A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Compare The Efficacy And Safety of Lenalidomide (Revlimid®) Versus Placebo In Subjects With Transufsion-Dependent Anemia Due to IPSS Low Or Imtermidate-1 Risk Myelodysplastic Syndromes Without Deletion 5Q(31) And Unresponsive Or Refractory To Erthropoiesis-Stimulating Agents

Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Compare The Efficacy And Safety of Lenalidomide (Revlimid®) Versus Placebo In Subjects With Transufsion-Dependent Anemia Due to IPSS Low Or Imtermidate-1 Risk Myelodysplastic Syndromes Without Deletion 5Q(31) And Unresponsive Or Refractory To Erthropoiesis-Stimulating Agents

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Jul 2017

At a glance

  • Drugs Lenalidomide (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms MDS-005
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 06 Dec 2016 Results (n=198) assessing relationship between somatic gene mutations and overall survival, presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 06 Dec 2016 Post hoc analysis results (n=160) presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 27 Jun 2016 Primary endpoint of percentage of participants who achieved red blood cell (RBC) transfusion independence for greater than or equal to 56 days has been met, according to results published in the Journal of Clinical Oncology.
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