A trial of panobinostat with bortezomib, thalidomide and dexamethasone for myeloma that has come back or is no longer responding to treatment (MUK Six)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Myeloma

Status:

Closed

Phase:

Phase 1/2

This trial is looking at a drug called panobinostat alongside bortezomib, thalidomide and dexamethasone (VTD) for myeloma that has come back or stopped responding to treatment.

Chemotherapy, steroids and biological therapy and are the main treatments for myeloma. Bortezomib, thalidomide and dexamethasone are drugs that doctors can use.

In this trial, researchers want to see if adding in a drug called panobinostat helps people with myeloma that has got worse or come back despite having other treatment.

Panobinostat is a drug that blocks certain proteins (enzymes Open a glossary item). Cells need these enzymes to grow and divide. Blocking them may stop cancer growing.

The aims of the trial are to

  • Find the highest safe dose of panobinostat you can have with bortezomib, thalidomide and dexamethasone
  • See how much this combination of drugs helps people with myeloma that has come back or stopped responding to treatment
  • Learn more about the side effects

Who can enter

You may be able to enter this trial if you

  • Have myeloma that has got worse during treatment or has come back after treatment
  • Have already had between 1 and 4 other types of treatment for your myeloma
  • Have myeloma that doctors can measure with blood or urine tests
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have a type of myeloma called non secretory myeloma
  • Have myeloma that did not respond to bortezomib, or came back within 2 months of having it
  • Have had any other treatment for myeloma in the last 4 weeks apart from steroids, drugs called bisphosphonates or radiotherapy for symptoms
  • Have had treatment for any other cancer in the last 12 months unless this was for carcinoma in situ of the cervix, non melanoma skin cancer,  or stage 1 prostate cancer - if you had another successfully treated cancer more than 12 months ago you can take part
  • Have damage to your nerves (peripheral neuropathy) unless it is very mild
  • Are known to be very sensitive to any of the drugs in the trial (or their ingredients)
  • Have a heart condition that is a cause for concern
  • Have a problem with your digestive system Open a glossary item that could affect how you absorb drugs
  • Have an active infection including HIV and hepatitis A, B or C
  • Have any other condition which may make you unwell if you take part, or affect the results of the trial – you can check this with the trial doctor
  • Are pregnant or breastfeeding

Trial design

The trial will recruit up to 54 people at a number of hospitals in England. Everybody taking part has bortezomib, thalidomide, dexamethasone and panobinostat.

The trial is in 2 parts. In the 1st part of the trial, researchers want to see if it is safe to have panobinostat alongside the other drugs. And if so, what the best dose is. The dose of panobinostat that you have will depend on when you join the trial. Everybody has the same doses of the other 3 drugs.

In the 2nd part of the trial, everybody will have the best dose found in part 1. The aim of this part of the trial is to learn more about how myeloma responds to this combination of drugs.

You have treatment in 3 week periods called cycles of treatment. In each cycle, you have

  • Bortezomib as an injection under the skin (subcutaneous injection) once in the 1st week and once in the 2nd week
  • Thalidomide tablets every day
  • Dexamethasone tablets on 2 days in the 1st week and 2 days in the 2nd week
  • Panobinostat tablets on 3 days in the 1st week and 3 days in the 2nd week

You have up to 16 cycles of treatment. As long as you don’t have bad side effects and your myeloma has not got worse, you may then be able to carry on having panobinostat on its own for up to a year. This is called maintenance treatment.

If you have maintenance treatment, you continue to have panobinostat tablets on 3 days in 2 weeks out of 3.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

During treatment, you have regular blood tests and bone marrow tests. The number of hospital visits and tests you have depends on the cycle of treatment you are having.

During maintenance treatment, you see the trial team every 6 weeks. You have blood and urine tests each time.

When you finish treatment, you see the trial team again. If you stop the trial treatment for any reason other than your myeloma getting worse, you carry on seeing the trial team every 6 weeks.

Side effects

As panobinostat is a new drug, there may be side effects we don’t know about yet. Possible side effects include

We have more information about the side effects of bortezomib, thalidomide and dexamethasone in our cancer drugs section.

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

Professor Jamie Cavenagh

Supported by

Experimental Cancer Medicine Centre (ECMC)
Myeloma UK
NIHR Clinical Research Network: Cancer
University of Leeds

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 10533

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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