A trial looking at bortezomib, adriamycin and dexamethasone as the first treatment for myeloma (PADIMAC)

Cancer type:

Blood cancers
Myeloma

Status:

Results

Phase:

Phase 2

This trial looked at a combination of bortezomib, adriamycin and dexamethasone (PAD) for myeloma. It was for people who had not had any other treatment for their myeloma.

The trial was open for people to join between 2011 and 2014. The team published the results in 2021.

More about this trial

Doctors can treat myeloma with chemotherapy and targeted cancer treatments, followed by a stem cell transplant. But sometimes the myeloma comes back (relapses).

People who have a very good response to their initial treatment can stay free of myeloma (in remission) for a long time. This is true whether they have a stem cell transplant or not. 

Doctors wanted to find out if it’s better for people to have a stem cell transplant:

  • straight after their initial treatment, or
  • later on, when their myeloma comes back

People taking part in this trial had a combination of drugs called PAD. This is a combination of a:

Everyone taking part had PAD to begin with. Some then had a stem cell transplant straight away. And some had a stem cell transplant later on, when their myeloma came back.

The main aim of this trial was to see if people who have a good response to PAD can safely wait to have a stem cell transplant.

Summary of results

The team found that it may be ok for some people to wait and have a stem cell transplant when their myeloma comes back.

Trial design
This trial was for people who had been recently diagnosed with myeloma and were due to start treatment.

Everyone had bortezomib, adriamycin and dexamethasone (PAD) to begin with. The doctors then looked at how well this treatment had worked. 

People whose myeloma responded very well had regular tests and scans to look for signs that it had come back. If the myeloma did come back, they were then offered a stem cell transplant.  People whose myeloma responded less well had a stem cell transplant.

The research team also measured something called minimal residual disease (MRD). This is when people have a very small number of cancer cells left after treatment. They wanted to see if MRD levels were linked to how well people did after treatment.

Results
A total of 153 people joined this trial. They all had PAD to begin with.

The research team were able to look at how well PAD worked in 151 people. They didn’t have results for 2 people. 

They found that the myeloma:

  • got a lot better in 63 people (41%)
  • got a bit better in 63 people (41%)
  • stayed the same in 17 people (11%)
  • got worse in 8 people (5%)

Two years after people joined the trial, the team looked at how many people were living and their myeloma had not got any worse.

They found it was:

  • nearly 4 out of 10 people (37%) whose myeloma responded very well to PAD
  • more than 3 out of 10 people (33%) whose myeloma responded less well to PAD and who’d then had a transplant 

Then they looked in more detail at the levels of minimum residual disease (MRD) in people whose myeloma had responded very well to PAD. They found that people who had MRD sometimes did less well.

Two years after people joined the trial, the team looked at how many of these people were living and their myeloma had not got any worse.

They found it was:

  • nearly 6 out of 10 people (56%) who had no MRD
  • just over than 3 out of 10 people (31%) who had some MRD

Side effects
Most people taking part had at least one side effect from treatment. Many were mild or didn’t last long. But some were more severe.

The most common of the more severe side effects was a drop in white blood cells or blood clotting cells (platelets).

We have more information about the side effects bortezomib, adriamycin and dexamethasone in our Cancer drugs section

Conclusion
The research team concluded that it could be an option for people to wait until their myeloma comes back before they have a stem cell transplant.

They also concluded that MRD levels can help predict how well people will do. They suggest that anyone with MRD after initial treatment should have a stem cell transplant straight away rather than wait.

It’s hard to draw firm conclusions from this trial because there weren’t very many people in each group. The team recommend larger trials are done to look at these treatment options in more detail.

Where this information comes from
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.

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 Kwee L Yong

Supported by

Blood Cancer UK 
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
Janssen Cilag
Chugai Pharma UK

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 7445

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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