A trial looking at pomalidomide for myeloma (STRATUS)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:






This trial is looking at pomalidomide to treat myeloma that has come back after treatment or continued to get worse during treatment.   

Doctors often treat myeloma that has come back with lenalidomide or bortezomib. Both are biological therapy drugs. They may also use a steroid Open a glossary item drug, such as dexamethasone. But sometimes the disease can continue to get worse during treatment or come back afterwards. Doctors are looking for new ways to treat people in this situation.

Pomalidomide is another drug therapy. It works by stimulating the body’s own immune system to fight myeloma.

The researchers want to combine pomalidomide with dexamethasone to see if it can help people who have already had treatment with lenalidomide and bortezomib.

Who can enter

You may be able to enter this trial if you

  • Have myeloma that continued to get worse during treatment or came back within 2 months after you finished your last treatment
  • Have myeloma that can be measured using a blood test or urine test
  • Have had treatment with lenalidomide or bortezomib but your myeloma got worse within 2 months of finishing or if you had responded to treatment and it came back within 6 months
  • Have had an alkylating chemotherapy drug Open a glossary item such as cyclophosphamide, ifosfamide, carmustine or melphalan
  • Have already had at least 2 different types of treatment for your myeloma
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception for a month before treatment, during treatment and for a month afterwards if there is any chance you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have already had pomalidomide
  • Are going to have a stem cell transplant
  • Have already had a bone marrow or stem cell transplant using marrow or cells from a donor and are still taking medication to damp down your body’s immune system or finished this less than a month ago
  • Have had an experimental drug as part of another clinical trial in the past month
  • Are allergic to thalidomide, lenalidomide or dexamethasone
  • Are not able or willing to take medication to prevent blood clots
  • Have moderate to severe nerve damage
  • Have had a heart attack in the past year or any other serious heart problem
  • Have had another cancer in the past 5years apart from non melanoma skin cancer, in situ carcinoma of the cervix, in situ carcinoma of the breast Open a glossary item, prostate cancer that is too small to be seen on a scan or felt during an examination of the prostate (stage T1) or any other cancer that has been successfully treated and there has been no sign of it in the past 5 years
  • Have had major surgery in the past 2 weeks
  • Have problems with your digestive system Open a glossary item that may interfere with how the trial drug is absorbed
  • Are HIV, hepatitis A, hepatitis B or hepatitis C positive
  • Have any other medical condition that could affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This is an international trial. It will recruit 720 people in Europe and Israel. Everyone taking part will have pomalidomide and dexamethasone.  

Both pomalidomide and dexamethasone are tablets. You take pomalidomide every day for 3 weeks and then have a week of not taking it. You take dexamethasone once each week. You can continue treatment as long as the side effects aren’t too bad and it is still helping you.  

If you agree to take part in this study, the researchers will ask for a sample of blood and bone marrow tissue taken before you start treatment and after you have finished treatment. They will use these to look for substances in your body (biomarkers Open a glossary item) that may help them tell how your myeloma is going and how well the treatment is working. If you don’t want to give these samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

  • A physical examination
  • Blood tests
  • Urine test
  • Heart trace (ECG Open a glossary item)
  • X-ray
  • Bone marrow test

During treatment you see the doctor every 2 weeks for the first 6 months and then every month to see how you are and to have the same tests apart from the bone marrow test.

After treatment you see the doctor every 3 months for up to a maximum of 5 years.

Side effects

The most common side effects of pomalidomide include

Your doctor will talk to you about the possible side effects before you agree to take part in the trial.

We have information about pomalidomide and  dexamethasone in our cancer drugs section.

Recruitment start:

Recruitment end:

How to join a clinical trial

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

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

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

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.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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