
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is looking at adding a drug called belantamab mafodotin to usual treatment for myeloma.
It is for people:
Myeloma that has come back or did not go away following treatment can be more difficult to treat. So doctors are looking for new treatments to help this group of people.
Belantamab mafodotin is a new type of called an antibody drug conjugate (ADC). There are 2 parts to an ADC. It is a combination of a
and chemotherapy.
Belantamab mafodotin works by attaching to a particular receptor on the surface of the myeloma cell. It then delivers the chemotherapy to kill the myeloma cells.
In this trial you have belantamab mafodotin in combination with cyclophosphamide and dexamethasone. These 2 drugs are a option for myeloma.
The main aims of the trial are to find out:
The following bullet points are a summary of 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.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
Myeloma related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This is a phase 1 trial. There is one part of the trial that is open. This part is Prommise-B. The team need 26 people to join Prommise-B.
The trial team hope to add more treatment groups. We’ll update this information when they open.
Prommise-B
You:
Cyclophosphamide is a chemotherapy drug. Dexamethasone is a drug.
The dose of belantamab mafodotin depends on when you join the trial.
Everyone has treatment for up to 3 years. You have it as long as it is working and the side effects aren’t too bad. You stop treatment if your myeloma gets worse. Your doctor will talk to you about other treatment options.
Samples for research
The team ask you to give some extra blood samples. Where possible you have these when you have your routine blood tests. You may have some extra bone marrow tests if treatment is working.
The team plan to use the samples to:
You need to agree to give the bone marrow sample when you join the trial. You can say no giving the other bone marrow samples. It won’t affect you taking part in the rest of the trial.
Quality of life
The trial team ask you to fill out a questionnaire:
The quality of life questionnaire asks about side effects and how you’ve been feeling.
You see the doctor and have tests before you can take part. These include:
You have regular blood tests, eye tests and check ups during the trial.
You have another PET-CT scan if your cancer goes away completely.
The team may ask you to have another bone marrow test if treatment is working well. You have this after you start treatment at:
You have a final bone marrow test as part of this trial when you stop treatment.
Follow up
When you stop treatment you see the doctor a month later. You then see the trial doctor:
This is to see how you are getting on and if you have started a new treatment.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
Some of the most common side effects of belantamab mafodotin include:
The trial doctor will talk to you about all the possible side effects of treatment before you can take part. You’ll have a chance to ask any questions you may have.
We have more information about the following drugs and their side effects:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Rakesh Popat
GlaxoSmithKline Ltd
UKMRA-Myeloma UK-CARP
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.