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CSR Summary
Not Yet Available
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NCT02252172
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Primary Citation
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Trial Information
Generic NameDaratumumabProduct NameDARZALEX®Therapeutic AreaCancers and Other NeoplasmsEnrollment737% Female47.9%% White91.6%
Product ClassMonoclonal AntibodySponsor Protocol Number54767414MMY3008Data PartnerJohnson & JohnsonCondition StudiedMultiple MyelomaMean/Median Age (Years)73
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
- 2024-0468 : Longitudinal Adverse Event Analysis using ToxT in The MAIA Study
- 2024-0252 : Covariate-adjusted response-adaptive designs and their properties for censored survival responses
- 2023-5316 : Prospective Assessment of ISS-R2 as a Prognostic Indicator in Patients with Newly Diagnosed Multiple Myeloma in the Anti-CD38 Era
- 2023-5197 : Allostatic Load, Treatment Outcomes, and Mortality in Transplant-Ineligible Patients with Multiple Myeloma
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 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
- 2022-4869 : Using Electronic Health Records to derive a Synthetic Control Arm for a historical trial on Relapsed/Refractory Multiple Myeloma
- 2021-4770 : Indirect comparison of daratumumab-based regimen versus bortezomib, lenalidomide, and dexamethasone for newly diagnosed, transplant ineligible MM
- 2021-4663 : Thromboembolism Prophylaxis and the Incidence of Venous Thromboembolism in Newly Diagnosed Multiple Myeloma Patients Enrolled on the MAIA trial
- 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
- 2021-4638 : Impact of frailty on outcomes of patients treated with Daratumumab, Lenalidomide and Dexamethasone for newly diagnosed 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