KCT0005635招募中未知
Phase II, single-arm trial of carfilzomib, lenalidomide, and dexamethasone re-induction followed by the 2nd ASCT in multiple myeloma patients relapsed after the 1st ASCT
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Age 20~70
- •2. Progressive disease after 1st ASCT
- •3. Duration of response after 1st ASCT > 12 months
- •4. Measurable disease (+)
- •Serum M-protein = 1 g/dL
- •Urine M-protein = 200 mg/24 hr
- •Serum Free Light Chain(FLC) assay: involved FLC level =10 mg/dL
- •(serum Free Light Chain ratio is abnormal)
- •5. Adequate organ function for induction & ASCT
- •Absolute Neutrophil Count (ANC) = 1.0 x 109/L
- •Platelets = 50 x 109/L (= 30 x 109/L if myeloma involvement is >
- •50% in the bone marrow)
- •Hemoglobin = 8.0 g/dL
- •Creatinine clearance = 30 mL/minute
- •Serum Bilirubin = 1.5 x upper limit of normal
- •Aspartate aminotransferase(AST) and Alanine
- •aminotransferase(ALT) = 3 x upper limit of normal
- •6. Eastern Cooperative Oncology Group performance scale 0~2
- •7. Survival expectancy > 3 months
- •8. Adequately controlled hepatitis B(HBV) & hepatitis C(HCV)
- •9. Written informed consent
- •10. Optimal contraceptions
排除标准
- •1. Prior refractoriness or intolerance to carfilzomib
- •2. Prior refractoriness or intolerance to lenalidomide/dexamethasone
- •3. Any treatment after progressive disease after 1st ASCT. High-dose
- •dexamethasone or palliative radiation is permitted.
- •4. Waldenstroem’s macroglobulinemia, POEMS syndrome, or plasma cell
- •5. Pregnant or nursing lactating women
- •6. Myocardial infarct within 6 months, heart failure of New York Heart
- •Association(NYHA) Class III~IV, uncontrolled ventricular arrhythmia,
- •severe coronary arterial obstructive disease
- •7. Uncontrolled hypertension (Defined as an average systolic blood
- •pressure >= 160 mmHg or diastolic >= 100 mmHg) or diabetes
- •8. Grade 3~4 neuropathy
- •9. HIV infection
- •10. Severe or uncontrolled medical conditions, laboratory abnormalities, or
- •psychiatric disorders that may preclude the participation of the study by
- •the physician’s discretion
- •11. Contraindication to any of the required concomitant drugs or supportive
- •treatments, including hypersensitivity to all anticoagulation and
- •antiplatelet options, antiviral drugs, or intolerance to hydration due to
- •preexisting pulmonary or cardiac impairment
- •12. Diagnosis of other malignant disease other than myeloma within 5
- •year. Exceptions are properly treated non-melanomatous skin cancers,
- •cervical intraepithelial neoplasia, prostate cancer that do not require
- •treatment, or properly excised well-differentiated thyroid cancers
研究者
相似试验
进行中（未招募）
1 期
A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) compared to cyclophosphamide, velcade and dexamethasone (CVD)for first relapse or primary refractory mutiple myeloma patients.EUCTR2012-001320-36-GBniversity of Leeds300
招募中
2 期
Study to evaluate the effectiveness of a combination of 3 treatments, followed by transplantation of their own blood cell progenitor cells for patients under 70 years of age with asymptomatic multiple myeloma at high risk of developing into symptomatic myeloma2024-516908-42-00Fundacion PETHEMA90
已完成
2 期
Phase II study assessing the effect of carfilzomib treatment on early free light chain kinetics in myeloma patients with renal impairmentACTRN12614000301662Australiasian Leukemia and Lymphoma Group38
进行中（未招募）
1 期
Research study to determine whether a combination of 3 drugs calledlenalidomide, carfilzomib and dexamethasone given to persons afterautologous stem cell (a young cell without a specific purpose from whichother cell types develop) transplant is better than lenalidomidemaintenance alone.MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Multiple MyelomaEUCTR2015-002380-42-PLPolish Myeloma Consortium180
进行中（未招募）
不适用
Phase I/II trial of Carfilzomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma. - CARMYSAPEUCTR2010-019462-92-FRCHU de Nantes