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

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

Cancer type:

Myeloma

Status:

Closed

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 Open a glossary item. If you have amyloidosis, your bone marrow makes abnormal plasma cells Open a glossary item. 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.

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 Open a glossary item
  • 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 Open a glossary item)
  • Have a drop in a type of white blood cells called neutrophils (neutopenia Open a glossary item)
  • 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 Open a glossary item 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.

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 Ashutosh Wechalekar

Supported by

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

Other information

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

Contact our cancer information nurses for other questions about cancer by:

Phone - 0808 800 4040

Last review date

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

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

Last reviewed:

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