A trial of lenalidomide and dexamethasone for solitary bone plasmacytoma (IDRIS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at treating newly diagnosed solitary bone plasmacytoma with lenalidomide and dexamethasone after having radiotherapy.
Cancer Research UK supports this trial.
More about this trial
is a tumour made up of a collection of , a type of blood cell. Solitary bone plasmacytoma is a collection of these cells in one place in the skeleton.
Radiotherapy is the treatment used for solitary bone plasmacytoma. For some people this can cure it. But for others it might come back or develop into myeloma.
After radiotherapy people are followed up regularly. They only have further treatment if their plasmacytoma comes back or develops into myeloma.
Plasmacytoma is similar to the areas of plasma cells found in people with myeloma. Lenalidomide and dexamethasone are used to treat myeloma.
Lenalidomide is an immunotherapy. It helps the body’s target cancer cells. Dexamethasone is a steroid that is often used with cancer drugs.
Researchers think having lenalidomide and dexamethasone might help prevent solitary bone plasmacytoma coming back or stop it developing into myeloma.
To find this out, following radiotherapy some people will:
- have lenalidomide and dexamethasone
- be followed up as usual
The aims of this trial are to find out:
- if lenalidomide and dexamethasone after radiotherapy can prevent or slow down solitary bone plasmacytoma coming back or developing into myeloma
- more about the side effects of lenalidomide and dexamethasone
- how
quality of life is affected
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply.
- You have a solitary bone plasmacytoma that is newly diagnosed
- You are having or have had radiotherapy to the area of bone with the aim of curing the plasmacytoma
- If you've completed radiotherapy this shouldn't have finished more than 28 days ago
- Your blood test results are satisfactory
- You are up and about for at least half the day and can look after yourself (performance status 0 to 2)
- You are willing to use 2 types of contraception, including a barrier type before starting treatment , during treatment and for at least a month afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply.
Cancer related
- You have more than 1 plasmacytoma
- You have a single plasmacytoma that isn’t in the bone
- You have
myeloma - Your
bone marrow test shows you have 10% or more plasma cells in the bone marrow - You are taking, or your doctor intends to treat you with, steroids – if you are taking steroids for another medical condition you might be able to take part
- You have had a
solid cancer in the past 3 years apart from some early cancers , some cancers that have been successfully treated and some cancers that were removed by surgery and considered to be cured
Medical conditions
- You are at a high risk of developing a blood clot because you are having drugs, such erythropoietin, that encourage your bone marrow to make red blood cells or you are at risk for another reason and aren’t able to take medication, such as heparin or warfarin, to prevent a blood clot forming
- You have an active infection that affects your whole body and isn't controlled by medication
Other
- You are pregnant or breastfeeding
Trial design
This is a phase 3 trial. The trial team want 140 people to join.
After agreeing to take part you have a bone marrow test to find if your plasmacytoma is at a high or low risk of becoming myeloma.
Low risk
People who are at a low risk are followed up regularly for 5 years. You won’t have any further treatment unless the plasmacytoma comes back or develops into myeloma.
High risk
People who are at a high risk are put into 1 of 2 treatment groups by a computer (they are randomised).
Half the people will have lenalidomide and dexamethasone. The other half won’t.
Lenalidomide is a capsule. You take it every day for 3 weeks and then have a week off. Dexamethasone is a tablet you take once a week every 4 weeks.
Each 4 week period is called a cycle of treatment. You have up to 9 cycles.
Quality of life
You fill in a questionnaire before starting treatment and then every 3 months for 2 years. The questions ask about how you are and any side effects you might have. This is called a quality of life questionnaire.
Samples
When you agree to take part you have a bone marrow test. The team use this to see if your plasmacytoma is at a high or low risk of coming back.
People having lenalidomide and dexamethasone have another bone marrow test a month after finishing treatment.
Hospital visits
You see the doctor to have some tests before taking part. These tests include:
- a physical examination
- blood tests
You see the doctor every month before each cycle of treatment if you are taking lenalidomide and dexamethasone. This for a physical examination and blood tests.
A month after finishing treatment people having lenalidomide and dexamethasone have a bone marrow test.
Everyone sees the doctor for blood tests and a physical examination every:
- 3 months up to 2 years after radiotherapy
- 6 months for another 3 years
After this your doctor will tell you how often they want to see you.
Side effects
The common side effects of lenalidomide are:
- a drop in blood cells causing an increased risk of infection, tiredness, breathlessness, bruising and bleeding
- tiredness and lack of energy
- constipation or diarrhoea
- muscle cramps and aches
- skin reaction including a rash or dry, itchy, red skin
- nerve damage including shakiness, numbness or tingling in fingers or toes, difficulty performing certain tasks with your hands, such as doing up buttons
- headaches
- blurred vision
- dizziness
- feeling or being sick
- changes in the levels of calcium, potassium and sodium in your blood
- bone pain
- high temperature (fever) and flu like symptoms
- loss of appetite and taste changes that could cause weight loss
- high levels of sugar in your blood
- tummy (abdominal) pain
- mood changes
- toothache
- clouding of the lens of your eye (cataract)
- difficulty sleeping
- swelling or puffiness
- sore, dry mouth
blood clots
We have more information about lenalidomide.
We have information about dexamethasone and its side effects.
Your doctor will talk to you about the side effects of lenalidomide and dexamethasone before you agree to take part.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Roger Owen
Supported by
Cancer Research UK
Celgene Ltd
University College London (UCL)
Other information
This is Cancer Research UK trial number CRUK/14/032.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
