Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of bortezomib and thalidomide in people with myeloma whose kidneys are not working well (OPTIMAL)
This trial is comparing 2 drugs called bortezomib and thalidomide for newly diagnosed myeloma. It is for people who have myeloma and whose kidneys are not working well.
Some people with myeloma have damage to their
In this trial, doctors are looking at 2 drugs called bortezomib and thalidomide. Earlier research has shown that both drugs can lower the number of free light chains in the blood. But the doctors aren’t sure which works better so they want to find out more.
Bortezomib and thalidomide are both types of
The aims of the trial are to
- Compare bortezomib with thalidomide to see which works better to reduce the number of free light chains in the blood
- Find out if lowering the number of free light chains earlier on improves the chances of the kidneys recovering
- Learn more about the side effects and how these drugs affect quality of life
Who can enter
You may be able to join this trial if all of the following apply. You
- Have recently been diagnosed with myeloma
- Have severe kidney damage caused by myeloma (your doctor can tell you more about this)
- Have satisfactory blood test results
- Are willing to use reliable contraception during the trial if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot join this trial if any of these apply. You
- Have had myeloma treatment in the last 2 weeks (apart from dexamethasone)
- Have kidney failure that is not related to your myeloma
- Are going to have another treatment to reduce the free light chains in the blood such as plasma exchange or ‘high cut off dialysis’ (your doctor can tell you more about this)
- Have had an experimental drug as part of another clinical trial in the last 3 months
- Have had another cancer in the last 2 years apart from
carcinoma in situof the cervix or breast, non melanoma skin canceror early stage prostate cancer that was successfully treated
- Have moderate to severe nerve damage (neuropathy)
- Are known to be allergic to any of the trial drugs
- Have any other serious medical condition that the trial team think could affect you taking part
- Are pregnant or breastfeeding
- People in group 1 have bendamustine, dexamethasone and bortezomib
- People in group 2 have bendamustine, dexamethasone and thalidomide
You have treatment in 3 week periods called cycles of treatment. You have between 4 and 6 cycles.
You have bendamustine as a drip into a vein twice during each cycle. You take dexamethasone tablets for 2 days on 4 occasions in each treatment cycle.
Thalidomide is a tablet that you take every day.
You have bortezomib as either injections under the skin or as a drip into a vein. You have it 4 times in each treatment cycle.
You may also need to have treatment to remove the free light chain proteins from the blood with a machine to help your kidneys to work (dialysis). If this is necessary, your doctor can tell you more about it.
The trial team will ask you to fill out a questionnaire before you start treatment and when you stop treatment. 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 in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
- Bone marrow test
You go to hospital to have bendamustine and bortezomib. During treatment everyone will see the doctor every 3 weeks for a check up and blood tests. When you finish treatment, you see the trial doctor 1 month later and a year after that. But in between you will see the doctor for your routine myeloma appointments.
The most common side effects of bortezomib include
- Pain or numbness and tingling in your hands or feet which can cause difficulty with fiddly things such as doing up buttons
- Sore muscles and joints
- Feeling or being sick
- Tiredness (fatigue) and breathlessness
- Loss of appetite
- Increased risk of getting an infection
- Diarrhoea or constipation
- A high temperature
The most common side effects of thalidomide include
- Muscle weakness
- Tingling or numbness in your hands or feet
- Skin rash
- Mood changes
- Feeling sick
We have more information about
How to join a clinical trial
Dr. Karthik Ramasamy
NIHR Clinical Research Network: Cancer
Oxford University Hospitals NHS Trust
Warwick Clinical Trials Unit