A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, 3-ARM STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF LENALIDOMIDE VERSUS PLACEBO IN RED BLOOD CELL (RBC) TRANSFUSION-DEPENDENT SUBJECTS WITH LOW- OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES (MDS) ASSOCIATED WITH A DELETION (DEL) 5Q[31] CYTOGENETIC ABNORMALITY.

Trial Profile

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, 3-ARM STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF LENALIDOMIDE VERSUS PLACEBO IN RED BLOOD CELL (RBC) TRANSFUSION-DEPENDENT SUBJECTS WITH LOW- OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES (MDS) ASSOCIATED WITH A DELETION (DEL) 5Q[31] CYTOGENETIC ABNORMALITY.

Completed
Phase of Trial: Phase III

Latest Information Update: 06 May 2016

At a glance

  • Drugs Lenalidomide (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Adverse reactions; Pharmacogenomic; Registrational; Therapeutic Use
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 08 Dec 2015 Pooled analysis of 2 trials (n=286) including this study and another study [see CTP 70029048] were presented at the 57th Annual Meeting and Exposition of the American Society of Hematology.
    • 08 Dec 2015 Results of pooled analysis on conditional survival analysis (n=286), presented at the 57th Annual Meeting and Exposition of the American Society of Hematology.
    • 10 Dec 2013 Post-hoc subgroup analysis presented at the 56th Annual Meeting and Exposition of the American Society of Hematology.
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