A trial of belantamab mafodotin to improve treatment for myeloma (ProMMise)

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

Cancer type:

Blood cancers




Phase 1

This trial is looking at adding a drug called belantamab mafodotin to usual treatment for myeloma. 

It is for people:

  • whose myeloma has come back or treatment has stopped working
  • who have had 2 to 4 courses of treatment Open a glossary item for myeloma

More about this trial

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 targeted drug Open a glossary item called an antibody drug conjugate (ADC). There are 2 parts to an ADC. It is a combination of a monoclonal antibody Open a glossary item 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 standard treatment Open a glossary item option for myeloma. 

The main aims of the trial are to find out:

  • the best dose of belantamab mafodotin to give 
  • if adding belantamab mafodotin to standard treatment Open a glossary item is safe and improves treatment 
  • more about the side effects treatment 

Who can enter

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:

  • have myeloma that has come back or treatment has stopped working and you have had 2 to 4 previous treatments. The treatment must have included certain targeted drugs Open a glossary item such as bortezomib or thalidomide or similar drugs. 
  • have myeloma that can be measured in a blood or urine test
  • agree to not donate blood during the trial and for a period after 
  • have satisfactory blood test results 
  • are willing to use reliable contraception during the trial and for a period after if there is any chance you or your partner could become pregnant 
  • are well enough to be up and about for at least half the day but might not be able to work (performance status 0, 1 or 2)
  • are at least 18 years old 

Who can’t take part

Myeloma related 
You cannot join this trial if any of these apply. You:

  • don’t have myeloma symptoms (smouldering myeloma
  • have a type of myeloma called monoclonal gammopathy of undetermined significance (MGUS) 
  • have a type of myeloma made up of plasma cells (plasmacytoma) 
  • have a plasmacytoma outside of the bone marrow Open a glossary item with no sign of having myeloma
  • have plasma cell leukaemia
  • have a condition called POEMS syndrome 
  • have amyloidosis Open a glossary item
  • have a build up of proteins around the heart (heart amyloidosis) or your doctor suspects you have this 
  • have had belantamab mafodotin in the past 
  • are going to have stem cell transplant Open a glossary item
  • have had chemotherapy, small molecule therapy, radiotherapy or a monoclonal antibody within 14 days of finding out the dose of treatment you have. Your doctor will know this. 
  • have had a monoclonal antibody within 14 days of finding out what dose of belantamab mafodotin you have
  • have side effects from past treatment unless they are mild. You can take part if you have hair loss. 
  • have had recent steroid treatment
  • have more than a trace of protein in your urine. Your doctor will check this. 
  • have any other cancer that is getting worse or needs treatment. You may be able to take part if you have basal cell skin cancer Open a glossary item or squamous cell skin cancer Open a glossary item that has been successfully treated. Or if you have carcinoma in situ Open a glossary item of the cervix or prostate cancer and you aren’t having treatment straight away (active surveillance).
  • are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 28 days of being put in a treatment group for this trial.

Medical conditions
You cannot join this trial if any of these apply. You:

  • have a significant heart condition Open a glossary item that needs treatment or have had a heart attack or major heart surgery in the last 3 months  
  • have a problem with the lens (cornea) that covers your eye unless the problem is mild 
  • need to wear contact lenses while in the trial 
  • have a problem with your kidneys such as an infection or you need to have dialysis to filter your blood 
  • have a significant problem with your liver 
  • have HIV, an active hepatitis B or hepatitis C infection or you have any other recent infection that needs treatment
  • have had major surgery in the last 4 weeks 
  • have a bleeding problem
  • have moderate numbness and tingling in your hands or feet or this is mild but is causing pain 
  • have any other medical condition or mental health problem that the trial team think will affect you taking part 

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

  • are allergic to belantamab mafodotin, any of the treatments in the trial or anything they contain
  • are pregnant or breastfeeding

Trial design

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.


  • have belantamab mafodotin as a drip into a vein once every 2 months 
  • take cyclophosphamide tablets on days 1, 8 and 15 of each treatment cycle Open a glossary item 
  • take dexamethasone tablets on days 1, 8, 15 and 22 of each treatment cycle 

Cyclophosphamide is a chemotherapy drug. Dexamethasone is a steroid Open a glossary item 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:

  • see if it is possible to predict how treatment will work for myeloma
  • look at genes Open a glossary item in myeloma cells to learn more about myeloma
  • measure the amount of myeloma in the bone marrow  Open a glossary item

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:

  • before you start treatment
  • at set times during treatment

The quality of life questionnaire asks about side effects and how you’ve been feeling. 

Hospital visits

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:

  • 6 months
  • 12 months 
  • 18 months

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:

  • once every 3 months for a year if you have eye problems or
  • you see them at routine follow up appointments 

This is to see how you are getting on and if you have started a new treatment. 

Side effects

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:

  • eye problems such as eye dryness or blurry vision 
  • a drop in blood cells causing an increased risk of bleeding or an increased risk of an infection 
  • a reaction during the infusion and shortly afterwards. Symptoms may include fever, chills, flushing, itching, a cough, feeling breathless, discomfort in your chest, changes to your heartbeat and blood pressure, back or tummy pain, diarrhoea or a skin rash.
  • tiredness (fatigue
  • changes to your liver
  • fever (high temperatures)
  • cough
  • diarrhoea or constipation 
  • cold or cold like symptoms (upper respiratory tract infections)
  • pneumonia or other lung infections
  • back, chest, arm, leg, joint or muscle pain
  • headache
  • loss of appetite
  • nose bleeds 
  • high levels of calcium in the blood
  • changes to some of the enzymes in your blood. This shows up in blood tests and you might not get symptoms. 
  • feeling or being sick 

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:

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

GlaxoSmithKline Ltd

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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

Last reviewed:

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