A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide (CC-5013) in Combination With Low-dose Dexamethasone in Japanese Patients With Previously Untreated Multiple Myeloma

Trial Profile

A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide (CC-5013) in Combination With Low-dose Dexamethasone in Japanese Patients With Previously Untreated Multiple Myeloma

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 01 May 2016

At a glance

  • Drugs Lenalidomide (Primary) ; Dexamethasone
  • Indications Multiple myeloma
  • Focus Therapeutic Use
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 21 Dec 2015 Results published in the Celgene International SARL media release.
    • 21 Dec 2015 According to a Celgene International SARL media release, the Japan's Ministry of Health, Labour and Welfare (MHLW) has granted full marketing authorization to lenalidomide (Revlimid) in combination with dexamethasone for treatment of newly diagnosed multiple myeloma patients. The approval was based on results from this and the global phase III FIRST trial (CTP 700033737).
    • 28 Jan 2015 Planned End Date changed from 1 Dec 2014 to 1 Jun 2018 as reported by ClinicalTrials.gov.
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