
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is for people whose myeloma has come back or whose treatment has stopped working.
The usual treatment for myeloma is chemotherapy and a . You might have these 2 drugs on their own or alongside a targeted drug such as thalidomide or bortezomib.
But if the myeloma comes back or doesn’t go away afterwards, it can be more difficult to treat. So researchers are looking at ways to improve treatment.
In this study, they are looking at 2 drugs called carfilzomib and daratumumab. They are both targeted cancer drugs.
These 2 drugs stop signals that cancer cells use to divide and grow.
We know from research that having carfilzomib and daratumumab together might help if treatment stops working or if your myeloma comes back. But they aren’t sure, so want to find out more.
In this study, some people have carfilzomib, daratumumab and dexamethasone (a steroid drug). And some have carfilzomib and dexamethasone.
The aims of the study are to:
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.
Who can take part
You may be able to join this study if all of the following apply.
You:
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This phase 3 study will take place worldwide. The study team hope 400 people will take part including 30 from the UK. It is a randomised study. You are put into 1 of the following 2 treatment groups by a computer.
You have a 2 in 3 chance of having daratumumab. So for every 2 people having daratumumab and carfilzomib, 1 will have carfilzomib alone.
Neither you nor your doctor will be able to decide which group you will be in.
You have darafatumumab and carfilzomib as a drip into a vein. You have dexamethasone tablets or you might have it as drip into a vein. You have treatment in cycles. Each 4 week period (or 28 days) is a cycle of treatment. The first day of each treatment cycle is called day 1.
Carfilzomib and dexamethasone
You have:
Carfilzomib, daratumumab and dexamethasone
You have:
Everyone has treatment for as long as it is working and the side effects aren’t too bad.
Research samples
You have extra blood tests as part of this study. Where possible you have these at the same time as your routine blood tests.
The researchers want to:
They will look at your genetic material (DNA), in your body cells such as blood and tissue cells. They might ask for a saliva sample to do this. Knowing more about people’s genetic material might help the doctors to understand more about myeloma and how treatment works. This is known as pharmacogenetic testing.
They will also ask to use any leftover samples for research purposes. You don’t have to agree to give these research samples if you don’t want to. You can still take part in the study.
Quality of life
The study 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 start treatment. The tests include:
You have your treatment in the hospital outpatient department. You shouldn’t need to stay overnight.
Follow up appointments
When you finish treatment, you see the study doctor for a check up after:
You see your doctor at routine hospital appointments after that. The study team might see you at these appointments or they will check your medical notes to see how you are getting on.
Only a few people have had carfilzomib and daratumumab together. So there might be some side effects we don’t know about yet.
The most common side effects of carfilzomib include:
The most common side effects of daratumumab include:
The study team will talk to you about the side effects of all treatment before you take part.
We have information about the side effects of dexamethasone.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr James Cavet
Amgen
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”