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CSR Summary
Not Yet Available
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NCT01998971
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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 AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupMonoclonal Antibodies and Antibody Drug ConjugatesChemical SubgroupClusters of Differentiation 38 (CD38) InhibitorsCondition StudiedMultiple Myeloma
Sponsor Protocol Number54767414MMY1001Enrollment242Data PartnerJohnson & Johnson% Female45.0%Mean/Median Age (Years)65.0% White77.0%
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
- 2024-0028 : Thrombotic events in patients with relapsed and refractory multiple myeloma treated with single agent daratumumab or daratumumab-based triplet regimens
- 2023-5502 : Development of a model to simulate the pharmacokinetics of drugs in patients with different characteristics to advance precision medicine
- 2023-5254 : Identifying Prognostic and Predictive Factors for Causal Dose-Response Analysis of Daratumumab in Multiple Myeloma
