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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：
10555731
负责人：
herve Avet loiseau
金额：
$ 17.93万
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 2028-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10555731
关键词：
17p Address Antibodies Biochemical Bortezomib Categories Chemicals Clinical Clinical Research Clonality Combined Modality Therapy Cox Models Data Dexamethasone Diagnosis Disease remission Dose France Frequencies Funding Genomics Goals Immune Immunotherapy Maintenance Maintenance Therapy Measures Melphalan Modeling Modernization Multiple Myeloma Mutation Neoadjuvant Therapy Newly Diagnosed Outcome Patient-Focused Outcomes Patients Prognosis Prognostic Factor Prognostic Marker Progression-Free Survivals Proteasome Inhibitor Quadruplet Multiple Birth Randomized Residual Neoplasm Residual state Risk Role Therapeutic Transplantation Tumor Burden Untranslated RNA Vertebral column arm cancer genomics cohort conventional dosing epigenomics follow-up immune modulating agents improved improved outcome inhibitor therapy lenalidomide new therapeutic target novel relapse patients response risk stratification standard of care transcriptome treatment arm

项目摘要

Project Summary – Project 1 CHU-Toulouse / DFCI To improve overall outcome in multiple myeloma (MM), period this project in the current funding achieved three major goals: 1: Defined the role of transplant in the era of novel agents with long term maintenance; 2: Established the feasibility of measuring minimal residual disease (MRD) at 10-6 sensitivity, and demonstrated its significant impact on prolongation of PFS irrespective of the type of treatment used; and 3) Demonstrated that quadruplet therapies achieve high frequency of MRD negative response. In this renewal application, we now propose to build upon our highly successful collaborative clinical study to address the next most important question, whether high-dose therapy (HDT) can still provide benefit in patients achieving MRD negative status. We hypothesize that quadruplet therapy followed by ASCT will achieve deeper MRD negative status (10-6), and that sustained MRD negativity will be of therapeutic importance. Our proposed study will: 1) define the role of ASCT in MM in the context of quadruplet induction therapy; determine whether ASCT further decreases tumor burden, increases MRD negativity rates (NGS, 10-6), and improves patient outcome; and define whether achieving early, late, and sustained MRD negativity impacts clinical outcome (Sp Aim 1). We will conduct a large (n=716) study using induction therapy with isatuximab, carfilzomib, lenalidomide and dexamethasone (IsaKRD) and then randomize those patients who are MRD negative to either further IsaKRD versus HDT. In Specific Aim 2, we will redefine new risk stratification incorporating MRD status and modern biochemical, genomic, epigenomic, and immune and microenvironmental correlates. Our proposed study will determine the impact of MRD informing prognosis and therapy. .

项目总结-项目1 CHU-Toulouse / DFCI