KCT0008848尚未招募Unknown
A phase 2 clinical trial of Selinexor, Bortezomib, and dexamethasone combination (SVd) in Korean Patients with Relapsed or Refractory Multiple Myeloma
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 30
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
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Age = 19 years
- •2.Multiple myeloma with measurable lesions
- •-Serum M-protein = 0.5 g/dL
- •-Urine M-protein = 200 mg/24 hr
- •-Serum free light chain (FLC) assay: Difference between involved and uninvolved FLC = 10 mg/dL (100 mg/L) (if serum EP or urine EP cannot be determined, serum FLC ratio must be abnormal (?/? ratio < 0.26 or > 1.65))
- •3.Had at least one or two previous therapies for multiple myeloma
- •4.Not refractory to bortezomib (Enrollment is allowed for patients who have previously received bortezomib-containing therapy, have had a partial response or higher during treatment with bortezomib, have not discontinued treatment due to a bortezomib-related adverse event grade 3 or higher, and have maintained the treatment response for more than 6 months after the last dose of bortezomib)
- •5.Eastern Cooperative Oncology Group (ECOG) performance score: 0-2
- •6.Proper organ function
- •-Hemoglobin = 8.5 g/dL
- •-Liver function: total bilirubin < 1.5 × ULN (except Gilbert’s syndrome), AST/ALT = 3 × ULN
- •-Bone marrow function: Absolute Neutrophil Count (ANC) = 1.0 × 109/L, Platelet count = 75 ×109/L (= 30 × 109/L Myeloma involvement > 50% on bone marrow examination)
- •7. Patients who experienced toxicity (including peripheral neuropathy) in previous treatment have completely resolved the toxicity or are stable below grade 1
- •8.Written Informed consent obtained
- •9. Women of childbearing age should be negative in serum or urine pregnancy tests before starting clinical trials.
排除标准
- •1.Prior exposure to a SINE compound (i.e. an XPO-1 inhibitor), including selinexor.
- •2.History of acute coronary syndrome (myocardial infarction, unstable angina), NYHA Class III to IV heart failure, uncontrolled ventricular arrhythmias, and uncontrolled clinically significant cardiac conduction disorder without pacemaker insertion (sick sinus syndrome, complete atrioventricular block, etc.) within 6 months
- •3.Uncontrolled hypertension (mean systolic blood pressure =160 mmHg or diastolic blood pressure = 100 mmHg)
- •4.Plasma cell leukemia, POEMS syndrome, Waldenström macroglobulinemia
- •5.Patients receiving hemodialysis or peritoneal dialysis
- •6.Persistent grade 2 or higher peripheral neuropathy despite appropriate treatment
- •7.Uncontrolled acute active infection requiring treatment with systemic antibiotics, antiviral agents, antifungals, etc. within 1 week before administration of the investigational product
- •8.Patients infected with HIV, hepatitis B and C (acceptable if they are receiving appropriate antiviral therapy for hepatitis B and C)
- •9. Hematopoietic stem cell transplantation within 12 weeks of registration, or patients with active GVHD or active gastrointestinal disease are not suitable for trial treatment
- •10.When the investigator determines that participation in this study is difficult due to severe or uncontrolled medical disease, abnormal test results, or psychiatric abnormalities
- •11.Where the necessary concomitant drug administration or supportive care is contraindicated. For example, if there is a hypersensitivity reaction to antiviral agents or if fluid administration is not possible due to underlying cardiopulmonary disease
- •12.Diagnosis with a malignancy other than multiple myeloma within the past 5 years. Exceptions include properly treated non-melanoma skin cancer, intraepithelial cancer of the cervix or breast, prostate cancer that does not require treatment, or well-resected differentiated thyroid cancer.
- •13.Among men who have not had a vasectomy and women of childbearing potential, when planning to conceive during the study participation period, or when one is unable to use a medically accepted method of contraception (partner’s sterilization, partner’s intrauterine contraceptive device, barrier contraceptive method, combination of diaphragm or condom)
- •14.Pregnant or lactating women
研究者
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