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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

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

    • 01 Sep 2022 Data from 3 studies (DS-003, MDS-004, and MDS-005) assessing impact of lenalidomide treatment on overall survival in patients with lower-risk myelodysplastic syndromes, published in the Clinical Lymphoma, Myeloma & Leukemia.
    • 23 Jul 2018 Status changed from active, no longer recruiting to completed.
    • 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
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