A trial of panobinostat with bortezomib and dexamethasone for myeloma that has come back or is no longer responding to treatment

Cancer type:

Blood cancers

Myeloma

Status:

Results

Phase:

Phase 3

This trial looked at 3 drugs called bortezomib, panobinostat and dexamethasone for myeloma that had come back or stopped responding to treatment.

More about this trial

Doctors usually treat myeloma with chemotherapy and this can get the cancer under control (into remission Open a glossary item ). But the treatment may stop working and myeloma can come back.

If this happens, you may have a drug called bortezomib (also known as Velcade). Bortezomib is a type of biological therapy called a proteasome inhibitor. Proteasomes are in all cells. They help to break down proteins that the cell doesn’t need. If the proteasomes are blocked, the proteins build up in the cell. The cell then dies.

Bortezomib was already used on its own to treat myeloma that had come back after chemotherapy. People taking part in this trial had it with a steroid called dexamethasone. Some people also had a drug called panobinostat.

Panobinostat (also known as LBH589) is a drug that blocks enzymes Open a glossary item called deacetylases (pronounced dee-ass-et-isle-azes). Cells need these enzymes to grow and divide. Blocking them may stop cancer growing.

The aims of this trial were to

See if adding panobinostat to bortezomib and dexamethasone helped people with myeloma that had come back or stopped responding to treatment
Learn more about the side effects of this drug combination

Summary of results

The trial team found that panobinostat did help people whose myeloma had stopped responding to treatment or had come back afterwards.

This was a phase 3 trial. It was a randomised trial that recruited 768 people. They were put into 1 of 2 groups. Neither they nor their doctor could choose which group they were in.

387 people had panobinostat, bortezomib and dexamethasone
381 had a dummy drug (placebo ), bortezomib and dexamethasone

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The overall number of people whose myeloma responded to treatment was

235 for those who had panobinostat
208 for those who had the dummy drug

The researchers looked at the average length of time the treatment worked for. They found that it was

Just under a year for people in the panobinostat group
Just over 8 months for people in the dummy drug group

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The most common side effects of panobinostat, bortezomib and dexamethasone were

Diarrhoea or constipation
Numbness, tingling or pain in the hands and feet
Weakness and tiredness
Feeling or being sick

The trial team concluded that panobinostat was a useful addition to the treatment of people with myeloma that had come back after previous treatment or had stopped responding to treatment.

The trial team are continuing to follow up the people in the trial to find the overall average length of time people live after treatment. When these results become available, we will update this summary.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.