ASH News Daily - Monday, December 12, 2011 - (Page B-43)

fo r Myelodysplastic Syndromes CURRENTLY ENROLLING Phase III Regions/Countries • Australia • Europe • Japan • North America Pa N tie ow nt O Re p e cr n ui tm en t Transfusion-Dependent Anemia CC-5013-MDS-005: A Phase III, Multicenter, Randomized, Double-Blind, PlaceboControlled, Parallel-Group Study to Compare the Efficacy and Safety of Lenalidomide (REVLIMID®) Versus Placebo in Subjects With Transfusion-Dependent Anemia Due to IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes Without Deletion 5Q[31] and Unresponsive or Refractory to Erythropoiesis-Stimulating Agents Primary Objective: Compare the efficacy of lenalidomide versus placebo in red blood cell (RBC) transfusion-dependent, low- or intermediate-1 risk, non-del 5q MDS, that is unresponsive or refractory to erythropoiesisstimulating agents, in the overall population and in a prespecified subgroup of subjects with an erythroid differentiation signature predictive of lenalidomide response (Ebert 2008) N=375 Key Eligibility Criteriaa • Age ≥18 years • IPSS low- or intermediate-1 risk MDS without del 5q abnormality • RBC-transfusion-dependent anemia • Unresponsive to ESA or serum erythropoietin >500 mU/mL Screening (Day -56 to Day 1) Randomization 2:1 Treatment Ab • Lenalidomide 10 mg po once daily c Treatment B • Placebo po once dailyc Evaluate for Erythroid Response on Study Day 169: • Responders continue on blinded treatment • All subjects followed for survival, transformation to AML, and subsequent MDS therapies for at least 4 years End Points • Primary – RBC-transfusion independence in the overall population and in a prespecified subgroup with an erythroid differentiation gene expression signature predictive of lenalidomide response • Secondary – Proportion of subjects achieving RBC-transfusion independence for ≥24 weeks (168 days) – Duration of RBC-transfusion independence – Erythroid response – Time to RBC-transfusion independence – Progression to AML – Overall survival – Safety – Subject-reported outcomes – Healthcare resource utilization Information For more information: www.clinicaltrials.gov (NCT01029262) Study Manager: Anne McClain (amcclain@celgene.com) Additional criteria apply. Reduce the dose in half for those subjects with a CLcr ≥40 mL/min to <60 mL/min. c Best supportive care allowed. Ebert BL et al. PLoS Med. 2008 Feb;5(2):e35. a b Investigational use of lenalidomide (REVLIMID®). ©2011 Celgene Corporation 11/11 US-CELG110031b REVLIMID® is a registered trademark of Celgene Corporation. Cosmos Communications C M Y K 1 js Q1 Q2 

Table of Contents for the Digital Edition of ASH News Daily - Monday, December 12, 2011

ASH News Daily - Monday, December 12, 2011

https://www.nxtbookmedia.com