A study of bortezomib, dexamethasone and venetoclax for myeloma

Cancer type:

Blood cancers
Myeloma

Status:

Open

Phase:

Phase 3

This study is for people with myeloma that has come back or treatment has stopped working.  

More about this trial

Doctors are always looking for ways to improve treatment for people with myeloma. In this study, they are looking at giving a new drug called venetoclax with bortezomib and dexamethasone. 

Venetoclax blocks the functions of a protein found in myeloma cells. This causes these cells to die. Researchers think this might be a useful treatment for myeloma but they want to find out for sure.

Bortezomib and dexamethasone (a steroid Open a glossary item) are 2 drugs that doctors already use to treat myeloma

In this study, some people have bortezomib, dexamethasone and venetoclax. And some people have bortezomib and dexamethasone. 

The aims of the study are to:

  • find out how well venetoclax, bortezomib and dexamethasone works
  • find out how safe it is
  • learn more about the side effects and how it affects quality of life Open a glossary item

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

You might be able to join this study if all of the following apply. 

  • You have myeloma that can be measured with a blood or urine test
  • Your myeloma has come back or got worse after treatment or the last treatment you had didn’t work
  • You have had at least 1 but no more than 3 different treatments in the past 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 are willing to use reliable contraception during treatment and for 90 days after the last dose of the study drug, if applicable
  • You are at least 18 years old

As well as the above, if you have had bortezomib or a similar drug, all of the following must also apply.

  • Your myeloma didn’t get worse during treatment or within 60 days of the last dose
  • The myeloma went away a little bit (you had a partial response Open a glossary item
  • You didn’t need to stop treatment because of severe side effects

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

Cancer related

  • Have myeloma that doesn’t show up in a blood or urine test (non secretory myeloma) 
  • Have active plasma cell leukaemia
  • Have had bortezomib or a similar drug within 60 days of starting treatment
  • Are allergic or hypersensitive to any treatments in the study or anything they contain including bortezomib, boron, mannitol, or dexamethasone
  • Have already had venetoclax or a similar drug such as BCL201 in the past
  • Have had a stem cell transplant Open a glossary item with somebody else’s cells in the last 16 weeks
  • Have had a stem cell transplant with your own cells in the last 12 weeks
  • Have had a stem cell transplant and have graft versus host disease (GVHD Open a glossary item
  • Have had a live vaccination Open a glossary item in the last 8 weeks
  • Have had monoclonal antibody treatment in the last 6 weeks 
  • Have had chemotherapy, radiotherapy, biological therapy, immunotherapy or an experimental drug that has not completely cleared your body 
  • Have had any other cancer in the last 3 years apart from carcinoma insitu of the cervix (CIS) or breast, non melanoma skin cancer Open a glossary item or early stage prostate cancer that has been successfully treated

Medical conditions

  • Have problems with your heart, such as a heart attack in the last 6 months, high blood pressure that is not well controlled, angina that is not well controlled, an abnormal rhythm of your heart or congestive heart  failure
  • Have a condition called Waldenstroms macroglobulinaemia
  • Have a condition called amyloidosis
  • Have diabetes that has been difficult to control with medication within 2 weeks of joining the study
  • Have a rare condition called POEMS syndrome
  • Have an infection and have had treatment as a drip into a vein within 2 weeks of joining the study
  • Have had moderate to severe numbness in your hands and feet (peripheral neuropathy Open a glossary item) within 2 weeks of joining the study
  • Have had major surgery in the 4 weeks before joining the study 
  • Have HIV
  • Have an active hepatitis B or C infection
  • Have any other serious medical condition or mental health problem that the study team think could affect you taking part

Other

  • Have had high dose steroid treatment within 3 weeks of starting study treatment
  • Take some of the medications that affects body substances called CYP enzymes  - your doctor can advise you if this applies to you.
  • Are pregnant or breastfeeding

Trial design

This is an international phase 3 study. The researchers need 240 people to take part worldwide. 

It is randomised. You are put into 1 of 2 groups. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind study. 

You have 1 of the following:

  • venetoclax, bortezomib and dexamethasone
  • bortezomib, dexamethasone and a dummy drug (placebo Open a glossary item)

For every 2 people having venetoclax, 1 will have the dummy drug. 

study diagram

You have bortezomib as an injection under the skin or as a drip into a vein. 

Venetoclax and the dummy drug are tablets.

Dexamethasone is a tablet. 

Everyone has treatment over 21 days. Each 21 day period is a cycle of treatment. The 1st day of treatment is called day 1.

For the first 8 cycles you have:

  • bortezomib on day 1,4,8 and 11
  • dexamethasone on day 1, 2, 4, 5, 8, 9, 11 and 12
  • venetoclax or the dummy drug once a day, every day 

After that, the length between cycles is slightly longer. The study team can tell you more about this.

Your doctors will ask you to drink more water a few days before you start treatment. This is to reduce the chance of getting a side effect of treatment called tumour lysis syndrome. This happens because when cancer cells die, chemicals in the cells are suddenly released into your blood. This changes the normal balance of chemicals circulating in your body. Your doctor will keep a close eye on you and may give you medication to prevent it.

You have treatment for 14 months or longer as long as it is working and the side effects aren’t too bad. 

Research samples
The researchers will ask for some extra blood samples and samples from the bone marrow tests.

They plan to look at:

  • what happens to venetoclax in the body – this is called (pharmacokinetics Open a glossary item)
  • your genes Open a glossary item - this to learn more about how genes affect the way people respond to drugs and the side effects they have (pharmacogenetics) 
  • substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others

You don’t have to give these extra samples if you don’t want to. You can still take part in the study.

Quality of life 
The trial team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study Open a glossary item.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

  • a physical examination
  • blood tests
  • heart trace (ECG) Open a glossary item
  • heart scan (echocardiogram Open a glossary item) or MUGA Open a glossary item scan
  • x-rays or a CT or MRI scan of your bones including your skull, spine, ribs, arms, the bones around your hips (pelvis) and legs 
  • bone marrow test
  • a CT scan or MRI scan

You have bortezomib at the hospital. You go to the hospital 4 times in each 3 week treatment cycle. You see the doctors for a check up every 3 weeks. 

Follow up
When you finish treatment, you see the study team a month later. They will repeat some of the tests you had when you joined the study. 

If your myeloma didn’t get worse on treatment, you see the study team every:

  • 4 weeks for a year
  • 3 months  after that

If your myeloma gets worse, you see the study team every:

  • 3 months for a year 
  • 6 months after that

Side effects

As venetoclax is a new drug, there might be side effects that we don’t know about yet. The study team will monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything. 

Bortezomib, dexamethasone and venetoclax
Only a few people have had these 3 drugs together. There is a small risk that having them might cause:

Bortezomib and dexamethasone
The most common side effects of having bortezomib and dexamethasone include:

We have more information about:

Location

Blackpool
Canterbury
Leicester
London
Manchester
Nottingham
Wolverhampton

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 Rakesh Popat

Supported by

AbbVie

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14531

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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