An Open label, International, Multicenter, Dose Escalating Phase 1/2 Trial Investigating the Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma

Trial Profile

An Open label, International, Multicenter, Dose Escalating Phase 1/2 Trial Investigating the Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Jun 2017

At a glance

  • Drugs Daratumumab (Primary) ; Dexamethasone; Lenalidomide
  • Indications Multiple myeloma
  • Focus Therapeutic Use
  • Sponsors Genmab; Janssen Research & Development
  • Most Recent Events

    • 28 Apr 2017 According to a Genmab media release, based on the data from CASTOR, POLLUX, MMY1001 and GEN503 studies, the European Commission has granted a marketing authorization for DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. This approval also converts the previous conditional marketing authorization for DARZALEX to a full approval.
    • 02 Mar 2017 Planned End Date changed from 1 Jun 2020 to 1 Dec 2020.
    • 30 Jan 2017 Planned End Date changed from 1 Aug 2017 to 1 Jun 2020.
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