A trial comparing giving carfilzomib once a week with giving it twice a week for myeloma (ARROW)

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

Cancer type:

Myeloma

Status:

Closed

Phase:

Phase 3

This trial is open to people with myeloma that has come back after treatment (relapsed) or stopped responding to treatment (refractory). 

More about this trial

Carfilzomib is a type of biological therapy called a proteasome inhibitor. It works by stopping the breakdown of abnormal proteins in the cancer cell. This causes the cancer cell to die. 

We know from research that carfilzomib can help people with myeloma. Currently doctors give carfilzomib twice in one week. In this trial half the people will get carfilzomib twice a week and the other half will get it once a week. 

The aim of the trial is to find out if having carfilzomib once a week is just as good as having it twice a week.

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 come back after treatment or didn’t respond to treatment 
  • You have had at least 2 and no more than 3 previous treatments for your myeloma 
  • Your myeloma had responded well enough (a partial response Open a glossary item) to at least one of the treatments
  • You have had a type of treatment that changes how the immune system Open a glossary item responds to myeloma (an immunmodulator)
  • You have already had treatment with another proteasome inhibitor Open a glossary item 
  • Your doctor was able to measure the M protein in a blood sample or urine sample  within the past 21 days
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1
  • Your heart works well enough 
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for at least 1 month afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

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

  • Have Waldenström macroglobulinemia Open a glossary item
  • Have myeloma with the immunoglobulin M (IIgM)
  • Have a myelodysplastic syndrome Open a glossary item
  • Have a syndrome called POEMS that affects your nerves and many body organs 
  • Have had another cancer in the past 5 years apart from some early cancers Open a glossary item that were successfully treated
  • Have or had amyloidosis Open a glossary item
  • Have had chemotherapy in the past 28 days
  • Have had treatment that stimulates the immune system (immunotherapy) in the past 21 days
  • Have had a total dose of more than 160mg dexamethasone or 1000mg (1 gram) prednisolone  within the 14 days before been randomised for this trial
  • Have had radiotherapy to a small area in the past 7 days 
  • Have had radiotherapy to a large area in the past 21 days 
  • Have already had carfilzomib or a similar drug called oprozomib
  • Are allergic to carfilzomib or any of its ingredients
  • Have certain heart problems
  • Have had an infection in the past 2 weeks that needed to be treated with antibiotics
  • Have fluid between the sheets of skin covering the lungs (pleural effusion) that needed to be drained within 2 weeks of been randomised for this trial
  • Have fluid in the abdomen (ascites) that needed to be drained within the 2 weeks of been randomised into this trial
  • Have ongoing problems with graft versus host disease (GVHD) after a bone marrow transplant from a donor 
  • Have high blood pressure or diabetes that isn’t controlled by medication
  • Have moderate to severe damage to the nerves (neuropathy) caused by other treatments within 2 weeks of been randomised into this trial
  • Have a liver disease called cirrhosis 
  • Have HIV, hepatitis B or hepatitis C
  • Have taken an experimental drug or used a device as part of another clinical trial in the past month
  • Have had major surgery in the past month
  • Have any other medical condition or mental health problem that the trial team think could affect you taking part in the trial 
  • Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need 460 people worldwide to join. Everyone will have carfilzomib and a steroid called dexamethasone.

It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.  

  • People in one group have carfilzomib once a week and dexamethasone
  • People in the other group have carfilzomib twice a week and dexamethasone

Diagram showing ARROW randomisation

You have carfilzomib as a drip into a vein every 3 weeks and then you have a week off. Each 4 week period is called a cycle of treatment

You have dexamethasone as a drip into a vein or as a tablet once a week for 4 weeks. You have this for 9 cycles of treatment. From cycle 10 you have dexamethasone once a week for 3 weeks. 

You continue having treatment as long as it is helping you and the side effects aren’t too bad.

The researchers will ask your permission to take some extra blood samples. They will use these to find out what happens to carfilzomib in the body and how it affects the body. You don’t have to agree to this if you don’t want to. You can still take part in the trial. 

The trial team will ask you to fill out a questionnaire

  • before you start treatment
  • every 8 weeks during treatment
  • at the end of treatment 
  • then every 12 weeks afterwards 

The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor to have some tests before taking part. These include 

  • A physical examination
  • Blood tests
  • Heart scan (ECG Open a glossary item)
  • Heart trace (ECHO Open a glossary item or MUGA Open a glossary item)

During treatment you see the doctor regularly for a physical examination and blood tests. 

You see the doctor at the end of treatment to see how you are. You then see the doctor every 3 months. Or a member of the trial team will phone you to see how you are. 

Side effects

The most common side effects of carfilzomib are 

We have information about the side effects of dexamethasone

The trial team will talk to you about the side effects of carfilzomib and dexamethasone before you agree to take part.

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 Catherine Williams

Supported by

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

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13691

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

A picture of Wendy

"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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