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CSR Summary Not Yet Available
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NCT03180736
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Primary Citation
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Trial Information
Generic NameDaratumumabProduct NameDARZALEX®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupMonoclonal Antibodies and Antibody Drug ConjugatesChemical SubgroupClusters of Differentiation 38 (CD38) InhibitorsCondition StudiedMultiple Myeloma
Sponsor Protocol Number54767414MMY3013Enrollment304Data PartnerJohnson & Johnson% Female47%Mean/Median Age (Years)67.5% White89.5%
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
- 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
- 2024-0416 : Predicting Treatment Response to Daratumumab in patients with Relapsed or Refractory multiple myeloma
- 2024-0252 : Covariate-adjusted response-adaptive designs and their properties for censored survival responses
- 2024-0028 : Thrombotic events in patients with relapsed and refractory multiple myeloma treated with single agent daratumumab or daratumumab-based triplet regimens
- 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
- 2022-5048 : Predictors of exposure, therapeutic and adverse effects of medicines used in the treatment of multiple myeloma
- 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