Pilot Study Using Propranolol To Promote Prenylation Of The Gtpase Rap1b In Hematopoietic Stem Cell Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Prenylation levels in response to propranolol in a population of patients undergoing autologous hematopoietic stem cell transplantation
研究概览
简要总结
This is a an ancillary study designed to explore whether an additional cell signaling pathway (prenylation of Rap1) that was recently identified as being under beta-adrenergic control may be affected by beta-blocker use.
详细描述
This is a proof of concept randomized controlled pilot study assessing whether prenylation and membrane localization of Rap1 in PBMCs can be altered in individuals undergoing autologous Hematopoietic Cell Transplant (HCT) for Multiple Myeloma by administering a daily beta-blocker (propranolol) to 20 participants. Outcomes of patients on this clinical trial will be compared to 20 participants in a control arm.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma receiving an autologous HCT are eligible when the following criteria are met:
- •18-75 years of age
- •≤ 1 year since initiation of systemic anti-myeloma therapy
- •Patient is scheduled for autologous hematopoietic stem cell transplant as the upfront therapy for their multiple myeloma
- •Karnofsky Performance Status of ≥90 %; patients eligible for HCT are eligible for the study
- •All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile.
排除标准
- •Prior autologous HCT
- •Non secretory multiple myeloma
- •Concurrent beta-blocker therapy at or within 3 weeks of study entry.
- •Previous intolerance to beta-blocker therapy
- •Any medical contraindications to beta-blocker therapy including, but not limited to, symptomatic hypotension; drug hypersensitivity; sinus bradycardia, sick sinus syndrome, or 2nd or 3rd degree atrioventricular block without a pacemaker; uncompensated heart failure; or uncontrolled asthma
- •Active, untreated depression screened for by the HCT physician (Patients who screen positive will be offered a referral to the MCW Psycho-Oncology program for further evaluation and treatment)
- •Concurrent use of medications as specified in the protocol throughout the study or within one week of study entry.
- •Pregnant or lactating women
结局指标
主要结局
Prenylation levels in response to propranolol in a population of patients undergoing autologous hematopoietic stem cell transplantation
时间窗: 1 year
Level of prenylation will be compared between patients exposed vs. not exposed to propranolol from 1-3 weeks before to 4 weeks following transplantation.
次要结局
未报告次要终点
研究者
Jennifer M. Knight
Assistant Professor
Medical College of Wisconsin