The U.S. Food and Drug Administration (FDA) has approved lenalidomide as maintenance therapy following autologous hematopoietic cell transplantation for patients with multiple myeloma.1
The current approval was based on findings from 2 phase 3 trials that evaluated the efficacy and safety of lenalidomide maintenance therapy after autologous HCT in patients with multiple myeloma. The CALGB 100104 (ClinicalTrials.gov Identifier: NCT00114101) and IFM 2005-02 ClinicalTrials.gov Identifier: NCT00430365) trials demonstrated a significant 62% (hazard ratio, 0.38; 95% CI, 0.27-0.54; P < .001) and 50% (hazard ratio, 0.50; 95% CI, 0.39-0.64; P < .001) reduction in the risk of progression or death, respectively, for patients treated with lenalidomide compared with those who received placebo.
In the CALGB trial, median overall survival was 9.3 years with lenalidomide vs 7 years with no maintenance; in the IFM trial, median survival was 8.8 and 7.3 years, respectively.
The safety profile of lenalidomide in these trials was consistent with previous reports. The most frequently reported grade 3 to 4 adverse event was neutropenia, affecting 56% of the overall population. Investigators also observed an increased incidence of second primary malignancies among lenalidomide-treated patients, with 7.5% of patients who received lenalidomide developing second primary malignancies vs 3.3% in the placebo group.
The recommended dose and schedule for this lenalidomide indication is 10 mg orally once daily continuously on days 1 to 28 of each 28-day cycle.
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The expanded indication makes lenalidomide the only treatment approved for maintenance therapy after autologous HCT in patients with multiple myeloma.
- FDA expands indication for Revlimid (lenalidomide) as a maintenance treatment for patients with multiple myeloma following autologous hematopoietic stem cell transplant (auto-HSCT) [news release]. Summit, NJ: Celgene; February 22, 2017. http://ir.celgene.com/releasedetail.cfm?ReleaseID=1014013. Accessed February 23, 2017.