Study Phase 3

A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma

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 Number54767414MMY3012Enrollment522Data PartnerJohnson & Johnson% Female45.4%Mean/Median Age (Years)66.1% White78.2%

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

Disclaimer

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