NL-OMON53932已完成2 期
Alternative dosing scheme of pomalidomide 4 mg every other day versus pomalidomide 2 mg and 4 mg every day: reduction in costs, same efficacy? A PKPD bioequivalence pilot study - the POMAlternative study - POMAlternative
Amsterdam UMC0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- •Patients with relapsed/refractory multiple myeloma, who are eligible for a
- •treatment regimen which contains pomalidomide. Either monotherapy or in
- •combination with bortezomib, daratumumab, cyclophosphamide, or elotuzumab.
- •Patients who received a minimum of two cycles of pomalidomide 4mg every day
- •on day 1-21/28.
- •Age > 18 years
- •WHO performance status 0-3
- •Written informed consent
排除标准
- •Usage of CYP1A2 inhibitors (e.g. ciprofloxacin, enoxacin, ketoconazole,
- •carbamazepine, fluvoxamine, and grapefruit juice)
- •Renal insufficiency requiring dialysis
- •Significant hepatic dysfunction (total bilirubin =>30 micromol/l or
- •transaminases => 3 times normal level)
- •Current smoker
- •Thrombocytes <100 *10^9/L
- •Neutrophiles <1.0 *10^9/L
- •Pregnant patients
- •Female patients who are able to get pregnant and who do not agree to adequate
- •birth control or complete abstinence (see appendix G, protocol)
- •Male patients who do not agree to adequate birth control or complete
- •abstinence (see appendix G, protocol)
- •Hypersensitivity to pomalidomide or constituents
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