Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at lenalidomide, bortezomib and vorinostat for myeloma (Myeloma XI – non intensive group)
This trial looked at lenalidomide, bortezomib and vorinostat for people having non intensive treatment for newly diagnosed myeloma. It was supported by Cancer Research UK.
More about this trial
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:
This information is about the non intensive group. We have separate information about the intensive group. The trial treatments for the non intensive group were lenalidomide, bortezomib and vorinostat.
The people taking part were put into 1 of 2 groups for induction treatment at random:
- group 1 had cyclophosphamide, dexamethasone and thalidomide
- group 2 had cyclophosphamide, dexamethasone and lenalidomide
What they had next depended on how well their induction treatment worked. They either had:
- no consolidation treatment
- cyclophosphamide, dexamethasone and bortezomib
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 thalidomide work better 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.
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.
Adding bortezomib to consolidation treatment increased the time it took for myeloma to start growing again.
Minimal Residual Disease (MRD)
MRD means the number of myeloma cells left after treatment. The research team looked at the level of MRD after induction treatment. The results showed that people with no MRD (this is called being MRD negative) did better at the end of treatment than those who were MRD positive.
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.
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 (
How to join a clinical trial
Professor Graham Jackson
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Leeds
This is Cancer Research UK trial number CRUK/09/014.