A trial looking at plasma exchange in patients with newly diagnosed myeloma and kidney failure (MERIT)

Please note this trial is no longer recruiting patients.

This trial is looking at plasma exchange to help treat kidney damage in people with myeloma.

People with myeloma often have high levels of proteins called immunoglobulins in their blood. These extra proteins can damage the kidneys, as they pass through from the blood into the urine.

About 5 out of every 100 myeloma patients (5%) have serious kidney failure when they are first diagnosed with myeloma. At the moment, these patients often need to have dialysis for life.

Doctors think that a process called ‘plasma exchange’ may help damaged kidneys to work again. Plasma exchange is a way of removing some of the extra proteins in the blood. They hope that lowering the levels of these proteins will stop damage to the kidneys, which will then be able to recover. So patients will not need dialysis.

But doctors aren’t sure if this way of treating kidney failure caused by myeloma works very well or not. The aim of this trial is to see if plasma exchange together with steroid and chemotherapy treatment will help damaged kidneys to recover.

Recruitment

Start 05/01/2004

End 23/01/2009

Phase

Phase 3

Who can enter

You can enter this trial if you

Have recently been diagnosed with myeloma and have kidney failure (renal failure) caused by your myeloma
Are at least 18 years old
Are prepared to use reliable contraception while you are taking part in this trial

You cannot enter this trial if you

Have had chemotherapy for your myeloma before
Are known to be HIV positive (but you will not be tested as part of this trial)
Have kidney failure that is not related to your myeloma
Have heart failure
Have liver failure
Have a stomach ulcer
Are pregnant

Trial design

This is a randomised trial. It will recruit 286 patients. There are 2 groups. The patients taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1 you will have 2 four day courses of dexamethasone tablets in the first 2 weeks, and then have chemotherapy
If you are in group 2 you will have 2 four day courses of dexamethasone tablets and have plasma exchange 7 times in first 2 weeks, then have chemotherapy

If you have plasma exchange you will have a central line put into a vein above your collar bone, or maybe in your groin. Your blood will pass through a machine, which will remove some of the blood plasma which contains the extra proteins that are damaging your kidneys. You will have some purified blood plasma given back to you in return. This process takes about 2 or 3 hours each time.

All patients taking part will have chemotherapy. Your doctor will talk to you about the combination of drugs that you will have. Your chemotherapy treatment will last for about 3 months (100 days).

You may have a biopsy of your kidney. If you do, you will be asked if this can be sent to the trial pathologist for analysis.

You will be asked to fill out a questionnaire before you start treatment, and again 3, 6 and 12 months later. This will ask you how you are feeling and about any side effects you are having. It is called a Quality of Life study.

Hospital visits

You will probably already be in hospital when you start treatment. You will not be in hospital any longer as a result of taking part in this trial.

You will have some tests as part of your treatment for myeloma. The only extra tests you will have because you are taking part in this trial are small number of blood tests.

The tests you will have include

Blood tests
Urine test
Heart trace (ECG)
Bone marrow aspirate

You may also have a kidney biopsy. You will have blood tests and urine tests before each cycle of chemotherapy. You are likely to be in hospital for treatment to start with. But once the doctors are happy that you are stable you should be able to have chemotherapy as an outpatient.

After the trial you will see the doctors regularly as part of your treatment for myeloma. You will have blood tests 6 months and a year after you join the trial.

Side effects

As with most treatments, there are some possible side effects of plasma exchange. You may

Feel light headed when you have the exchange
Notice you bleed or bruise more easily than usual (some proteins that help the blood to clot may be removed in the exchange - you will have blood tests to check the level of these proteins), although this is rare
Be at increased risk of getting an infection

The most common side effects of Adriamycin and vincristine are

A drop in blood cells causing an increased risk of infection, bleeding problems, breathlessness and tiredness
Feeling or being sick
Hair loss
Sore mouth
Numbness and tingling in hands and feet (peripheral neuropathy)

There is more information about Adriamycin and vincristine on CancerHelp UK.