A trial looking at ixazomib for people with myeloma that has come back (Myeloma XII ACCoRd)

Cancer type:

Myeloma

Status:

Open

Phase:

Phase 3

This trial is for people who have had a stem cell transplant and who had no sign of their myeloma (in remission) for at least 12 months before it came back. The people taking part must be fit and healthy enough to have another stem cell transplant.  

Cancer Research UK supports this trial. 

More about this trial

Following a stem cell transplant for myeloma, there can be no signs of the disease. This is called remission Open a glossary item.

After some time, your myeloma might come back. This is a relapse Open a glossary item. If this happens, you can have treatment with:

In this trial doctors are looking at a new drug called ixazomib. 

Ixazomib is a targeted cancer drug called a cancer growth blocker. It blocks certain proteins that tell cancer cells to divide and grow. 

Everybody taking part has thalidomide, dexamethasone and ixazomib. This is re-induction treatment.  

Then, you might have 1 of the following: 

  • a transplant using your own stem cells (autologous stem cell transplant or ASCT). This is the standard treatment Open a glossary item
  • ixazomib and a transplant using your own stem cells (augmented autologous stem cell transplant) 

Then you have either regular follow up or more treatment with thalidomide, dexamethasone and ixazomib. Doctors call this consolidation and maintenance treatment. 

The main aims of this trial are to:

  • find out if ixazomib can help people with relapsed myeloma
  • learn about the side effects
  • find out more about people’s quality of life Open a glossary item

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:

  • Your myeloma has come back (relapsed) at least 12 months after you have had a transplant using your own stem cells (autologous stem cell transplant)
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2
  • You have satisfactory blood test results 
  • You can swallow and absorb tablets 
  • Your lungs and heart are working well 
  • You are at least 18 years old
  • You are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance that you or your partner could become pregnant

After you have had treatment with thalidomide, dexamethasone and ixazomib (re-induction), you might be able to continue in this trial if all of following also apply:

  • You have had at least 4 but no more than 6 doses (treatment cycles) of thalidomide, dexamethasone and ixazomib
  • Your myeloma stayed the same (stable disease Open a glossary item) or got better (responded) after treatment with thalidomide, dexamethasone and ixazomib
  • Your doctor thinks you will be able to have a transplant using your own stem cells 

After you have had the autologous stem cell transplant, you might be able to continue in this trial if your myeloma got better after the transplant.

You cannot join this trial if any of these apply:

Cancer related

  • You have had treatment for relapsed myeloma. You might still be able to take part if it was a plasma exchange, radiotherapy to help with pain that finished more than 2 weeks ago, or dexamethasone that you stopped more than a month ago
  • You have myeloma in the brain or the spinal cord Open a glossary item
  • You have moderate or severe side effects from previous chemotherapy
  • You have had treatment with ixazomib
  • You have had another cancer apart from successfully treated early cancers (carcinoma in situ Open a glossary item) or successfully treated basal or squamous cell skin cancer 

Medical conditions

  • You have had a major surgery in the past 2 weeks 
  • You have had moderate or severe problems with your nerves causing numbness or tingling in your hands or feet (peripheral neuropathy) in the past 2 weeks   
  • You are sensitive to thalidomide, dexamethasone, ixazomib or any other drug used in this trial 
  • You have had, or have, an infection that needed treatment in the past 2 weeks 
  • You have taken drugs that affect some enzymes called CYP3A4 (such as rifampin or St. John’s wort) in the past 2 weeks   
  • You have heart problems such as congestive heart failure, high blood pressure that is not controlled by medication, angina that is not controlled or a heart attack in the past 6 months 
  • You have HIV
  • You have hepatitis B or hepatitis C
  • You have any other medical condition or mental health problem that the trial team thinks could affect you taking part in this trial 

Other

  • You have had an experimental treatment in the past month 
  • You are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The researchers need about 406 people to take part.

Re-induction
You have between 4 and 6 treatment cycles of:

  • ixazomib capsules that you take once a week
  • thalidomide capsules that you take every day
  • dexamethasone tablets that you take once a week 

Each treatment cycle lasts 4 weeks (it takes between 16 and 24 weeks in total). 

Then you have blood tests and a bone marrow Open a glossary item biopsy to find out how well the treatment worked. 

If your myeloma has got worse, you have no more treatment as part of this trial. Your doctor will talk to you about what other treatments you can have. But if your myeloma stayed the same or got better, you might be able to continue in this trial. 

Transplant    
This part of the trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:

  • a transplant using your own stem cells (autologous stem cell transplant)
  • ixazomib and a transplant using your own stem cells (augmented autologous stem cell transplant) 

Neither you nor your doctor are able to decide which group you are in.

study diagram

You have a chemotherapy drug called melphalan and then the autologous stem cell transplant. This is standard treatment. Your doctor can tell you more about this. 

If you are in augmented autologous stem cell transplant group, you also have ixazomib capsules. You take them a day before and a day after you have melphalan. 

After about 3 months you have more tests to see how well the treatment has worked. You might be able to continue in this trial if your myeloma got better. 

Consolidation and maintenance 
This part of the trial is also randomised. The people taking part are put into 1 of the following treatment groups by computer:

  • regular follow up 
  • more treatment with thalidomide, dexamethasone and ixazomib

Neither you nor your doctor are able to decide which group you are in.

study diagram

You have regular follow up visits to check how you are and to look for signs of myeloma coming back. This is standard treatment. 

If you are in the thalidomide, dexamethasone and ixazomib group you have: 

  • 2 treatment cycles of thalidomide, dexamethasone and ixazomib. This is consolidation treatment
  • then ixazomib alone. This is maintenance treatment

You continue to have maintenance treatment for as long as your myeloma stays the same.  

Quality of life 
Everybody taking part in this trial completes a quality of life questionnaire before starting treatment and: 

  • before the autologous stem cell transplant
  • about 3 months after the transplant
  • then 1 and 2 years after the transplant  

It asks about how you have been feeling and what side affects you have had.

You do not have to agree to complete questionnaires if you don’t want to. You can still take part in this trial. 

Blood and urine tests
You have some extra blood and urine tests as part of this trial. Researchers want to look at how well the treatment works. 

You have the extra blood and urine tests at set times during the trial. 

Bone marrow tests 
Everyone taking part has a bone marrow Open a glossary item sample (a biopsy) before treatment and then:

  • before the autologous stem cell transplant
  • after the consolidation treatment (if you are in the consolidation treatment group)

Some of the bone marrow biopsies you have are part of your standard treatment. Your doctor can tell you what extra trial samples you need. 

Hospital visits

You see a doctor and have some tests before taking part. These tests include: 

  • physical examination
  • blood tests
  • urine test
  • bone marrow biopsy 
  • heart scan such as echocardiogram (ECHO Open a glossary item
  • a test to find out how well your lungs work (lung function test) Open a glossary item

During treatment you see the doctor regularly. You have tests such as blood tests, urine tests and bone marrow biopsy. How often you see them depends on the treatment you have. 

When you finish treatment, if you are in the consolidation treatment group you see the doctor after 2 months. Then you see them every 3 months.  If you are in the regular follow up group, you also see the trial doctor every 3 months. 

This continues for as long as your myeloma doesn’t get worse. 

Side effects

The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.

Ixazomib is a new drug and there may be side effects we don’t know about yet. The most common side effects include: 

  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness 
  • skin rashes 
  • tiredness (fatigue)
  • feeling or being sick
  • diarrhoea or constipation
  • dehydration Open a glossary item
  • numbness or tingling in your hands and feet (peripheral neuropathy
  • high temperature (fever) and other flu like symptoms such as chills 
  • taste changes and loss of appetite 
  • difficulty sleeping (insomnia) or feeling very sleepy 
  • headaches
  • lung problems such as shortness of breath, cough and infections 
  • kidney problems
  • feeling dizzy and low blood pressure
  • pain in your joints, muscles, bones, arms and legs, back and tummy (abdomen)
  • a build up of fluid in your arms and legs causing swelling 

We have information about: 

And information about having a stem cell transplant.

Location

Aberdeen
Airdrie
Ashington
Ayr
Barnsley
Basingstoke
Bath
Birmingham
Birmingham
Blackpool
Boston
Bournemouth
Bradford
Bristol
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Chester
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Dudley
Dundee
East Kilbride
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Gloucester
Grantham
Great Yarmouth
Grimsby
Halifax
Harrogate
Huddersfield
Hull
Inverness
Ipswich
Kidderminster
Kilmarnock
Leeds
Leicester
Lincoln
Liverpool
London
Manchester
Melrose
Middlesbrough
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Salford
Salisbury
Scunthorpe
Sheffield
Southampton
St Helens
Stafford
Stockport
Stoke-on-Trent
Sutton in Ashfield
Swansea
Taunton
Torquay
Tunbridge Wells
Wakefield
Winchester
Wishaw
Wolverhampton
Worcester

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

Professor Gordon Cook

Supported by

Cancer Research UK
NIHR Haematological Oncology Clinical Studies Group
University of Leeds

Other information

This is Cancer Research UK trial number CRUK/15/008

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14291

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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