[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cryoglobulinemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cryoglobulinemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100340846","registry-for-adults-with-plasma-cell-disorders-pcds-100340846",false,"NCT03717844","Registry for Adults With Plasma Cell Disorders (PCD's)","Inclusion Criteria:\n\n* Patients have an outpatient appointment or are hospitalized inpatient at UNC Cancer Hospitals, or affiliated clinic settings or participating sites for the evaluation and management of a PCD.\n* Patients have a documented diagnosis of PCD defined as the presence of a monoclonal protein and\u002For monoclonal plasma cell population. Examples of PCDs include but are not limited to monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple (active) myeloma; plasma cell leukemia; Castleman's disease; amyloidosis; light and\u002For heavy chain deposition disease; Polyneuropathy, Organomegaly, Endocrinopathy,Monoclonal gammopathy and Skin changes (POEMS) syndrome; and cryoglobulinemia.\n* Age ≥18 years.\n* Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points.\n* Must be able to read and speak English.\n\nExclusion Criteria:\n\n* Physical or psychiatric\u002Fbehavioral illnesses or problems that the treating clinician feels would preclude successful participation in the study.\n* There are no imaging or lab studies required to determine eligibility.","ALL","18 Years",{"count":18,"type":19},2000,"ESTIMATED","10 Years","OBSERVATIONAL","The primary purpose of this protocol is to create a registry of patients with plasma cell disorders (PCDs), including for example the cancer multiple myeloma (MM), who complete the assessment, previously known as a \"geriatric assessment,\" as is outlined in this protocol. Secondary objectives include measuring the response rate to participation of patients in this study, assessing patient satisfaction with the questionnaire, and gathering information that would lend support for future research into these types of assessments in patients with PCDs. Additionally the study offers an optional blood draw to look at a genetic marker of aging called p16INK4a (IRB 15-1899, IRB 15-0244).",[24,25,26,27,28,29,30,31,32],"Multiple Myeloma","Amyloidosis","Cryoglobulinemia","Castleman's Disease","Light Chain Deposition Disease","Heavy Chain Deposition Disease","Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes","Smoldering Multiple Myeloma","Plasma Cell Leukemia","RECRUITING","2025-11-19",{"date":36,"type":37},"2025-11-20","ACTUAL",{"date":39,"type":37},"2018-02-09",{"date":41,"type":19},"2029-02",{"name":43,"class":44},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100410794","phase-2-efficacy-and-safety-of-belimumab-in-the-treatment-of-non-infectious-active-cryoglobulinemia-vasculitis-compared-to-placebo-tribeca-study-treatment-nd-belimumab-in-cryoglobulinemia-associated-vasculitis-100410794","NCT04629144","Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)","Multicenter Randomized Double-blind Study Comparing the Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)","TRIBECA","Inclusion Criteria:\n\nThe eligibility criteria will be checked at the inclusion\u002Frandomization visit. Patients meeting the following criteria may be included in the study:\n\n1. Age \\> 18 years\n2. Written inform consent\n3. Active mixed cryoglobulinemia vasculitis, at initiation of rituximab, define by a. a clinically active vasculitis with skin, joint, renal, peripheral nerve, central neurological, digestive, pulmonary and\u002For cardiac involvement , b. history of positive cryoglobulinemia and\u002For positive Rheumatoid factor associated with low C4 complement level , and\u002For a monoclonal component (IgM Kappa) and\u002For a histologal proof of vasculitis in the affected organs\n4. Affiliated to National French social security system\n5. Having received Rituximab as induction therapy within 6 weeks (1 to 4 infusions, dose at the discretion of the investigator)\n6. Female subjects of childbearing potential must have a negative serum or urinary pregnancy test at inclusion visit, and confirmed monthly while in study, out to at least 92 days (5 half lives) post last dose.\n7. For subjects with reproductive potential (male or female), a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study from 2 weeks prior to administration of the 1st dose of study agent until 92 days after the last dose of study agent. Therefore the subjects agree to 1 of the following:\n\n   1. Complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent until 92 days after the last dose of study agent (Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception) OR\n   2. Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the study agent, during the study, and 92 days after the last dose of study agent o Oral contraceptive, either combined or progestogen alone o Injectable progestogen o Implants of levonorgestrel or etonogestrel o Estrogenic vaginal ring o Percutaneous contraceptive patches o Intrauterine device (IUD) or intrauterine system (IUS) with \\\u003C1% failure rate as stated in the product label\n\n      o Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, \"documented\" refers to the outcome of the investigator's\u002Fdesignee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records\n      * Double barrier method: condom and occlusive cap (diaphragm or cervical\u002Fvault caps) plus spermicidal agent (foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception.\n8. HIV negative serology ; negative HBs Ag test and HBc Ab test; HCV negative serology or negative HCV RNA if positive HCV serology within 3 months before inclusion:\n\n   o In case of negative AgHBs and positive HBc Ab test, HBV DNA test must be negative; AND Hepatitis B surveillance should be started (monthly HBsAg and HBV DNA testing for the duration of the study treatment and at least every 12 weeks after treatment is discontinued for the duration of study treatment. In addition, antiviral prophylaxis should be started before the first administration of the study treatment and continued until 12 months after completion of study treatment; HCV negative serology or negative HCV RNA if positive HCV serology within 3 months before inclusion\n9. neutrophils (ANC) \\>1x109\u002FL\n\nExclusion criteria :\n\nSubjects will be not included from the study if they meet any of the following criteria:\n\n1. Patient with a vasculitis unrelated to cryoglobulinemia\n2. Patient with non active cryoglobulinemia vasculitis, at initiation of rituximab. Patients with mixed inactive vasculitis following rituximab administration may be included.\n3. Excluded concomitant medications:\n\n   1. 365 days Prior to Investigational Medicinal Product (Belimumab or placebo):: Any biologic investigational agent (e.g., abetimus sodium, anti CD40L antibody, BG9588\u002F IDEC 131) Investigational agent applies to any drug not approved for sale in the country in which it is being used\n   2. 180 Days Prior to Investigational Medicinal Product (Belimumab or placebo):: Intravenous cyclophosphamide\n   3. 30 Days Prior to Investigational Medicinal Product (Belimumab or placebo): (or 5 half lives, whichever is greater) Any non-biologic investigational agent Investigational agent applies to any drug not approved for sale in the country in which it is being use\n   4. Live vaccines within 30 days prior to baseline or concurrently with Investigational Medicinal Product (Belimumab or placebo)\n4. Have a history of malignant neoplasm within the last 5 years, other than carcinoma in situ of the cervix or excised basal cell, squamous cell carcinoma of the skin and low grade hemopathy with no indication for a specific treatment\n5. Have evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and\u002For any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk\n6. Have a Progressive multifocal leukoencephalopathy\n7. Have a history of a primary immunodeficiency\n\n9\\. Have a history of major organ transplant or hematopoietic stem cell\u002Fmarrow transplant or renal transplant\n\n10\\. Infection history:\n\n* Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus\n* Infection requiring hospitalization and\u002For use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of the inclusion visit.\n\n  11\\. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to the inclusion visit\n\n  12\\. Have a historically positive HIV test according to results obtained within 3 months prior to inclusion visit\n\n  13\\. Hepatitis status according to results obtained within 3 month prior to inclusion visit :\n* Positive test for hepatitis B RNA\n* Positive test for Hepatitis C RNA\n\n  14\\. Have a history of a hypersensitivity or an anaphylactic reaction to parenteral administration of Belimumab, corticosteroids or any excipients of the treatments administered during the study\n\n  15\\. If Women of Child Bearing Potential (WCBP) are included please see special instructions in Inclusion criteria\n\n  16\\. Pregnant or breast feeding women\n\n  17\\. Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study\n\n  18\\. Patients under legal protection or unable to consent\n\n  19\\. Participation to another interventional study",{"count":55,"type":19},48,"INTERVENTIONAL",[58],"PHASE2","Cryoglobulinemia vasculitis (CV) is a systemic immune-mediated small vessel vasculitis. Rituximab proved effective on main vasculitis signs, with a complete clinical response of 65%. However, CV relapse is noted in up to 40% of patients. Following rituximab, serum Blys concentration significantly increased and may favor relapses. Tribeca is a multicentre randomized controled study comparing safety and efficacy of belimumab to placebo in non infectious cryoglobulinemia vasculitis.",[61,26],"Vasculitis",[63,61,26,64],"Belimumab","Non-infectious","2024-06-24",{"date":67,"type":37},"2024-06-26",{"date":69,"type":37},"2021-10-20",{"date":71,"type":19},"2025-10-20",{"name":73,"class":44},"Assistance Publique - Hôpitaux de Paris",20,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100461081","a-cohort-study-of-plasma-cell-disorders-pcds-in-pkufh-100461081","NCT05283993","A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH","A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH","Inclusion Criteria:\n\n1. Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)\n2. Patients of plasma cell disorders (PCDs) are recruited. PCDs include monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple myeloma; plasma cell leukemia; amyloidosis; light chain deposition disease; heavy chain deposition disease; Castleman's disease (CD); Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes syndrome; cryoglobulinemia; Monoclonal Gammopathy of Renal Significance (MGRS); Monoclonal gammopathy of neurological significance (MGNS).\n3. Patients are included into this cohort after signing the ICFs.\n\nExclusion Criteria:\n\nSignificant comorbidity may be life-threatening.",true,{"count":18,"type":19},"The primary aim is to establish a prospective cohort of patients with plasma cell disorders (PCDs). All of the hospitalized PCD patients who are willing to sign the informed consent form (ICF) will be included in this study. Clinical characteristics, treatment options and responses will be collected. Peripheral blood, bone marrow aspirate and urine samples before and after the treatment will banked for future research. Our team will focus on the clinical and pathological features of PCDs, the correlation between the minimal residual disease (MRD) status and prognosis, and the role of Tumor Microenvironment (TME) in the pathogenesis and progress of PCDs.",[24,25,26,27,28,29,30,31,32,86,87,88],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","Monoclonal Gammopathy of Renal Significance (MGRS)","Monoclonal Gammopathy of Neurological Significance (MGNS)","2022-04-21",{"date":91,"type":37},"2022-04-25",{"date":93,"type":37},"2021-07-01",{"date":95,"type":19},"2030-12-31",{"name":97,"class":44},"Peking University First Hospital"]