CTIS2024-513396-41-00进行中（未招募）1 期
CARFILZOMIB - LENALIDOMIDE - DEXAMETHASONE (KRd) versus LENALIDOMIDE - DEXAMETHASONE (Rd) IN NEWLY DIAGNOSED MYELOMA PATIENTS NOT ELIGIBLE FOR AUTOLOGOUS STEM CELL TRANSPLANTATION: A RANDOMIZED PHASE III TRIAL (EMN20) - EMN20
Fondazione European Myeloma Network Italy O.N.L.U.S.0 个研究点目标入组 340 人开始时间: 2024年7月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Newly diagnosed symptomatic MM based on either standard CRAB criteria (at least 10% of bone marrow plasma cells plus CRAB defined as the onset of any of the following clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) or at least 10% of bone marrow plasma cells plus the presence of at least one of the following biomarkers of malignancy: 60% or greater clonal plasma cells on bone marrow examination; Serum involved/uninvolved free light chain (FLC) ratio of 100 or greater; More than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size., LVEF (left ventricular ejection fraction) = 40%: 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation; multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available, Pre-treatment blood pressure value < 140/90 mmHg even with adequate therapy: 24 hours blood pressure monitoring is the preferred method of evaluation; blood pressure diary at home for 2 weeks is acceptable., Females of childbearing potential (FBCP) comply with the conditions of the Pregnancy Prevention Plan, including confirmation that she has an adequate level of understanding, FBCP must follow the Pregnancy Prevention Plan and use a highly effective and an additional barrier contraception method simultaneously for 4 weeks before starting therapy, during treatment and dose interruptions and for at least 30 days after the last dose of study drugs., Males must use an effective barrier method of contraception if sexually active with FCBP during the treatment and for at least 90 days after the last administration of study drug/s. Male subjects must agree to refrain from sperm donation for at least 90 days after the last dose of carfilzomib., Patient not eligible for ASCT (age = 65 years or abnormal cardiac, pulmonary and liver function)., Patient defined as fit or intermediate according to the IMWG (International Myeloma Working Group) frailty score., Patient has given voluntary written informed consent., Patient is able to be compliant with hospital visits and procedures required per protocol., Patient agrees to use acceptable methods for contraception., Patient has measurable disease according to IMWG criteria., Patient has ECOG (Eastern Cooperative Oncology Group) performance status < 3., Pre-treatment clinical laboratory values within 30 days before randomization: Platelet count =50 x 10^9/L (=30 x 10^9 /L if myeloma involvement in the bone marrow is > 50%), Absolute neutrophil count (ANC) = 1 x 10^9/L without the use of growth factors, Corrected serum calcium =14 mg/dL (3.5 mmol/L), Alanine transaminase (ALT): = 3 x the ULN, Total bilirubin: = 2 x the UL, Calculated or measured creatinine clearance: = 30 mL/minute.
排除标准
- •Serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the screening or place the subject at unacceptable risk., Presence of peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 5.0., Presence of incontrolled hypertension defined as persistent hypertension (>140/90 mmHg) regardless treatment with 3 drugs, including a diuretic., Contraindication to any of the required drugs or supportive treatments and hypersensitivity to any excipient of the study drugs., Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)., Invasive malignancy within the past 3 years., Administration of any experimental drug within 4 weeks prior to the baseline or within 5 drug half-lives., Patient defined as frail according to the IMWG frailty score (pts with age >80 years old)., Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid < to the equivalent of dexamethasone 40 mg/day for 4 days), Pregnant or lactating females., Presence of clinical active infectious hepatitis type A, B, C or HIV., Presence of acute active infection requiring antibiotics or infiltrative pulmonary disease., Presence of pulmonary hypertension and interstitial lung disease., Presence of uncontrolled arrhythmias or history of QT prolongation., Presence of myocardial infarction or unstable angina = 6 months or other clinically significant heart disease.
研究者
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