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A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Trial Profile

A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2019

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At a glance

  • Drugs Ixazomib (Primary) ; Cyclophosphamide; Dexamethasone; Lenalidomide; Melphalan; Thalidomide
  • Indications Amyloid light-chain amyloidosis
  • Focus Registrational; Therapeutic Use
  • Acronyms TOURMALINE-AL1
  • Sponsors Takeda Oncology
  • Most Recent Events

    • 14 Jun 2019 Planned End Date changed from 31 Aug 2022 to 30 Jun 2022.
    • 14 Jun 2019 Planned primary completion date changed from 31 Aug 2022 to 30 Jun 2022.
    • 05 Jun 2019 According to a Takeda media release, An Independent Data Monitoring Committee (IDMC) did not raise any concerns about the safety profile of NINLARO.
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