For many people with multiple myeloma, maintenance therapy becomes part of everyday life. After initial treatment, many patients continue taking lenalidomide (Revlimid) to help keep multiple myeloma under control. Currently, the standard of care is to continue maintenance therapy until myeloma gets worse. Now researchers are trying to learn how long patients need maintenance therapy. New results from the phase 3 ENDURANCE trial show that, for patients who did not receive an autologous stem cell transplant, continuing lenalidomide for a long period of time may not be necessary for better survival outcomes. In fact, researchers also found that longer treatment was linked to more side effects and a higher risk of developing second cancers.
What is maintenance therapy?
Maintenance therapy is lower-intensity treatment given after initial therapy to help delay disease progression. Current guidelines often recommend continuing lenalidomide until there is progression or side effects become too difficult to manage.
This approach has helped many patients but comes with challenges. Long-term treatment can increase costs, affect quality of life, and lead to ongoing side effects. There has been little research on how long maintenance therapy should continue for patients who do not undergo a stem cell transplant.
About the ENDURANCE trial
The phase 3 ENDURANCE (E1A11) trial included 516 adults with newly diagnosed multiple myeloma who completed induction therapy but did not receive a stem cell transplant. None of the participants had high-risk abnormalities.
Patients were randomly assigned to one of two groups:
Continue lenalidomide until the disease progressed
Stop lenalidomide after two years
Researchers compared survival, progression-free survival, side effects, and the development of second cancers.
Overall survival was the same for both treatment groups
There was no meaningful difference in overall survival between the two groups.
After seven years:
Overall survival was 69.0% for patients who continued maintenance until disease progression.
Overall survival was 68.6% for patients who stopped treatment after two years.
Patients who stayed on maintenance therapy longer experienced some improvement in progression-free survival. Median progression-free survival was:
42.5 months with indefinite maintenance
38.9 months with two years of maintenance
Patients receiving treatment beyond two years experienced:
More grade 3 to grade 5 treatment-related side effects (23.5% vs. 16.9%)
A higher rate of second primary cancers (11.2% vs. 8.3%)
Why these results matter
For many patients, maintenance therapy affects daily routines, finances, and quality of life for years after diagnosis.
These findings suggest that some patients with standard-risk multiple myeloma who do not receive a stem cell transplant may be able to stop maintenance therapy after two years without reducing their chances of long-term survival. Reducing treatment duration could also decrease side effects, lower healthcare costs, and ease the burden of ongoing therapy.
What this means for patients
This study provides new evidence that may help patients and their healthcare teams have more informed conversations about how long maintenance therapy should continue.
Treatment decisions about maintenance therapy depend on many factors, including disease risk, response to treatment, side effects, and personal preferences. If you are currently receiving maintenance therapy, talk with your healthcare team before making any changes to your treatment plan.
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Sources:
NEJM - Continuous or Fixed-Duration Maintenance Therapy in Multiple Myeloma
HealthTree - What Is the Best Consolidation/Maintenance Therapy for People with Myeloma?
HealthTree - The Complete Patient's Guide to Autologous Stem Cell Transplant (ASCT)
HealthTree - New Guidelines Define High-Risk Myeloma with Genetics in Mind
