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Based on ISS (n ISS I/ II/ III = 48/ 92/ 46) and SKY92, 186 patients were classed into four risk groups: SKY92 high-risk combined with any ISS stage (13%), SKY92 standard-risk and ISS III (21%), SKY92 standard-risk and ISS II (45%) and SKY92 standard risk and ISS I (21%; Kuiper et al., 2015; Blood, 126: 1996 Blood, 126: -2004. The median PFS of these respective groups was 11, 21, 22 and 25 months and the median OS was 18, 49, 56 and 88 mo (PFS: LR p-value = 5x10 -3 ; OS: LR p-value = 2x10 -4 ). Classifying in R-ISS stages (n R-ISS I/II/III = 12/129/28) demonstrated a median PFS of 13, 20 and 30 months (LR p-value = 5x10 -3 ) and a median OS of 25, 54 and 78 months (LR p-value = 1x10 -3 ). Factors independently associated with OS in the multivariate analysis were SKY92-ISS, R-ISS and del17p, whereas only SKY92-ISS and R-ISS remained independently associated with PFS. Eleven SKY92 high-risk patients were treated with lenalidomide and demonstrated a median OS of 55 months compared to 17 months for thalidomide treated high-risk patients (n = 15). The median OS in standard-risk patients was 59 months (lenalidomide) vs 61 months (thalidomide). Using an interaction term in the Cox regression model, a significant difference in OS (p = 0.04) was found between the treatment arms conditional on SKY92 risk status. Summary/Conclusion: Also in non-transplant eligible MM patients, the SKY92 classifier is a robust marker to identify high-risk patients. The SKY92-ISS has prognostic value independent of the revised ISS. In addition, SKY92 high-risk patients appear to have a survival benefit of lenalidomide treatment over thalidomide treatment, which is not found for SKY92 standard risk patients.

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