Purpose of trial
The aim of this trial is to find out more about using a new treatment called GSK2857916 for people with myeloma (a type of blood cancer) and some types of non-Hodgkin lymphoma.
The trial aims to find:
- the best dose to use
- how well the treatment works
- how the treatment behaves in the body
- what side effects the treatment might cause.
GSK2857916 is an antibody treatment that works by binding (sticking) to a protein called ‘B-cell maturation antigen’ (BCMA ), which is found on some lymphoma and myeloma cells. Blocking BCMA with this treatment could cause these cells to die.
The trial is in two parts.
- Part 1,‘dose escalation’, is now closed. It established the highest safe dose of GSK2857916, which is now used in Part 2 of the trial.
- Part 2 tests how well the study drug works. People entering this part of the trial all have the same dose of GSK2857916.
You have GSK2857916 intravenously (into a vein through a drip) once every 3 weeks – this is a cycle of treatment. You have up to 16 cycles of treatment if GSK2857916 is benefitting you.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 85 people are needed for this trial.
You may be able to enter if:
- You have diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma.
- Your lymphoma cells have BCMA - a sample of your biopsy is used to check for this.
- You have had at least two courses of treatment for your lymphoma.
- If you have DLBCL, your previous treatment included at least one course of chemotherapy together with a CD20 antibody treatment (for example, rituximab) and you have had an autologous stem cell transplant or you cannot have a stem cell transplant.
- Your autologous stem cell transplant was at least 100 days ago, if you have had one.
- You are well enough to take part in this trial.
- Your blood and other health test results are satisfactory.
- You have recovered sufficiently from the side effects of any previous treatments.
- You and your partner are willing to use reliable contraception, during the trial and for at least 60 days after the last dose of trial treatment, if there is any chance of you or your partner becoming pregnant.
- You are 18 or over.
You will not be able to enter if:
- You have received other anti-cancer treatments in the last 14 days or an antibody treatment in the last 30 days.
- You have had a donor (allogeneic) stem cell transplant.
- You have kidney, liver or cornea (your eye’s outer protective layer) problems.
- You have bleeding problems, for example internal bleeding.
- You have an infection and need antibiotics.
- You have any significant or uncontrolled health problems (for example, heart problems).
- You have had a bad reaction to a similar drug or any of the ingredients of the trial drug before.
- You have HIV, hepatitis C virus or hepatitis B virus.
- You are pregnant or breastfeeding.
More information about this trial is available at clinicaltrials.gov.