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Summary  An updated survival analysis was conducted for the Phase II study O‐12‐M1 of melphalan flufenamide (melflufen) plus dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) with two or more prior lines of therapy (including bortezomib and lenalidomide). Partial response or better was seen in 31%. After a 46‐month median overall survival (OS) follow‐up, melflufen plus dexamethasone had a median OS of 20·7 months (75th percentile OS, 47·5 months). The median time‐to‐next treatment for melflufen plus dexamethasone was 7·9 months. In summary, melflufen plus dexamethasone resulted in sustained long‐term clinical benefit in patients with RRMM.

Melflufen plus dexamethasone in relapsed/refractory multiple myeloma: long‐term survival follow‐up from the Phase II study O‐12‐M1