A trial looking at lenalidomide after a donor stem cell transplant for myeloma - LenaRIC

This trial is looking at lenalidomide after a stem cell transplant using cells from a donor. It is for people who have myeloma.

Doctors can treat myeloma with a stem cell transplant using cells from another person (a donor). This is called an allogeneic stem cell transplant. 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

Recruitment

Start 31/05/2011

End 30/05/2013

Phase

Phase 2

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 ciclosporin and anti thymocyte globulin (ATG) to help damp down your immune system. You also 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