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

Trial Profile

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

Completed
Phase of Trial: Phase I/II

Latest Information Update: 04 Dec 2018

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

    • 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
    • 31 Aug 2018 Biomarkers information updated
    • 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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