Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at pomalidomide for myeloma (STRATUS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at pomalidomide to treat myeloma that has come back after treatment or continued to get worse during treatment.
Doctors often treat myeloma that has come back with lenalidomide or bortezomib. Both are biological therapy drugs. They may also use a
The researchers want to combine pomalidomide with dexamethasone to see if it can help people who have already had treatment with lenalidomide and bortezomib.
Who can enter
You may be able to enter this trial if you
- Have myeloma that continued to get worse during treatment or came back within 2 months after you finished your last treatment
- Have myeloma that can be measured using a blood test or urine test
- Have had treatment with lenalidomide or bortezomib but your myeloma got worse within 2 months of finishing or if you had responded to treatment and it came back within 6 months
- Have had an
alkylating chemotherapy drugsuch as cyclophosphamide, ifosfamide, carmustine or melphalan
- Have already had at least 2 different types of treatment for your myeloma
- 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 willing to use reliable contraception for a month before treatment, during treatment and for a month afterwards 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 already had pomalidomide
- Are going to have a stem cell transplant
- Have already had a bone marrow or stem cell transplant using marrow or cells from a donor and are still taking medication to damp down your body’s immune system or finished this less than a month ago
- Have had an experimental drug as part of another clinical trial in the past month
- Are allergic to thalidomide, lenalidomide or dexamethasone
- Are not able or willing to take medication to prevent blood clots
- Have moderate to severe nerve damage
- Have had a heart attack in the past year or any other serious heart problem
- Have had another cancer in the past 5years apart from non melanoma skin cancer, in situ carcinoma of the cervix,
in situ carcinoma of the breast, prostate cancer that is too small to be seen on a scan or felt during an examination of the prostate (stage T1) or any other cancer that has been successfully treated and there has been no sign of it in the past 5 years
- Have had major surgery in the past 2 weeks
- Have problems with your
digestive systemthat may interfere with how the trial drug is absorbed
- Are HIV, hepatitis A, hepatitis B or hepatitis C positive
- Have any other medical condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
This is an international trial. It will recruit 720 people in Europe and Israel. Everyone taking part will have pomalidomide and dexamethasone.
Both pomalidomide and dexamethasone are tablets. You take pomalidomide every day for 3 weeks and then have a week of not taking it. You take dexamethasone once each week. You can continue treatment as long as the side effects aren’t too bad and it is still helping you.
If you agree to take part in this study, the researchers will ask for a sample of blood and bone marrow tissue taken before you start treatment and after you have finished treatment. They will use these to look for substances in your body (
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Urine test
- Heart trace (
- Bone marrow test
During treatment you see the doctor every 2 weeks for the first 6 months and then every month to see how you are and to have the same tests apart from the bone marrow test.
After treatment you see the doctor every 3 months for up to a maximum of 5 years.
The most common side effects of pomalidomide include
- A drop in blood cells causing an increased risk of infection, bruising or bleeding
- Changes to the level of sugar in your blood
- Increased sweating
- Numbness, tingling or burning sensation in the hands and feet
- Chills or fever
- Constipation or diarrhoea
- Cough or shortness of breath
- Dry skin or a rash
- Feeling shaky and weak
- Feeling or being sick (nausea)
- Hair loss
- Muscle cramps
- Difficulty sleeping
- Ringing in your ears
- Sore throat
- Chest infection
- Swelling of your arms or legs
- Tiredness (fatigue)
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Gordon Cook
NIHR Clinical Research Network: Cancer