Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of KW-2478 and bortezomib for myeloma that has come back
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a combination of 2 drugs called KW-2478 and bortezomib for myeloma that has come back or got worse despite having other treatment.
Doctors can treat myeloma with chemotherapy, stem cell transplant and biological therapy. But myeloma may come back or stop responding to treatment and researchers are looking for new ways to help people in this situation.
In this trial, they are looking at bortezomib and KW-2478.
Bortezomib is a type of biological therapy called a proteasome inhibitor. Proteasomes are found in cells and help break down proteins that the cell doesn't need. Bortezomib blocks the action of proteasomes. This leads to a build up of proteins, which can make myeloma cells die. Bortezomib is already used to treat myeloma.
KW-2478 is a drug called a heat shock protein 90 inhibitor. Heat shock protein (HSP90) is involved in cell growth. If KW-2478 can stop HSP90 working, the myeloma cells may die.
Doctors think that having bortezomib and KW-2478 together may work better than having either drug on its own.
The aims of this trial are to
- See if this drug combination helps people with myeloma that has come back after other treatment
- Learn more about the side effects
Who can enter
You can enter this trial if you
- Have myeloma that has got worse despite having between1 and 3 other treatments
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are at least 18 years old
- Are willing to use reliable contraception during the trial if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have had radiotherapy, thalidomide, lenalidomide, chemotherapy or an experimental drug in the last 4 weeks
- Have had bortezomib in the last 60 days
- Have had a bone marrow or stem cell transplant using cells from a brother or sister – you can take part if you have had a transplant using your own cells
- Had major surgery or treatment with a monoclonal antibody in the last 6 weeks
- Are taking a high dose of steroids
- Have any other severe illness such as heart pain (angina) or nerve damage (peripheral neuropathy) unless it is very mild
- Have had any other type of cancer
- Are having any other treatment that damps down your immune system
This trial is in 2 parts called phase 1 and phase 2. Phase 1 recruited 15 people and the researchers found the highest doses of KW-2478 and bortezomib you can safely have at the same time.
Phase 2 will recruit about 77 people in the UK, the USA and the Philippines. Everybody will have both KW-2478 and bortezomib. They will all have the safe doses of the drugs found in phase 1.
You have both drugs on days 1, 4, 8 and 11 of a 21 day (3 week) cycle of treatment. You have bortezomib as an injection into a vein which takes just a few seconds each time. Then you have KW-2478 through a drip which takes about an hour. Then there are 10 days without any treatment before the next cycle begins.
You may have up to 8 cycles of treatment. After this, if the trial doctors think the treatment is helping you, they may suggest you carry on having KW-2478 on its own for up to a year after your first treatment.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood and urine tests
- Heart trace (
You may also have a bone marrow test and X-rays.
You go to hospital 5 times during each cycle of treatment. You have treatment on 4 days and then another visit to see the doctors and have some tests. Each visit can last up to 3 hours. At most hospital visits you have blood tests, and you may have an ECG.
When you finish the treatment, you go back to see the trial doctors about a month later.
KW-2478 is a new drug so there may be side effects that we don’t know about yet. From an earlier study, researchers know that side effects can include
- Runny nose
- Raised blood pressure
- Feeling or being sick
- Tiredness (fatigue)
- Back pain or other pain
It may also affect your eyes, causing problems such as blurred vision. So it is important to let the trial doctors know if you notice any changes to your vision.
The side effects of bortezomib include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Numbness, tingling or pain in the hands or feet due to nerve changes
- Shortness of breath
- Diarrhoea or constipation
- Muscle pain or headache
There is more about the side effects of bortezomib on CancerHelp UK. It is possible that having both drugs together could make side effects worse.
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.
Dr Jamie Cavenagh
Kyowa Hakko Kirin Pharma, Inc, USA
NIHR Clinical Research Network: Cancer
Experimental Cancer Medicine Centre (ECMC)