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A Phase 1b, Open Label, Multicenter, Dose Escalation Study of Venetoclax and ABBV-838 Combination Therapy With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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Trial Profile

A Phase 1b, Open Label, Multicenter, Dose Escalation Study of Venetoclax and ABBV-838 Combination Therapy With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Status: Suspended
Phase of Trial: Phase I

Latest Information Update: 27 Mar 2019

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At a glance

  • Drugs Azintuxizumab-vedotin (Primary) ; Dexamethasone (Primary) ; Dexamethasone (Primary) ; Venetoclax (Primary)
  • Indications Multiple myeloma
  • Focus Adverse reactions
  • Sponsors AbbVie

    • Most Recent Events

    • 19 Mar 2019 According to an AbbVie media release, the company announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all clinical trials evaluating venetoclax for the investigational treatment of multiple myeloma. The partial clinical hold follows a review of data from BELLINI study.As a result of this action, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed.
    • 19 Mar 2019 Status changed from withdrawn prior to enrolment to suspended according to an AbbVie media release.
    • 01 Jun 2017 Planned End Date changed from 1 Jan 2021 to 28 Apr 2021.

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