A trial looking at lenalidomide for mantle cell lymphoma - EMERGE

Who can enter

You can enter this trial if

• You have mantle cell lymphoma that has come back (relapsed) within a year of having bortezomib, or continued to grow ( is ‘refractory’) while having bortezomib
• Your lymphoma has been treated with the chemotherapy drugs called cyclophosphamide, rituximab and an anthracycline (for example doxorubicin and etoposide)
• You have mantle cell lymphoma that has come back after having high dose chemotherapy and a transplant of your own stem cells (autologous stem cell transplant)
• You have a CT scan of your tumour that shows it is at least 2 cm across
• You are well enough to be up and about for at least half the day (performance status 0, 1or 2)
• You have satisfactory blood test results
• Your kidneys work well enough (your doctor will test for this)
• You are willing to take medication to stop blood clots forming
• You are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
• You are at least 18 years old

You cannot enter this trial if you

• Have any type of lymphoma other than mantle cell lymphoma
• Have lymphoma that has changed from low grade to high grade lymphoma
• Have lymphoma in your spinal cord or brain (central nervous system) unless it has been treated, has caused no symptoms in the past 3 months and you have a clear lumbar puncture result
• Are able to have high dose chemotherapy and a bone marrow transplant unless you do not want to have this treatment
• Have lymphoma that has come back (relapsed) after having a stem cell transplant from someone else and these stems cells are still working in your bone marrow
• Have had lenalidomide before
• Have had chemotherapy in the last 2 weeks (for nitrosoureas 6 weeks)
• Have had antibody treatment in the last 8 weeks
• Have had radiotherapy in the last 3 weeks except for radiotherapy to the head
• Have had a drug that delivers radiotherapy straight to your cancer, for example Zevalin, in the last 12 weeks
• Got blisters on your skin after taking thalidomide
• Have had any medication as a part of another clinical trial in the last 4 weeks
• Have had another cancer, unless it was successfully treated and there has been no sign of it (complete remission) for at least 3 years (you may join the trial if you have non melanoma skin cancer, carcinoma in situ of the cervix or breast, or prostate cancer stage 1)
• Are known to be HIV, hepatitis B or hepatitis C positive
• Have an infection that is being treated with antibiotics by a drip into the vein (intravenous)
• Have diabetes that is not controlled with medication
• Have congestive heart failure that is causing symptoms
• Have had angina or a heart attack in the last 6 months
• Have an irregular heart beat that is being treated or causing symptoms except atrial fibrillation (your doctor can advise about this)
• Have another serious medical condition that could affect you taking part in this trial

Trial design

This is a phase 2 international trial. It will recruit about 133 people from different countries around the world.

Everyone taking part in this trial will have lenalidomide. You take the lenalidomide capsule once a day for 3 weeks and have 1 week of no lenalidomide. This is called a cycle of treatment.

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

When you start lenalidomide, you may still have some lymphoma cells around. When cancer cells die, chemicals in the cells are suddenly released into your blood. This changes the normal balance of chemicals circulating in your body. It is called tumour lysis syndrome. Your doctor will give you medication to control it.

Hospital visits

You will see the doctor and have some tests before you start treatment. These tests may include

• Physical examination
• Heart trace (ECG)
• CT scan
• MRI scan
• Blood tests
• Pregnancy test (if appropriate)
• Lumbar puncture (if needed)

During treatment you will see the doctor every 4 weeks and have the following tests

• Physical examination
• Blood tests

During treatment you may have a bone marrow test, if needed your doctor will discuss this with you.

After your treatment, you will see the doctor and have the following tests

• Physical examination
• Blood tests
• CT scan or MRI scan
• Pregnancy test (if appropriate)

If you have stopped treatment due to your lymphoma coming back or getting worse you will see the doctor every 3 months. And the research team may telephone you every 3 months, to see how you are.

But if you have stopped treatment due to side effects you will see the doctor every 8 weeks and have a CT scan or MRI scan.

During and after treatment if your doctor thinks you need to have any other tests or scans. They will discuss this with you.

Side effects

All treatments have side effects. The most common side effects of lenalidomide are

• Feeling tired (fatigue)
• A drop in blood cells causing an increased risk of infection, bruising , bleeding problems and shortness of breath
• Constipation
• Diarrhoea
• Feeling sick
• Loss of appetite
• Back or joint pain
• Muscle cramps
• Shortness of breath or difficulty catching your breath
• Chest infections
• Difficulty sleeping
• Fever
• Swollen arms or legs
• Rash, itching or dry skin
• Dizziness
• Headache
• Lack or loss of strength
• Cough or infection in your airways

When you start lenalidomide, you may have an increase in symptoms. This is called tumour flare. It is not a common reaction to starting treatment and does not mean your lymphoma is getting worse. Your doctor may give you medication to control this.