A trial looking at treatment for myeloma that has come back after a transplant with your own blood stem cells or bone marrow (MMVAR)

Who can enter

You can enter this trial if you

• Have myeloma that has come back (relapsed) or has continued to grow (progressive disease) after an autologous transplant
• Have satisfactory blood tests
• Are well enough to take part (Karnofsky performance status of more than 50)
• Are willing to use reliable contraception 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 no myeloma proteins in your blood or urine (non secretory myeloma)
• Have moderate or severe damage to the nerves in your hands or feet from earlier chemotherapy (peripheral neuropathy) in the 2 weeks before starting the trial
• Have had a heart attack in the last 6 months or have another serious heart problem
• Have high blood pressure or diabetes that is not well controlled
• Have any other condition or illness that could affect you taking part in this trial
• Have had any other cancer in the last 5 years, apart from non melanoma skin cancer or carcinoma in situ of the cervix that has been successfully treated
• Have had an allergic reaction to bortezomib (Velcade), boron or mannitol in the past
• Are known to have HIV, or hepatitis A, B or C
• Are pregnant or breastfeeding

Trial design

This is a randomised trial. The people taking part are put into one of two treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everybody taking part in the trial will have thalidomide and dexamethasone tablets. You take thalidomide every night. And take dexamethasone for 4 days every 3 weeks. You will have treatment for up to one year depending on your situation.

People in group 2 will also have bortezomib. For the first 6 months you have treatment every 3 weeks. Each 3 weeks is one cycle of treatment. You have bortezomib as an injection into a vein twice a week for the first 2 weeks of each cycle. And then no treatment in the third week.

For the second 6 months you have bortezomib every 6 weeks. Each 6 weeks of treatment is one cycle. You have bortezomib once a week for 4 weeks of each cycle. And then no treatment for 2 weeks.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

• Physical examination
• ECG (electrocardiogram)
• Blood tests
• 24 hour urine collection
• Bone marrow test
• X-rays

You will fill out a short questionnaire about symptoms from possible nerve damage that you may have had because of earlier chemotherapy (peripheral neuropathy).

You will see the doctor every 3 weeks for the first 4 months and every 4 to 6 weeks for the next 8 months. Each appointment will last 1 to 2 hours.

If you are in group 2, you will have 4 extra trips to the hospital with each treatment cycle to have bortezomib. The treatment itself takes a few minutes, but you will need to stay in the hospital for an hour after each injection.

When you finish treatment, you will have follow up appointments with your doctor every three months. You will also see your GP every 6 weeks for blood and urine tests.

Side effects

Bortezomib is still quite a new drug and there may be some side effects the doctors don't know about yet. In trials so far, the most common side effects have been

• Tiredness (fatigue)
• Constipation or diarrhoea
• Feeling or being sick
• Loss of appetite
• Fever
• Numbness or tingling in your hands or feet
• A drop in your blood count causing an increased risk of infection, bruising or bleeding problems and tiredness

There is more about the side effects of thalidomide and steroids on CancerHelp UK.