Individualized Treatment for Relapsed/Refractory Multiple Myeloma Based on High Throughput Drug Sensitivity and Genomics Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Actionable assay result
研究概览
简要总结
This pilot clinical trial studies whether using high throughput drug sensitivity and genomics data is feasible in developing individualized treatment in patients with multiple myeloma or plasma cell leukemia that has come back or does not respond to treatment. High throughput screen tests many different drugs that kill multiple myeloma cells in individual chambers at the same time. Matching a drug or drug combination to a patient using high throughput screen and genetic information may improve the ability to help patients by choosing drugs that work well for their disease.
详细描述
OUTLINE:
Patients undergo collection of bone marrow aspirate and blood for high-throughput drug sensitivity assay and mutational analysis using next generation sequencing. Patients and their treating physicians receive the results of the tests. Treatment decisions are then made by the patients and their treating physicians.
After completion of study, patients are followed up every 3 months for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple myeloma or plasma cell leukemia with documented relapsed or refractory disease according to International Myeloma Working Group (IMWG) criteria, in any one of the following categories:
- •3 prior lines of therapy including an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI)
- •Less than a very good partial response (VGPR) to initial therapy
- •Early relapse (< 12 months) after autologous hematopoietic cell transplant (HCT) or after 1st line of therapy
- •Collection of a bone marrow, fluid or tissue sample that is expected to have enough cells to run the assay
- •Measurable disease defined by one of the following:
- •Serum monoclonal protein >= 0.5 g/dL by serum protein electrophoresis (SPEP)
- •>= 200 mg/monoclonal protein in urine on 24 hr urine protein electrophoresis (UPEP)
- •Involved serum free light chain (FLC) >= 10 mg/dL and abnormal involved:uninvolved ratio
- •Plasma cytomas that are palpable per exam or measurable per standard radiologic review
- •Circulating plasma cells >= 2,000 if diagnosis of plasma cell leukemia
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
- •Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control
- •Ability to understand purpose and risks of the study and provide signed and dated informed consent, and authorization to use protected health information
- •Expected survival is > 100 days
- •Adequate organ function as determined by the investigator
排除标准
- •Mucosal or internal bleeding, or platelet transfusion refractory
- •Any medical conditions that would impose excessive risk to the patient, or would adversely affect his/her participation in the study
- •Known active infection requiring antibiotics within 7 days of initiation of study treatment, unless considered controlled in the opinion of the investigator
- •Other malignancy with life expectancy < 1 year due to the other malignancy
- •Pregnant or breast feeding women
- •Serious psychiatric illness, alcoholism, or drug addiction
- •Human immunodeficiency virus (HIV), or active hepatitis B or C infection
- •Previous treatments for multiple myeloma (MM) within 2 weeks of initiation of study treatment
- •Prior autologous or allogeneic stem cell transplantation (SCT) within 12 weeks of initiation of study treatment
- •Prior allogeneic hematopoietic cell transplantation (HCT) with active graft versus host disease (GVHD) on therapeutic dosing of immunosuppression or prednisone > 20 mg daily equivalent
- •Prior major surgical procedure or radiation treatment within 2 weeks of initiation of study treatment (not including limited radiation used for palliation of bone pain)
研究组 & 干预措施
Device feasibility (high-throughput assay, sequencing)
Patients undergo collection of bone marrow aspirate and blood for high-throughput drug sensitivity assay and mutational analysis using next generation sequencing. Patients and their treating physicians receive the results of the tests. Treatment decisions are then made by the patients and their treating physicians.
干预措施: High Throughput Screening (Device)
Device feasibility (high-throughput assay, sequencing)
Patients undergo collection of bone marrow aspirate and blood for high-throughput drug sensitivity assay and mutational analysis using next generation sequencing. Patients and their treating physicians receive the results of the tests. Treatment decisions are then made by the patients and their treating physicians.
干预措施: Laboratory Biomarker Analysis (Other)
Device feasibility (high-throughput assay, sequencing)
Patients undergo collection of bone marrow aspirate and blood for high-throughput drug sensitivity assay and mutational analysis using next generation sequencing. Patients and their treating physicians receive the results of the tests. Treatment decisions are then made by the patients and their treating physicians.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Actionable assay result
时间窗: Up to 21 days
The feasibility of this approach will be assessed in terms of obtaining an actionable response from the proposed assay in at least 50% of patients examined.
次要结局
- Overall response rate to the therapy chosen after performing the assay(Up to 2 years)
研究者
Danai Dima
Assistant Professor
University of Washington