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CSR Summary Not Yet Available
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NCT03277105
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Primary Citation Trial has yet to be published
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Trial Information
Generic NameDaratumumabProduct NameDARZALEX®Therapeutic AreaAntineoplastic and Immunomodulating AgentsEnrollment522% Female45.4%% White78.2%
Product ClassAntineoplastic AgentsSponsor 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
- 2025-0008 : Characterization of the trajectory of infections among patients with Multiple Myeloma treated with daratumumab
- 2024-0828 : Prognostic Impacts of Clinical and Molecular Characteristics of Patients with Hematologic Malignancy and Potential Mechanisms
- 2024-0636 : Adaptive Trial for Rare Diseases
- 2024-0252 : Covariate-adjusted response-adaptive designs and their properties for censored survival responses
- 2023-5254 : Identifying Prognostic and Predictive Factors for Causal Dose-Response Analysis of Daratumumab in Multiple Myeloma
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 2022-5048 : Predictors of exposure, therapeutic and adverse effects of medicines used in the treatment of multiple myeloma