A study using GSK2857916 for people with myeloma and lymphoma

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.

You may be able to join part 2 of this study if all of the following apply.

• You are at least 18 years old
• You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
• You have satisfactory blood results
• You are willing to use reliable contraception during the time you have treatment and for 2 months after if there is any possibility you or your partner could become pregnant

If you have lymphoma you must have either diffuse large B cell lymphoma (DLBCL) or follicular lymphoma and you have BCMA on the surface of your lymphoma cells. Also for:

• Diffuse B cell lymphoma- you must have had at least 2 previous treatments that reached your whole body (systemic treatment). At least one of these must have included an anti-CD20 drug such as rituximab. You must have also had a stem cell transplant using your own stem cells or are not able to have a transplant. If you have had a stem cell transplant this must have been more than 100 days before starting this study and you must have no infection which needs treatment
• Follicular lymphoma- you must have had at least 2 previous treatments that reached your whole body (systemic treatment)

You cannot join this study if any of these apply. You

• Have had any treatment for your myeloma or lymphoma 14 days before starting the study treatment
• Have had plasmapheresis (the removal of excess protein from your blood) 7 days before starting the study treatment
• Have had an experimental cancer drug in the last 14 days (or have no traces of the drug in your body) before starting the study treatment
• Have had a monoclonal antibody in the month before starting the study treatment
• Have had a stem cell transplant using stem cells from a donor (an allogeneic transplant)
• Have had major surgery in the last 4 weeks
• Have any serious side effects from previous treatment apart from hair loss and mild tingling and numbness in your fingers and toes (neuropathy)
• Have problems with your heart such as a problem with the rhythm of your heart, angina not controlled by medication, you have had a heart attack, or you have had certain heart procedures such as angioplasty in the 6 months before starting the study
• Have significant heart failure
• Have high blood pressure not controlled by medication
• Have a permanent pacemaker or intra cardiac defibrillator
• Have had any problems with bleeding
• Have a kidney condition that requires treatment such as dialysis
• Have a liver or biliary disease that is causing symptoms and needs treatment
• Have or have had any disease that has affected your cornea (the outer layer of your eye) such as a corneal ulcer
• Have a disease that affects you whole body and this disease is severe or not controlled by medication
• Have an infection that needs treating with antibiotics
• Have HIV
• Have hepatitis B or hepatitis C
• Are sensitive or allergic to any drugs similar to GSK2857916
• Have any other serious medical condition or mental health problem that the study team think could affect you taking part
• Are pregnant or breastfeeding

You might be able to take part if you have another type of cancer as long as:

• this cancer is not affecting your myeloma or lymphoma
• you are not having any treatment apart from hormone therapy
• your cancer has been stable for at least 2 years