[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631168":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":35,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":52,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":21,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Shanxi Bethune Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients Receiving Epunamin Combined With DECP-Based Regimen",null,"Patients with relapsed\u002Frefractory Multiple Myeloma will receive Epunamin in combination with a DECP-based regimen as follows:\n\nEpunamin 10 mg\u002Fkg administered on days 1-5, or days 1-3 and days 15-17 Cisplatin 10 mg\u002Fm² on days 1-4 Etoposide 40 mg\u002Fm² on days 1-4 Cyclophosphamide 300 mg\u002Fm² on days 1-4 Dexamethasone 20-40 mg on days 1-4 Each treatment cycle lasts 28 days. Patients achieving clinical benefit will receive at least 4-6 cycles of treatment.\n\nFor first administration, Epunamin will be introduced using a step-up dosing strategy, particularly in patients with high tumor burden or extramedullary bulky disease. The DECP regimen will start at 1\u002F2 to 2\u002F3 of the standard dose, and in patients older than 70 years, treatment will begin at 1\u002F2 dose.During treatment, thromboprophylaxis with low-molecular-weight heparin or Rivaroxaban will be administered to prevent thrombotic events.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Tian Weiwei Tian Weiwei, PhD","CONTACT","+156-13485304136","tianweiwei@yesh.net",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"ShanxiBethuneH","RECRUITING","Taiyuan","Shanxi","030000","China","CN",{"type":28,"coordinates":29},"Point",[30,31],112.56028,37.86944,{"lat":31,"lon":30},[34],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Weiwei Tian","Chief of Department","100631168","epunamin-combined-with-decp-for-relapsedrefractory-multiple-myeloma-100631168",false,"NCT07497165","Epunamin Combined With DECP for Relapsed\u002FRefractory Multiple Myeloma","A Multicenter Real-World Study Evaluating Epunamin in Combination With a DECP-Based Regimen for Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\nAdults aged 18 to 75 years with relapsed\u002Frefractory Multiple Myeloma diagnosed according to revised IMWG criteria.\n\nReceived at least one prior systemic treatment regimen. Eastern Cooperative Oncology Group Performance Status score of 0-3. Able to understand treatment-related changes and management options during therapy and follow-up, with good treatment adherence and follow-up compliance.\n\nProvided written informed consent. -\n\nExclusion Criteria:\n\nSevere dysfunction of major organs, including cardiac, pulmonary, hepatic, or renal impairment, defined as left ventricular ejection fraction \\\u003C50%, diffusion capacity for carbon monoxide \\\u003C50% of predicted value due to chronic respiratory disease, serum bilirubin \\>2 mg\u002FdL, alanine aminotransferase or aspartate aminotransferase \\>2.5 × upper limit of normal, or estimated glomerular filtration rate \\\u003C30 mL\u002Fmin.\n\nToxicities from prior chemotherapy not recovered to baseline or grade ≤1. Peripheral neuropathy grade ≥2, or grade 1 with pain. Major surgery, radiotherapy, infection requiring systemic antibiotic treatment, or other severe infection within 14 days before enrollment.\n\nHigh-risk plasma cell leukemia with peripheral blood plasma cells ≥20%. Psychiatric disorders, cognitive impairment, or other conditions affecting self-control or study compliance.\n\nPregnant or breastfeeding women, or fertile patients unwilling to use adequate contraception during the study. Male patients unwilling to use effective contraception or refrain from sperm donation during treatment and for 3 months after the last dose.\n\nDiagnosis or treatment of another malignancy within 2 years before enrollment. Known hypersensitivity to Epunamin, Dexamethasone, Cisplatin, Etoposide, or Cyclophosphamide.\n\nHuman Immunodeficiency Virus Infection positive. Participation in another clinical trial within 30 days before enrollment or during the study period.\n\nAny condition considered unsuitable for participation by the investigator.","ALL","18 Years","75 Years",{"count":50,"type":51},48,"ESTIMATED","17 Months","OBSERVATIONAL","Background:\n\nMultiple Myeloma remains an incurable hematologic malignancy, and outcomes for relapsed\u002Frefractory multiple myeloma (RRMM) remain unsatisfactory despite advances in therapy. This study aims to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in a real-world clinical setting.\n\nMethods:\n\nThis multicenter, single-arm, real-world observational study will enroll 48 patients aged 18-75 years with RRMM diagnosed according to revised IMWG criteria who have received at least one prior systemic treatment. Eligible patients must have an ECOG performance status of 0-3, adequate treatment compliance, and written informed consent.\n\nKey exclusion criteria include severe cardiac, pulmonary, hepatic, or renal dysfunction; unresolved prior treatment toxicity above grade 1; grade ≥2 peripheral neuropathy or grade 1 with pain; severe infection within 14 days; plasma cell leukemia; psychiatric disorders affecting compliance; pregnancy or lactation; recent other malignancies; hypersensitivity to study drugs; HIV infection; participation in another clinical trial within 30 days; or any condition deemed unsuitable by investigators.\n\nEndpoints:\n\nThe primary endpoint is overall response rate (ORR) after four treatment cycles. Secondary endpoints include very good partial response (VGPR), complete response (CR), stringent complete response (sCR), minimal residual disease (MRD), duration of response (DOR), and time to next treatment (TTNT), assessed according to revised IMWG criteria.\n\nStatistical Analysis:\n\nContinuous variables will be summarized using mean, median, standard deviation, minimum, and maximum values. Normally distributed data will be analyzed using Student's t-test or ANOVA, while non-normally distributed data will use rank-sum tests. Categorical variables will be analyzed using chi-square or Fisher's exact tests, and ordinal variables by Ridit analysis or nonparametric tests. Survival outcomes including progression-free survival (PFS) and overall survival (OS) will be estimated using Kaplan-Meier analysis and compared by log-rank test. A two-sided P value \\\u003C0.05 will be considered statistically significant.\n\nStudy Period:\n\nOctober 2025 to September 2027.",[56,57],"Relapsed\u002FRefractory Multiple Myeloma (RRMM)","Multiple Myeloma",[59,60,57],"Epunamin","DECP-Based Regimen","2026-03-23",{"date":63,"type":64},"2026-03-27","ACTUAL",{"date":66,"type":64},"2025-11-01",{"date":68,"type":51},"2027-06-30",{"name":5,"class":6},1]