(Core 5) Studies from the previous grant period confirmed that achieving MRD negative (sensitivity of 1 cell in 10-6) status provides significantly superior progression free and overall survival outcome. In this proposal, we will address the question of how MRD status will inform the therapeutic approach in a randomized phase III study comparing two maintenance schedules for MRD negative patients. To support this effort, the Bioinformatics and Biostatistics Core E will provide 1) support and direction on the formatting, quality control and annotation procedures of clinical and research data as well as the process of transferring the research data a data warehouse for integrative analysis, 2) bioinformatics support for primary and integrative analysis of the high- throughput data and 3) biostatistics support in terms of design and analysis for all projects. Core members will work closely with project members as well as Cores 1 and 2 with regard to quality control, specimen tracking and data transfer procedures as well as Cores 3 and 4 which will perform microarray based gene and miRNA expression profiling, and SNP genotyping and next generation sequencing for identifying genomic and transcriptomic changes. Bioinformatics and biostatistics support and analysis is not only required for individual projects, but it is crucial for the integrative analysis from data across the projects and thus overall success of the program.
(Core 5) This core will help analyze both clinical data to determine the role of MRD status in informing therapeutic approaches. A randomized study phase III study comparing two maintenance schedules for MRD negative patients (N=780) will provide a large resource of patients. In addition, there will be samples on patients who continue to be MRD positive after a second transplant. The bioinformatic support will unravel genomic changes to better understand disease biology, features predictive of progression to myeloma and define those changes that will predict outcome and will form the basis for development of novel therapeutics.
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