A study using GSK2857916 for people with myeloma and lymphoma

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

Cancer type:

Blood cancers

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 1

This study is for people with myeloma or lymphoma that has come back after standard treatment or has not responded to treatment.

Please note enough people with myeloma are taking part in the study. The team are no longer asking these people to join the study.

More about this trial

Both myeloma and lymphoma can come back after previous treatment. Doctors are trying to find new treatments for people in this situation.

GSK2857916 is a monoclonal antibody. It is designed to work on a protein found on myeloma and some lymphoma cells. This protein is called B-cell Maturation Antigen (BCMA). GSK2857916 attaches to the BCMA receptors on the myeloma or lymphoma cells and kills them.

Researchers think most people with myeloma have BCMA on the surface of their cells. They think it is also found on the cells of the some types of non Hodgkin lymphoma- diffuse large B cell lymphoma (DLBCL) and follicular lymphoma.

The doctors will need to test a sample of your lymphoma to look for BCMA if you have either of these types.

This study is in 2 parts. In the first part of the study the doctors wanted to find the best dose and how often to have GSK2857916 (the schedule).This part has now closed and part 2 of the study is now open.

The main aims of the study are to:

find the best dose and how often to have GSK2857916
learn more about how the drug works in the body
learn about the side effects of GSK2857916
see if it is a useful treatment

Who can enter

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

Trial design

This is a phase 1 international study that is in 2 parts. Researchers hope up to 14 people in the UK will join part 1 and 2. Part 1 has now closed.

Everyone in part 2 has the best dose of GSK2857916 found in part 1.

You have GSK2857916 once every 3 weeks.

Every 3 week period is called a cycle of treatment. You have up to 16 cycles as long as you don’t have any severe side effects and the drug is helping you.

You have GSK2857916 as a drip into your vein. It takes about an hour.

Samples for research
As well as some routine blood tests to check your general health you have some extra blood tests. These are to look at how the drug is working in your body. This is called pharmacokinetics Open a glossary item .

The blood samples may also be used to look for biomarkers Open a glossary item . The doctors also take some bone marrow samples to look for biomarkers. These samples could help them to learn more about who would benefit most from drugs like GSK2857916.

Hospital visits

You’ll see the doctors and have some tests before you start treatment. The tests might include

A physical examination
Blood tests
Urine test
Heart trace (ECG )
Heart scan (echocardiogram )
Eye examination
Chest X-ray
Bone marrow test
A sample of your bone (bone biopsy)
CT scan if you have lymphoma

You may also need a CT scan to check if you any myeloma outside of your bone marrow.

You go to hospital for your treatment. You might need to stay overnight. The study team will explain how often they need to see you.

During the time you are having treatment you have regular

Examinations by the doctor
Blood tests
Urine tests
ECGs

You also have steroid eye drops on the day you have treatment and for 3 days afterwards.

You have CT scans and bone marrow tests at different points during treatment. These check your myeloma or lymphoma and how the GSK2857916 is working.

3 months after you have completed treatment someone from the study team will telephone to see how you are.

Side effects

As this is the first time people have had GSK2857916 there may be some unknown side effects.

Your doctors closely monitor you during the time you are in hospital. They will give you a number for the hospital when your return home. Contact the hospital straightaway if you are worried about anything once you have gone home.

The possible side effects of GSK2857916 include

a reaction when the drug is given, this can include high temperature (fever), chills, low blood pressure, a fast pulse, cough, back or tummy pain, feeling or being sick, diarrhoea, itching, rash, shortness of breath and problems breathing
decrease in the amount of urine you pass
dry and itchy eyes
blurred vision
high temperature (fever)
bleeding
difficulty breathing

The study doctors will explain all the possible side effects to you before you join the study.