NCT04984330撤回早期 1 期
Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Compare number of dose limiting toxicity (DLT) occurence to measure safety and toxicity
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of Selinexor and Dexamethasone and see what effects it has on AL amyloidosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of primary AL amyloidosis
- •Relapsed and/or refractory AL amyloidosis
- •Measurable disease
- •Male or female patients 18 years or older
- •Able to give voluntary written consent
- •Eastern Cooperative Oncology Group performance status and/or other performance status 0, 1, or
- •Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm
- •Total bilirubin ≤ 1.5 × the upper limit of the normal range (ULN).
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
- •Calculated creatinine clearance ≥ 30 mL/min
排除标准
- •Non-AL amyloidosis
- •Clinically overt myeloma
- •Prior exposure to Selinexor
- •Clinically significant cardiac disease
- •Severe obstructive airway disease
- •Female patients who are lactating or have a positive serum pregnancy test during the screening period
- •Planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment
- •Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy.
- •Major surgery within 14 days before enrollment.
- •Radiotherapy within 14 days before enrollment.
- •Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before study enrollment. Systemic treatment, within 14 days before the first dose, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, see Appendix 11.7), or use of Ginkgo biloba or St. John's wort.
- •Positive for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
- •Serious medical or psychiatric illness
- •GI disease or GI procedure that could interfere with the oral absorption or tolerance including difficulty swallowing
- •Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- •Participation in another clinical trials involving investigational agents within 30 days of starting this trial
- •Peripheral neuropathy (grade 2 with pain or grade 3 or higher).
研究组 & 干预措施
selinexor/ dexamethasone (Sd)
Experimental
Selinexor • 60mg PO once weekly on days 1, 8, 15, 22 until disease progression or toxicity
Dexamethasone
• 20 mg PO administered 30-60 minutes prior to selinexor on days 1, 2, 8, 9, 15, 16, 22, 23
干预措施: Selinexor (Drug)
selinexor/ dexamethasone (Sd)
Experimental
Selinexor • 60mg PO once weekly on days 1, 8, 15, 22 until disease progression or toxicity
Dexamethasone
• 20 mg PO administered 30-60 minutes prior to selinexor on days 1, 2, 8, 9, 15, 16, 22, 23
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Compare number of dose limiting toxicity (DLT) occurence to measure safety and toxicity
时间窗: approximately 12 months
Safety and toxicity will be determined by how many occurrence of dose limiting toxicity (DLT) occured during 12 months of treatment for each subject
次要结局
- Hematologic Complete Response (CR) rate(approximately 12 months)
- minimal residual disease (MRD) negative CR/VGPR rate(approximately 12 months)
- Median hematologic Progression Free Survival (PFS)(End of Study (approximately 3 years))
- Time to organ response(approximately 12 months)
- Stringent dFLC response rate(approximately 12 months)
- Percentage of participants with organ response(End of Study (approximately 3 years))
- Time to hematologic progression(End of Study (approximately 3 years))
- Compare Hematologic Overall Response Rate (ORR)(approximately 12 months)
- Time to best hematologic response(approximately 12 months)
- Hematologic Very Good Partial Response (VGPR) or better rate(approximately 12 months)
- Time to first hematologic response(approximately 12 months)
- Time to next therapy(End of Study (approximately 3 years))
- Duration of organ response(End of Study (approximately 3 years))
- Number of patients with peripheral blood mass spectrometry for monoclonal protein detection (MALDI-TOF)(End of Study (approximately 3 years))
- Duration of hematologic response(End of Study (approximately 3 years))
- Median organ Progression Free Survival (PFS)(End of Study (approximately 3 years))
- Time to organ progression(End of Study (approximately 3 years))
研究者
研究点 (1)
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