A study looking at targeted radiotherapy as part of a stem cell transplant for amyloidosis (TRALA)

Cancer type:

Blood cancers

Myeloma

Status:

Results

Phase:

Phase 1/2

This study looked at a type of radiotherapy for amyloidosis, a condition that affects the bone marrow. It was for people with a type of amyloidosis called systemic amyloid light-chain (AL) amyloidosis, or S-ALA.

The study was open for people to join between 2016 and 2020. The team analysed the results in 2021.

More about this trial

Amyloidosis is a condition where your bone marrow Open a glossary item makes abnormal plasma cells . These cells make an abnormal protein called amyloid. This protein can build up in the body and cause symptoms.

Some people with myeloma develop amyloidosis. And doctors often use the same treatments they use for myeloma.

When this trial was done, doctors often used high dose chemotherapy and then a stem cell transplant to treat S-ALA. But high dose chemotherapy can cause serious side effects.

Doctors wanted to find out if they could use targeted radiotherapy instead of high dose chemotherapy. This means giving radiotherapy directly to the bone marrow.

To do this they use a radiolabelled antibody. This is an antibody with a radioactive molecule called Yttrium 90 attached to it. The antibody delivers the Yttrium 90 directly to the bone marrow.

The main aims of this study were to find out:

if it is safe use targeted radiotherapy before a stem cell transplant
more about the side effects
how well it works

Summary of results

Study design
This study was for people with systemic amyloid light-chain amyloidosis (S-ALA) who were due to have a stem cell transplant.

Everyone taking part had an antibody with Yttrium 90 attached to it.

The research team wanted to find the best dose to use. The first few people had the lowest dose. They didn’t have any serious side effects caused by the antibody treatment. So the next few people had a higher dose. The team looked at 3 doses in total.

Results
A total of 10 people joined this trial. The research team were able to analyse the results for 9 of them.

They found that no one had any serious side effects caused by the Yttrium 90. Some people did have side effects, but they were caused by other parts of the treatment plan.

They looked at how well the radiolabelled antibody and the stem cell transplant worked. They found that the amyloidosis had:

gone away in 2 people (22%)
got a bit better in 5 people (56%)
stayed the same in 1 person (11%)
got worse in 1 person (11%)

TRALA trial bar chart - Showing the effect on people's amyloidosis

Everyone who took part in the trial was living when the research team looked at the results 100 days after treatment.

These results are better than you might expect to see for people having high dose chemotherapy before their stem cell transplant. The number of people in this trial was small, so it is hard to say for sure.

Conclusion
The research team concluded that using Yttrium 90 as targeted radiotherapy caused no additional side effects. They also said that it might be a good alternative to high dose chemotherapy before a stem cell transplant for amyloidosis.

They suggest more trials are done.

Where this information comes from
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item ) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.