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NCT01985126 - An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or Are Double

An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or Are Double Refractory to a Proteasome Inhibitor and an IMiD


CSR Summary

Not Yet Available


Data Specification

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Annotated CRF

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Product Info

Generic Name
Daratumumab
Product Name
DARZALEX®
Therapeutic Area
Cancers and Other Neoplasms
Enrollment
124
% Female
51.0%
% White
79.0%
Product Class
Monoclonal Antibody
Sponsor Protocol Number
54767414MMY2002
Data Holder
Johnson & Johnson
Condition Studied
Multiple Myeloma
Mean/Median Age (Years)
63.5

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
2

Disclaimer

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