Study Phase 2

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

Trial Information

Generic NameDaratumumabProduct NameDARZALEX®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupMonoclonal Antibodies and Antibody Drug ConjugatesChemical SubgroupClusters of Differentiation 38 (CD38) InhibitorsCondition StudiedMultiple Myeloma
Sponsor Protocol Number54767414GEN501Enrollment106Data PartnerJohnson & Johnson% Female31.7%Mean/Median Age (Years)61.4% WhiteN/A

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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