This trial showed that lenalidomide worked better than chemotherapy for mantle cell lymphoma that had continued to grow despite other treatment.
This trial recruited 254 people with mantle cell lymphoma from 12 different countries, including the UK. They had already had treatment for their lymphoma.
They were put into 1 of 2 groups at random
- 170 people were in the lenalidomide group
- 84 people were in the standard treatment group
The doctors could decide which treatment was best for their patients in the standard treatment group. Of the 84 people in this group:
- 27 had rituximab
- 20 had gemcitabine
- 18 had fludarabine
- 11 had chlorambucil
- 8 had cytarabine
The research team looked at how well the treatments worked. They found that out of 152 of the people in the lenalidomide group, the lymphoma had:
- gone away completely in 8 people (5%)
- got smaller in 60 people (35%)
- stayed the same in 50 people (29%)
- continued to grow in 34 people (20%)
And out of 79 of the people in the standard treatment group, the lymphoma had:
- not gone away completely in anyone
- got smaller in 9 people (11%)
- stayed the same in 44 people (52%)
- continued to grow in 26 people (31%)
They were unable to assess how well treatment worked for 18 people in the lenalidomide group, and 5 people in the standard treatment group.
They also looked at the most common length of time before the lymphoma started to grow again. They found it was:
- 8.7 months for the lenalidomide group
- 5.2 months for the standard treatment group
When they look at how long people lived in each group, they found the most common time was:
- 28 months for the lenalidomide group
- 21 months for the standard treatment group
The trial team also looked at the side effects for most of the people taking part:
- 140 out of 167 people (84%) in the lenalidomide group had side effects
- 50 out of 83 people (60%) in the standard treatment group had side effects
More people in the lenalidomide group had serious side effects, including a drop in white blood cells, red blood cells and clotting blood cells (platelets). These side effects were managed with treatments such as growth factors
The lenalidomide group also had more of the less serious side effects such as tiredness, diarrhoea, constipation and cold like symptoms.
The number of people who stopped treatment because of side effects was similar in both groups. It was 25 out of 167 (15%) in the lenalidomide group, and 13 out of 83 (16%) in the standard treatment group.
Patients were asked to fill in Quality of Life questionnaires
at various points in the trial. The results showed that quality of life did not go down with treatment. Those in the lenalidomide group had the same or better quality of life as those in the standard treatment group.
The trial team concluded that lenalidomide worked better than the other treatments for mantle cell lymphoma that had continued to grow despite previous treatment. Although lenalidomide did cause more side effects, the doctors were able to treat them.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed
) 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.