KCT0008467尚未招募Unknown
Phase 2 study of selinexor plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma (KMM 2205)
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 48
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
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Age = 20 years
- •2. Symptomatic multiple myeloma with evidence of disease progression
- •3. Prior treatment with one or two regimens for multiple myeloma (patients who have only one anti-myeloma regimen can be enrolled if the patient was exposed to lenalidomide)
- •4. Not refractory to carfilzomib (those who have previously received carfilzomib-containing therapy can be enrolled if the treatment response has been maintained for more than 6 months after the last dose of carfilzomib administration)
- •5. Have not previously received selinexor
- •6. 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 (Kappa/Lambda ratio < 0.26 or > 1.65))
- •7. Eastern Cooperative Oncology Group (ECOG) performance score: 0-2
- •8. Adequate organ function
- •- hepatic function: total bilirubin < 1.5 x ULN (except Gilbert’s syndrome), AST/ALT = 3 x ULN
- •- renal function: creatinine clearance = 20 mL/min or serum creatinine <3.0 g/dL
- •- hematopoietic function: Absolute Neutrophil Count (ANC) = 1.0 x 109/L, Platelet count = 50 x 109/L (= 30 x 109/L myeloma involvement > 50% on bone marrow examination)
- •9. Life expectancy =3 months
- •10. Written informed consent
排除标准
- •1. Non-hematologic toxicity of 3 or 4 due to carfilzomib, if previously treated with carfilzomib
- •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. Left ventricular ejection fraction < 40% on 2D echocardiography or MUGA scan
- •4. Uncontrolled hypertension (mean systolic blood pressure =160 mmHg or diastolic blood pressure = 100 mmHg)
- •5. AL amyloidosis with cardiac involvement, plasma cell leukemia, POEMS syndrome, Waldenstrom’s macroglobulinemia
- •6. Central Nervous System (CNS) involvement
- •7. Radiation therapy, chemotherapy, or chemotherapy including immunotherapy within 2 weeks before administration of the study drug
- •8. autologous hematopoietic stem cell transplantation (HSCT) within 4 weeks or allogeneic HSCT within 3 months prior to first dose
- •9. Evidence of ongoing graft-versus-host disease in case of allogeneic HSCT
- •10. Major surgery within 2 weeks prior to first dose
- •11. Acute active infection requiring treatment with systemic antibiotics, antiviral agents, antifungals within 2 weeks prior to first dose
- •12. Known HIV infection, active hepatitis B or C infections (Patients are eligible if they are receiving appropriate antiviral therapy for hepatitis B or C)
- •13. Any other clinically significant or uncontrolled medical conditions, abnormal laboratory results, or psychiatric abnormalities that, in the Investigator’s opinion, may interfere with study participation and protocol adherence
- •14. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- •15. Other malignancy within the past 3 years with the exception of adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or breast, prostate cancer that does not require treatment, or adequately resected differentiated thyroid cancer.
- •16. Planning to become pregnant during the study period among women of childbearing potential or men who have not had a vasectomy, or one do not agree to follow one of the medically accepted pregnancy avoidance measures (partner’s sterilization, partner’s intrauterine contraceptive device, barrier contraceptive method, combination of diaphragm or condom)
- •17. Pregnant or lactating women
研究者
相似试验
进行中（未招募）
2 期
Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple MyelomaRecurrent Plasma Cell MyelomaRefractory Plasma Cell MyelomaNCT04756401Academic and Community Cancer Research United8
招募中
1 期
Pilot phase II study of Selinexor in combination with Ifosfamide, Etoposide and Dexamethasone (SIDE) in patients with relapsed or refractory Peripheral T-cell LymphomasRelapsed or Refractory Peripheral T-cell LymphomasMedDRA version: 21.0Level: PTClassification code: 10001416Term: Adult T-cell lymphoma/leukaemia recurrent Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10001417Term: Adult T-cell lymphoma/leukaemia refractory Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10001413Term: Adult T-cell lymphoma/leukaemia Class: 100000004864CTIS2024-513295-18-00Fondazione IRCCS Istituto Nazionale Dei Tumori30
尚未招募
Unknown
Phase 1/2 study of Selinexor in combination with dexamethasone, ifosfamide, carboplatin, etoposide chemotherapy in patients with secondary central nervous system involving relapsed or refractory B-cell non-Hodgkin lymphoma: a single arm, open label, multicenter studyKCT0008884Samsung Medical Center35
已完成
1 期
Selinexor, Carfilzomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple MyelomaRefractory Multiple MyelomaNCT02199665University of Chicago52
进行中（未招募）
1 期
Phase 2 study of carfilzomib + elotuzumab + dexamethasone for relapsed or progressed multiple myeloma after 1-3 prior treatment linesMultiple myeloma patientsMedDRA version: 21.1Level: LLTClassification code 10067095Term: Multiple myeloma progressionSystem Organ Class: 100000004864EUCTR2016-001178-13-FIHelsinki University Central Hospital15