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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers
Myeloma

Status:

Closed

Phase:

Phase 3

This trial is looking at using lenalidomide, bortezomib and carfilzomib 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 intensive treatment. The summary about non intensive treatment is listed separately.

More about this trial

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

Lenalidomide is a new 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 is an effective treatment for myeloma that has come back and has stopped responding to other treatments (refractory).

Carfilzomib is another type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

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

For those people who had lenalidomide and their myeloma responded well enough they may have a drug called vorinostat.

In cancer cells, there are chemical messengers (enzymes) that send signals telling the cells to grow and divide. Vorinostat blocks some of these signals, which can slow down the growth of cancer cells. We know from research that vorinostat may help stop myeloma coming back.

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 lenalidomide, cyclophosphamide, carfilzomib and dexamethasone worked 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 myelodsyplastic 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

 

Trial design

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.

Induction Chemotherapy

The 3 treatment groups for induction chemotherapy are

  • Cyclophosphamide, thalidomide and dexamethasone
  • Cyclophosphamide, lenalidomide and dexamethasone
  • Cyclophosphamide, lenalidomide, carfilzomib and dexamethasone

After 4 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. You then have high dose melphalan and a transplant of your own stem cells (autologous stem cell transplant).

If your myeloma stays the same, or gets worse, you will have consolidation chemotherapy. You then have high dose melphalan and a transplant of your own stem cells (autologous stem cell transplant).

If your myeloma responds only a little, the doctors are not sure whether you would benefit from consolidation chemotherapy and so you will be put into 1 of 2 treatment groups by a computer. One group will have consolidation chemotherapy and then have high dose melphalan and a transplant of your own stem cells. The other group will have no consolidation chemotherapy before their high dose melphalan and transplant of their own stem cells.

If your myeloma has responded and you had carfilzomib, you won't need to have consolidation chemotherapy. You then have high dose melphalan and a transplant of your own stem cells. If your myeloma hasn't responded you continue to have the same treatment but not as part of this trial.

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.

If you had lenalidomide as part of your induction chemotherapy and your myeloma did respond well enough, you will go on to have maintenance therapy.

In maintenance therapy you will have either

  • Lenalidomide
  • 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 and carfilzomib 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, but only 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.

Hospital visits

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, after treatment you will see the doctor every 8 weeks until your myeloma starts to grow.

Side effects

The most common side effects of the drugs used in this trial are

You can find more about cyclophosphamide, lenalidomide, thalidomide, bortezomib, dexamethasone, melphalan and stem cell transfusion 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.

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

Chief Investigator

Prof Graham Jackson

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Leeds

Other information

This is Cancer Research UK trial number CRUK/09/014.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 3350

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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