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CSR Summary CSR(s) for this product are publicly available on Health Canada's website - https://clinical-information.canada.ca/search/ci-rc
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NCT01615029
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Primary Citation
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Trial Information
Generic NameDaratumumabProduct NameDARZALEX®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupOther Antineoplastic AgentsChemical SubgroupAntineoplastic Cell and Gene TherapyCondition StudiedMultiple Myeloma
Sponsor Protocol Number54767414GEN503Enrollment45Data PartnerJohnson & Johnson% Female28.9%Mean/Median Age (Years)60.4% WhiteN/A
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
- 2024-0636 : Adaptive Trial for Rare Diseases
- 2024-0416 : Predicting Treatment Response to Daratumumab in patients with Relapsed or Refractory multiple myeloma
- 2024-0100 : Estimate MTD in Phase 1 Clinical Trials through Distributionally Robust Optimization and Machine Learning
- 2024-0028 : Thrombotic events in patients with relapsed and refractory multiple myeloma treated with single agent daratumumab or daratumumab-based triplet regimens
- 2023-5254 : Identifying Prognostic and Predictive Factors for Causal Dose-Response Analysis of Daratumumab in Multiple Myeloma
- 2021-4599 : Outcomes with Early versus Late Response to Daratumumab in Patients with Refractory/Relapsed or Newly Diagnosed Multiple Myeloma
- 2018-3321 : Evaluation of longitudinal serum M protein (or free light chain) to predict survival in patients with relapsed/refractory multiple myeloma