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CSR Summary
Not Yet Available
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NCT02136134
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Primary Citation
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Trial Information
Generic NameDaratumumabProduct NameDARZALEX®Therapeutic AreaCancers and Other NeoplasmsEnrollment498% Female43%% WhiteN/A
Product ClassMonoclonal AntibodySponsor Protocol Number54767414MMY3004Data PartnerJohnson & JohnsonCondition StudiedMultiple MyelomaMean/Median Age (Years)63.3
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
- 2023-5162 : Is minimal residual disease a valid surrogate endpoint for survival in 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
- 2021-4660 : Associations between response, progression, and overall survival in phase III daratumumab clinical trials in relapsed/refractory multiple myeloma
- 2021-4640 : An individual patient data meta-analysis of daratumumab in the treatment of different cytogenetic subsets of multiple myeloma
- 2021-4599 : Outcomes with Early versus Late Response to Daratumumab in Patients with Refractory/Relapsed or Newly Diagnosed Multiple Myeloma
- 2020-4299 : Impact of Daratumumab on the Risk of Venous Thromboembolism in Patients with Multiple Myeloma: A Post-hoc Analysis of Phase III trials
- 2019-3936 : Unbiased Treatment Efficacy Detection Methods with Patient Centered Outcomes
- 2018-3321 : Evaluation of longitudinal serum M protein (or free light chain) to predict survival in patients with relapsed/refractory multiple myeloma