A trial looking at bendamustine chemotherapy in people with myeloma that has come back or is resistant to treatment (MUK one)

Cancer type:

Blood cancers

Myeloma

Status:

Results

Phase:

Phase 2

This trial looked at giving bendamustine chemotherapy with thalidomide and dexamethasone. The trial was for people who had already had treatment for myeloma, but it had come back (recurred).

More about this trial

The main treatments for myeloma are chemotherapy, steroids and biological therapy. Doctors can also use radiotherapy. The aim of treatment is to try to get the myeloma under control (in remission).

If myeloma comes back, it can be more difficult to treat. So doctors want to find new treatments to give if this happens.

This trial looked at a chemotherapy drug called bendamustine. Doctors have used bendamustine in combination with other drugs to treat myeloma that has come back after treatment but not in combination with thalidomide and dexamethasone.

In this trial, people had bendamustine with thalidomide and the steroid dexamethasone. These are drugs that doctors could already use to treat myeloma that had come back after treatment.

The aim of the trial was to see which dose of bendamustine worked best with thalidomide and dexamethasone for myeloma that had come back or was resistant Open a glossary item to treatment.

Summary of results

The trial team found that bendamustine did work with thalidomide and dexamethasone for myeloma that had come back or was resistant to treatment.

This was a phase 2 trial. Everyone had bendamustine with thalidomide and dexamethasone.

The researchers looked at 2 different doses of bendamustine. One was the maximum dose Open a glossary item that is used if you were newly diagnosed with myeloma. The other was a reduced dose of bendamustine.

94 people were treated in this randomised trial.

29 people had the maximum dose
65 people had the reduced dose

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After 20 people had had at least 2 treatments in each group, the committee that oversees the running of the trial (data monitoring committee Open a glossary item ) looked at whether the researchers should continue putting people into both groups.

The committee decided it wasn’t safe to continue putting people into the maximum dose group because it caused too great a drop in their blood cells. So the team closed recruitment to this group. After that, everyone joining the trial had bendamustine at the reduced dose.

The trial team looked at how many people were able to have 2 cycles of treatment without changing the dose of bendamustine. They found that just under 7 out of every 10 people (70%) could. They then looked at how many people completed their treatment. They found that 6 out of every 10 people (61%) were able to.

The researchers then looked at how well the myeloma had responded to the reduced dose. They did this by measuring the amount of protein in the blood and urine that was made by the myeloma. They found that in more than 4 out of every 10 people (46%) the amount of protein made by the myeloma was reduced by at least half. This is called a partial response Open a glossary item .

For those who had the reduced dose of bendamustine, the average length of time it took for their myeloma to start getting worse was 7½ months.

The trial team concluded that for people with myeloma that had come back or was resistant to treatment the combination of bendamustine, thalidomide and dexamethasone worked and was well tolerated.

We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.