Phase 3 trial results support the use of carfilzomib, lenalidomide, and dexamethasone as maintenance after autologous stem cell transplant in patients with multiple myeloma, according to researchers.
Results from the ATLAS trial showed that carfilzomib plus lenalidomide and dexamethasone significantly prolongs progression-free survival (PFS) when compared with lenalidomide alone. The findings were published in The Lancet Oncology.
The phase 3 trial (ClinicalTrials.gov Identifier: NCT02659293) included 193 patients with newly diagnosed multiple myeloma. They underwent induction and autologous stem cell transplant and were randomly assigned to maintenance with carfilzomib plus lenalidomide and dexamethasone (n=93) or lenalidomide alone (n=87).
After cycle 8, 44% of patients in the triplet arm were switched to lenalidomide alone. After 36 cycles of assigned maintenance, all patients received lenalidomide alone.
At the interim analysis, the median follow-up was 33.8 months. The median PFS was 59.1 months in the triplet arm and 41.4 months in the monotherapy arm (hazard ratio, 0.51; 95% CI, 0.31-0.86; P =.012).
In a post hoc subgroup analysis, the triplet conferred a significant PFS benefit in patients younger than 60 years, women, patients with an ECOG performance status of 0, those with ISS stage I-II disease, those with very good partial response or better after transplant, and those with standard-risk cytogenetics.
Grade 3-4 adverse events occurred in 76% of patients in the triplet arm and 73% of patients in the lenalidomide-alone arm. Serious adverse events were reported in 30% and 22%, respectively. Treatment discontinuation due to adverse events occurred in 4% of patients in the triplet arm and 12% of those in the lenalidomide arm.
“Overall, the toxicity and efficacy results indicate a favorable therapeutic index for carfilzomib, lenalidomide, and dexamethasone, which might be considered when making informed decisions about treatment after autologous stem cell transplantation,” the researchers concluded. “The treatment regimen and outcomes require further confirmation with a longer follow-up of this ongoing trial.”
Disclosures: This study was supported by Amgen and Celgene. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Dytfeld D, Wróbel T, Jamroziak K, et al. Carfilzomib, lenalidomide, and dexamethasone or lenalidomide alone as maintenance therapy after autologous stem-cell transplantation in patients with multiple myeloma (ATLAS): Interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. Published online January 12, 2023. doi:10.1016/S1470-2045(22)00738-0