Abstract 4561: The MMRF CoMMpassSM Study: A prospective, longitudinal, multicenter observational study in newly diagnosed multiple myeloma patients to assess the relationship between patient outcomes, treatment regimens and molecular profiles

Abstract

Abstract The Multiple Myeloma Research Foundation (MMRF) CoMMpass®; trial opened in July 2011 and will follow 1000 patients with newly diagnosed multiple myeloma (ND-MM) [http://clinicaltrials.gov/ct2/show/NCT01454297]. The goal of this study is to understand the molecular and genetic changes underpinning the evolution of myeloma in individuals and to facilitate future clinical trials based on those results. Comprehensive clinical annotation will accompany individual molecular profiles at baseline, treatment response and disease recurrence over the course of 5-8 years. The study will yield an extensive molecular and clinical database providing information on the longitudinal aspect of multiple myeloma disease progression in individual patients. Eligible patients include those with symptomatic ND-MM who have not received prior therapy. Initial treatments permitted in the study include those containing either a proteasome inhibitor, an IMiD or both. Centralized bone marrow aspirate and peripheral blood specimen processing building upon the experience of the Multiple Myeloma Research Consortium (MMRC) Tissue Bank is being conducted to support profiling of the patient samples. Here we describe the workflow for biospecimens and characterization including the analysis of bone marrow aspirates by multiplex flow cytometry to identify patient-specific immunophenotypic markers and sequencing of BRAF V600 mutations. CD138-enriched tumor cells derived from the aspirates will enable a breadth of sequencing analysis comprising whole genome and whole exome sequencing, as well as, transcriptome analysis via RNA Seq. Chromosomal alterations and ploidy will be assessed by cytogenetic and FISH analysis. Altogether, these efforts will provide an unprecedented myeloma dataset on copy number variation, mutation and levels of gene expression. Samples collected at suspected complete response will be evaluated by quantitative flow cytometry using multiple markers to follow immunophenotypic changes and to monitor minimal residual disease. The MMRF CoMMpass® study aims to comprehensively catalog genetic alterations in patients treated with standard-of-care 1st line agents and at milestones of relapse. The knowledge obtained in CoMMpass® will provide key insights into mechanisms of disease and drug response in myeloma, reveal targets and biomarkers for drug development, provide insights into refined classification of subtypes of myeloma and be used as a foundation to build personalized medical care initiatives for myeloma patients. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 4561. doi:1538-7445.AM2012-4561