Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at different ways of giving bortezomib for myeloma that has come back or stopped responding to treatment
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This trial was comparing 2 different ways of giving bortezomib (Velcade) for myeloma that had come back or stopped responding to previous treatment.
But some people can have fragile veins, which makes it difficult for doctors and nurses to get a cannula in. And some people do not want to have a long term central line. So doctors thought it may be helpful if they could give bortezomib as an injection under the skin (subcutaneous) instead.
The aims of this trial were to
- Find out if giving bortezomib as an injection under the skin worked as well as giving it into a vein
- Learn more about the side effects of bortezomib, particularly when given as an injection under the skin
Summary of results
The researchers found that subcutaneous injections of bortezomib worked as well as injections into a vein. And that people who had bortezomib as an injection under the skin had fewer side effects.
The trial included 222 people. Everybody taking part had bortezomib on 4 days of a 21 day cycle of treatment.
- 148 people had bortezomib as a subcutaneous injection under their skin
- 74 people had bortezomib as an injection into a vein
People taking part in the trial had an average of 8 cycles of treatment and the researchers have results for
- 145 people who had subcutaneous injections
- 73 people who had intravenous injections
They found that, after 4 cycles of reatment, myeloma responded to bortezomib in about the same percentage of people in each group. This was just over 4 out of 10 people (42%).
After 8 cycles, and adding in a drug called dexamethasone which also has an effect on myeloma, the number of people in each group whose myeloma had responded to the treatment increased to just over 5 out of 10 (52%).
Compared to the people who had intravenous injections, people who had the subcutaneous injections had fewer side effects such as
- A drop in the number of blood cells that can cause an increased risk of infection, bleeding or bruising, tiredness and shortness of breath
- Nerve damage (peripheral neuropathy)
About 6 out of 10 people (58%) who had subcutaneous injections had a reaction at the injection site. This was most commonly redness. Other less frequent reations were swelling, tenderness, itching and a hardening of the skin. In most cases, these local reactions were mild and always got better - usually within 6 days. Only rarely did the bortezomib treatment need to be changed.
The researchers found that for people in both groups, it took about the same length of time before their myeloma started getting worse. And the percentage of people who were alive a year after starting treatment was also about the same in both groups.
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (
How to join a clinical trial
Dr J Cavet
Millennium Pharmaceuticals Inc