A trial looking at carfilzomib for myeloma (MUK 5)

Cancer type:

Blood cancers

Myeloma

Status:

Results

Phase:

Phase 2

This trial looked at combining carfilzomib with cyclophosphamide and dexamethasone to treat myeloma.

It was open to people with myeloma that continued to grow during treatment or came back after treatment.

More about this trial

Doctors use different combinations of treatment when myeloma has come back after treatment or continued to grow despite treatment.

One combination they use is:

Like bortezomib, carfilzomib is a type of targeted cancer drug. It is a cancer growth blocker that stops signals cancer cells need to grow and divide.

In this trial, the researchers compared carfilzomib, cyclophosphamide and dexamethasone (KCD) with CVD.

They also looked at whether having carfilzomib after KCD helped stop myeloma coming back after treatment.

The main aims were to find:

which worked best for myeloma that had come back after treatment or continued to grow while having treatment
if having carfilzomib after KCD stopped the myeloma coming back

Summary of results

The team found that continuing with carfilzomib after KCD increased the time people lived without their myeloma coming back.

Method

This was a phase 2 trial. There were 2 parts to this trial. Both parts were randomised.

Results of part 1

300 people joined this part. They were put into 1 of 2 treatment groups. Neither they or their doctor chose which group they were in.

Out of every 3 people who joined, 2 were in the carfilzomib group:

201 people had the combination treatment carfilzomib, cyclophosphamide and dexamethasone (KCD)
99 people had the combination treatment cyclophosphamide, bortezomib and dexamethasone (CVD)

10193r-part-1-randomisation.png

After 24 weeks of treatment, the researchers looked at how well the combinations had worked.

For this the team wanted to know how many people’s myeloma had a complete response or a very good partial response. They measured the amount of certain proteins in the people’s blood sample and urine sample to find this out.

If no proteins were found in the samples after treatment, this was a complete response. If there were 10% or less of the proteins in the sample after treatment than before treatment, this was a very good partial response.

Those whose myeloma had a complete response or very good partial response was:

just over 40 out of every 100 people (40.2%) in the KCD group
just under 32 out of every 100 people (31.9%) in the CVD group

10193-part-1-bar-chart-1.png

The total number of people whose myeloma had got better after treatment (overall response rate) was:

84 out of every 100 people (84%) in the KCD group
just over 68 out of every 100 people (68.1%) in the CVD group

After an average follow up of 14 months, researchers looked at how long people in each group lived with no sign of their myeloma. They found it was:

just under a year (11.9) for those who had KCD
just over 10 months (10.2) for those who had CVD

10193-part-1-bar-chart-2.png

Results of part 2

Only people who had KCD could join this part of the trial. Of the 201 people, 141 took part.

They were put into 1 of 2 groups (randomised):

69 people continued with carfilzomib
72 people didn’t continue with carfilzomib

10193r-part-2-randomisation.png

After an average follow up of 10½ months, the team looked at how long people in each group lived with had no sign of their myeloma. They found it was:

just under a year (11.9 months) for those who continued with carfilzomib
just over 5½ months for those who didn’t continue with carfilzomib

10193-part-2-bar-chart-.png

Conclusion
The trial team concluded that continuing with carfilzomib increased the length of time people lived and had no sign of their myeloma after their initial treatment.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed) but may not have been published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.

Recruitment start:

07/02/2013

Recruitment end:

05/09/2016

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Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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Chief Investigator

Dr Kwee Yong

Supported by

Leeds Institute of Clinical Trials Research (University of Leeds)
Myeloma UK
Onyx Pharmaceuticals, a subsidiary of Amgen Inc
Institute of Cancer Research (ICR)
Haematological Malignancies Diagnostic Service (HMDS)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
UK Myeloma Research Alliance

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Email

Last review date

25 September 2018

CRUK internal database number:

10193