A trial looking at vorinostat, bortezomib and dexamethasone for myeloma that has come back (MUK four)

Cancer type:

Myeloma

Status:

Results

Phase:

Phase 2

This trial looked at adding vorinostat to bortezomib and dexamethasone for myeloma. 

It was for people whose myeloma had come back or treatment had stopped working. 

The trial was open for people to join between 2013 and 2014. The team published the results in 2021.

More about this trial

When this trial was done, doctors often treated myeloma with bortezomib and dexamethasone

Doctors thought that adding another drug called vorinostat could improve treatment. And that it might help stop myeloma becoming resistant Open a glossary item to bortezomib.

Vorinostat is a type of targeted cancer drug Open a glossary item. It was a newer drug at the time of this trial. It stops signals that cancer cells use to divide and grow.

Everyone taking part in the trial had vorinostat, bortezomib and dexamethasone.

The main aims of this phase 2 trial were to find out:

  • if adding vorinostat to bortezomib and dexamethasone improves treatment 
  • what the side effects are 

Summary of results

This trial showed that adding vorinostat to bortezomib and dexamethasone worked for some people but the side effects were bad.

Results
16 people took part in this trial. The team had hoped to find more people to join but the trial closed earlier than planned. This was because it was difficult to recruit enough people. 

Everyone had vorinostat, bortezomib and dexamethasone for up to 6 months. This was their initial treatment. After initial treatment the team looked at how well treatment worked. They found the myeloma:

  • went away completely in 4 people (a complete response)
  • shrunk a lot in 2 people (a very good partial response)
  • shrunk a bit in 7 people (a partial response)
  • shrunk even less in 3 people (a minimal response)

11 people continued to have vorinostat on its own. This is called maintenance treatment. They had it for as long as it was working and the side effects weren’t too bad. 

The team also looked at how long before the myeloma started to grow again. They found this was 11.9 months. This is better than having standard treatment with bortezomib and dexamethasone. 

Side effects 
Most people taking part had at least 1 side effect. Some of these were mild or didn’t last long. But some were more severe.

The severe side effects of dexamethasone, bortezomib and vorinostat included:

  • a drop in the number of blood cells called platelets Open a glossary item
  • diarrhoea
  • tiredness (fatigue)
  • a drop in the number of red blood cells (anaemia)

The team also looked at the side effects of vorinostat on its own. This was in the group of people who had maintenance treatment. The most common severe side effect was a drop in the number of blood cells called neutrophils Open a glossary item.

They looked at the number of people who had side effects and had to:

  • stop treatment
  • reduce the dose of treatment 

They found this happened in 12 out of 16 people (75%).

Researchers can class a side effect as serious for a number of reasons, including if:

  • the person has to go to hospital because of it
  • it is particularly important for the specific treatment in the trial

4 people had serious side effects that were related to treatment. These included:

  • heart palpitations 
  • diarrhoea 
  • sepsis Open a glossary item 
  • dehydration 
  • a drop in blood pressure 

Everyone recovered from these serious side effects. 

Conclusion
This was a very small trial. The team concluded that adding vorinostat to bortezomib worked for some people in the trial but the side effects were bad. 

The team hope these results highlight that these types of drugs need to be improved. Further research could look at hopefully reducing the side effects and help to treat people with myeloma.

More detailed information
There is more information about this research in the references below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Bortezomib, Vorinostat, and Dexamethasone Combination Therapy in Relapsed Myeloma: Results of the Phase 2 MUK four Trial
S Brown and others
Clinical Lymphoma, Myeloma & Leukemia, 2021. Volume 21, No 3, pages 154-161.

Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.

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 Faith Davies

Supported by

Myeloma UK
NIHR Clinical Research Network: Cancer
University of Leeds

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9534

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

Last reviewed:

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