A trial looking at the treatment of myeloma in older people

Who can enter

You can enter this trial if you

• Have myeloma that is causing symptoms
• Are well enough to take part in this trial (performance status 0, 1, 2)
• Have satisfactory blood results to take part in the trial
• Are prepared to use a reliable form of contraception during the trial and for 28 days after the end of treatment if there is a chance that you or your partner could become pregnant
• Are 65 years of age or over (younger patients can take part if they are not able to have a stem cell transplant)

You cannot enter this trial if you

• Have myeloma that does not produce enough paraprotein to take part in the trial
• Have been treated for myeloma before (except for radiotherapy and bisphosphonates)
• Have had more than a short course of steroids
• Have had a short course of steroids within 14 days of taking part in this trial
• Are unable, or unwilling, to take medication that stops blood clots forming
• Are having kidney dialysis
• Have had another cancer, unless it has been in complete remission for at least 3 years, except basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or breast, or stage 1 prostate cancer
• Are known to be HIV positive
• Are known to be hepatitis A, B or C positive
• Have nerve damage that affects you going about your daily activities (peripheral neuropathy)
• Have another medical condition that could affect you taking part in this trial
• Are pregnant or breastfeeding

Trial design

This is a phase 3 international trial. It will recruit about 1,600 people from different countries around the world. It is a randomised trial. The people taking part are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

All the medication is either a capsule or tablet which you take home.

The 3 groups are

• Lenalidomide and dexamethasone for up to 8 years
• Lenalidomide and dexamethasone for up to 72 weeks
• Melphalan, prednisone and thalidomide for up to 72 weeks

How long you have the treatment depends on how well your myeloma responds.

Both the lenalidomide and dexamethasone groups will have a 4 week cycle of treatment. You have dexamethasone once a week for 4 weeks. You take lenalidomide every day or every second day for 3 weeks and have 1 week off. Whether you have it every day or every second day depends on how well your kidneys work. You have a test done to find out how well your kidneys work before taking part in the trial.

The melphalan, prednisone and thalidomide group will have a 6 week cycle of treatment. You have thalidomide continuously for the 6 weeks. You have melphalan and prednisone on the first 4 days of the 6 week cycle only.

Before you take part in the trial, and at times during it, you will need to collect all the urine you pass in a 24 hour period. This is a 24 hour urine collection. The hospital will provide all the information and equipment you need to do this at home. This is to measure the levels of myeloma proteins in your urine and also to find out how well your kidneys work.

You will be asked to fill in 3 questionnaires before you start your treatment. You fill them in twice more in the first 12 weeks of the trial. Then again every 12 weeks for the next 72 weeks (so 6 times in total). They will ask about any symptoms you have had and how you are feeling. This is called a quality of life study.

Hospital visits

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

• Physical examination
• An examination for possible nerve damage in the arms and legs (peripheral neuropathy)
• Bone marrow test
• Blood tests
• Heart trace (ECG)
• X-rays
• Urine test
• 24 hour urine test
• Pregnancy test (if appropriate)

You have a blood test every week of the first and second cycle of treatment. And then every 2 weeks in the third cycle of treatment. You then have a blood test at the beginning of each cycle of treatment.

In both of the lenalidomide and dexamethasone groups, during treatment you will see the doctor every 4 weeks and have the following tests

• Physical examination
• An examination for possible nerve damage in the arms and legs (peripheral neuropathy)
• Blood tests
• 24 hour urine test
• Pregnancy test (if appropriate)

In the melphalan, prednisone and thalidomide group you will see the doctor every 6 weeks and have the same tests.

In all 3 groups, at 12 weeks you will have a heart trace (ECG) and urine test. These are repeated every 6 months.

During and after treatment your doctor will talk to you about how often they need to see you. If they think you need to have any other tests or scans, they will discuss this with you.

Side effects

Your doctor will be watching you carefully for side effects. The most common side effects of lenalidomide are

• Tiredness (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
• Difficulty sleeping
• Fever
• Swollen arm or legs
• Rash, ithcy or dry skin
• Dizziness
• Headache
• Lack or loss of strength
• Cough or infection in your airways

Your doctor will discuss all the possible side effects before you agree to take part in the trial. You can find out about the side effects of lenalidomide, thalidomide, melphalan, prednisone and dexamethasone on the CancerHelp UK website.