- CSR Summary CSR(s) for this product are publicly available on Health Canada’s website - https://clinical-information.canada.ca/search/ci-rc
- NCT00574288
- Primary Citation
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Trial Information
Generic NameDaratumumabProduct NameDARZALEX®Therapeutic AreaCancers and Other NeoplasmsEnrollment106% Female31.7%% WhiteN/A
Product ClassMonoclonal AntibodySponsor Protocol Number54767414GEN501Data PartnerJohnson & JohnsonCondition StudiedMultiple MyelomaMean/Median Age (Years)61.4
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
- 2023-5254 : Identifying Prognostic and Predictive Factors for Causal Dose-Response Analysis of Daratumumab in Multiple Myeloma
- 2022-5048 : Predictors of exposure, therapeutic and adverse effects of medicines used in the treatment of multiple myeloma
- 2021-4599 : Outcomes with Early versus Late Response to Daratumumab in Patients with Refractory/Relapsed or Newly Diagnosed Multiple Myeloma
- 2018-3321 : Evaluation of longitudinal serum M protein (or free light chain) to predict survival in patients with relapsed/refractory multiple myeloma