- CSR Summary CSR(s) for this product are publicly available on Health Canada’s website - https://clinical-information.canada.ca/search/ci-rc
- NCT01985126
- Primary Citation
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Trial Information
Generic NameDaratumumabProduct NameDARZALEX®Therapeutic AreaCancers and Other NeoplasmsEnrollment124% Female51%% White79%
Product ClassMonoclonal AntibodySponsor Protocol Number54767414MMY2002Data PartnerJohnson & JohnsonCondition StudiedMultiple MyelomaMean/Median Age (Years)63.5
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
- 2024-0416 : Predicting Treatment Response to Daratumumab in patients with Relapsed or Refractory multiple myeloma
- 2022-5048 : Predictors of exposure, therapeutic and adverse effects of medicines used in the treatment of multiple myeloma
- 2022-4974 : Association between adverse events and change in quality-of-life scores in phase II-III cancer clinical trials
- 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