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 AreaCancers and Other NeoplasmsEnrollment522% Female45.4%% White78.2%
Product ClassMonoclonal AntibodySponsor Protocol Number54767414MMY3012Data PartnerJohnson & JohnsonCondition StudiedMultiple MyelomaMean/Median Age (Years)66.1

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


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.