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)

Status:

Closed

Phase:

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 . People with anaemia can feel tired and breathless. Doctors often treat anaemia with blood transfusions .

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 )

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

A drop in blood cells causing an increased risk of infection, bleeding and bruising
Diarrhoea
Chest infection and other infections
Tiredness
Swelling
Loss of strength
Flu like symptoms
Constipation
Feeling or being sick
Tummy (abdominal) pain
Back pain, muscle and joint pain
Dizziness
Headache
Nose bleed
Rash, itching or dry skin
Loss of appetite

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.