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Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma

2016; Ferrata Storti Foundation; Volume: 101; Issue: 7 Linguagem: Inglês

10.3324/haematol.2015.137083

1592-8721

K. Weisel, Meletios Α. Dimopoulos, Philippe Moreau, Martha Q. Lacy, Kevin Song, M. Delforge, Lionel Karlin, Hartmut Goldschmidt, A. Baños, Albert Oriol, Adrián Alegre, C. Chen, Michèle Cavo, Laurent Garderet, V. L. Ivanova, Joaquín Martínez‐López, Stefan Knop, Xiaoyan Yu, Kevin Hong, Lars Sternås, Christian Jacques, Mohamed H. Zaki, Jesús F. San Miguel,

Protein Degradation and Inhibitors

Pomalidomide + low-dose dexamethasone is effective and well tolerated for refractory or relapsed and refractory multiple myeloma after bortezomib and lenalidomide failure. The phase III trial MM-003 compared pomalidomide + low-dose dexamethasone with high-dose dexamethasone. This subanalysis grouped patients by baseline creatinine clearance ≥ 30 − < 60 mL/min (n=93, pomalidomide + low-dose dexamethasone; n=56, high-dose dexamethasone) or ≥ 60 mL/min (n=205, pomalidomide + low-dose dexamethasone; n=93, high-dose dexamethasone). Median progression-free survival was similar for both subgroups and favored pomalidomide + low-dose dexamethasone versus high-dose dexamethasone: 4.0 versus 1.9 months in the group with baseline creatinine clearance ≥ 30 − < 60 mL/min (P