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 of panobinostat with bortezomib, thalidomide and dexamethasone for myeloma that has come back or is no longer responding to treatment (MUK Six)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called panobinostat alongside bortezomib, thalidomide and dexamethasone (VTD) for myeloma that has come back or stopped responding to treatment.
In this trial, researchers want to see if adding in a drug called panobinostat helps people with myeloma that has got worse or come back despite having other treatment.
Panobinostat is a drug that blocks certain proteins (
The aims of the trial are to
- Find the highest safe dose of panobinostat you can have with bortezomib, thalidomide and dexamethasone
- See how much this combination of drugs helps people with myeloma that has come back or stopped responding to treatment
- Learn more about the side effects
Who can enter
You may be able to enter this trial if you
- Have myeloma that has got worse during treatment or has come back after treatment
- Have already had between 1 and 4 other types of treatment for your myeloma
- Have myeloma that doctors can measure with blood or urine tests
- 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 a type of myeloma called non secretory myeloma
- Have myeloma that did not respond to bortezomib, or came back within 2 months of having it
- Have had any other treatment for myeloma in the last 4 weeks apart from steroids, drugs called bisphosphonates or radiotherapy for symptoms
- Have had treatment for any other cancer in the last 12 months unless this was for carcinoma in situ of the cervix, non melanoma skin cancer, or stage 1 prostate cancer - if you had another successfully treated cancer more than 12 months ago you can take part
- Have damage to your nerves (peripheral neuropathy) unless it is very mild
- Are known to be very sensitive to any of the drugs in the trial (or their ingredients)
- Have a heart condition that is a cause for concern
- Have a problem with your
digestive systemthat could affect how you absorb drugs
- Have an active infection including HIV and hepatitis A, B or C
- Have any other condition which may make you unwell if you take part, or affect the results of the trial – you can check this with the trial doctor
- Are pregnant or breastfeeding
The trial will recruit up to 54 people at a number of hospitals in England. Everybody taking part has bortezomib, thalidomide, dexamethasone and panobinostat.
The trial is in 2 parts. In the 1st part of the trial, researchers want to see if it is safe to have panobinostat alongside the other drugs. And if so, what the best dose is. The dose of panobinostat that you have will depend on when you join the trial. Everybody has the same doses of the other 3 drugs.
In the 2nd part of the trial, everybody will have the best dose found in part 1. The aim of this part of the trial is to learn more about how myeloma responds to this combination of drugs.
You have treatment in 3 week periods called cycles of treatment. In each cycle, you have
- Bortezomib as an injection under the skin (subcutaneous injection) once in the 1st week and once in the 2nd week
- Thalidomide tablets every day
- Dexamethasone tablets on 2 days in the 1st week and 2 days in the 2nd week
- Panobinostat tablets on 3 days in the 1st week and 3 days in the 2nd week
You have up to 16 cycles of treatment. As long as you don’t have bad side effects and your myeloma has not got worse, you may then be able to carry on having panobinostat on its own for up to a year. This is called maintenance treatment.
If you have maintenance treatment, you continue to have panobinostat tablets on 3 days in 2 weeks out of 3.
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 treatment, you have regular blood tests and bone marrow tests. The number of hospital visits and tests you have depends on the cycle of treatment you are having.
During maintenance treatment, you see the trial team every 6 weeks. You have blood and urine tests each time.
When you finish treatment, you see the trial team again. If you stop the trial treatment for any reason other than your myeloma getting worse, you carry on seeing the trial team every 6 weeks.
As panobinostat is a new drug, there may be side effects we don’t know about yet. Possible side effects include
- Feeling or being sick
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
How to join a clinical trial
Professor Jamie Cavenagh
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Leeds