A trial of bortezomib and thalidomide in people with myeloma whose kidneys are not working well (OPTIMAL)
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 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.
More about this trial
Some people with myeloma have damage to their 
. This is because myeloma often causes high levels of proteins called free light chains in the blood. These extra proteins can damage the kidneys, as they pass through from the blood into the urine.
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 . They are cancer growth blockers. They stop the signals that cancer cells use to divide and grow.
Everyone taking part will also have a standard chemotherapy drug called bendamustine and a steroid drug called dexamethasone.
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 situ of the cervix or breast, non melanoma skin cancer or 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
Trial design
This is a phase 2 trial. The researchers need 120 people to join. It is a randomised trial. You are put into 1 of 2 groups by a computer. Neither you nor doctor can choose which group you are in.
- 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.
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG ) - X-rays
- 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.
Side effects
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
- Headaches
The most common side effects of thalidomide include
- Constipation
- Muscle weakness
- Tingling or numbness in your hands or feet
- Dizziness
- Skin rash
- Mood changes
- Feeling sick
- Headaches
We have more information about
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. Karthik Ramasamy
Supported by
Bloodwise
Janssen-Cilag
NIHR Clinical Research Network: Cancer
Oxford University Hospitals NHS Trust
Warwick Clinical Trials Unit
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
