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Project 1. Developing MRD-based therapeutic strategy in newly-diagnosed multiple myeloma

项目1.针对新诊断的多发性骨髓瘤制定基于MRD的治疗策略

基本信息

批准号：
10226192
负责人：
herve Avet loiseau
金额：
$ 18.61万
依托单位：
DANA-FARBER CANCER INST
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-12-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10226192
关键词：
Address Affect Albumins Algorithms Autologous Stem Cell Transplantation Bortezomib Categories Cells Cessation of life Clinical Clinical Research Cytogenetics Data Dexamethasone Disease Disease remission Disease-Free Survival Dose Event Funding Genomics Goals Immunomodulators Individual International Lead Maintenance Measures Methods Modeling Modernization Multiple Myeloma Mutation Newly Diagnosed Outcome Patient-Focused Outcomes Patients Pharmaceutical Preparations Prognostic Factor Progression-Free Survivals Proteasome Inhibitor Randomized Residual Neoplasm Residual state Risk Role Staging System Therapeutic Time Transplantation Triplet Multiple Birth United States arm base cancer genomics cohort collaborative trial epigenomics high risk immunological status improved lenalidomide next generation novel randomized trial relapse patients response risk stratification standard of care survival outcome transcriptome trial comparing

项目摘要

Project Summary (Project 1) To improve overall outcome in multiple myeloma (MM), in the current funding period this project achieved two major goals: 1: Defined the role of transplant in the era of novel agents –establishing integration of transplant with novel agents as the standard of care for newly-diagnosed patients 2: Redefined Complete Remission, establishing the feasibility of measuring minimal residual disease (MRD) using sequencing-based method and its significant impact on prolongation of PFS. In this renewal application, we now propose to build upon our highly successful collaborative clinical study to address the next most important question, whether less intense maintenance (1-drug) provides adequate benefit compared to more intense maintenance (2-drug) and whether MRD negative status should be the ultimate goal. We hypothesize that achieving MRD negative status will lead to long- term disease free survival, and that irrespective of how one gets to MRD negative status, the overall outcome will be similar. To achieve these goals, in Specific Aim 1 we will perform a large 1,260 patient study utilizing lenalidomide, ixazomib, and dexamethasone with daratumumab (RID-Dara) as induction and consolidation post high-dose therapy. Those not achieving MRD negative status will receive 2nd HDT. All MRD negative patients will be randomized to lenalidomide versus lenalidomide plus daratumumab maintenance. The study will also evaluate MRD status at various time points and investigate whether early versus late MRD status will affect overall outcome. In specific Aim 2, we will redefine new risk stratification incorporating MRD status and all genomic/epigenomic correlates.

项目摘要（项目一）