EUCTR2017-004232-11-ES进行中（未招募）1 期
A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male of female, at least 18 years old
- •R/R MM with documented evidence of progression during or after the subject's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria
- •Measurable disease, defined by at least 1 of the following disease activity criteria:
- •- serum M-protein = 1.0 g/dL (= 10 g/L) for immunoglobulin (Ig)G MM
- •- serum M-protein = 0.5 g/dL (= 5 g/L) for IgA, IgD, IgE, and IgM MM
- •- urine M-protein = 200 mg/24 hours
- •- serum-free light chain (FLC) = 10 mg/dL provided serum FLC ratio is abnormal
- •Has received at least 1 prior line of therapy
- •Must meet all of the following prior antimyeloma treatment parameters:
- •- subject must have received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen
- •- subject must be refractory to lenalidomide
- •- subject must have been exposed to a proteasome inhibitor alone or in combination with another agent
- •- subject must have had a response of PR or better to prior therapy based on the investigator's determination of response as defined by IMWG criteria
- •Has t(11;14) status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per central laboratory testing of a bone marrow aspirate sample and meets the following criteria:
- •- For Part 1: MM subjects independent of cytogenetic profile
- •- For Part 2, Arm A: subject must be t(11;14) positive
- •- For Part 2, Arm B: subject must be t(11;14) negative
- •(ECOG) performance status = 2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide
- •known sensitivity to any IMiDs
- •allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease
- •autologous stem cell transplant within 12 weeks before the first dose of study drug
- •known meningeal involvement of MM
研究者
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