 other types of treatment, and now need to have more treatment
- 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 the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have myeloma that has spread into your brain or spinal cord
- Have had any other treatment for your myeloma in the last 4 weeks – you can take part if you’ve had radiotherapy to treat symptoms or drugs called bisphosphonates, and you may have taken steroids as long as you stop them a week before starting the trial treatment
- Have already had drugs that work in a similar way to vorinostat as treatment for myeloma – the trial team can advise you about this
- Have myeloma that did not respond to treatment that included bortezomib (Velcade) or came back within 2 months of finishing treatment that included bortezomib, or you weren’t able to take bortezomib because of the side effects
- Have damage to the nerves in your hands or feet (peripheral neuropathy) unless it is only mild
- Have had a
platelet transfusion or growth factors for blood cells in the last 2 weeks - Can’t take steroids
- Have had treatment for any other type of cancer in the last year, apart from carcinoma in situ of the cervix or non melanoma skin cancer
- Have had a heart attack in the last 6 months or have certain other heart problems – the trial team can advise you about this
- Have any other serious medical condition that the trial team think could affect you taking part
- Have HIV or hepatitis A, B or C
- Are known be very sensitive to bortezomib, vorinostat or dexamethasone (or anything in them)
- Have had surgery to your gut or have other problems with your
digestive system that could affect how you swallow or absorb tablets - Are pregnant or breastfeeding
Trial design
This phase 2 trial will recruit up to 68 people in the UK. Everybody taking part has vorinostat, bortezomib and dexamethasone.
You have 3 week cycles of treatment. You have
- Vorinostat tablets on 4 days each week
- Bortezomib injections under your skin (subcutaneous injections) on 2 days a week for the first 2 weeks of each treatment cycle
- Dexamethasone tablets on 4 days a week for the first 2 weeks of each cycle
You can have bortezomib through a drip into a vein if this is better for you.
You have up to 8 treatment cycles as described above. You then carry on having vorinostat alone. In this part of the trial, you take vorinostat for 4 days every other week. You can carry on having it for as long as it helps you.
Hospital visits
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Urine tests
- Bone marrow test
During the first 8 cycles of treatment, you go to hospital at least 4 times in each 3 week period to have bortezomib injections.
You have regular blood tests, urine tests and bone marrow tests during the trial treatment.
When you finish the treatment, you see the trial team every 2 months until your myeloma starts to get worse.
Side effects
The most common side effects of vorinostat include
- Feeling or being sick
- Tiredness (fatigue)
- Diarrhoea
- A drop in the number of blood cells called platelets causing bleeding problems
- Loss of appetite
The most common side effects of bortezomib include
- Weakness and fatigue
- Constipation or diarrhoea
- Feeling or being sick
- Loss of appetite or weight loss
- High temperature (fever)
- Numbness and tingling in your hands or feet
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Indigestion
- Bone or muscle pain
- Skin changes such as a rash, redness or itching
- Low blood pressure
- Dizziness
- A build up of fluid in your body (fluid retention)
- Cough
- Headache
- Blurred vision
- Taste changes
- Problems sleeping
- Anxiety
Shingles - Lung infections
The side effects of include
- Mood changes
- Difficulty sleeping
- Raised blood pressure
- Changes in blood sugar levels
- Weight gain
- Fluid retention causing swollen hands, feet and ankles
- Indigestion or heartburn
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 Faith Davies
Supported by
Myeloma UK
NIHR Clinical Research Network: Cancer
University of Leeds
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
