A trial looking at a second stem cell transplant for myeloma that has come back after having a transplant (Myeloma X Relapse - Intensive)

Cancer type:

Blood cancers
Myeloma

Status:

Results

Phase:

Phase 3

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 high dose chemotherapy followed by a drip of your own stem cells. Using your own stem cells rather than a donor’s is called an autologous transplant. This can control the growth of the myeloma for a period of time, but you will probably need more treatment at some stage. So doctors are looking at new ways to treat people if this happens.

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

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Gordon Cook

Supported by

Cancer Research UK
Clinical Trials Research Unit (CTRU), University of Leeds
NIHR Clinical Research Network: Cancer
The Leeds Teaching Hospitals NHS Trust

Other information

This is Cancer Research UK trial number CRUK/06/018.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

802

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

Rate this page:

Currently rated: 3 out of 5 based on 4 votes
Thank you!
We've recently made some changes to the site, tell us what you think

Share this page