Revlimid Combo Treatment Improved Survival in Newly-diagnosed Myeloma Patients in Phase 3 Trial

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by Alice Melão |

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Newly diagnosed multiple myeloma patients unable to undergo stem cell transplants lived significantly longer without their disease progressing when given continuous treatment with Revlimid (lenalidomide) and low-dose dexamethasone, compared to treatment with Alkeran (melphalan), prednisone, and thalidomide.

Results from the Phase 3 FIRST trial were revealed in the study, “Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma,” published in the journal Blood.

Sponsored by Celgene, FIRST (NCT00689936) was designed to evaluate the effectiveness and safety of two Revlimid-based regimens compared to a thalidomide-based standard treatment.

The study included 1,623 newly-diagnosed patients who were not suitable candidates for stem cell transplants. Participants were randomly assigned to either Revlimid plus low-dose dexamethasone until disease progression; Revlimid plus low-dose dexamethasone for 72 weeks; or thalidomide, Alkeran, and prednisone for 72 weeks.

After a median follow-up of 67 months, patients receiving continuous Revlimid lived for a median of 26 months without signs of disease progression. The figures for those treated with fixed Revlimid or thalidomide were 21 months and 21.9 months, respectively. This translated to a roughly 30% lower risk of progression or death among those receiving continuous Revlimid compared to the other two regimens.

Overall survival, however, was significantly higher in both Revlimid arms. Continuous Revlimid treatment extended the overall survival by 10 months compared to the thalidomide therapy (59.1 months vs. 49.1 months). Patients who received the fixed 72-week Revlimid treatment had a median overall survival of 62.3 months.

More patients receiving Revlimid continuously responded to the treatment, compared to patients treated with thalidomide – 81% vs. 67%. Response rates were similar in both Revlimid arms.

In addition to extending the time until disease progression, continuous Revlimid and dexamethasone was also better than the two other regimens at delaying the need for second-line myeloma treatment.

Patients receiving the continuous treatment took a median of 36.7 months before needing another treatment, while those on the fixed Revlimid or thalidomide regimens took 28.5 months and 26.7 months, respectively, before another treatment.

The benefits were particularly obvious in patients who had achieved a very good partial response. Treatment with continuous Revlimid delayed the next therapy for 69.5 months, compared to 37.7 months with thalidomide and 39.9 months with 72 weeks of Revlimid.

In general, the outcomes after second-line treatment were also better in patients who had received Revlimid compared to thalidomide.

During the trial, no additional safety issues were reported, with each regimen being associated with safety profiles similar to those reported in previous studies.

The findings suggest that continuous treatment with Revlimid and low-dose dexamethasone should be considered as standard care for newly diagnosed myeloma patients unable to undergo a stem cell transplant.