A Phase 2 Biomarker Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) Monotherapy to Assess the Association Between NK Cell Status and Efficacy in High Risk Smoldering Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 22
- 主要终点
- Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow
研究概览
简要总结
The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the health of the body's immune system)
详细描述
Intervention model: Dosing is sequential
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Participants with a confirmed diagnosis, according to criteria of the International Myeloma Working Group, of smoldering multiple myeloma, considered high risk according to the following:
- •Serum monoclonal (M) protein ≥3 gm/dL and bone marrow plasma cells (BMPC) ≥10% or
- •Serum M protein 1-3 g/dL and BMPC ≥10% and abnormal free light chain ratio of <0.125 or >8.0
- •Urine M protein >200 mg/24 hours, ≥10% BMPC, and serum free light chain ratio ≤0.125 or ≥8.0
排除标准
- •Active multiple myeloma
- •Monoclonal gammopathy of undetermined significance
- •Active plasma cell leukemia
- •Positive for hepatitis B or C virus or HIV infection
研究组 & 干预措施
Elotuzumab, 20 mg/kg
Intravenous solution administered in 28-day cycles. Cycle 1: Days 1 and 8. Cycle 2 and beyond: Day 1 only.
干预措施: Elotuzumab (BMS-901608; HuLuc63) (Biological)
Elotuzumab, 10 mg/kg
Intravenous solution administered in 28-day cycles. Cycle 1 and 2: Days 1, 8, 15, and 22. Cycle 3 and beyond: Days 1 and 15.
干预措施: Elotuzumab (BMS-901608; HuLuc63) (Biological)
结局指标
主要结局
Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow
时间窗: From day of last patient, first dose to 6 months
Estimated using linear regression model, with baseline CD56\^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56\^dim cells (% chg from BL in M pro/% chg CD56\^dim cs)
次要结局
- Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality(From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months)
- Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate(cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months)
- Progression Free Survival (PFS) Rate(Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months))
- Objective Response Rate (ORR)(From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months))
- Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions(From day of last patient, first dose to 6 months)