NL-OMON52761已完成3 期
A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2) - 20180015
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subject has multiple myeloma with documented relapse or progression after
- •most recent myeloma treatment.
- •Subjects must have at least PR to at least 1 line of prior therapy
- •Subjects must have received at least 1 but not more than 3 prior lines of
- •therapy for multiple myeloma (induction therapy followed by stem cell
- •transplant and consolidation maintenance therapy will be considered as 1 line
- •of therapy).
- •Prior therapy with a PI is allowed if the patient achieved at least a
- •PR to most recent treatment with a PI, did not relapse within 60 days of
- •discontinuation of the PI and the PI was not removed due to toxicity. A
- •history of prior neuropathy is permitted if this was not grade 3, grade 4 or
- •grade 2 with pain and if not resolved within the 14 days before enrollment, is
- •less than or equal to grade 2 without pain.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of < 2
- •Please refer to section 6.1 of the protocol.
排除标准
- •Waldenström macroglobulinemia
- •Multiple myeloma of IgM subtype
- •Active congestive heart failure (New York Heart Association [NYHA] Class III
- •to IV), symptomatic ischemia, uncontrolled arrhythmias, ECG abnormalities,
- •pericardial disease, or myocardial infarction within 4 months prior to
- •Uncontrolled hypertension
- •Please refer to section 6.2 of the protocol.
研究者
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