A trial looking at lenalidomide for myelodysplastic syndromes

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

Cancer type:

Blood cancers
Myelodysplastic syndrome (MDS)




Phase 3

This trial is looking at using lenalidomide (Revlimid) for myelodysplastic syndrome (MDS).

Myelodysplastic syndrome (MDS) is a condition affecting the bone marrow Open a glossary item. If you have MDS, your bone marrow makes abnormal blood cells, but not enough healthy blood cells. This can lead to a condition called anaemia Open a glossary item. People with anaemia can feel tired and breathless. Doctors often treat anaemia with blood transfusions Open a glossary item.

Lenalidomide is a type of biological therapy. It works mainly by helping the body’s immune system Open a glossary item target cancer cells.

The aim of this trial is to find out if taking lenalidomide can reduce the number of blood transfusions that people with MDS need.

Who can enter

You may be able to enter this trial if you

  • Have low or intermediate 1 risk myelodysplastic syndrome (MDS) – your doctor can confirm this
  • Have a low number of red blood cells and need blood transfusions
  • Have satisfactory blood results – your doctor will discuss this with you
  • Can look after yourself and are up and about for more than half the day (performance status 0, 1, 2)
  • Are willing to use reliable contraception if there is a chance you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have had lenalidomide before
  • May benefit from growth factors that encourage your bone marrow to make more red blood cells OR have had such growth factors in the last 8 weeks – your doctor can advise about this
  • Have had a stem cell transplant
  • Have had medication as part of another clinical trial and are still having side effects
  • Have a low number of red blood cells (anaemia) that is due to bleeding from the gut, an inherited condition or a low level of vitamin B12, iron or folate
  • Have had another cancer in the past 3 years apart from basal cell skin cancer, carcinoma in situ of the cervix or a very small cancer of the prostate (stage T1) that was found by chance during a medical procedure
  • Are allergic to thalidomide
  • Have had a blood clot in a deep vein (deep vein thrombosis - DVT) or in your lungs (pulmonary embolism – PE) in the last 3 years
  • Have a serious heart problem
  • Have a thyroid problem that is not controlled by medication
  • Have a kidney problem
  • Have moderate to severe nerve pain (neuropathy)
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Have any other serious medical condition that could affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. It will recruit 375 people from different countries around the world. It is a randomised trial. The people taking part are put into 1 of 2 groups. Neither you nor your doctor can choose which group you are in or be told which group you are in. This is called a double blind trial.

People in group 1 will have lenalidomide and best supportive care. The people in group 2 will have a dummy drug (placebo) and best supportive care. In this trial, 2 out of every 3 people will go into group 1 and 1 out of every 3 into group 2. So you have a 2 in 3 chance of being put into group 1.

You take 3 capsules of lenalidomide or placebo once a day.

Exactly how long you have treatment for, will depend on how bad your side effects are and whether the treatment is still helping.

You will be asked to fill in a questionnaire every 12 weeks while you are having treatment. It will ask you about any symptoms you have and how you have been. This is called a quality of life questionnaire.

There is an optional part to this trial. The researchers will ask your permission to store some of your blood and bone marrow samples. These samples will be stored safely and may be used in the future for research purposes. Studying these samples may help researchers learn more about lenalidomide and MDS.

If you don’t wish to have your optional blood and bone marrow samples stored for research, you don’t have to. You can still take part in the main trial.

Hospital visits

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

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

During treatment you see the doctor every week for the first 8 weeks, every other week for the next 8 weeks, then monthly. You have blood tests taken at every visit and a physical examination every 4 weeks. You have a bone marrow test done at weeks 12 and 24, then every 24 weeks after that and at the end of treatment.

You see the doctor 4 weeks after you finish treatment. They will then contact you every 3 months to see how you are.

Side effects

The most common side effects of lenalidomide include

Your doctor will discuss all the possible side effects before you agree to take part in the trial. You can find more information about lenalidomide on CancerHelp UK.

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

Dr Vyas

Supported by

Celgene Corporation
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 7971

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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