A trial looking at lenalidomide after a donor stem cell transplant for myeloma - LenaRIC
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 lenalidomide after a stem cell transplant using cells from a donor. It is for people who have myeloma. This trial is supported by Cancer Research UK.
Doctors can treat myeloma with a stem cell transplant using cells from another person (a donor). This is called an 
. Before having the transplant, you have a combination of chemotherapy and radiotherapy. Doctors can reduce the possible complications of a transplant by giving lower doses of chemotherapy. They call this a reduced intensity conditioning (RIC) transplant.
Lenalidomide is a type of biological therapy. It works mainly by helping the immune system target cancer cells. We know from research that lenalidomide can help people with newly diagnosed myeloma.
The researchers think that lenalidomide may also be useful for people who have a RIC allogeneic stem cell transplant to treat their myeloma.
The aims of this trial are to
- See if having lenalidomide after a reduced intensity conditioning transplant is safe and helps to stop myeloma coming back
- Learn more about the side effects
Who can enter
You may be able to enter this trial if you
- Have had high dose melphalan followed by a transplant of your own bone marrow (autologous transplant) in the last 6 months and your myeloma has completely gone or nearly gone – your doctor will discuss this
- Are able to have an allogeneic transplant with reduced intensity conditioning
- Are well enough to be up and about for half of the day (performance status 0, 1, 2)
- Have satisfactory blood test results
- Are willing to use reliable contraception if there is a chance you or your partner could become pregnant
- Are between 18 and 70 years old
You cannot enter this trial if you
- Are able to have intensive treatment for your myeloma
- Have had an organ transplant
- Are allergic to the drugs used in this trial
- Have had an experimental drug as part of another clinical trial in the last 4 weeks
- Have another medical condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
Trial design
This is a phase 2 trial. It will recruit 40 people in the UK. Everyone taking part will have chemotherapy and radiotherapy before having a transplant of stem cells from a donor.
You have the chemotherapy drug fludarabine. You also have drugs called ciclosporin and anti thymocyte globulin (ATG) to help damp down your immune system. You have one dose of radiotherapy to your whole body. This is called total body irradiation or TBI. Having these drugs and radiotherapy takes 4 days. On the 5th day you have the stem cell transplant.
About 1 month after your transplant you start lenalidomide. Lenalidomide is a capsule that you swallow. You take it every day for 3 weeks and then have a week without treatment. Each 4 week period is called a cycle of treatment. You can have up to 12 cycles of treatment within the first year after your transplant.
Hospital visits
You see the doctor and have some tests before starting treatment. These include
- A physical examination
- Bone marrow test
- Blood tests
After your transplant you have a blood test once a week for 3 months, once every 2 weeks for 3 months then every month for 18 months.
At the beginning of each cycle of lenalidomide you see the doctor and have a physical examination.
You have a bone marrow test at 6, 12 and 24 months.
Side effects
The most common side effects of lenalidomide are
- A drop in blood cells causing an increased risk of infection, bruising or bleeding
- Tiredness
- Back pain
- Feeling or being sick
- Shortness of breath
- Fever
- Loss of strength
- Problems sleeping
- Constipation
- Loss of appetite
- Joint pain
- Diarrhoea
- Muscle cramps
- Rash, itchy and dry skin
- Dizziness
- Headache
- Swelling of your arms and legs
- Blood clots
You can find more information about lenalidomide and side effects of a stem cell transplant on CancerHelp UK.
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 Mark Cook
Supported by
Cancer Research UK
Cancer Research UK Clinical Trials Unit, Birmingham
Celgene Ltd
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University Hospital Birmingham NHS Foundation Trust
Other information
This is Cancer Research UK trial number CRUK/09/026.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
