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Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM ‐003 trial for pomalidomide plus low‐dose dexamethasone

2014; Wiley; Volume: 168; Issue: 6 Linguagem: Inglês

10.1111/bjh.13227

1365-2141

Gareth J. Morgan, Antonio Palumbo, Sujith Dhanasiri, Dawn Lee, Katja Weisel, Thierry Façon, Michel Delforge, Albert Oriol, Mohamed H. Zaki, Xin Yu, Lars Sternås, Christian Jacques, Ron Akehurst, Fritz Offner, Meletios Α. Dimopoulos,

Cancer therapeutics and mechanisms

Summary In the phase III MM ‐003 trial, pomalidomide plus low‐dose dexamethasone ( POM +Lo DEX ) improved overall survival ( OS ) versus high‐dose dexamethasone (Hi DEX ) in 455 patients with relapsed and refractory multiple myeloma ( RRMM ) after treatment with bortezomib and lenalidomide. Here, a two‐stage Weibull method was used to adjust for the crossover of patients in the Hi DEX arm to pomalidomide‐based therapy. The adjusted difference in median OS between patients in the POM +Lo DEX and Hi DEX arms was 7·0 months (12·7 vs. 5·7 months, respectively). These findings provide important evidence for understanding the clinical efficacy of pomalidomide on OS benefits seen in RRMM patients.