A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Previously Untreated Multiple Myeloma who are Eligible for High-dose Therapy - EMN17/54767414MMY3014 - EMN1754767414MMY3014

European Myeloma Network Stichting0 个研究点目标入组 824 人开始时间: 2024年1月19日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: European Myeloma Network Stichting
入组人数: 824

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

•18 to 70 years of age, inclusive., Male subjects of reproductive potential who are sexually active with females of reproductive potential must always use a latex or synthetic condom during the study and for 3 months after discontinuing study treatment (even after a successful vasectomy)., Male subjects of reproductive potential must not donate sperm during the study or for 3 months after the last dose of study treatment., Criterion modified per Amendment 2 12.1 Signed an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. Subjects in emergency situations that do not allow for collection of informed consent are excluded., Able to adhere to the prohibitions and restrictions specified in this protocol., Monoclonal plasma cells in the bone marrow =10% or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria: CRAB criteria: 1. Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL) 2. Renal insufficiency: creatinine clearance <40mL/min or serum creatinine >177 µmol/L (>2 mg/dL) 3. Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL 4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT Biomarkers of Malignancy: a. Clonal bone marrow plasma cell percentage =60% b. Involved: uninvolved serum FLC ratio =100 c. >1 focal lesion on magnetic resonance imaging (MRI) studies, Measurable disease as defined by any of the following: a. Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level =200 mg/24 hours; or b. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin FLC =10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio, Newly diagnosed subjects for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan., Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see Attachment 1)., Clinical laboratory values meeting the following criteria during the Screening Phase (screening hematology and chemistry tests should be repeated if done more than 3 days before C1D1): Adequate bone marrow function: a. Hemoglobin =7.5 g/dL (=4.65 mmol/L; prior red blood cell [RBC] transfusion or recombinant human erythropoietin use is permitted however transfusions are not permitted within 7 days of randomization to achieve this minimum hemoglobin count); b. Absolute neutrophil count (ANC) =1.0 x 10^9/L (G-CSF use is permitted); c. Platelet count =50 x 10^9/L if bone marrow is >50% involved in myeloma. Otherwise =75 x 10^9/L Adequate liver function: a. Aspartate aminotransferase (AST) =2.5 x ULN; b. Alanine aminotransferase (ALT) =2.5 x ULN; c. Total bilirubin =1.5 x ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome, direct bilirubin =1.5 x ULN) Adequate renal function: a. Estimated creatinine clearance =30 mL/min. Creatinine clearance may be calculated using Cockcroft-Gault, eGFR (Modified Diet in Renal Disease [MDRD]; Attachment 2), or CKD-epi formula b. Corrected serum calcium =13.5 mg/dL (=3.4 mmol/L); or free ionized calcium =6.

排除标准

•Prior or current systemic therapy or SCT for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment., Concurrent medical or psychiatric condition or disease (such as, but not limited to, systemic amyloidosis, POEMS, 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., Criterion modified per Amendment 2 11.1 Any of the following: a. myocardial infarction within 6 months before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV) b. uncontrolled cardiac arrhythmia c. screening 12-lead ECG showing a baseline QT interval >470 msec (exception: subjects with pacemaker) d. screening ECHO or MUGA scan for subjects aged >65-70: left ventricular ejection fraction (LVEF) <40%, Received a strong CYP3A4 inducer within 5 half-lives prior to randomization (Flockhart 2016: http://medicine.iupui.edu/flockhart/), Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to the Investigator's Brochure), or sensitivity to mammalian-derived products or lenalidomide or its excipients., Criterion modified per Amendment 2 14.1 Not able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder). Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. Subject is taking any prohibited medications as per Section 8.3. Subject is deprived of their freedom by a judicial or administrative decision, or subject is in psychiatric care. Subject is subjected to a legal protection measure or unable to provide their consent., Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen. Or, subject is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of any component of the treatment regimen., Major surgery within 2 weeks before randomization or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Kyphoplasty or Vertebroplasty is not considered major surgery., Criterion modified per Amendment 2 17.1 Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or 5 half-lives of the respective drug/investigational medicinal product (IMP) (whichever is longer) before randomization or is currently enrolled in an interventional investigational study., Contraindications to the use of any components of the backbone treatment regimens, per local prescribing information., Gastrointestinal disease that may significantly alter the absorption of oral drugs, Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Termin

研究者

发起方

European Myeloma Network Stichting

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