A Phase 2 Study of Isatuximab in combination with Bortezomib, Cyclophosphamide and Dexamethasone followed by isatuximab and lenalidomide maintenance in Newly Diagnosed Patients with Multiple Myeloma and severe Renal Impairment

Hellenic Society of Hematology (EAE)0 个研究点目标入组 51 人开始时间: 2022年2月15日最近更新: 2023年1月9日

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: 51

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1.The patient has signed an informed consent form (ICF), stating that he or she understands the purpose of the procedures required for the study and is willing to participate in the study. The patient must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as stated in the ICF.
•2.Male or female patients aged 18 years or older at the time of the ICF signature.
•3.Patients diagnosed with MM based on the International Myeloma Working Group (IMWG) criteria.
•4.Patients with severe RI defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 (calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) or in need for dialysis.
•5.Patients with current evidence of measurable disease defined as:
•-Serum monoclonal protein (M-protein) level =0.5 g/dL, measured using serum protein electrophoresis (SPEP) and/or
•-Urine M-protein level =200 mg/24 hours, measured using urine protein electrophoresis (UPEP), or
•-Serum immunoglobulin free light chain (FLC) =10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
•6.Adequate bone marrow and hepatic function as defined by ALL the laboratory criteria:
•-Absolute Neutrophil Count (ANC) =1.0 x 109/L (GCSF administration is not allowed to reach this level)
•-Hemoglobin level =7.5 g/dL (=4.65 mmol/L)
•-Platelet count =75 x 109/L in patients in whom <50% of bone marrow nucleated cells are plasma cells OR Platelet count =50 x 109/L in patients in whom = 50% of bone marrow nucleated cells are plasma cells (transfusions are not allowed to reach this level)
•-Alanine aminotransferase (ALT) level =2.5 x the upper limit of normal (ULN)
•-Aspartate aminotransferase (AST) level =2.5 x ULN
•-Total bilirubin level =1.5 x ULN (except for Gilbert Syndrome: direct bilirubin =1.5 x ULN)
•-Serum calcium corrected for albumin =14.0 mg/dL (=3.5 mmol/L), or free ionized calcium = 6.5 mg/dL (=1.6 mmol/L)
•7.Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 2 (see Appendix C)
•8.For patients experiencing toxicities resulting from previous therapy, the toxicities must be resolved or stabilized to = Grade 1
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 31

排除标准

•1.Prior or current systemic therapy or stem-cell transplantation for any plasma cell dyscrasia, with the exception of emergency use of a short course (the equivalent of dexamethasone 40 mg/day for a maximum of 4 days) of corticosteroids before treatment.
•2.History of malignancy (other than MM) within three years before Cycle 1, Day 1 (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, are considered cured with minimal risk of recurrence within three years).
•3.Clinical signs of meningeal involvement of MM.
•4.Clinically significant cardiac disease, including:
•-Myocardial infarction within six months before Cycle 1, Day 1, or unstable or uncontrolled condition (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV).
•-Cardiac arrhythmia (Common Terminology Criteria for Adverse Events Grade 3 or higher) or clinically significant electrocardiogram (ECG) abnormalities
•-ECG showing a baseline QT interval as corrected QTc >470 msec.
•-Active hepatitis A
•-To be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen). Patients with resolved infection (i.e., patients who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded
•Exception: Patients with serologic findings suggestive of HBV vaccination (antiHBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
•-To be seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)
•-Known to be seropositive for human immunodeficiency virus.
•6.Patient has plasma cell leukemia (>2.0 × 109/L circulating plasma cells by standard differential) or Waldenström’s macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or amyloidosis.
•7.Any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.
•8.Ongoing =Grade 2 peripheral neuropathy.
•9.Patient has had major surgery within two weeks before C1D1, or has not fully recovered from an earlier surgery, or has a surgery planned during the time the patient is expected to participate in the study or within two weeks after the last dose of study drug administration. Note: patients with planned surgical procedures to be conducted under local anesthesia may participate.Kyphoplasty or vertebroplasty are not considered major surgery.
•10.Patient has known allergies, hypersensitivity, or intolerance to any of the study drugs, monoclonal antibodies, human proteins, or their excipients (refer to isatuximab Investigator’s Brochure) or known sensitivity to mammalian-derived products.
•11.Patient was vaccinated with live vaccines within four weeks prior to C1D1
•12.Pregnant or nursing women

研究者

发起方

Hellenic Society of Hematology (EAE)

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