Single Patient Use of Selinexor and Dexamethasone for a Patient With Multiple Myeloma

Masonic Cancer Center, University of Minnesota0 个研究点开始时间: 2019年2月22日最近更新: 2019年2月22日

适应症

试验速览

阶段: 不适用
状态: No Longer Available
发起方: Masonic Cancer Center, University of Minnesota

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

This is an individual patient, expanded access protocol using Selinexor and dexamethasone ("Sd") for the treatment of Relapsed, Refractory multiple myeloma in a 64 year old male, "19023-UMN-01" weighing 105.7 kg. 19023-UMN-01 has IgG kappa myeloma that has relapsed after numerous treatments.

详细描述

Selinexor is an oral, first in class, slowly reversible, potent and Selective Inhibitor of Nuclear Export (SINE) compound that specifically blocks Exportin 1 (XPO1). It is one of the most promising investigational drugs available for this patient with clear risk and benefit assessment favoring potential benefit.

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients having relapsed/refractory multiple myeloma and neuropathy (or who are otherwise unable to tolerate bortezomib)
•Aged 18 years and older
•Patient able to provide written, informed consent to participate in and follow the KEAP Treatment Plan

排除标准

•Known hypersensitivity to selinexor or any excipients.
•Patient receiving any other investigational agent.
•Any concurrent uncontrolled and active medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.).
•Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
•Active graft versus host disease (after allogeneic stem cell transplantation).
•Active, unstable cardiovascular function:
•Symptomatic ischemia, or uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics)
•Congestive heart failure of New York Heart Association Class ≥ 3 or known leftventricular ejection fraction < 40%, or
•Myocardial infarction within 3 months prior to C1D
•Significant renal impairment with ongoing dialysis treatment
•Active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could, in the treating physician's opinion, interfere with absorption of treatment.
•Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.

研究者

发起方

Masonic Cancer Center, University of Minnesota

申办方类型

Other

责任方

Sponsor

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