Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Complete Response (CR)
研究概览
简要总结
Phase I: The primary purpose of this study phase is to determine the best dose also referred to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant.
Phase II: The primary purpose of this study phase is to assess the complete response (CR) conversion rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •18 years of age or older with histologically confirmed multiple myeloma
- •Achieving partial response (PR) or very good partial response (VGPR) with systemic chemotherapy
- •Received less than 4 lines of anti-myeloma therapy.
- •Karnofsky performance status of >= 70%
- •Adequate pulmonary, cardiac, hepatic and renal function as outlined in the protocol
- •Signed informed consent form in accordance with institutional policies prior to the initiation of high-dose therapy
排除标准
- •Non-secretory multiple myeloma
- •Have achieved complete response (CR) prior to autologous hematopoietic cell transplantation (HCT)
- •Central nervous system (CNS) involvement
- •Uncontrolled bacterial, viral or fungal infections
- •Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •Prior malignancies within the last 5 years except resected basal cell carcinoma or treated cervical carcinoma in situ.
- •Females who are pregnant or breastfeeding
- •Have received other investigational drugs within 14 days prior to screening
- •Prior autologous or allogeneic HCT
- •Prior organ transplant or autoimmune disease requiring immunosuppressive therapy
研究组 & 干预措施
Selinexor Plus HDM HCT
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
干预措施: Selinexor (Drug)
Selinexor Plus HDM HCT
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
干预措施: Melphalan (Drug)
Selinexor Plus HDM HCT
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
干预措施: Dexamethasone (Drug)
Selinexor Plus HDM HCT
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
干预措施: Autologous Hematopoietic Cell Transplantation (HCT) (Procedure)
Selinexor Plus HDM HCT
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
干预措施: Fosaprepitant (Drug)
结局指标
主要结局
Complete Response (CR)
时间窗: 3 months post HCT
Complete response (CR) conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow. Complete Response conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.
Phase I: Recommended Phase II Dose (RPh2D)
时间窗: Up to 3 months
RPh2D/Maximum Tolerated Dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant. MTD: the highest dose level at which 1 or less of 6 participants experience a dose limiting toxicity (DLT).
次要结局
未报告次要终点