A trial looking at treatment for people with myeloma that has come back or stopped responding to treatment

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

Cancer type:

Blood cancers

Myeloma

Status:

Closed

Phase:

Phase 2

This trial is looking at bortezomib (Velcade) with or without CNTO 328 for myeloma.

Doctors usually treat myeloma with chemotherapy but sometimes the treatment stops working or the myeloma comes back (relapses). If this happens, doctors may use bortezomib to treat your myeloma. Bortezomib is a type of biological therapy called a proteasome inhibitor. It is currently used on its own to treat myeloma that has come back after chemotherapy. In this trial the researchers are looking at bortezomib in combination with another drug called CNTO 328.

CNTO 328 is a new and experimental treatment. It is a type of biological treatment called a monoclonal antibody. It blocks a protein made by the body called interleukin 6 (IL-6). High levels of IL-6 may help cancers to grow. So researchers think that blocking the action of this protein could help to slow the growth of myeloma or shrink it. But they are not sure yet.

The aims of this trial are to find out

If CNTO 328 and bortezomib is a better treatment than bortezomib alone
More about side effects and quality of life

Who can enter

You can enter this trial if you

Have myeloma that has come back or stopped responding to treatment
Have had at least one treatment for myeloma in the past, but no more than 3 different treatments
Have satisfactory blood test results
Are well enough for treatment (performance status 0, 1 or 2)
Are at least 18 years old
Are willing to use reliable contraception if there is any chance that you or your partner could become pregnant

You cannot enter this trial if you

Have no myeloma protein in your blood or urine (non secretory myeloma)
Have had bortezomib (Velcade) before
Have had treatment for your myeloma in the last 4 weeks
Have had treatment with nitrosourea chemotherapy drugs such as carmustine, lomustine, or fotemustine in the last 5 weeks
Have had an donor bone marrow or stem cell transplant in the past
Have had monoclonal antibody treatment in the last 2 months
Have had platelets or growth factors, such as GM-CSF or G-CSF , in the last 2 weeks
Have had any vaccinations in the last 4 weeks or are planning to have any
Have moderate or severe damage to the nerves in your hands or feet from earlier chemotherapy (peripheral neuropathy)
Are still having severe side effects from cancer treatment
Have had an organ transplant in the last 3 months
Have had any experimental treatment as part of a clinical trial in the last 4 weeks
Have had a heart attack in the last 6 months or have a serious heart problem
Have had any other cancer in the last 3 years, apart from non melanoma skin cancer or carcinoma in situ of the cervix that has been successfully treated
Have had an allergic reaction to boron, mannitol or any types of proteins in the past - you can check this with your doctor
Are known to have HIV or hepatitis A, B, or C
Have any other condition or illness that could affect taking part in this trial
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial and will recruit 290 people. It is a randomised trial. The people taking part are put into 2 different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in, or will be told which group you are in. This is called a double blind trial Open a glossary item .

If you are in group 1, you will have bortezomib and CNTO 328. If you are in group 2, you will have bortezomib and a dummy drug (placebo).

Each 6 week period is one cycle of treatment. You have bortezomib as an injection into a vein twice a week for 2 weeks. Then you have 10 days without treatment. And then 4 more bortezomib injections, 3 to 7 days apart. You have either CNTO 328 or the placebo as a drip into a vein. This takes about 2 hours. You have this every 2 weeks - a total of 3 treatments in each 6 week cycle. You will have up to 4 cycles of treatment.

At the end of each cycle, you will have some tests to see how well treatment is working. If the tests show the treatment is not helping you, your trial doctor will stop the bortezomib injections and ask you to start taking dexamethasone tablets instead. If the treatment is working well, you will continue as described above.

If the treatment is working after 4 cycles, you can join the ‘maintenance’ part of the trial. But if the treatment is not helping you, the trial doctor will probably decide to stop treatment. They will then discuss other treatment options with you.

During maintenance treatment, you continue to have bortezomib with or without CNTO 328. Or, if the bortezomib did not help you, you have dexamethasone tablets with or without CNTO 328. The trial doctor will give more information about how often you have this and for how long.

You will fill out a questionnaire at the beginning and end of each treatment cycle. The questionnaire will ask you about any side effects you have and about how you have been feeling. This is called a quality of life questionnaire.

Hospital visits

Before you can start treatment, your doctor will examine you and you will have some tests. The tests include

Blood tests
Urine tests
Chest X-ray
CT scan or MRI scan if your myeloma can be measured
Bone marrow test
Heart trace (ECG)

You will have your treatment in the hospital outpatient department. You will see the trial doctor at the hospital every 3 weeks for the first 4 cycles of treatment, and then every 5 weeks after that if you join the maintenance part of the trial.

You will have some blood and urine tests at the end of each cycle to see how well the treatment is working. You will also have a CT scan, MRI scan or X-rays if you have myeloma that can be measured.

Some people who take part will be asked to have extra blood samples and heart traces (ECGs). You won’t have any extra visits to hospital but you might have to stay a few hours longer after treatment. If you join this part of the trial your doctor will tell you more about it.

When you finish treatment, you will go to the hospital for follow up appointments with the trial doctor either 6 weekly or 12 weekly until the trial finishes.

Side effects

All treatments have side effects. The most common side effects of bortezomib are

Tiredness (fatigue)
Constipation or diarrhoea
Feeling or being sick
Loss of appetite
Fever
Weight loss
Dehydration
Numbness or tingling in your hands and feet (peripheral neuropathy)
A drop in blood cells causing an increased risk of infection, bruising and bleeding problems and tiredness

CNTO 328 is a new and experimental treatment and there may be some side effects that the doctors don’t know about yet. Looking at research done so far, doctors think the side effects may include

A drop in blood cells causing an increased risk of infection, tiredness and bruising and bleeding problems
Feeling or being sick
Diarrhoea
Shortness of breath
Joint pain
Rash
Dizziness
Headaches
Cough

There is a possibility that you may have an allergic reaction to CNTO 328, but this is very rare. The research team will keep a close eye on your during the trial and treat any problems straight away.