[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540273":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":41,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":39,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":39,"enrollmentInfo":56,"targetDuration":39,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":39,"overallStatus":66,"whyStopped":39,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":39},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Narlumosbart","EXPERIMENTAL","120 mg SC Q4W, up to 2 years.",[13],"Drug: Narlumosbart",{"label":15,"type":16,"description":11,"interventionNames":17},"Denosumab","ACTIVE_COMPARATOR",[18],"Drug: Denosumab",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Administered by subcutaneous injection once every 4 weeks.",[9],[25],"Narlumosbart Injection, JMT103",{"type":21,"name":15,"description":22,"armGroupLabels":27,"otherNames":28},[15],[29],"XGEVA®, AMG 162",[31],{"name":32,"affiliation":5,"role":33},"Jian Hou, M.D.","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Honghui Huang, M.D.","CONTACT","00862168383141",null,"honghui_huang@163.com",{"type":42,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[44],{"name":45,"class":46},"Shanghai JMT-Bio Inc.","INDUSTRY","100540273","phase-3-narlumosbart-compared-with-denosumab-in-patients-with-multiple-myeloma-bone-disease-100540273",false,"NCT06314698","Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease","A Multicenter, Randomized, Controlled, Non-inferiority Study of Narlumosbart Compared With Denosumab in the Treatment of Bone Disease in Patients With Multiple Myeloma","Inclusion Criteria:\n\n1. Subjects fully understand and voluntarily participate in this study and sign the informed consent;\n2. Age≥18, no gender limitation;\n3. Active multiple myeloma patients with newly diagnosed by International Myeloma Working Group (IMWG) 2014 criteria;\n4. Measurable lesion per at least one of the following criteria : Serum monoclonal protein ≥10 g\u002FL; Urinary monoclonal protein ≥200 mg\u002F24h; Serum free Light Chain (FLC) assay showed an involved FLC level ≥100 mg\u002FL with abnormal ratio for FLC (κ\u002Fλ);\n5. Radiographic \\[X-ray, computer tomography (CT), magnetic resonance imaging (MRI), positons emission tomography coupled with a computer tomography (PET-CT)\\] evidence of at least one lytic bone lesion;\n6. Plan to receive primary frontline anti-myeloma therapies, or receiving less than one cycle of frontline anti-myeloma therapy (less than 30 days, does not include radiotherapy or a single short course of steroid), the treatment regimens were limited to VRd, D-VRd, DRd, and VCd;\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n8. Adequate organ function, as defined by the following criteria (per laboratory values):\n\n   1. Liver function: Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN), Serum alanine aminotransferase ≤ (ALT) 2.0 x ULN, Serum aspartate aminotransferase (AST) ≤ 2.0 x ULN\n   2. Renal function: Serum creatinine clearance (CrCL) ≥ 30 mL\u002Fmin, calculated by the Cockcroft-Gault formula\n   3. Serum calcium or albumin-adjusted serum calcium ≥2.0 mmol\u002FL (8.0 mg\u002FdL) and ≤ 2.9 mmol\u002FL (11.5 mg\u002FdL)\n9. Reproductive potential subjects should be receiving effective contraception (Both male and female reproductive potential subjects, from the date of signing the informed consent to 6 months after the end of treatment);\n10. Expected survival time ≥ 3 months;\n\nExclusion Criteria:\n\n1. POEMS syndrome;\n2. Plasma cell leukemia;\n3. Prior history or current evidence of osteonecrosis\u002Fosteomyelitis of the jaw; Non-healed dental\u002Foral surgery, including tooth extraction; Active dental or jaw condition which requires oral surgery; Planned invasive dental procedures;\n4. Planned radiation therapy or Orthopedic surgery;\n5. Prior administration of denosumab or bisphosphonates;\n6. Patients with active bone metabolic diseases (Paget disease of bone, Cushing syndrome and hyperprolactinemia), rheumatoid arthritis, uncontrolled hyper\u002Fhypothyroidism or hyper\u002Fhypoparathyroidism;\n7. Uncontrolled concurrent diseases, including but not limited to: symptomatic congestive heart failure, hypertension (blood pressure remains \\> 150\u002F90 mmHg after standard therapy), unstable angina, arrhythmia requiring medication or instruments, history of myocardial infarction within 6 months, echocardiography showing left ventricular ejection fraction \\\u003C50%;\n8. Active bacterial or fungal infections requiring systemic treatment within 7 days before randomization;\n9. Known infection with human immunodeficiency virus (HIV), active infection with Hepatitis B virus (positive hepatitis B surface antigen and positive HBV-DNA) or Hepatitis C virus(positive hepatitis C surface antigen and positive HCV-RNA);\n10. Pregnancy (serum β-HCG positive) or lactation;\n11. Use of any of the following anti-bone metabolism drugs within 6 months before enrollment:\n\n    1. parathyroid hormonerelated peptides\n    2. calcitonin\n    3. osteoprotegerin\n    4. mithramycin\n    5. strontium ranelate\n12. Known sensitivity to narlumosbart, denosumab, calcium or vitamin D;\n13. Any other factors not suitable for participation in this study that in the opinion of the investigator.","ALL","18 Years",{"count":57,"type":58},478,"ESTIMATED","INTERVENTIONAL",[61],"PHASE3","The purpose of this study is to determine if narlumosbart is non-inferior to denosumab in the treatment of bone diseases from multiple myeloma (MM).",[64,65],"Multiple Myeloma","Bone Diseases","NOT_YET_RECRUITING","2024-03-14",{"date":69,"type":70},"2024-03-18","ACTUAL",{"date":72,"type":58},"2024-04-01",{"date":74,"type":58},"2027-04-30",{"name":5,"class":6}]