- CSR Summary Not yet available
- NCT03180736
- Primary Citation
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Trial Information
Generic NameDaratumumabProduct NameDARZALEX®Therapeutic AreaCancers and Other NeoplasmsEnrollment304% Female47%% White89.5%
Product ClassMonoclonal AntibodySponsor Protocol Number54767414MMY3013Data PartnerJohnson & JohnsonCondition StudiedMultiple MyelomaMean/Median Age (Years)67.5
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
- 2024-0252 : Covariate-adjusted response-adaptive designs and their properties for censored survival responses
- 2023-5162 : Is minimal residual disease a valid surrogate endpoint for survival in multiple myeloma?
- 2022-5108 : Personalized prediction of PFS in myeloma patients treated with DaraPomDex or Pom-Dex alone, using combined machine learning and mechanistic modeling
- 2021-4660 : Associations between response, progression, and overall survival in phase III daratumumab clinical trials in relapsed/refractory multiple myeloma
- 2018-3321 : Evaluation of longitudinal serum M protein (or free light chain) to predict survival in patients with relapsed/refractory multiple myeloma