A trial of bortezomib with R-CHOP for diffuse large B cell lymphoma (REMoDL-B)

This trial showed that bortezomib may be useful for people with activated B cell and molecular high grade lymphoma who haven’t had treatment before.

Results
A total of 801 people had treatment as part of this trial. They all had diffuse large B cell lymphoma (DLBCL) and had not had any treatment yet.

They were put into 1 of 2 treatment groups at random:

• 407 people had rituximab and CHOP chemotherapy (R-CHOP) 
• 394 people had bortezomib, rituximab and CHOP chemotherapy (RB-CHOP)

The team looked at the sub type of those taking part and in each treatment group about:

• 3 out of every 10 people (30%) had activated B cell (ABC) lymphoma
• 6 out of every 10 people (60%) had germinal centre B cell (GCB) lymphoma
• 1 out of every 10 people (10%) had molecular high grade (MHG) lymphoma

REMoDL-B trial diagram

The team looked at how many people were living, 5 years after they joined the trial. 

For those who had ABC lymphoma it was:

• nearly 7 out of 10 (67%) who had R-CHOP
• about 8 out of 10 (80%) who had RB-CHOP

For those who had GCB lymphoma it was:

• more than 8 out of 10 (85%) who had R-CHOP
• just over 8 out of 10 (82%) who had RB-CHOP

For those who had MHG lymphoma it was:

• nearly 5 out of 10 (48%) who had R-CHOP
• about 6 out of 10 (60%) who had RB-CHOP

REMoDL-B trial diagram

Side effects
Most people in both groups had at least 1 side effect. Many were mild or didn’t last long. These included:

• a drop in white blood cells
• numbness and tingling in the hands and feet (peripheral neuropathy)
• feeling or being sick
• extreme tiredness (fatigue)

More people who had RB-CHOP had peripheral neuropathy.

Some people had side effects that were more serious. This means they needed hospital treatment, they had longer term problems, or they died. This was:

• just over 4 out of 10 people (42%) who had R-CHOP
• just over 5 out of 10 people (51%) who had RB-CHOP

Of these, 9 people died because of side effects from treatment, 5 who had R-CHOP and 4 who had RB-CHOP. These were mostly due to a large drop in white blood cells, fever and infection.

A total of 20 people developed another primary cancer . This was 14 people (2%) who had R-CHOP and 6 people (1%) who had RB-CHOP.  These included blood cancers  such as myeloma and leukaemia. And solid cancers  such as lung, tonsil, prostate, kidney and breast cancer.

Conclusion
The team concluded that adding bortezomib to R-CHOP may be useful for people with ABC and MHG sub types of diffuse large B cell lymphoma. But not for people with the GCB sub type. This is for people who haven’t had treatment for their lymphoma already.

The team suggest more trials are done with bortezomib, and also with other targeted treatments. 

Where this information comes from  
We have based this summary on the information in the articles below. We have not analysed the data ourselves. 

These articles have been reviewed by independent specialists (peer reviewed ) and published in medical journals. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Find more information about what trial results mean in our information about clinical trials.

Gene-expression profiling of bortezomib added to standard chemoimmunotherapy for diffuse large B-cell lymphoma (REMoDL-B): an open-label, randomised, phase 3 trial
A Davies and others
The Lancet Oncology, 2019. Volume 20, Issue 5 pages 649-662.

Differential Efficacy From the Addition of Bortezomib to R-CHOP in Diffuse Large B-Cell Lymphoma According to the Molecular Subgroup in the REMoDL-B Study With a 5-Year Follow-Up 
A Davies and others
Journal of Clinical Oncology, 2023. Volume 41, Number 15, pages 2718 – 2724.