"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at a second stem cell transplant for myeloma that has come back after having a transplant (Myeloma X Relapse - Intensive)
This trial looked at a second stem cell transplant for myeloma that has come back after an earlier stem cell transplant. The trial was supported by Cancer Research UK.
If you are suitable for intensive treatment, doctors usually treat myeloma with
In this trial, patients whose myeloma had come back after an initial stem cell transplant were either treated with high dose chemotherapy and a second autologous stem cell transplant or had low dose chemotherapy with a drug called cyclophosphamide.
The researchers also wanted to find out more about a drug called bortezomib (Velcade) as part of induction treatment. The aim of induction treatment is to get rid of as much of the myeloma as possible. Everybody taking part had bortezomib alongside two other standard drugs for myeloma called doxorubicin and dexamethasone. This combination of drugs is known as PAD.
The aims of the trial were to find out
- Which treatment controls myeloma for longer (a second autologous stem cell transplant or lower dose chemotherapy)
- How well PAD works for people with myeloma that has come back
- More about the side effects
Summary of results
The researchers found that having a second stem cell transplant with their own cells helped people to stay free of myeloma for longer than low dose chemotherapy. They also found that PAD was a useful re-induction treatment for this group of people.
293 people took part in the trial. To begin with, everyone had PAD followed by a stem cell collection (harvest).
The researchers looked at how well PAD worked. They had the results for 281 people and found that
- In 49 people the myeloma went away completely (doctors call this complete remission)
- In 186 people the myeloma got a bit better (doctors call this partial remission)
- In 44 people the myeloma stayed the same (doctors call this stable disease)
- In 2 people the myeloma got worse
The main side effects of PAD were diarrhoea, feeling or being sick, pins and needles in your hands and feet, nerve changes causing problems with co ordination and balance and a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness.
174 people had enough stem cells available to continue with treatment and were randomised into 1 of 2 treatment groups by computer. Neither they nor their doctor could decide which group they were in.
- 89 people had high dose chemotherapy and a stem cell transplant with their own cells (an autologous transplant)
- 85 people had low dose chemotherapy
The researchers were able to look at the results of 80 people who’d had a second transplant. They found that
- In 35 people the myeloma went away completely (complete remission)
- In 39 people the myeloma went away a little bit (partial remission)
- In 4 people the myeloma stayed the same (stable disease)
- In 2 people the myeloma got worse
The researchers were also able to look at the results of 81 people who’d had low dose chemotherapy. They found that
- In 19 people the myeloma went away completely
- In 45 people the myeloma went away a little bit
- In 2 people the myeloma stayed the same
- In 15 people the cancer got worse
The researchers followed up the patients for just under 3 years. They looked at the average length of time that people lived without any signs of their myeloma getting worse. Doctors call this progression free survival. This was
- 19 months in the group who had high dose chemotherapy and an autologous transplant
- 11 months in the group who had low dose chemotherapy
The researchers need to follow up the people for longer to see if there is a difference in the average length of time they live overall after treatment. Doctors call this overall survival. The trial team hope that this information will be available in summer 2015.
The people who had high dose chemotherapy and an autologous transplant group had more side effects including a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness.
The trial team concluded that having a second autologous stem cell transplant after relapsing from a prior transplant improved progression free survival and worked better than low dose chemotherapy. They suggest that the findings of this trial might help guide doctors on the best way to treat this group of patients.
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
Professor Gordon Cook
Cancer Research UK
Clinical Trials Research Unit (CTRU), University of Leeds
NIHR Clinical Research Network: Cancer
The Leeds Teaching Hospitals NHS Trust
This is Cancer Research UK trial number CRUK/06/018.