KCT0006285招募中未知
Phase II study of carfilzomib, pomalidomide, and dexamethasone for multiple myeloma patients who had relapsed or progressed after carfilzomib, lenalidomide, and dexamethasone (KAPPA trial)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 33
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 80?(Year)（—）
- 性别
- All
入选标准
- •1. Age 20-80 years old
- •2. Recurrent or progressive multiple myeloma after KRd (carfilzomib, lenalidomide, dexamethasone) treatment
- •3. After 12 cycles of KRd or more, lenalidomide monotherapy for 6 months or more, or autologous stem cell transplantation after 4 to 6 cycles of KRd or more, and lenalidomide maintenance therapy for 6 months or more
- •4. Measurable lesions
- •- Serum M-protein = 1 g/dL (10 g/L)
- •- Urine M-protein = 200 mg/24 hr
- •- Serum FLC assay: Involved FLC = 10 mg/dL (100 mg/L) (if serum EP or urine EP cannot be measured, serum FLC ratio should be abnormal (KL ratio < 0.26 or > 1.65))
- •5. Organ function adequate to receive treatment
- •- Absolute Neutrophil Count (ANC) = 1.0 x 109/L
- •- Platelet count = 50 x 109/L (= 30 x 109/L if myeloma involvement > 50% on bone marrow examination)
- •- Hemoglobin = 8.0 g/dL
- •- Creatinine clearance = 30 mL/minute or serum creatinine <3.0 g/dL
- •- Serum bilirubin = 1.5 x ULN
- •- AST and ALT = 3 x ULN
- •6. Eastern Cooperative Oncology Group performance scale 0~2
- •7. Life expectancy of 3 months or more
- •8. Obtaining Voluntary Consent
- •9. Previously administered bortezomib-based therapy
- •10. Patients who meet the following criteria
- •For women of childbearing age
- •- Women who are willing to use two reliable methods of contraception from 4 weeks prior to administration of the investigational drug, during treatment, during cessation of administration, and until 4 weeks after administration of the investigational drug
- •- Women with a negative pregnancy test with a minimum sensitivity of 25 IU/mL under medical management
- •If you are male
- •Men who consented to absolute abstinence or appropriate contraception for the entire duration of treatment and for 28 days after the last dose
- •?Women of childbearing age
- •Women who have not undergone hysterectomy or bilateral oophorectomy, women who have not had spontaneous menopause for at least 24 consecutive months (i.e., have menstruated at any time in the past 24 months. However, if amenorrhea after chemotherapy does not rule out pregnancy) not).
- •? Appropriate method of contraception
- •Very effective method
- •Intrauterine devices, hormone therapy (hormonal implants, intrauterine systems that release levonorgestrel, medroxyprogesterone acetate depot injection, tablets containing ovulation-suppressing progesterone), tubal ligation, vasectomy in men
- •Effective way
- •Male use of condoms, diaphragms, and cervical caps
排除标准
- •1. Non-hematologic toxicity of 3 to 4 degrees or greater due to carfilzomib during previous carfilzomib treatment
- •2. Previously treated with pomalidomide
- •3. Thalidomide or lenalidomide hypersensitivity
- •4. carfilzomib refractory according to IMWG criteria
- •5. History of myocardial infarction within 6 months, NYHA Class III to IV heart failure, uncontrolled ventricular arrhythmias, severe coronary artery disease
- •6. Active infection within 14 days of study initiation
- •7. Uncontrolled hypertension (mean systolic =160 mmHg or diastolic =100 mmHg) or uncontrolled diabetes mellitus (HbA1c > 7.0%)
- •8. HIV-infected, hepatitis B and C patients (acceptable as long as they are receiving appropriate antiviral therapy for hepatitis B and C).
- •9. In case the researcher judges that participation in this study is difficult due to severe or uncontrolled medical disease, abnormal test result, or psychiatric abnormality
- •10. When the necessary concomitant drug administration or conservative treatment is contraindicated. For example, if there is a hypersensitivity to anticoagulants or antiviral drugs, or if fluid administration is impossible due to underlying cardiopulmonary disease
- •11. If you have been diagnosed 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, untreated prostate cancer, or well-resected differentiated thyroid cancer.
- •12. Pregnant or lactating women
- •13. Waldenstroem’s macroglobulinemia, POEMS syndrome, or plasma cell leukemia, light chain amyloidosis
- •14. LV ejection fraction < 40%
研究者
相似试验
进行中（未招募）
1 期
Phase II study of carfilzomib- cyclophosphamide-dexamethasone and high-dose melphalan followed by randomization between observa-tion or maintenance with carfil-zomib and dexamethasone in pa-tients with relapsed multiple myeloma after high-dose melphalan with autologous stem cell supportMedDRA version: 19.1 Level: LLT Classification code 10067095 Term: Multiple myeloma progression System Organ Class: 100000004864Multiple MyelomaEUCTR2013-003789-15-DKordic Myeloma Study Group200
进行中（未招募）
1 期
Phase II study of carfilzomib- cyclophosphamide-dexamethasone and high-dose melphalan followed by randomization between observa-tion or maintenance with carfil-zomib and dexamethasone in pa-tients with relapsed multiple myeloma after high-dose melphalan with autologous stem cell supportMultiple MyelomaEUCTR2013-003789-15-LTordic Myeloma Study Group200
进行中（未招募）
1 期
Phase II study of carfilzomib- cyclophosphamide-dexamethasone and high-dose melphalan followed by randomization between observa-tion or maintenance with carfil-zomib and dexamethasone in pa-tients with relapsed multiple myeloma after high-dose melphalan with autologous stem cell supportMultiple MyelomaEUCTR2013-003789-15-FIordic Myeloma Study Group200
进行中（未招募）
1 期
Phase II study of carfilzomib- cyclophosphamide-dexamethasone and high-dose melphalan followed by randomization between observa-tion or maintenance with carfil-zomib and dexamethasone in pa-tients with relapsed multiple myeloma after high-dose melphalan with autologous stem cell supportMedDRA version: 20.0 Level: LLT Classification code 10067095 Term: Multiple myeloma progression System Organ Class: 100000054086Multiple MyelomaEUCTR2013-003789-15-SEordic Myeloma Study Group200
进行中（未招募）
1 期
Phase II study of carfilzomib- cyclophosphamide-dexamethasone and high-dose melphalan followed by randomization between observa-tion or maintenance with carfil-zomib and dexamethasone in pa-tients with relapsed multiple myeloma after high-dose melphalan with autologous stem cell supportMedDRA version: 17.1Level: LLTClassification code 10067095Term: Multiple myeloma progressionSystem Organ Class: 100000004864Multiple MyelomaEUCTR2013-003789-15-NOordic Myeloma Study Group200