A trial of ixazomib, lenalidomide and dexamethasone for people with myeloma (FITNEsS)

Cancer type:

Blood cancers
Myeloma

Status:

Open

Phase:

Pilot

This trial is for people who might not be able to have the full dose of treatment because they have other illnesses or are not fit enough. It is looking at changing the dose of ixazomib, lenalidomide and dexamethasone to see if these people are better able to cope with treatment.
The trial is for people who can’t have a stem cell transplant.

It is also looking at whether taking ixazomib with lenalidomide after the initial treatment works better than lenalidomide on its own. This is to keep myeloma under control. 

Cancer Research UK supports this trial. 

More about this trial

Treatment for people with newly diagnosed myeloma who can’t have a stem cell transplant Open a glossary item can include:

  • targeted drugs Open a glossary item
  • chemotherapy Open a glossary item
  • steroids  Open a glossary itemor 
  • a combination of the above

These treatments work for people who are otherwise fit and healthy. But for people who aren’t as fit and have other illnesses the outcomes are not so good. Researchers are looking for ways to help these people. 

In this trial researchers are looking at 3 drugs that you might have as part of your treatment for myeloma. These are:

There are 2 parts to this trial. 

Part 1 is about initial treatment to control or have no signs of myeloma (complete recovery). This is induction treatment. 

Part 2 is about continuing treatment to make sure it does not get any worse. This is maintenance treatment. 

Induction treatment
In part 1 everyone has lenalidomide, ixazomib and dexamethasone. Doctors look at:

  • your age
  • other illnesses you have
  • what you are able to do 

This a scoring system of frailty. It is to see how fit you are. The doctor works out your frailty score before you start treatment.  

There are 2 groups in this part of the trial. 

In the 1st group you have the standard treatment. During your treatment the dose can change considering how bad your side effects are. So your dose of treatment might change through your treatment. This can include stopping treatment.

In the 2nd group the doctor can change your dose of lenalidomide and dexamethasone. They can reduce it if you are having side effects. Or they can increase it if it is work well and you have no side effects. And changes to the standard dose of treatment reflect this. You continue to have the same dose through your treatment.

The aim in this part of the trial is to find out whether using the scoring system before the start of treatment helps:

  • people cope with treatment and continue with it 
  • them to have a better outcome
  • with their quality of life Open a glossary item

Maintenance treatment
In part 2 researchers are comparing:

  • lenalidomide and ixazomib
  • lenalidomide and a dummy drug (placebo Open a glossary item)

The aim of this part of the trial is to find out:

  • how well the combination of lenalidomide and ixazomib works
  • how it 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. 

There are 2 parts to this trial. 

Part 1 

Who can take part
You may be able to join part 1 of this trial if all of the following apply. You:

  • have a new diagnosis of myeloma  
  • are not able to have a stem cell transplant 
  • have satisfactory blood test results within 2 weeks of being put into a treatment group (randomised)
  • are willing to use contraception during treatment and for 3 months after you finish treatment if there is any chance you or your partner could become pregnant
  • are at least 18 years old

Part 2

Who can take part
You may be able to join part 2 of this trial if all of the following apply. 

  • You took part in part 1 and you had 12 cycles of treatment Open a glossary item with ixazomib and lenalidomide. 
  • Your myeloma got better after treatment and has not got any worse before starting treatment in part 2.   
  • You have satisfactory blood test results within 2 weeks of going into a treatment group (randomised) for part 2. 
  • You are willing to use contraception during treatment and for 3 months after you finish treatment if there is any chance you or your partner could become pregnant. 

Who can’t take part

Cancer related
You cannot join this trial if any of these apply. You have:

  • myeloma but don’t have symptoms (smouldering myeloma
  • a type of myeloma called Monoclonal gammopathy of undetermined significance (MGUS) 
  • a type of myeloma made up of a single lump of plasma cells (plasmacytoma
  • a plasmacytoma outside of the bone marrow Open a glossary item with no sign of having myeloma
  • had treatment for myeloma apart from a radiotherapy to a single area to relieve bone pain or pressure on the spinal cord (spinal cord compression Open a glossary item), treatment to prevent bone damage (bisphosphonates) or steroids as long as the total dose was not more than 160mg 
  • had another cancer apart from successfully treated non melanoma skin cancer Open a glossary item, prostate cancer Open a glossary item with a Gleason score Open a glossary item of 6 that does not need treatment, successfully treated carcinoma in situ Open a glossary item of the breast or cervix or any other treated cancer and there has been no sign of it for at least 3 years

Medical conditions
You cannot join this trial if any of these apply. You:

  • are sensitive to or are not able to have any of the trial treatment
  • had major surgery within 2 weeks of going into a treatment group (randomisation) 
  • had medication or herbal treatments that affect the CYP enzymes within 2 weeks of starting treatment 
  • are taking other medication that your doctor or the trial team think could affect you taking part
  • have problems swallowing
  • have a problem with your digestive system Open a glossary item that could affect how well your body absorbs tablets
  • have mild to severe damage to the nerves in your hands or feet (peripheral neuropathy Open a glossary item)
  • have HIV
  • have hepatitis B or hepatitis C
  • have an active infection that affects your whole body
  • have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part

Other
You cannot join this trial if any of these apply. You:

  • have a live vaccine Open a glossary item within 30 days of going into a treatment group (randomised) for part 1 of the trial or any time between finishing part 1 treatment and going into a treatment for part 2
  • are pregnant or breastfeeding

Trial design

This is a phase 3 trial. There are 2 parts to this trial. 

Part 1
In part 1 the trial team need 740 people to take part. 

This part is a randomised trial. You go into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The groups are:

  • 370 people in the standard dose of ixazomib, lenalidomide and dexamethasone
  • 370 people have the reduced dose (frailty adjusted) of lenalidomide and dexamethasone with ixazomib
     

 

In the reduced dose group the doctor works out your dose according to:

  • your age
  • what other illness you have
  • what you can do

Ixazomib, lenalidomide and dexamethasone are tablets. Your doctor tells you how many to take. You have treatment in cycles each cycle of treatment Open a glossary item is 4 weeks. 

You take ixazomib once a week for 3 weeks and then have a week of not taking it.

You take lenalidomide once a day for 3 weeks and then have a week of not taking it. 

You take dexamethasone once a week for 4 weeks. 

You have 12 cycles of treatment as long as it is working and the side effects are not too bad. 

After the 12 cycles of treatment your doctor will talk to you about how well the treatment has worked. You can go into part 2 if the treatment has worked well enough. 

Part 2
In part 2 the team need 478 people to join. 

This part is a double blinded randomised trial. You go into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. Neither you nor your doctor will know which group you are in. The 2 groups are:

  • 239 people have lenalidomide and ixazomib
  • 239 people have lenalidomide and a dummy drug (placebo Open a glossary item)

 


Lenalidomide, ixazomib and the dummy drug are tablets. Your doctor tells you how many to take. You have treatment in cycles. Each treatment cycle is 4 weeks. 

You take lenalidomide once a day for 3 weeks and then have a week of not taking it.

You take ixazomib or the dummy drug once a week for 3 weeks and then have a week of not taking it. 

You continue treatment as long as it is helping you and the side effects are not too bad. 

Quality of life
You fill in questionnaires:

  • before starting treatment
  • at regular times during treatment 
  • at the end of treatment

The questions ask about:

  • your general health
  • any symptoms or side effects you have
  • what daily activities you can do
  • if you have seen your GP or gone to the hospital

These are quality of life questionnaires

Research samples
When you have a bone marrow sample Open a glossary item to diagnose myeloma the team take an extra sample of bone marrow. You also give an extra blood sample. 

You can agree to either:

  • give these samples and take part in the trial or
  • give these samples and not take part in the trial

Researchers can use these samples to find out:

  • more about myeloma
  • if differences between people’s immune systems Open a glossary item can tell them who might get bad side effects from treatment

Hospital visits

You see the doctor to have some tests before joining the trial. These tests include:

  • a physical examination
  • blood tests
  • urine test
  • bone marrow test
  • x-ray or a scan Open a glossary item

Your doctor will also look at:

  • your age
  • whether you have any other illnesses
  • your lifestyle and what you can do

This is the scoring system for frailty. The information is to work out how fit you are. And whether you should have a reduced dose of lenalidomide and dexamethasone with ixazomib in the 1st part of the trial. 

Part 1
During treatment you see the doctor every 4 weeks for blood tests and to see how you are. 

At the end of treatment you see the doctor to see how well treatment has worked. You can go into part 2 if the treatment has worked well enough. 

Part 2
Before going into a treatment group you see the doctor for:

  • a physical examination
  • blood tests
  • urine test

During treatment you see the doctor every 4 weeks to see how you are and for blood tests. 

Follow up
After you finish treatment in either part 1 or part 2 your doctor will tell you how often they want to see you.

Location

Ashford
Bangor
Bath
Birmingham
Blackpool
Bodelwyddan
Bournemouth
Bristol
Canterbury
Carshalton
Cheltenham
Chester
Chichester
Colchester
Croydon
Derby
Dewsbury
Dudley
Dundee
Edinburgh
Epsom
Exeter
Gloucester
Halifax
Harrogate
Hereford
Huddersfield
Hull
Huntingdon
Kettering
Kidderminster
Kings Lynn
Leeds
Leicester
Lincoln
Livingston
London
Maidstone
Manchester
Margate
Middlesbrough
Newcastle upon Tyne
Northallerton
Norwich
Nottingham
Oldham
Peterborough
Plymouth
Pontefract
Portsmouth
Prescot
Reading
Redditch
Romford
Salford
Salisbury
South Shields
Southampton
St Helens
Stafford
Stoke-on-Trent
Sunderland
Swansea
Torquay
Uxbridge
Wakefield
Wigan
Wirral
Wolverhampton
Worcester
Worthing
Wrexham

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
Professor Graham Jackson

Supported by

Cancer Research UK
University of Leeds
Myeloma Research Alliance (UK-MRA)
Takeda
Celgene 

Other information

This is Cancer Research UK trial number CRUK/16/019.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15160

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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