A trial of cyclophosphamide, dexamethasone and ixazomib for myeloma (MUK 8)

Cancer type:

Myeloma

Status:

Results

Phase:

Phase 2

This trial was for people whose myeloma had come back or whose treatment had stopped working.

The trial was open for people to join between 2016 and 2018. The team published some results in 2022.

More about this trial

When this trial was done, the usual treatments for myeloma included cyclophosphamide and the steroid drug dexamethasone. People had these on their own or alongside 1 of the following:

thalidomide
lenalidomide
a drug called a proteasome inhibitor such as bortezomib (Velcade) or carfilzomib (Kyprolis)

In this trial researchers were looking at a drug called ixazomib alongside cyclophosphamide and dexamethasone. Ixazomib is a type of targeted cancer drug. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The researchers wanted to find out if having ixazomib as well could help stop the cancer coming back.

Everyone taking part in this trial had myeloma that had come back after standard treatment Open a glossary item .

This was a phase 2 trial. People taking part were put into one of 2 groups at random:

half had cyclophosphamide and dexamethasone (CD)
half had ixazomib, cyclophosphamide and dexamethasone (ICD)

The main aims of the trial were to find out:

if ixazomib helps stop myeloma coming back
more about the side effects

Summary of results

The research team found that having ixazomib with cyclophosphamide and dexamethasone did not help stop myeloma coming back. This was for people who had already had treatment for their myeloma.

Results
The research team hoped that about 250 people would join this trial. But they found it harder than they expected to find people to take part in this trial. So it closed earlier than planned.

A total of 112 people joined the trial. A computer put people taking part into 1 of 2 groups at random. There were

58 people in the ixazomib, cyclophosphamide and dexamethasone (ICD) group
54 people in the cyclophosphamide and dexamethasone (CD) group

13908-randomisation.png

A total of 110 people had treatment as part of this trial. The research team analysed the results in 2019.

They looked at how many people’s myeloma had got a bit better. They found it was:

24 out of 57 people (42%) who had ICD
21 out of 53 people (40%) who had CD

The also looked how long it was before people’s myeloma started to get worse. They found this was:

5.6 months for those who had ICD
6.7 months for those who had CD

They looked at the time until half the people in each group were living. They call this median overall survival. They found it was:

about 14 months for those who had ICD
about 19 months for those who had CD

The results for the two groups look different, but there is not a big enough difference to say for sure that it’s due to the treatment. It could be due to chance.

Quality of life
The researchers also looked at the quality of life of people taking part. They asked people to complete questionnaires at regular times during treatment. These asked how people were feeling and about any problems they were having.

They found that the quality of life in the two groups was similar at the start of the trial and at 3 months.

At 6 months, people in the CD group had a slightly higher quality of life compared to those in the ICD group.

Side effects
Most people (98%) who took part had at least one side effect from treatment. But many were mild or didn’t last long.

The most common side effects were:

a drop in red blood cells causing shortness of breath and tiredness
a drop in blood clotting cells (platelets) causing bruising or bleeding problems
severe tiredness (fatigue)
diarrhoea
a drop in white blood cells causing an increased risk of infection
infection

Some people had more severe side effects. This was:

34 people (60%) who had ICD
26 people (49%) who had CD

More people who had ICD had:

a drop in white blood cells causing an increased risk of infection
diarrhoea
nerve changes in their hands and feet such as numbness or pins and needles
extreme tiredness (fatigue)
infection
a drop in blood clotting cells (platelets) causing bruising or bleeding

More people who had CD had:

low blood pressure
high blood sugar
a drop in red blood cells causing shortness of breath and tiredness

Some people decided to stop treatment because of side effects they were having. This was:

8 people in the ICD group
5 people in the CD group

Three people who had ICD died because of side effects from treatment. Two people had a serious infection. And one had bleeding in the brain. No one who had CD died because of side effects from treatment.

Conclusion
The trial team concluded that ixazomib, cyclophosphamide and dexamethasone did not work better than cyclophosphamide and dexamethasone. This is for people who’d already had treatment for their myeloma but it had come back.

Sometimes trials show a different combination of treatment isn’t useful for a particular type or stage Open a glossary item of cancer. But these trials still add to our knowledge and understanding of cancer and how to treat it.

More detailed information
There is more information about this research in the reference below.

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Ixazomib with cyclophosphamide and dexamethasone in relapsed or refractory myeloma: MUKeight phase II randomised controlled trial results
H Auner and others
Blood Cancer Journal, 2022. Volume 12, Issue 52

Where this information comes from
We have based this summary on the information in the article above. As far as we are aware, this has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.