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NCT02076009 - Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma


CSR Summary

Not Yet Available


Data Specification

Not Available


Annotated CRF

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Product Info

Generic Name
Daratumumab
Product Name
DARZALEX®
Therapeutic Area
Cancers and Other Neoplasms
Enrollment
570
% Female
40.8%
% White
68.0%
Product Class
Monoclonal Antibody
Sponsor Protocol Number
54767414MMY3003
Data Holder
Johnson & Johnson
Condition Studied
Multiple Myeloma
Mean/Median Age (Years)
64.4

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.