A trial looking at elotuzumab in people with multiple myeloma (Eloquent 1)

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

Cancer type:

Myeloma

Status:

Closed

Phase:

Phase 3

This trial is looking at a new drug called elotuzumab in people with multiple myeloma (MM) who have not had treatment yet.

Multiple myeloma is a type of cancer that develops from cells in the bone marrow called plasma cells. Doctors can treat multiple myeloma (MM) with lenalidomide and dexamethasone. But sometimes the cancer can start to grow again.

In this trial doctors want to use a new drug, elotuzumab, with lenalidomide and dexamethasone to find out if it works better than lenalidomide and dexamethasone alone.

Elotuzumab is a type of biological therapy called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins.

The aims of this trial are to find out

If elotuzumab, lenalidomide and dexamethasone work better than lenalidomide and dexamethasone for people with myeloma that has not been treated before
About the side effects

Who can enter

You may be able to enter this trial if you

Have myeloma that has not been treated
Have myeloma that can be measured with blood and urine tests
Have satisfactory blood test results
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Are willing to use reliable contraception if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have non secretory myeloma, oligo secretory myeloma, free light chain only myeloma, active plasma cell leukaemia, smoldering multiple myeloma, monoclonal gammopathy, (MGUS) or Waldenstrom’s disease
Have certain heart problems
Are HIV positive
Have active hepatitis B or hepatitis C
Have any medical condition that is a cause for concern
Have had any other cancer, apart from adequately treated non melanoma skin cancer or cancer that was successfully treated at least 5 years ago
Have diabetes that is not under control
Are unable to take blood thinning medication such as aspirin or warfarin
Have had any treatment for multiple myeloma in the past
Have taken steroid tablets in the last 3 weeks unless in an emergency – your doctor will discuss this with you
Have had major surgery in the last 4 weeks
Know you are allergic to the drugs used in this trial

Trial design

This trial will recruit 750 people from the UK and around the world.

This is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Both groups have lenalidomide and dexamethasone. You have lenalidomide as a tablet daily for 3 weeks, followed by a week without treatment. Each 4 week period is called a cycle of treatment. You have dexamethasone once a week, every week.

Group 2 also has elotuzumab. You have elotuzumab through a drip into a vein. You have it once a week for the first 8 weeks. After that you have it every 2 weeks for 16 months, then once a month after that. You have treatment for as long as it is helping you and you want to continue.

You fill out a questionnaire

Before you start treatment
Every 4 weeks while you have treatment
When you stop treatment

The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

If you agree to take part in this study, the researchers will ask for an extra blood sample for research. You give this at the same time as other blood tests. If you don’t want to give an extra blood sample, you don’t have to. You can still take part in the trial.

Hospital visits

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

Physical examination
Blood tests
Urine tests
Pregnancy test
Heart trace (ECG )
X rays of your long bones, spine, pelvis and skull (skeletal survey)
Heart ultrasound (echocardiogram ) or MUGA scan
CT scan or MRI scan if your doctor thinks it is necessary
Bone marrow biopsy

While you are having treatment you see the research team frequently for blood and urine tests.

You see the research team and have a blood and urine test when you stop treatment, and then every 4 weeks until your cancer starts to grow. After that, the research team contact you every 4 months to see how you are.

Side effects

The most common side effects of dexamethasone and lenalidomide are

Feeling and being sick
Diarrhoea
Constipation
Dizziness
Difficulty sleeping
Increased appetite
Weight gain
Muscle cramps
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
A rash
Restlessness
Headache
Mood swings
Upset stomach
Blood clots

Elotuzumab is a new treatment so there may be side effects we don’t know about yet. But the most common side effects we know about so far are

Feeling and being sick
Change in heart rhythm
Changes in how your kidneys work
Tiredness (fatigue)
Diarrhoea
Constipation
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Taste changes
Muscle spasms
Night sweats

Some people have an allergic reaction to elotuzumab. You will have some medication before each treatment to help stop this happening. And your nurse will keep a close eye on you while you are having treatment.

We have more information about the side effects of lenalidomide and dexamethasone in our cancer drugs section.