A trial of pomalidomide and dexamethasone in people with myeloma whose kidneys are not working well

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Myeloma

Status:

Closed

Phase:

Phase 2

This trial is looking at a drug called pomalidomide with a low dose of the steroid dexamethasone for myeloma that is not responding to treatment or has come back. The people taking part have myeloma and their kidneys are not working very well.

More about this trial

The main treatments for myeloma include chemotherapy, steroids such as dexamethasone, and biological therapies such as bortezomib and lenalidomide. If these 2 drugs don’t help, or stop working, doctors can use another drug called pomalidomide alongside a low dose of dexamethasone.

Pomalidomide affects how your immune system works. It is a type of drug called an immunomodulatory agent.

Many people with myeloma have some damage to their kidneys Open a glossary item . Doctors call this renal impairment. People taking part in this trial have either moderate or severe renal impairment.

The main aim of the trial is to see how well pomalidomide and low dose dexamethasone works for people who have myeloma and renal impairment.

Who can enter

You may be able to join this trial if all of the following apply. You

Have myeloma that is getting worse despite having treatment that included the drug lenalidomide
Have kidney damage caused by myeloma (the trial team may take a biopsy from your kidney to check this)
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception during the trial and for at least 4 weeks afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply. You

Have kidney damage that is caused by something other than myeloma or is only due to a high level of calcium in your blood
Are able to have a stem cell transplant
Have already had pomalidomide
Are known to be very sensitive to lenalidomide, thalidomide or dexamethasone
Have damage to the nerves in your hands and feet (peripheral neuropathy) unless this only mild
Have had a bone marrow or stem cell transplant using cells from a donor in the last year if you didn’t stop taking drugs to damp down your immune system (as part of this treatment) at least 4 weeks ago
Have had surgery or any treatment for myeloma in the last 2 weeks
Have had another experimental drug in the last 4 weeks (or longer if there is any chance some of the drug could still be in your body)
Have had any other cancer in the last 5 years, apart from very early stage (in situ ) cancer of the breast or cervix, or early stage non melanoma skin cancer or prostate cancer
Have any problem with your digestive system that could affect how you absorb tablets
Have an infection that can’t be treated or a virus called hepatitis
Have had a heart attack in the last year, or have certain other heart problems (the trial team can advise you about this)
Have any other medical condition or mental health problem that the trial team think could affect your taking part
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 80 people to join. Everybody taking part has pomalidomide and low dose dexamethasone.

You have treatment in 4 week periods called cycles of treatment. You take

Pomalidomide tablets every day for the first 3 weeks of each treatment cycle
Dexamethasone tablets once a week throughout each cycle

As long as you don’t have bad side effects, you can carry on having the treatment for as long as it helps you.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Heart trace (ECG )
Blood tests
Urine tests
Bone marrow test
X-rays or an MRI scan

You may also need to have a biopsy Open a glossary item of your kidney.

You go to hospital once a week for the first 8 weeks of treatment. After that, you go once every 4 weeks. You have regular blood tests and urine tests. You have a heart trace every 3 months.

You may need to have another bone marrow test. And you may need to have more X-rays, MRI scans or CT scans.

When you finish treatment, you see the trial team again about 4 weeks later and have a physical examination, blood tests and urine tests. After that, they will check how you are every 3 months for up to 5 years. This can either be at routine hospital visits or by phone calls.

Side effects

The most common side effects of pomalidomide include

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Constipation or diarrhoea
Cough
Loss of appetite
High temperature (fever)
Muscle cramps
Feeling sick
Pain
Infection in your lungs (pneumonia)
Shortness of breath
Swelling in your arms or legs due to a build up of fluid
Tiredness (fatigue)