A Phase 3 randomized, open-label, multicenter study of isatuximab (SAR650984) in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering multiple myeloma - EFC15992

Sanofi-Aventis Recherche & Developpement0 个研究点目标入组 530 人开始时间: 2023年11月17日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 530

研究概览入排标准研究者记录与标识符相似试验

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

•Participant must be at least 18 years of age inclusive or older, Participants who are diagnosed within 5 years with SMM (per International Myeloma Working Group [IMWG] criteria), defined as serum M-protein =30 g/L or urinary M- protein =500 mg per 24 hour or both, and/or clonal bone marrow plasma cells (BMPCs) 10% to <60%, and absence of myeloma defining events or other related conditions and with high-risk SMM, Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or 2, Capable of giving voluntary written informed consent, Absolute neutrophil count (ANC) =1000/µL (1 × 109/L), Platelets =50,000/µL (50 × 109/L), Total bilirubin =3 mg/dL (except Gilbert syndrome, in which direct bilirubin should be - =5 mg/dL)., Alanine aminotransferase =3× upper limit of normal (ULN), aspartate aminotransferase = 3 × ULN.

排除标准

•-Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Increased calcium levels: Corrected serum calcium >1 mg/dL above the ULN or >11 mg/dL, - Prior exposure to approved or investigational treatments for SMM or MM (including but not limited to conventional chemotherapies, immunomodulatory imid drugs, or Proteasome inhibitors); concurrent use of bisphosphonates or receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor denosumab is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted, - Ongoing treatment with corticosteroids with a dose >10 mg prednisone or equivalent per day at the time of randomization (or first study intervention administration in safety run-in cohort), -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Renal insufficiency: Determined by glomerular filtration rate (GFR) <40 mL/min/1.73 m²(Modification of Diet in Renal Disease [MDRD] Formula) or serum creatinine >2 mg/dL, - Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control, Vaccination with a live vaccine 4 weeks before the start of the study drug. Seasonal flu vaccines that do not contain live virus are permitted, -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Anemia (hemoglobin 2 g/dL below lower limit of normal or <10 g/dL or both). Transfusionsupport or concurrent treatment with erythropoietin stimulating agents is not permitted, -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): = 1 bone lytic lesion of =5mm in size, -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): BMPCs =60%, -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Serum involved/uninvolved FLC ratio =100 and an involved FLC =100mg/L, -Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography computed tomography (PET-CT) with more than 1 bone focal lesion (=5 mm in diameter by MRI), - Clinically significant cardiac or vascular disease within 3 months prior to randomization, e.g. Myocardial Infarction; Unstable Angina; Coronary (e.g. Coronary Artery Bypass Graft, Percutaneous Coronary Intervention) or peripheral artery revascularization, Left Ventricular Ejection Fraction <40%, Heart Failure NYHA III-IV, Stroke, Transient Ischemic Attack, Pulmonary Embolism, other thromboembolic

研究者

发起方

Sanofi-Aventis Recherche & Developpement

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