A study looking at palifermin for a painful mouth in people having intensive treatment for myeloma

Cancer type:

Blood cancers

Myeloma

Status:

Results

Phase:

Phase 3

This study looked at palifermin for a very sore mouth in people having high dose melphalan chemotherapy and a stem cell transplant for myeloma.

Doctors sometimes treat myeloma with high dose chemotherapy Open a glossary item , followed by a stem cell transplant . This is called intensive treatment. High doses of chemotherapy can often give you a very sore mouth (mucositis).

More about this trial

A sore mouth can stop you being able to swallow or eat. You may also be more likely to get mouth infections. So it is important that it is treated as soon as possible.

There is a drug called palifermin (Kepivance) which doctors already use to treat mucositis. People having intensive treatment for myeloma may already have this drug before and after their chemotherapy and transplant. But researchers wanted to find out more about giving palifermin to people having high dose melphalan chemotherapy.

The aim of this study was to find out more about using palifermin to prevent a painful mouth in people having melphalan chemotherapy and a stem cell transplant.

Summary of results

The trial team found that palifermin didn’t prevent a very sore mouth or help people who’d developed one.

This was a randomised trial. The people taking part were put into 1 of 3 groups at random. Neither they nor their doctor knew which group they were in. Researchers call this a double blind study. 277 people had treatment in the trial.

113 people had palifermin before and after melphalan chemotherapy and a stem cell transplant
107 people had palifermin before chemotherapy and a dummy drug (placebo ) after having a stem cell transplant
57 people had a dummy drug before and after chemotherapy and a transplant.

Specially trained nurses checked the patients’ mouths everyday while they were in hospital. The nurses checked for mouth soreness, redness and whether the patient was able to eat, drink and swallow without too much pain. The patients also filled in a questionnaire everyday that asked about their mouth pain and how this affected their quality of life.

The trial team looked at the number of people who developed a very sore mouth and how people rated their quality of life. They found that there was no difference between the 3 groups for either of these.

People in the palifermin group had more problems with a skin rash, skin redness and swelling in their hands and feet. This was more common in people who’d had palifermin both before and after intensive treatment. Mouth problems such as mouth herpes and infections were more common in people who’d had palifermin compared with those who’d only had the dummy drug (placebo).

The trial team concluded that palifermin didn’t help people with myeloma who had mucositis. In this trial, it didn’t prevent a sore mouth or help heal a sore mouth that had already developed in people having high dose melphalan and a stem cell transplant.

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 team who did the research. We have not analysed the data ourselves.