A trial looking at lenalidomide, carfilzomib, bortezomib and vorinostat for myeloma (Myeloma XI - intensive group)

Cancer type:

Blood cancers
Myeloma

Status:

Results

Phase:

Phase 3

This trial looked at lenalidomide, carfilzomib, bortezomib and vorinostat for people having intensive treatment for newly diagnosed myeloma. It was supported by Cancer Research UK.

More about this trial

When this trial was done, doctors often treated newly diagnosed myeloma with a combination of drugs such as cyclophosphamide, thalidomide and dexamethasone.

This trial looked at these drugs alongside other treatments at various points, to see if they could help stop myeloma coming back.

There were two groups in this trial – the intensive group and the non intensive group. The people taking part were put into one of the two groups depending on how fit and well they were. Treatment for both groups included these 3 stages:

  • induction
  • consolidation
  • maintenance

The information here is about the intensive group. We have separate information about the non intensive group. The trial treatments for the intensive group were lenalidomide, carfilzomib, bortezomib and vorinostat.

The people taking part were put into 1 of 3 groups for induction treatment at random:

  • group 1 had cyclophosphamide, dexamethasone and thalidomide
  • group 2 had cyclophosphamide, dexamethasone and lenalidomide
  • group 3 had cyclophosphamide, dexamethasone, lenalidomide and carfilzomib 

What they had next depended on how well their induction treatment worked. They either had:

  • no consolidation treatment
  • cyclophosphamide, dexamethasone and bortezomib

They then had a high dose of a chemotherapy drug called melphalan, followed by a stem cell transplant.

People whose treatment hadn’t worked then left the trial to have other treatments. People whose treatment had worked were put into one of these 3 groups at random:

  • no maintenance treatment
  • lenalidomide alone
  • lenalidomide with vorinostat

The main aims of this trial were to see whether:

  • lenalidomide or lenalidomide and carfilzomib work better than thalidomide as part of induction treatment
  • bortezomib improves consolidation treatment
  • vorinostat improves maintenance treatment
  • the research team can identify differences in cells or proteins which might help predict how well treatment will work in different people

Summary of results

There are several parts to this trial, and the various parts have been analysed and published separately. Here is a summary of what the results have shown so far.

Lenalidomide
The combination of cyclophosphamide, dexamethasone and lenalidomide worked better than cyclophosphamide, dexamethasone and thalidomide as induction treatment.

Those who had lenalidomide as part of maintenance treatment also did better than those who didn’t. The research team concluded that lenalidomide should be part of maintenance treatment for everyone with myeloma.

Carfilzomib
The research team looked at how many people’s myeloma had gone away completely or got much better by the end of induction treatment. They found this was higher in the group who had carfilzomib. It was:

  • more than 5 out of 10 people (53%) who had cyclophosphamide, dexamethasone and thalidomide
  • about 6 out of 10 people (61%) who had cyclophosphamide, dexamethasone and lenalidomide
  • nearly 8 out of 10 people (79%) who had cyclophosphamide, dexamethasone, lenalidomide and carfilzomib 

Carfilzomib was only used in the intensive group, for people who went on to have a stem cell transplant. The research team found that the benefit of carfilzomib carried on after transplant. People who had carfilzomib as part of induction did better after transplant than those who hadn’t.

Bortezomib
The results showed that adding bortezomib to consolidation treatment increased the time it took for myeloma to start growing again.

Genetic analysis
The research team looked at the genes of people taking part, to try and find links between genetic changes and how well treatment works. This work is still ongoing. But so far they have found a couple of changes in specific genes such as PAX4 and CD226, which may be useful in deciding who is most likely to benefit from treatment.

Predicting how well treatment will work
The research team used information about people in this trial to come up with what they call a predictive prognostic score. It combines information on the stage of their myeloma, how fit and well they are, their age and the level of a protein called CRP in their blood. It needs more work to make sure it is accurate before it can be widely used.

The results of this trial also showed that the treatment people need should depend on how fit and well they are, rather than how old they are.

Future results
Some of the people taking part in this trial are still having treatment and follow up appointments. The research team plan to analyse and publish more results in future. We hope to update this page once this information is available.

We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

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

Chief Investigator

Prof Graham Jackson

Supported by

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

Other information

This is Cancer Research UK trial number CRUK/09/014.

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Freephone 0808 800 4040

Last review date

CRUK internal database number:

3350

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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