KCT0008537尚未招募Unknown
A Phase II study of carfilzomib, oral cyclophosphamide, and dexamethasone for relapsed and/or refractory multiple myeloma
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 49
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 or older
- •2. ECOG activities 0, 1, 2
- •3. Patients diagnosed with multiple myeloma based on IMWG criteria
- •4. Patients previously treated with one or more therapies
- •5. Patients treated with combination or monotherapy including lenalidomide among previous drugs
- •6. Patients with relapsed and/or refractory multiple myeloma since last chemotherapy
- •** Relapsed multiple myeloma: A patient who has obtained a partial response after previous chemotherapy but has relapsed and does not meet the criteria for relapse and refractory or primary refractory multiple myeloma below
- •**Relapsed and refractory multiple myeloma: recurrence of disease within 60 days of previous treatment; Patients who have obtained more than minimal response to previous treatment but are refractory to the next salvage treatment
- •** Primary refractory multiple myeloma: Patients who have not obtained a response beyond the minimal response to any treatment
- •7. Patients with measurable lesions at the start of treatment
- •- Serum M protein = 0.5 g/L, or
- •- 24-hour urine M protein = 200mg/24h, or
- •- Light chain multiple myeloma: serum free light chain (sFLC) = 10 mg/dL and abnormal serum kappa/lambda free light chain ratio
- •8. Patients with adequate organ function
- •- Absolute neutrophil count (ANC) = 1.0 x 109/L
- •- Platelet count = 50 x 109/L (platelet count = 30 x 109/L if myeloma invasion is present in bone marrow examination)
- •- Hemoglobin = 8 g/dL
- •- Serum creatinine < 3.0 mg/dL or CrCl = 15 mL/min
- •- AST and ALT = 3 x ULN
- •- Serum total bilirubin = 3 x ULN
- •9. Patients who can take oral medication
- •10. Patients who have experienced toxicity (including peripheral neuropathy) from prior treatment, complete resolution of toxicity or stable to Grade 1 or lower
- •11. Patients who have undergone previous allogeneic hematopoietic stem cell transplantation without active graft-versus-host disease
- •12. Patients without clinically uncontrolled bleeding
- •13. Each patient must sign a patient consent form stating that he/she understands the purpose of the clinical trial and necessary procedures, and voluntarily participates in the clinical trial. The patient must be willing and able to comply with the prohibitions and limitations set forth in these treatment guidelines, as stated in the patient consent form.
- •Women of childbearing potential must have a negative serum or urine pregnancy test prior to initiating clinical trials. : For pre-menopausal women or women with amenorrhea within 1 year (after menopause within 1 year)
排除标准
- •1. Patients previously treated with carfilzomib
- •2. Patients previously treated with cyclophosphamide
- •3. Patients diagnosed with POEMS SD, Waldenstrom macroglobulinemia, or Plasma cell leukemia
- •4. Clinically significant heart disease
- •- A. Myocardial infarction within 6 months, or New York Heart Association class III or IV heart failure, uncontrolled angina pectoris, previous severe coronary artery disease
- •B. Arrhythmias (Grade 2 or higher based on CVDAE version 4) or clinically significant ECG abnormalities
- •- Screening 12 ATcF > 470msec ( pacemaker )
- •- (MUGA scan) < 40%
- •- : >= 160 mmHg or >= 100 mmHg
- •5. FEV1 < 60% of chronic obstructive pulmonary disease (COPD, including history of asthma within 2 years), patients with or suspected chronic obstructive pulmonary disease must perform a pulmonary function test at the time of screening
- •6. Patients who underwent surgery under general anesthesia within 2 weeks of screening
- •7. Patients with a history of malignancy other than multiple myeloma within the last 5 years. (However, patients who have been cured or have a minimum risk of recurrence among skin cancer, cervical, breast, gastrointestinal intraepithelial cancer, or malignant tumors within 3 years, excluding melanoma, who have been treated for the purpose of curative treatment can be enrolled)
- •8. Serious medical condition or illness (including dementia, epilepsy, serious neurological or psychiatric disease, active, uncontrolled infection (including HIV, hepatitis B and C), as determined by the attending medical staff (provided that hepatitis B or hepatitis C infection is receiving appropriate antiviral therapy and the infection is controlled)
- •9. Pregnant or Nursing Mothers
研究者
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