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

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  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  with no sign of having myeloma
• have plasma cell leukaemia
• have a condition called POEMS syndrome 
• have amyloidosis
• 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
• 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  or squamous cell skin cancer  that has been successfully treated. Or if you have carcinoma in situ  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  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 

Other 
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