A trial looking at pomalidomide, bortezomib and dexamethasone for myeloma

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 for people whose myeloma has stopped responding to treatment or has come back.

More about this trial

Doctors are always looking for ways to improve treatment for people with myeloma. In this trial, they are looking at giving pomalidomide with bortezomib and dexamethasone. Pomalidomide affects how your immune system works. It is a type of drug called an immunomodulatory agent.

Bortezomib and low dose dexamethasone (a steroid) are 2 drugs that doctors already use to treat myeloma. 

Some people in this trial have pomalidomide, bortezomib and low dose dexamethasone. And some people have bortezomib and low dose dexamethasone. 

The aims of the trial are to 

  • Find out which treatment works best 
  • Learn more about the side effects
  • Find out how treatment affects quality of life

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to join this trial if all of the following apply. You

  • Have myeloma that has stopped responding to treatment or got worse after the last treatment
  • Have had at least 1 but no more than 3 types of myeloma treatment in the past
  • Have had treatment that included a drug called lenalidomide and you had at least 2 treatment cycles in a row
  • Are willing to take low dose aspirin to help you stop getting a blood clot
  • Are well enough to be up and about for at least half the day (performance status 0,1 or 2)
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use reliable contraception during treatment and for a minimum of 1 month afterwards if there is any chance that you or your partner could become pregnant

You cannot join this trial if any of these apply.

  • You have a type of myeloma called non secretory myeloma
  • Your myeloma got worse while taking bortezomib or within 60 days of having the last dose of this drug
  • You have already taken pomalidomide
  • You have moderate to severe numbness or tingling in your hands and feet (peripheral neuropathy). If you have moderate numbness or tingling you may be able to take part as long as you haven’t had any pain in the last 2 weeks
  • You have severe kidney damage and you need to have dialysis
  • You are sensitive or allergic to drugs called thalidomide, lenalidomide, bortezomib, boron, mannitol or dexamethasone
  • You had a severe rash after taking lenalidomide or thalidomide
  • You have had problems with your digestive system Open a glossary item that may interfere with how you absorb the trial drug
  • You have had major surgery, a procedure called plasma exchange, radiotherapy or any treatment for your myeloma in the last 2 weeks
  • You have an autoimmune condition Open a glossary item such as rheumatoid arthritis, multiple sclerosis or lupus and you need to take a regular high dose of a steroid or other treatment to manage your condition
  • You have had experimental treatment as part of a clinical trial in the last month
  • You have had any other cancer in the last 5 years apart from very early breast cancer, cervix or prostate cancer or non melanoma skin cancer Open a glossary item that was successfully treated
  • You are known to be HIV or hepatitis B positive
  • You have an active hepatitis A or hepatitis C infection
  • You have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
  • You are pregnant or breastfeeding

Trial design

This is phase 3 trial. The trial team need 544 people to join.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • One group will take pomalidomide, bortezomib and low dose dexamethasone
  • The other group will take bortezomib and low dose dexamethasone

Trial diagram

You will have treatment in 3 week cycles (21 days). In each 3 week period you will have

  • Bortezomib injections under your skin (subcutaneous injections) on 2 days a week for the first 2 weeks of each treatment cycle
  • Dexamethasone tablets on 4 days a week for the first 2 weeks of each cycle
  • Pomalidomide is a tablet. If you are taking these you will take them every day for the first 2 weeks of each treatment cycle

You will start by having 8 treatment cycles. After that, you will have treatment less frequently in each cycle. But the trial team can tell you more when you reach this stage of treatment.

As long as you don’t have bad side effects, you can carry on having the treatment for as long as it helps you.

Samples for research
If you are in the pomalidomide group, the researchers may ask to take extra blood tests as part of this trial. Where possible you have these at the same time as your routine blood tests. The researchers want to find out what happens to pomalidomide in the body (pharmacokinetics Open a glossary item) and to look for substances called biomarkers Open a glossary item to find out why treatment might work for some people and not for others.

The researchers may also ask to take an extra bone marrow biopsy of your myeloma at the beginning and end of treatment. They will look for biomarkers and they may use it for other tests in the future.

If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Quality of life questionnaires
The trial team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study Open a glossary item.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood tests
  • Urine tests
  • A heart trace (ECG Open a glossary item)
  • Bone marrow test
  • X- rays of your long bones, spine, the area between your hip bones (pelvis) and skull (skeletal survey)

During the first 8 cycles of treatment, you go to hospital at least 4 times in each 3 week period for treatment and a check up.

If you stop treatment but your myeloma hasn’t got worse, the trial team will follow you up every 3 weeks. 

If your myeloma gets worse, you stop having treatment. You see the trial team every 3 month for 5 years. This may be at a routine hospital appointment or they may phone you.

Side effects

The most common side effects of pomalidomide include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Constipation or diarrhoea
  • Cough
  • Loss of appetite
  • Fevers (high temperatures)
  • Muscle cramps
  • Infection in the lungs (pneumonia)
  • Feeling sick
  • Bone pain
  • Shortness of breath
  • Swelling of the arms and legs due to a build up of fluid
  • Tiredness (fatigue)

This is not a complete list of side effects. The trial doctor or nurse will talk to you about other possible side effects before you agree to take part in the trial.

We have more information about

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

Dr Mathew Streetly

Supported by

Celgene

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13386

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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