Study Phase 3

Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) 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 Number54767414MMY3004Enrollment498Data PartnerJohnson & Johnson% Female43%Mean/Median Age (Years)63.3% 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

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.