EUCTR2020-004972-17-AT进行中（未招募）1 期
Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged =70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650) - AGMT_MM-4
AGMT gGmbH0 个研究点目标入组 198 人开始时间: 2021年4月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 70 years
- •Able to provide written informed consent in accordance with federal, local, and institutional guidelines
- •Patients must have newly diagnosed, symptomatic multiple myeloma with evidence of measurable disease (assessed within 21 days prior to randomization)
- •o Serum M protein =0.5 g/dL measured using serum protein immunoelectrophoresis
- •o Urine M protein =200 mg/24 hours measured using urine protein immunoelectrophoresis
- •o In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) =100 mg/L (involved light chain) and an abnormal FLC ratio
- •No prior treatment for multiple myeloma
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
- •Patients at cardiac risk (NYHA >ll) or pre-existing coronary heart disease, or any other clinically relevant cardiac complication) should be scheduled for a baseline ECHO and can only be included if the LVEF is >40%
- •Adequate organ and bone marrow function within the 21 days prior to randomization defined by:
- •o Bilirubin < 2 times the upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN
- •o Absolute neutrophil count (ANC) = 750/mm3 (growth factor support for max 3 days allowed to achieve this value)
- •o Hemoglobin >8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.)
- •o Platelet count >50,000/mm3
- •o Calculated or measured creatinine clearance (CrCl) of =30 mL/min (Calculation should be based on the MDRD formula (age, gender, black/non- black, weight, height)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 198
排除标准
- •ECOG status >2
- •Patients unlikely to tolerate Rd
- •Waldenström macroglobulinemia
- •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •Plasma cell leukemia (> 2.0 x 10^9/L circulating plasma cells by standard differential)
- •Myelodysplastic syndrome
- •Smoldering Myeloma and MGUS
- •Second malignancy within the past 5 years except:
- •o Adequately treated basal cell or squamous cell skin cancer
- •o Carcinoma in situ of the cervix
- •o Prostate cancer = Gleason score 6 with stable prostate-specific antigen (PSA over 12 months)
- •o Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins)
- •o Treated medullary or papillary thyroid cancer
- •o Other tumors with low risk of recurrence/metastases and/or early stage R0 surgery
- •History of or current amyloidosis
- •Glucocorticoid therapy within the 14 days prior to randomization that exceeds an accumulated dose of 160 mg dexamethasone or 1000 mg prednisone
- •Extended field radio therapy (more than 3 fields) within the 21 days prior to randomization
- •Contraindication to isatuximab, dexamethasone, lenalidomide or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs
- •Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 4 months prior to enrolment
- •Active infection within the 14 days prior to randomization requiring systemic antibiotics and/or antiviral therapy
- •Uncontrolled hypertension or uncontrolled diabetes despite medication
- •Significant neuropathy (Grade 2 with pain or Grade 3 or higher) within the 14 days prior to randomization
- •Known cirrhosis
- •Known human immunodeficiency virus (HIV) seropositivity or active hepatitis C or hepatitis B infection (subjects with past hepatitis B virus [HBV] infection or resolved HBV infection defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test are eligible; subjects positive for hepatitis C virus [HCV] antibody are eligible only if polymerase chain reaction [PCR] is negative for HCV RNA.)
- •Participation in another interventional study within the 28 days prior to randomization
- •Major surgery (except kyphoplasty) within the 28 days prior to randomization
- •Any other clinically significant medical disease or social condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent, be compliant with study procedures, or provide accurate information.
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