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.

Cancer type:

Blood cancers




Phase 2

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


Trial design

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.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood and urine tests
  • Heart trace (ECG Open a glossary item)

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.

Side effects

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

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
  • Sickness
  • Numbness, tingling or pain in the hands or feet due to nerve changes
  • Fever
  • Shortness of breath
  • Diarrhoea or constipation
  • Muscle pain or headache
  • Tiredness

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.

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Jamie Cavenagh

Supported by

Kyowa Hakko Kirin Pharma, Inc, USA
NIHR Clinical Research Network: Cancer
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 6651

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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