A study looking at using bortezomib for myeloma after stem cell transplant (BCT)

Cancer type:

Blood cancers

Myeloma

Status:

Results

Phase:

Phase 2

This study looked at bortezomib for people with myeloma after they have had a transplant of their own stem cells.

An autologous stem cell transplant Open a glossary item is one using your own stem cells. Doctors might refer to this as intensive treatment.

This trial was open for people to join between 2009 and 2014. These results were published in 2018.

More about this trial

Doctors can treat myeloma with high dose chemotherapy, followed by a transplant of your own stem cells. We know that people who have a good response to their transplant may stay free of myeloma for longer.

Bortezomib is a targeted cancer drug Open a glossary item . We knew from research that bortezomib worked well as a treatment for cancer.

Researchers thought that people may have a better response to their stem cell transplant if they had bortezomib after. If so, this would increase the amount of time they stayed free of myeloma.

The aims of this trial were to find out:

how safe and acceptable it is to give bortezomib after a stem cell transplant
if bortezomib increased the amount of time people are free of myeloma
how bortezomib affects quality of life
if bortezomib improves bone health

Summary of results

The trial team found that after an autologous stem cell transplant bortezomib was safe, acceptable and worked well.

This was a phase 2 trial Open a glossary item .

40 people took part in the trial. Everyone had bortezomib starting 3 months after their autologous stem cell transplant.

They had it once a week for 32 weeks either as an injection under the skin (sub cutaneous) or by a drip into a vein (intravenous).

Everyone had a bone marrow sample Open a glossary item and a blood sample taken at 6 months and 1 year after their transplant to see how well bortezomib worked.

Results
The average follow up was just over 4½ years. Of the 40 people:

12 (30%) were alive and had no sign of their myeloma coming back
24 (60%) were alive and their myeloma had come back
4 (10%) had died from their myeloma

6502-graph-1.png

Of the 40 people, the team were able to look at the results of 34 people to see how well bortezomib worked at 6 months and 1 year after their transplant.

They found that at 6 months for:

5 people (14.7%) there was no sign of myeloma cells in their bone marrow or myeloma proteins in their blood (a complete response)
23 people (67.6%) there were few myeloma cells in their bone marrow or a low level of myeloma proteins in their blood (a very good partial response)
6 people (17.6%) there were some myeloma cells in their bone marrow or measurable proteins in their blood (a partial response)

6502-graph-2.png

At 1 year they found that:

7 people (20.6%) had a complete response
22 people (64.7%) had a very good partial response
4 people (11.8%) had a partial response

6502-graph-3.png

The team looked at the average length of time people were alive and free of their myeloma (progression free survival) after their transplant. They found it was just under 3½ years (41.6 months).

A year after treatment they compared the progression free survival for those who:

didn’t have myeloma cells detectable in their bone marrow sample (MRD negative)
did have myeloma cells detectable in their bone marrow sample (MRD positive)

They found it was:

just over 3½ years (44 months) for those who were MRD negative
just under 2 years (22 months) for those who were MRD positive

6502-graph-4.png

Side Effects
13 people had moderate to severe side effects. 5 people stopped treatment due to side effects.

Quality of life
The quality of life of the people didn’t change much throughout the trial.

Bone health
To find out about bone health the team looked at proteins in the blood (biomarkers Open a glossary item ) called osteoblasts markers. These markers indicate the amount of bone forming activity in the body. They found that people whose myeloma responded very well to bortezomib had a higher amount of these markers than people whose myeloma didn’t respond as well.

Conclusion
The team concluded that bortezomib can be used after an autologous stem cell transplant for people with myeloma. People who didn’t have myeloma cells detected in their bone marrow at one year after transplant lived with no sign of myeloma for a longer time.

About the average length of time people were free of their myeloma, the team say it was longer in this trial when compared to similar trials using bortezomib after a stem cell transplant. This could have been due to the overall higher dose achieved by giving bortezomib once a week.

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.

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.

Bortezomib consolidation post-ASCT as frontline therapy for multiple myeloma deepens disease response and MRD-negative rate whilst maintaining QOL and response to re-treatment at relapse

O C Cohen and others

British Journal of Haematology, 2018. Volume 185, issue 5, Correspondence.