[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-myeloma-and-other-plasma-cell-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-myeloma-and-other-plasma-cell-neoplasms":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100633676","phase-1-study-to-assess-safety-and-efficacy-of-hdp-101-in-chinese-patients-with-relapsed-or-refractory-multiple-myeloma-100633676",false,"NCT07529782","Study to Assess Safety and Efficacy of HDP-101 in Chinese Patients With Relapsed or Refractory Multiple Myeloma","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Chinese Patients With Plasma Cell Disorders Including Multiple Myeloma","Inclusion Criteria:\n\n* Male or female aged ≥18 years.\n* Life expectancy \\>12 weeks.\n* Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2.\n* A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).\n* Must have undergone SCT or is considered transplant ineligible.\n* Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and anti-CD38 treatment, alone or in combination. In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator.\n* Measurable disease as per IMWG criteria (Dose-escalation part only: patients with non-secretory or oligo-secretory myeloma (NSMM) not meeting the measurability criteria are eligible).\n* Adequate organ system function as defined in protocol.\n\nExclusion Criteria:\n\n* Known central nervous system involvement.\n* Plasma cell leukemia.\n* History of congestive heart failure.\n* Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.\n* Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.\n* Radiotherapy within 21 days prior to the first study treatment infusion.\n* History of any other malignancy known to be active.\n* Known human immunodeficiency virus infection.\n* Patients with active infection requiring systemic anti-infective therapy.\n* Patients with positive hepatitis B virus (HBV) infection or positive hepatitis C virus (HCV) infection.\n* Current active liver or biliary disease.\n* Pregnancy or breast feeding.\n* Pneumonia or symptomatic pneumonitis.","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is a 2-part study with a dose-escalation part and a dose-expansion part. The aim of the dose-escalation part is to determine the maximum tolerated dose (MTD) and\u002For establish the recommended Phase 2 dose (RP2D) in the Chinese population, in order to select the treatment dose for the dose-expansion part. The dose-escalation part will be followed by the dose-expansion part once the MTD(s) and\u002For RP2D of HDP-101 monotherapy in the Chinese population have been determined. The dose-expansion part of the study is intended to collect preliminary evidence of antitumor activity and to confirm the safety of the HDP-101 as monotherapy in Chinese patients with r\u002Fr MM.",[26],"Multiple Myeloma and Other Plasma Cell Neoplasms",[28,29],"multiple myeloma","myeloma","RECRUITING","2026-04-13",{"date":33,"type":34},"2026-04-14","ACTUAL",{"date":36,"type":34},"2026-03-17",{"date":38,"type":20},"2026-12-31",{"name":40,"class":41},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",5,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100574497","longitudinal-data-registry-of-plasma-cell-dyscrasia-100574497","NCT06760052","Longitudinal Data Registry of Plasma Cell Dyscrasia","Longitudinal Data Registry of a Spectrum of Plasma Cell Dyscrasia with Long-term Follow-up","Inclusion Criteria:\n\nPatients with pathological diagnosis of PCD \\[e.g.: symptomatic\u002Fasymptomatic multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), POEMS syndrome, light chain (AL) amyloidosis) from 2007 to 2027 in Zhonshan Hospital.\n\nPatients who had complete diagnostic, treatment and follow-up records. With fully comprehension and signature of the informed consent form (ICF) for participation.\n\nExclusion Criteria:\n\nPatients who refused to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.\n\nPatients who suffered from severe mental illness. Patients who were deemed unsuitable for inclusion by the investigator.","19 Years","99 Years",{"count":53,"type":20},2000,"OBSERVATIONAL","This study aims to identify clinical characteristics, response and clinical outcome of plasma cell dyscrasia (PCD) diagnosed in Zhongshan Hospital, Fudan University from May 2023. In its current version, the registry incorporates historical data (collected from 2007) and is prospectively collecting follow-up data and recording patient outcomes.",[26],"2024-12-30",{"date":59,"type":34},"2025-01-06",{"date":61,"type":34},"2023-03-01",{"date":63,"type":20},"2028-12-31",{"name":65,"class":66},"Shanghai Zhongshan Hospital","OTHER",1]