A trial looking at different ways of giving bortezomib for myeloma that has come back or stopped responding to treatment

Cancer type:

Blood cancers

Myeloma

Status:

Results

Phase:

Phase 3

This trial was comparing 2 different ways of giving bortezomib (Velcade) for myeloma that had come back or stopped responding to previous treatment.

Bortezomib is a type of drug called a proteasome inhibitor. You usually have it as an injection into a vein (intravenously) through a fine tube called a cannula or through a central line.

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 (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.