A trial looking at pomalidomide for myeloma (STRATUS)

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Cancer type:

Blood cancers
Myeloma

Status:

Results

Phase:

Phase 3

This trial looked at pomalidomide to treat myeloma that had come back or got worse during treatment. 

It was for people who had already had lenalidomide and bortezomib.

More about this trial

Doctors often treat myeloma that has come back with lenalidomide or bortezomib. They are both targeted drugs. Doctors may also give people a steroid drug such as dexamethasone. 

But sometimes myeloma gets worse during treatment or comes back afterwards. So, researchers are looking for ways to improve treatment for this group of people. 

In this trial, they looked at a drug called pomalidomide. It is a targeted drug. It works in 3 ways. It:

  • blocks new blood vessels developing, cancer cells need to make new blood vessels, so they can grow and spread
  • helps the immune system find and kill myeloma cells
  • kills myeloma cells

Everyone in this trial had pomalidomide and low dose dexamethasone.

The aims of the trial were to:

  • see how safe treatment was 
  • find out how well treatment worked
  • learn more about the side effects
     

Summary of results

The trial team found that pomalidomide and low dose dexamethasone worked for people with myeloma that had come back or got worse during treatment. And most of the side effects were manageable.  

The researchers published the results in 2016. 

This was a phase 3 trial. 676 people had treatment. The trial took place in Europe. 

Treatment 
Everyone pomalidomide and dexamethasone for as long as it worked, and the side effects weren’t too bad. On average, people had treatment for about 4.9 months. 

Results 
The researchers looked at how well treatment worked. They looked at whose myeloma went away completely or at least a little bit. They found this was just over 32 out of every 100 people (32.6%).  

The myeloma stayed the same in 339 people. And got worse in the rest.

The trial team followed everyone up for an average of 16.8 months. They looked at the average length of time people lived without signs of their myeloma getting worse. Researchers call this progression free survival. They found this was 4.6 months.

They also looked at the average length of time people lived after starting treatment. This was 11.9 months. 

Side effects
The most common severe side effects of pomalidomide were:

  • a drop in blood cells causing an increased risk of infection, tiredness and breathlessness and bruising or bleeding
  • pneumonia
  • tiredness (fatigue)

111 people (9.5%) developed pneumonia. 13 people (1.9%) died because of this. 

Conclusion 
The trial team concluded that the combination of pomalidomide and low dose dexamethasone worked for people with myeloma who had a lot of treatment, including lenalidomide in the past. And it was possible to manage most of the side effects. 

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) 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:

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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

Professor Gordon Cook

Supported by

Celgene Corporation
NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:

Oracle 10644

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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