[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655535":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":11,"studyPopulation":11,"armGroups":41,"interventions":49,"overallOfficials":11,"centralContacts":59,"locations":65,"responsibleParty":80,"collaborators":11,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":11,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":103,"whyStopped":11,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Response Rate (ORR)",null,"From the first dose to the end of Cycle 24 (each cycle is 28 days).",[14,16,18,20,23,26,29,32],{"measure":15,"description":11,"timeFrame":12},"Extramedullary Disease Objective Response Rate (EMD-ORR)",{"measure":17,"description":11,"timeFrame":12},"Very Good Partial Response or Better Rate (≥VGPR Rate)",{"measure":19,"description":11,"timeFrame":12},"Complete Response or Stringent Complete Response Rate (CR\u002FsCR Rate)",{"measure":21,"description":11,"timeFrame":22},"Time to Response (TTR)","From the first dose to the date of the first documented overall response of PR or better, assessed through the end of Cycle 24 (each cycle is 28 days).",{"measure":24,"description":11,"timeFrame":25},"Duration of Response (DoR)","From the date of the first documented overall response of PR or better to the date of disease progression or death from any cause, whichever occurs first, with follow-up through 12 months after the last dose.",{"measure":27,"description":11,"timeFrame":28},"Progression-Free Survival (PFS)","From the date of the first dose to the date of disease progression or death from any cause, whichever occurs first, with follow-up through 12 months after the last dose.",{"measure":30,"description":11,"timeFrame":31},"Overall Survival (OS)","From the date of the first dose to the date of death from any cause, with follow-up through 12 months after the last dose.",{"measure":33,"description":11,"timeFrame":34},"Incidence and Severity of Adverse Events (AEs)","Up to 2 years.",{"allocation":36,"interventionModel":37,"interventionModelDescription":11,"primaryPurpose":38,"observationalModel":11,"timePerspective":11,"maskingInfo":39},"NA","SINGLE_GROUP","TREATMENT",{"masking":40,"maskingDescription":11,"whoMasked":11},"NONE",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"HP-001 Plus Dexamethasone","EXPERIMENTAL","Participants will receive HP-001 capsules at 0.6 mg orally once daily on Days 1-10 of each 28-day treatment cycle, in combination with dexamethasone 40 mg administered orally or intravenously on Days 1, 8, 15, and 22 of each cycle. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, the investigator determines that continued treatment is no longer appropriate, or completion of 24 treatment cycles, whichever occurs first.",[47,48],"Drug: HP-001","Drug: Dexamethasone",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":11},"DRUG","HP-001","HP-001 capsules will be administered orally at a dose of 0.6 mg once daily on Days 1-10 of each 28-day treatment cycle.",[43],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":11},"Dexamethasone","Dexamethasone will be administered at a dose of 40 mg orally or intravenously on Days 1, 8, 15, and 22 of each 28-day treatment cycle.",[43],[60],{"name":61,"role":62,"phone":63,"phoneExt":11,"email":64},"Gang An, PhD&MD","CONTACT","13502181109","angang@ihcams.ac.cn",[66],{"facility":67,"status":11,"city":68,"state":11,"zip":11,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin, 300000","Tianjin","China","CN",{"type":72,"coordinates":73},"Point",[74,75],117.17667,39.14222,{"lat":75,"lon":74},[78],{"name":61,"role":62,"phone":79,"phoneExt":11,"email":64},"008613502181109",{"type":81,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655535","phase-2-hp-001-plus-dexamethasone-for-relapsedrefractory-multiple-myeloma-with-extramedullary-disease-100655535",false,"NCT07811986","HP-001 Plus Dexamethasone for Relapsed\u002FRefractory Multiple Myeloma With Extramedullary Disease","A Prospective, Single-Arm, Exploratory Phase II Clinical Trial of HP-001 in Combination With Dexamethasone for Relapsed\u002FRefractory Multiple Myeloma With Extramedullary Disease","BEYOND-MM 001","Inclusion Criteria\n\n1. Age ≥18 years at the time of signing informed consent; male or female.\n2. ECOG performance status of 0-2.\n3. Diagnosis of multiple myeloma according to IMWG criteria, with relapsed\u002Frefractory disease after at least 1 prior systemic treatment regimen; disease progression or failure to achieve a response after the most recent line of therapy; and extramedullary disease confirmed by imaging, defined as at least 1 soft-tissue extramedullary lesion ≥2 cm, at least 1 paramedullary lesion ≥5 cm, or \\>2 lesions.\n4. With or without measurable hematologic disease at screening. Measurable disease, if present, is defined as serum M-protein ≥1.0 g\u002FdL, urine M-protein ≥200 mg\u002F24 hours, or serum free light chain ≥10 mg\u002FdL with an abnormal free light chain ratio.\n5. Adequate organ function, including ANC ≥1.0 × 10⁹\u002FL, hemoglobin ≥60 g\u002FL, platelet count ≥50 × 10⁹\u002FL, creatinine clearance ≥30 mL\u002Fmin, total bilirubin ≤2 × ULN (≤3 × ULN for Gilbert syndrome), AST and ALT ≤2.5 × ULN, and INR or aPTT ≤1.5 × ULN.\n6. Willing and able to comply with study procedures and follow-up.\n\nExclusion Criteria\n\n1. Smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, Waldenström macroglobulinemia, POEMS syndrome, amyloidosis, or primary\u002Fsecondary plasma cell leukemia.\n2. Central nervous system involvement or clinical evidence of meningeal involvement.\n3. Severe or uncontrolled cardiovascular disease, including unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months before enrollment, severe uncontrolled arrhythmia, or other cardiovascular\u002Fcerebrovascular conditions considered unsuitable by the investigator.\n4. Major surgery within 4 weeks before the first dose or planned major surgery during the study.\n5. Active infection, including HIV infection, active hepatitis B (HBV-DNA positive), active hepatitis C (HCV-RNA positive), active or latent syphilis, active tuberculosis, or other active infections considered unsuitable by the investigator.\n6. Concurrent malignancy or other serious concomitant disease that may compromise participant safety or completion of the study.\n7. Pregnant or breastfeeding women.\n8. History of severe allergy or hypersensitivity to any component of the study treatment.\n9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","ALL","18 Years",{"count":93,"type":94},20,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","This is a prospective, single-arm, exploratory Phase II clinical study evaluating the efficacy and safety of HP-001 capsules in combination with dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) with extramedullary disease (EMD).",[100],"Multiple Myeloma (MM)",[102],"extramedullary multiple myeloma","NOT_YET_RECRUITING","2026-09-04",{"date":106,"type":107},"2026-09-10","ACTUAL",{"date":109,"type":94},"2026-09-01",{"date":111,"type":94},"2028-12-31",{"name":5,"class":6},1]