Haematologica (Jul 2016)

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

  • Katja C. Weisel,
  • Meletios A. Dimopoulos,
  • Philippe Moreau,
  • Martha Q. Lacy,
  • Kevin W. Song,
  • Michel Delforge,
  • Lionel Karlin,
  • Hartmut Goldschmidt,
  • Anne Banos,
  • Albert Oriol,
  • Adrian Alegre,
  • Christine Chen,
  • Michele Cavo,
  • Laurent Garderet,
  • Valentina Ivanova,
  • Joaquin Martinez-Lopez,
  • Stefan Knop,
  • Xin Yu,
  • Kevin Hong,
  • Lars Sternas,
  • Christian Jacques,
  • Mohamed H. Zaki,
  • Jesus San Miguel

DOI
https://doi.org/10.3324/haematol.2015.137083
Journal volume & issue
Vol. 101, no. 7

Abstract

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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