
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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
You can enter this trial if you
You cannot enter this trial if you
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 .
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.
Before you can start treatment, your doctor will examine you and you will have some tests. The tests include
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.
All treatments have side effects. The most common side effects of bortezomib are
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
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Gareth Morgan
Experimental Cancer Medicine Centre (ECMC)
Global Clinical Operations (Division of Janssen-Cilag Ltd) representing Centocor B.V.
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”