EUCTR2021-006646-12-NL进行中（未招募）1 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. - Alternative dosing scheme of pomalidomide 4 mg every other day; reduction in costs, same efficacy?
Amsterdam UMC0 个研究点目标入组 12 人开始时间: 2022年8月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- All
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
- •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 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
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
- •Hemoglobin <6.5 mmol/L
- •Thrombocytes <100 *10^9/L
- •Neutrophiles <1.5 *10^9/L
研究者
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