Abstract
8016 Background: Response and survival outcomesare poor in pts with RRMM who are refractory to BORT and immunomodulatory drugs. POM+LoDEX has demonstrated activity in pts with advanced multiple myeloma who have received multiple lines of therapy. This analysis evaluates outcomes in pts with disease refractory to LEN, BORT, or both, as well in pts with disease refractory to both LEN and BORT who had received prior transplant. Methods: In the MM-002 phase II trial, pts received POM (4 mg/day on days 1–21 of each 28-day cycle) alone (n=108) or in combination with LoDEX (40 mg/week) (n=113). Refractory disease was defined as documented progression during treatment or within 60 days of the last dose of treatment. Response rates were assessed using European Group for Bone Marrow Transplantation (EBMT) criteria by independent adjudication committee. Results: Patients who received POM+LoDEX were refractory to LEN (77%), BORT (73%), or both (61%). Forty-two percent were refractory to both LEN and BORT and had received prior transplant. Overall, 20% of pts achieved ≥ PR, median PFS was 3.5 months, and 1-year survival rate was 59%. Response rates and duration were comparable in pts with disease refractory to LEN, BORT, or both, and in pts who had received prior transplant (response rate 25-34%, median duration of response 5.7-7 months). Survival outcomes were similar across the groups (median PFS 3.8-4.6 months; 1-year survival rate 60-67%). Conclusions: POM, given at 4 mg/day on days 1–21 of each 28-day cycle in combination with LoDEX, 40 mg/week, is effective in pts with RRMM refractory to LEN, BORT, or both, and including those with prior transplant. These results suggest a lack of cross-resistance between POM and LEN, and confirm activity not only in BORT-refractory pts but also those for whom transplant has failed. [Table: see text]
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