Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study of bortezomib, dexamethasone and venetoclax for myeloma
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
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
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
- You didn’t need to stop treatment because of severe side effects
You cannot join this study if any of these apply. You
- 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 transplantwith 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 (
- Have had a live
vaccinationin 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 canceror early stage prostate cancer that has been successfully treated
- 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) 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
- 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
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 (
For every 2 people having venetoclax, 1 will have the dummy drug.
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.
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 (
genes- this to learn more about how genes affect the way people respond to drugs and the side effects they have (pharmacogenetics)
- substances called
biomarkersto 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
You see a doctor and have some tests before you can take part. These include:
- a physical examination
- blood tests
- heart trace (
- heart scan (
echocardiogram) or MUGAscan
- 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.
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
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:
- tumour lysis syndrome
- drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Bortezomib and dexamethasone
The most common side effects of having bortezomib and dexamethasone include:
- numbness or tingling in your hands and feet (peripheral neuropathy)
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- diarrhoea or constipation
- feeling or being sick
- muscle pain or weakness
- tiredness (fatigue)
- blisters and pain along nerves (shingles)
- loss of appetite
- shortness of breath
- skin rash
We have more information about:
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.
Dr Rakesh Popat