“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at lenalidomide and bortezomib for myeloma - non intensive treatment group Myeloma XI
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at using lenalidomide and bortezomib for people who have been newly diagnosed with myeloma. This trial is supported by Cancer Research UK.
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 listed separately.
More about this trial
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.
For people whose myeloma responded well enough to lenalidomide, they may go on to have a drug called vorinostat.
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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 only and the combination of lenalidomide and vorinostat works to stop myeloma coming back
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 myelodysplastic syndrome (MDS)
- 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, or have had, another cancer (the trial team can advise about this)
- Have another medical condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
This is a phase 3 trial. It will recruit about 2200 people into the intensive treatment group and about 1800 in the non intensive treatment group. This will make a total of 4000 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.
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 is bortezomib, cyclophosphamide and dexamethasone. You can have up to 8 cycles of treatment. The number will depend on how well your myeloma responds.
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.
If you had lenalidomide as a part of your induction chemotherapy and your myeloma did respond well enough, you will take part in the maintenance part of this trial.
In maintenance therapy you will have either
- Lenalidomide and vorinostat (Please note people are no longer been put into this group as the researchers have enough to answer the question)
- No maintenance treatment
You can continue to have treatment 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.
You will see the doctor and have some tests before starting treatment. These tests include
During treatment you see the doctor every 4 weeks and have the following
- A physical examination
- Blood tests
- Urine test
As a part of the trial, you will see the doctor every 8 weeks after treatment until your myeloma starts to grow again.
The most common side effects of the drugs used in this trial are
- A drop in blood cells causing an increased risk of infection, bruising or bleeding
- Feeling, or being, sick
- Loss of appetite
- Tingling in hands and feet
- Rash, or dry skin
- Mood changes
- Increased risk of blood clots
- General aches and pain
- Swelling of ankles and feet
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.
Professor Graham Jackson
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Leeds
This is Cancer Research UK trial number CRUK/09/014.