A trial looking at lenalidomide and bortezomib for myeloma - non intensive treatment group Myeloma XI

This trial is looking at using lenalidomide and bortezomib for people who have been newly diagnosed with myeloma.

There are two treatment groups in this trial, intensive treatment and non intensive treatment. Your doctor will explain the difference and discuss with you which one may be best for you. This summary is about non intensive treatment. The summary about intensive treatment is entered separately on the CancerHelp UK database.

Doctors usually treat newly diagnosed myeloma with a combination of drugs. One combination they use is cyclophosphamide, thalidomide and dexamethasone.

Lenalidomide is a biological therapy. It works mainly by helping the immune system target cancer cells. We know from research that lenalidomide is very helpful for people whose myeloma has come back during treatment. The researchers now want to find out if lenalidomide can help people with newly diagnosed myeloma. The researchers also want to find out if lenalidomide can stop your myeloma coming back after treatment (relapsing).

Bortezomib is a type of biological therapy called a proteasome inhibitor. We know from research that bortezomib can work for myeloma that has come back and has stopped responding to other treatments (refractory).

For people whose myeloma does not have the best response to their first treatment in the trial, the researchers will use bortezomib with cyclophosphamide and dexamethasone to see if the result can be improved.

The aims of this trial are to find out

How well the combination of lenalidomide, cyclophosphamide and dexamethasone works for people with myeloma
How well the combination of bortezomib, cyclophosphamide and dexamethasone works for people whose myeloma did not respond well enough to their first treatment
How well lenalidomide works to stop myeloma coming back

Recruitment

Start 25/05/2010

End 25/05/2014

Phase

Phase 3

Who can enter

You can enter this trial if you

Have myeloma that is causing symptoms or
myeloma that doesn’t produce enough paraprotein to be found in a blood or urine test (non secretory myeloma)
Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have a single area of myeloma (solitary plasmacytoma) in the bone
Have areas of abnormal plasma cells outside the bone but no sign of myeloma in the bone
Have had treatment for your myeloma before apart from radiotherapy for bone pain or pressure on your spinal cord, drugs to relieve bone pain or treatment with steroids in the last 3 months
Have weakness, pain or tingling in your hands or feet (peripheral neuropathy) unless it is very mild
Have acute kidney (renal) failure
Have had another cancer in the last 5 years – you may join if you have had in situ carcinoma or basal cell skin cancer that has been successfully treated
Have another medical condition that could affect you taking part in this trial

Trial design

This is a phase 3 trial. It will recruit about 1183 people into the intensive treatment group and about 787 in the non intensive treatment group. This will make a total of 1970 people. This is a randomised trial. In each part of the trial you will be put into a treatment group by a computer. Neither you nor your doctor will be able to choose which group you are in.

There are 3 parts to this trial. The first part is to get rid of the myeloma in your bone marrow. This is called induction chemotherapy. The second part is only for people whose myeloma has not responded well enough to the induction chemotherapy. This is called consolidation chemotherapy. The third part is to stop your myeloma coming back. This is called maintenance therapy.

Induction Chemotherapy

The 2 treatment groups for induction chemotherapy are

Cyclophosphamide, thalidomide and dexamethasone
Cyclophosphamide, lenalidomide and dexamethasone

After 6 cycles of treatment, your doctor will check how your myeloma has responded to treatment.

If your myeloma has responded very well, or there is no sign of it (complete response), you won’t need to have consolidation chemotherapy.

If your myeloma stays the same, or gets worse, you will have consolidation chemotherapy.

If your myeloma responds only a little, the doctors are not sure whether you would benefit from consolidation chemotherapy so you will be put into 1 of 2 groups by a computer. One group will have consolidation chemotherapy, the other group will not have any more treatment for now.

Consolidation Chemotherapy

Consolidation chemotherapy is bortezomib, cyclophosphamide and dexamethasone. You can have up to 8 cycles of treatment. The number will depend on how well your myeloma responds.

Maintenance Therapy

If you had lenalidomide as a part of your induction chemotherapy and your myeloma did not respond well enough, you will not take part in the maintenance therapy part of this trial. Your doctor will discuss this with you.

In maintenance therapy you will have either lenalidomide or no lenalidomide.

You can continue to have lenalidomide as long as it is helping you.

Cyclophosphamide, lenalidomide, thalidomide and dexamethasone are tablets. You have bortezomib as an injection into a vein.

If you take part in this trial, the researchers will ask your permission to take some blood, urine and bone marrow samples. These samples will be stored safely and may be used in the future for research purposes. Studying these samples may help researchers learn more about myeloma.

You can choose to have these samples taken, or not. Your choice will not stop you taking part in the trial.