A trial looking at different ways of having isatuximab for multiple myeloma that has come back or stopped responding to treatment (IRAKLIA)

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 stopped responding to treatment (refractory or relapsed myeloma)  
• you have myeloma that shows up in blood and urine tests  
• you have had at least one type of treatment for myeloma in the past 
• you have had at least 2 treatment cycles of lenalidomide alone or with bortezomib, carfilzomib or ixazomib 
• if you only had one type of treatment, your cancer must have got worse (progressed) within 2 months of having treatment with lenalidomide
• you can look after yourself but may not be able to do heavy physical work (performance status 0 or 1)
• you have satisfactory blood tests results 
• you are at least 18 years old
• you are willing to use contraception during the study and for a certain time after if there is any chance you or your partner could become pregnant

Who can’t take part

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

• your myeloma never responded to any treatment you had. This is primary refractory myeloma. 
• you have a rare type of cancer called plasma cell leukaemia. Your doctor can tell you more about this.
• you have had pomalidomide 
• you had any cancer treatment in the past 2 weeks such as surgery, radiotherapy or drug treatments
• your cancer got worse within 2 months of having treatment with isatuximab, daratumumab or any other similar drug 
• you had a stem cell transplant from a donor and have symptoms of graft versus host disease (GvHD) 
• have had drugs that damp down your immune system  in the last 2 months 
• you are sensitive to isatuximab, thalidomide, lenalidomide, dexamethasone or any other similar drug 

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

• can’t take drugs to prevent blood clots such as warfarin for any reason 
• have a high risk of bleeding 
• take a large amount of prednisolone or any other similar drug every day and you need to continue taking it for more than a week 
• have heart problems such as angina  that isn’t controlled or you had a heart attack in the last year
• have had an experimental drug in the last 28 days  
• have had any other cancer in the last 3 years, apart from non melanoma skin cancer, any carcinoma in situ  or low risk prostate cancer that has been treated  
• are known to be HIV, hepatitis B or hepatitis C positive 
• have a condition that affects the way you absorb nutrients from food
• have a rare condition where an abnormal protein accumulates in the tissues (AL amyloidosis)

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

• are pregnant or breastfeeding 
• have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial 
• are directly involved in running this trial or you are a family member of someone who is