A trial looking at ixazomib for people with myeloma that has come back (Myeloma XII ACCoRd)

Cancer type:

Blood cancers

Myeloma

Status:

Results

Phase:

Phase 3

This trial was for people who had already had a stem cell transplant and who had no sign of their myeloma for at least 12 months before it came back (relapsed).

The people taking part were fit and healthy enough to have another stem cell transplant. It was looking at a type of targeted cancer drug Open a glossary item called ixazomib. Ixazomib is pronounced icks-azz-owe-mib.

The trial was open for people to join between 2017 and 2022. The team presented some of the results at a conference in 2023. They looked at how safe ixazomib was and how well it worked for people after their second stem cell transplant.

The research team plan to publish more results at a later date. We will add longer term results when they are available.

This trial was supported by Cancer Research UK.

More about this trial

Following a stem cell transplant for myeloma, the aim is to have no signs of the disease. This is called remission Open a glossary item .

After some time, the myeloma might come back. This is a relapse Open a glossary item . At the time of this trial, if this happened, people had treatment with:

a targeted cancer drug called thalidomide
a steroid drug called dexamethasone

In this trial doctors were looking at a drug called ixazomib.

Ixazomib is a targeted cancer drug called a cancer growth blocker. There are different types of cancer growth blockers. Ixzomib is a proteosome inhibitor. It blocks certain proteins that tell cancer cells to divide and grow. You take it as a tablet.

Everybody taking part had thalidomide, dexamethasone and ixazomib. This was called re-induction treatment.

Then, they had 1 of the following:

the chemotherapy drug melphalan and a transplant using their own stem cells (autologous stem cell transplant or ASCT). This was the standard treatment when the trial took place.
melphalan, ixazomib and a transplant using their own stem cells (augmented autologous stem cell transplant)

This part of the trial was randomised.

Then they had either:

regular follow up or
more treatment with thalidomide, dexamethasone and ixazomib. This was called consolidation and maintenance treatment.

This part of the trial was also randomised. The results presented here are for the consolidation and maintenance part of the trial.

The main aims of this trial were to:

find out if ixazomib can help people with relapsed myeloma
learn about the side effects of treatment
find out more about people’s quality of life

Summary of results

This trial showed that consolidation and maintenance treatment with thalidomide, dexamethasone and ixazomib worked better than regular follow up after a stem cell transplant.

496 people joined the trial. And 206 people took part in this randomisation Open a glossary item 100 days after their second stem cell transplant.

103 people had consolidation and maintenance treatment with thalidomide, dexamethasone and ixazomib
103 people had regular follow up (observation). They had clinic visits to check for signs of myeloma.

When these results were presented at a conference, the trial team had monitored the people taking part for on average 27 months.

The researchers looked at how long it was on average between randomisation and signs that the myeloma had come back. This is called progression free survival.

They found that on average it was:

21 months for people in the consolidation and maintenance treatment group
13 months for people in the regular follow up group

The trial team say they aren’t sure if there are any differences between the two groups at this stage in terms of how long people are living. They think it has not been long enough yet to say for sure. They will publish more results about this when they are available.

Quality of life
The researchers aim to provide information on quality of life at a later date.

Side effects
There were some side effects of treatment. These were usually mild. And most people in the consolidation and maintenance group finished the consolidation part of treatment.

Some people had more severe side effects. In the consolidation and maintenance treatment group the most common side effects were:

upper respiratory tract infection (7 people)
a drop in platelet level (6 people)
lung infection (3 people)
a drop in the level of a type of white blood cell called lymphocytes (3 people)
a drop in neutrophil level (3 people)

Conclusion
The results so far show that consolidation and maintenance treatment with thalidomide, dexamethasone and ixazomib worked better than regular follow up after a second stem cell transplant.

The researchers will publish more results of how people are doing longer term when they are available.

They also hope to publish more results about having a stem cell transplant with either melphalan or melphalan and ixazomib when they are available.

More detailed information
There is more information about this research in the reference below.
Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Ixazomib-Based Consolidation and Maintenance Prolongs Progression-Free Survival after Salvage Autologous Stem Cell Transplantation (sASCT): Results from Interim Analysis of UK-MRA Myeloma XII (ACCoRD)
G Cook and others
Blood, 2023. Volume 142, supplement 1, page 783, (ASH conference abstract).

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 ). The figures we quote above were provided by the research team. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.