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Daratumumab (HuMax-CD38) Safety Study in Multiple Myeloma - Open Label, Dose-escalation Followed by Open Label, Single-arm Study

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Trial Profile

Daratumumab (HuMax-CD38) Safety Study in Multiple Myeloma - Open Label, Dose-escalation Followed by Open Label, Single-arm Study

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Daratumumab (Primary) ; Dexamethasone; Methylprednisolone; Methylprednisolone
  • Indications Multiple myeloma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Genmab; Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 20 Feb 2020 PK analysis results of splitting the first daratumumab IV dose into two separate infusions published in the Advances in Therapy
    • 04 Dec 2018 Results reporting on ten patients that are still responding to DARA therapy, several years after their inclusion in the GEN501 and GEN503 trials presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
    • 17 Jun 2018 Results assessing the effect of Daratumumab on normal plasma cells, polyclonal immunoglobulins and vaccination responses in extensively pretreated myeloma patients using healthy controls baseline CD38 expression levels data, presented at the 23rd Congress of the European Haematology Association.

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