NCT02756728终止1 期
A Randomized Phase I/II Study of BI-505 in Conjunction With High-dose Melphalan and Autologous Stem Cell Transplantation for Multiple Myeloma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Phase I: Determine the safety and feasibility of administering BI-505 in conjunction with HDM+ASCT in multiple myeloma patients
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of administering BI-505 in conjunction with high dose melphalan and stem cell transplantation in multiple myeloma patients.
详细描述
N/A study is closed
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of multiple myeloma by 2014 IMWG criteria and have been recommended to undergo HDM + ASCT as a standard-of-care therapy for their multiple myeloma.
- •Subjects must have adequate vital organ function and functional status for HDM + ASCT
- •Subjects must have collected and cryopreserved ≥4x106 hematopoietic stem cells per kg of actual body weight that are suitable for use in autologous stem cell transplantation in the judgment of the investigator.
- •At the time of enrollment, subjects must have had at least a partial response, as defined by IMWG criteria and in comparison to baseline/pre-treatment parameters, to an induction regimen containing lenalidomide and/or bortezomib.
- •Subjects must have measurable disease according to one of the following criteria:
- •Serum M-spike ≥0.1 g/dl
- •Urine M-spike >200 mg in a 24-hour urine collection
- •Involved serum free light chain above the upper limit of normal and a serum free light chain ratio outside the normal range.
- •At the time of enrollment, subjects must be within 12 months of the first dose of initial/induction therapy, and the anticipated day of ASCT must be within 12 months of the first dose of initial/induction therapy
排除标准
- •Prior allogeneic or autologous hematopoietic stem cell transplant
- •Current active infections, including HIV and hepatitis C and B
- •Autoimmune disease requiring ongoing immunosuppressive therapy.
- •History of atrial fibrillation or flutter, including paroxysmal atrial fibrillation or flutter.
- •History of transient ischemic attack or stroke.
- •At the time of enrollment, subjects must not have required multi-agent continuous-infusion cytotoxic chemotherapy (e.g., regimens such as D-PACE) as part of their initial/induction therapy.
研究组 & 干预措施
HDM+ASCT
Active Comparator
Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation
干预措施: High dose melphalan (Other)
HDM+ASCT
Active Comparator
Standard of care; High dose Melphalan + Autologous Stem Cell Transplantation
干预措施: Autologous stem cell transplantation (Other)
BI-505
Experimental
Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation
干预措施: High dose melphalan (Other)
BI-505
Experimental
Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation
干预措施: Autologous stem cell transplantation (Other)
BI-505
Experimental
Biweekly infusions of BI-505 in addition to High dose Melphalan + Autologous Stem Cell Transplantation
干预措施: BI-505 (Biological)
结局指标
主要结局
Phase I: Determine the safety and feasibility of administering BI-505 in conjunction with HDM+ASCT in multiple myeloma patients
时间窗: Adverse events will be assessed within 30 days of ASCT in the safety part of the study.
UNK
Phase II: Determine the effect of BI-505 on rate of stringent complete response for multiple myeloma patients with measurable disease pre-ASCT.
时间窗: At Day 100 after ASCT
UNK
次要结局
- Determine the effect of BI-505 on rate of stringent complete response (sCR) at day 100 in subgroups stratified according to response to initial therapy (+/- VGPR).(Day 100 after ASCT)
- Determine the effect of BI-505 administered in conjunction with HDM + ASCT on IMWG response category (PR, VGPR, CR, sCR) at one year post-ASCT and progression-free survival.(At one year and up to three years after ASCT)
- Evaluate the effect of BI-505 on MRD-negative rate at day 100 and change in MRD status at day 100 compared to baseline.(Day 100)
- Evaluate anti-myeloma effect of BI-505 monotherapy, prior to HDM + ASCT(Prior to HDM + ASCT (from Day -17 until Day 0))
- Evaluate bone marrow immune cell composition and phenotype, including macrophage infiltration and expression of intracellular adhesion molecule (ICAM)-1 expression on multiple myeloma plasma cells, as potential biomarkers of response to BI-505(Day 100 compared to Baseline (Day -17 and Day -2))
- Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Cmax(All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123)
- Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Tmax(All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123)
- Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing AUC(All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123)
- Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing CL(All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123)
- Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing Vss(All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123)
- Evaluate the pharmacokinetic profile of BI-505 in this clinical setting by analysing t1/2(All dosing visits throughout the study (up to 9 biweekly infusions of BI-505). Day -17, day -3, day 11, day 25, day 39, day 53, day 67, day 81, day 95, day 123)
研究者
研究点 (1)
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