A trial of lenalidomide and dexamethasone for solitary bone plasmacytoma (IDRIS)

Cancer type:

Blood cancers
Myeloma

Status:

Open

Phase:

Phase 3

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

Plasmacytoma Open a glossary item is a tumour made up of a collection of plasma cells Open a glossary item, 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 immune system Open a glossary item 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 Open a glossary item 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 have had radiotherapy to the area of bone with the aim of curing the plasmacytoma 
  • Your radiotherapy finished at least 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, 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 Open a glossary item
  • Your bone marrow test Open a glossary item shows you have 10% or less plasma cells Open a glossary item in the bone marrow
  • Your doctor thinks your radiotherapy didn’t work
  • 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 Open a glossary item in the past 3 years apart from some early cancers Open a glossary item, 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 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.

study diagram

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

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.

Location

Glasgow
London

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12865

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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