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

Cancer type:

Blood cancers

Myeloma

Status:

Results

Phase:

Phase 3

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

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

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. It includes information about:

lenalidomide
carfilzomib
cyclophosphamide, bortezomib and dexamethasone
genetic analysis
predicting how well treatment will work

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

The research team also compared the results of those who had lenalidomide as maintenance treatment with those who didn’t.

They looked at how long it was before the myeloma started to grow, and found it was:

39 months for those who had lenalidomide
20 months for those who didn’t have lenalidomide

They then looked at how many people were living, 3 years after joining the trial. First they looked at everyone taking part – those in the intensive arm who had a stem cell transplant, and those in the non intensive arm who didn’t.

They found the number of people living was nearly 8 out of 10 (80%) in each group:

79% of those who’d had lenalidomide
76% of those who hadn’t had lenalidomide

When they looked at how many people in the non intensive arm were living 3 years after joining the trial, they found it was:

nearly 7 out of 10 people (67%) of those who’d had lenalidomide
7 out of 10 people (70%) of those who hadn’t had lenalidomide

Most people who had lenalidomide had at least one side effect, but many were mild or didn’t last long. Nearly half the people (45%) had more severe side effects. The most common side effects were infections and a drop in white blood cells, red blood cells and blood clotting cells (platelets).

The research team concluded that lenalidomide helped stop myeloma coming back but didn’t help people live longer.

Cyclophosphamide, bortezomib and dexamethasone
About half the people who didn’t respond very well to induction treatment went on to have cyclophosphamide, bortezomib and dexamethasone (CVD) treatment.

The research team looked at how long it was before the cancer started to grow, and found it was:

30 months for those who’d had CVD
20 months for those who hadn’t had CVD

They looked at how many people were living 3 years after joining the trial, and found it was nearly 8 out of 10 (80%) in each group:

77% for those who’d had CVD
79% for those who hadn’t had CVD

The research team concluded that the combination of cyclophosphamide, bortezomib and dexamethasone stopped the myeloma coming back, but didn’t help people live longer.

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.

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.

Where this information comes from
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.