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A trial looking at bortezomib with chemotherapy for amyloidosis (REVEAL)

This trial is looking at using bortezomib (Velcade) with chemotherapy to treat people newly diagnosed with amyloidosis. This trial is supported by Cancer Research UK.

Amyloidosis is a condition affecting the bone marrow. If you have amyloidosis, your bone marrow makes abnormal plasma cells. These abnormal plasma cells make an abnormal protein (amyloid) that can build up in your body tissues and affect the way your organs work. Some people with myeloma may have or develop amyloidosis.

Doctors often treat amyloidosis with the same combination of chemotherapy drugs they use to treat myeloma.  

Bortezomib is a type of biological therapy called a proteasome inhibitor. Doctors use bortezomib and chemotherapy to treat myeloma. We know from research that bortezomib and chemotherapy can treat amyloidosis that has come back. The researchers think that combining bortezomib with chemotherapy may also help to treat people newly diagnosed with amyloidosis.  

The aim of this trial is to compare 2 combinations of bortezomib and chemotherapy to find out which is best to treat people with amyloidosis. And to find out what the side effects of each combination are.

Recruitment

Start 15/03/2012
End 30/04/2015

Phase

Phase 2

Who can enter

You may be able to enter this trial if you

  • Have amyloidosis that causes a build up of abnormal protein in your body’s organs and tissue this is called (AL amyloidosis) – your doctor can confirm this
  • Have amyloidosis that has developed to a level called stage 2 or 3 – your doctor can explain this
  • Have amyloidosis that is affecting more than one of your body organs
  • Are in bed or a chair for half the day and need help looking after yourself (performance status 0, 1, 2 and 3)
  • Are willing to use reliable contraception if there is any chance you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have amyloidosis that is a non AL type or an unknown type – your doctor can confirm this
  • Have already had treatment for amyloidosis
  • Have symptoms of myeloma that are not caused by amyloidosis
  • Have amyloidosis that affects only 1 body organ, such as the bladder
  • Have a small collection of amyloid protein that does not significantly affect your body organs, such as carpal tunnel syndrome
  • Have had a stem cell transplant using donor stem cells
  • Have had an organ transplant
  • Have severe nerve problems that significantly affect your activities
  • Have a low platelet count (thrombocytopenia)
  • Have a drop in a type of white blood cells called neutrophils (neutopenia)
  • Have moderate to severe liver problems caused by amyloidosis
  • Have a serious heart problem
  • Are sensitive to any of the drugs used in this study
  • Have another cancer apart from basal cell carcinoma of the skin or in situ carcinomas that have been removed
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. This trial will recruit 52 people. It is a randomised trial. You are put into 1 of 2 groups by a computer. Neither you nor doctor can choose which group you are in.

One group will have bortezomib and dexamethasone. The other group will have bortezomib, cyclophosphamide and dexamethasone.  

You have treatment every 5 weeks. Each 5 week period is called a cycle of treatment. You have 3 to 6 cycles of treatment.

Your doctor or research nurse will explain the detail of the treatment cycles You have bortezomib as an injection under the skin 4 times in each cycle. You also take a dexamethasone tablet on these days. Cyclophosphamide is a tablet you take 3 times in each cycle.
 
Depending on how well the treatment is working after 3 cycles, you may have up to 3 more cycles of treatment.  

The research team will take some blood samples. They will use a part of each sample to see how the treatment is working. The remainder will be frozen and stored at the National Amyloidosis Centre and used for future research into amyloidosis. If you don’t want to donate the remainder of these samples to the National Amyloidosis Centre you don’t have to. 

Hospital visits

You see the doctor and have some tests before taking part in this trial. These tests may include

During treatment you see the doctor at the start of each cycle for a physical examination and blood tests. You also have 2 more ECGs.

You see the doctor 7½ months after starting treatment (or a month after finishing treatment if you had 6 cycles) for the same tests, apart from the bone marrow test.

Side effects

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

We have more information on bortezomib, dexamethasone and cyclophosphamide  in our cancer drugs section.

Location of trial

  • Leeds
  • Leicester
  • London
  • Southampton

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Dr Ashutosh Wechalekar

This is Cancer Research UK trial number CRUK/09/027

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
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Updated: 19 May 2014