[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512029":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":155,"collaborators":157,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":163,"sex":168,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":28,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":58,"whyStopped":28,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"Centre Leon Berard","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), specific and proactive referrals will be made systematically after each detection visit according to the level of risk, estimated on the basis of decision trees (management guide) and via the dedicated PASCA network of healthcare professionals, to initiate early treatment and follow-up where necessary.",[13,14,15],"Behavioral: Interpretation of the results from the detection visit","Behavioral: Explaining detection results and referrals to the patient","Behavioral: Early medical care through the network",{"label":17,"type":18,"description":19,"interventionNames":20},"Control group","ACTIVE_COMPARATOR","For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective): all the data from each detection visit will be sent to the referring forwarded to the referring onco-haematologists, so that they can initiate their own management.",[21],"Behavioral: Transmission of results from each detection visit to the referring onco-haematologists - Control Group",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BEHAVIORAL","Interpretation of the results from the detection visit","\\- An interpretation of the results of the detection tests concerning\n\n* the 7 complications of interest assessed at T1, T2, T3 and T4 ;\n* the 13 secondary complications assessed at T1, T3 and T4. This interpretation will be based on decision trees (1 tree\u002Fcomplication) to guide investigators in their decision-making and to standardise orientations;",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Explaining detection results and referrals to the patient","Explanation of results and directions to the patient using plain language;The aims of this call are as follows:\n\n* Clearly explain the results of the detection visit and the action to be taken for each referral;\n* Evaluate the help to be given to the patient. This help will consist of making bookings with a healthcare professional in the PASCA network;\n* Reassure patients about their results, but also make them aware of the importance of taking action to improve or prevent the onset of complications.",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Early medical care through the network","Early, proactive medical care through a network of dedicated healthcare professionals.",[9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Transmission of results from each detection visit to the referring onco-haematologists - Control Group","For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective): all the data from each detection visit will be sent to the referring onco-haematologists, so that they can initiate their own management.",[17],[42],{"name":43,"affiliation":5,"role":44},"Mauricette MICHALLET, PhD, MD","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Romain BUONO, PharmaD, MPH","CONTACT","+33469856358","romain.buono@lyon.unicancer.fr",{"name":52,"role":48,"phone":53,"phoneExt":28,"email":54},"Meyssane DJEBALI, Msc","++33426556743","meyssane.djebali@lyon.unicancer.fr",[56,75,90,111,126,140],{"facility":57,"status":58,"city":59,"state":28,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"CH Annecy Genevois","RECRUITING","Épagny","74370","France","FR",{"type":64,"coordinates":65},"Point",[66,67],6.08302,45.93584,{"lat":67,"lon":66},[70,73],{"name":71,"role":48,"phone":28,"phoneExt":28,"email":72},"Marie Lebouc","mlebouc@ch-annecygenevois.fr",{"name":74,"role":44,"phone":28,"phoneExt":28,"email":28},"Adrien CONTEJEAN",{"facility":76,"status":58,"city":77,"state":28,"zip":78,"country":61,"countryCode":62,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"CHU La Tronche","Grenoble","38300",{"type":64,"coordinates":80},[81,82],5.71479,45.17869,{"lat":82,"lon":81},[85,88],{"name":86,"role":48,"phone":28,"phoneExt":28,"email":87},"Marie Moreau","mmoreau2@chu-grenoble.fr",{"name":89,"role":44,"phone":28,"phoneExt":28,"email":28},"Clara Mariette",{"facility":91,"status":58,"city":92,"state":28,"zip":93,"country":61,"countryCode":62,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Centre Léon Bérard","Lyon","69373",{"type":64,"coordinates":95},[96,97],4.84789,45.74906,{"lat":97,"lon":96},[100,104,107,109],{"name":101,"role":48,"phone":102,"phoneExt":28,"email":103},"Mauricette MICHALLET, MD","+3346998566358","mauricette.michallet@lyon.unicancer.fr",{"name":105,"role":106,"phone":28,"phoneExt":28,"email":28},"Amine BELHABRI","SUB_INVESTIGATOR",{"name":108,"role":106,"phone":28,"phoneExt":28,"email":28},"Anne-Sophie MICHALLET",{"name":110,"role":106,"phone":28,"phoneExt":28,"email":28},"Philippe REY",{"facility":112,"status":58,"city":113,"state":28,"zip":114,"country":61,"countryCode":62,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"CENTRE HOSPITALIER UNIVERSITAIRE de MONTPELLIER","Montpellier","34295",{"type":64,"coordinates":116},[117,118],3.87635,43.61093,{"lat":118,"lon":117},[121,124],{"name":122,"role":48,"phone":28,"phoneExt":28,"email":123},"Aude Cavailles","aude.cavailles@chu-montpellier.fr",{"name":125,"role":44,"phone":28,"phoneExt":28,"email":28},"Laure VINCENT",{"facility":127,"status":58,"city":128,"state":28,"zip":28,"country":61,"countryCode":62,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"CHU de St-Etienne","Saint-Etienne",{"type":64,"coordinates":130},[131,132],4.39,45.43389,{"lat":132,"lon":131},[135,138],{"name":136,"role":48,"phone":28,"phoneExt":28,"email":137},"Coralie Durieux","Coralie.Durieux@chu-st-etienne.fr",{"name":139,"role":44,"phone":28,"phoneExt":28,"email":28},"Manon Sapet",{"facility":141,"status":58,"city":142,"state":28,"zip":143,"country":61,"countryCode":62,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Le Centre Hôpitaux Nord-Ouest Villefranche-sur-Saône","Villefranche-sur-Saône","69655",{"type":64,"coordinates":145},[146,147],4.71961,45.98967,{"lat":147,"lon":146},[150,153],{"name":151,"role":48,"phone":28,"phoneExt":28,"email":152},"Manon Collaudin","MCollaudin@hno.fr",{"name":154,"role":44,"phone":28,"phoneExt":28,"email":28},"Jean-François Brantus",{"type":156,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[158],{"name":159,"class":160},"National Cancer Institute, France","OTHER_GOV","100512029","pasca-mm-study-impact-of-the-pasca-parcours-de-sant-au-cours-du-cancer-program-on-complications-associated-with-multiple-myeloma-andor-its-treatments-in-the-context-of-a-first-hematopoietic-stem-cell-autograft-in-adults-aged-18-to-70-100512029",false,"NCT05947136","PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and\u002For Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.","PASCA -MM","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 70 years old.\n2. Patient treated in an investigation center.\n3. Symptomatic multiple myeloma eligible for autologous hematopoietic stem cell transplantation (HSCT).\n4. In complete response, complete response, very good complete response, or partial before HSCT.\n5. First induction-type treatment (Isa-KRD\u002Fdara-VRD\u002Fdara-VTD\u002FVRD\u002FVTD\u002Fdara-VRD), intensification therapy with melphalan, HSCT, consolidation, maintenance including at least one drug immunomodulator.\n6. ECOG performance status WHO ≤ 2.\n7. No history or coexistence of other primary cancer apart from basal cell cancer cutaneous\n8. Able to understand, read and write French.\n9. Having signed and dated the informed consent.\n\nExclusion Criteria:\n\n1. Unable to be monitored for medical, social, family, geographical or psychological, throughout the duration of the study.\n2. Deprived of liberty by court or administrative decision.\n3. Not affiliated with a health insurance plan.\n4. Not having declared an attending physician.\n5. Not domiciled in the Auvergne-Rhône-Alpes region or in the Saône-et-Loire department.\n6. Not available and\u002For not willing to participate in the project for the entire duration of the study.\n7. Pregnant women, breastfeeding women, people in emergency situations, people incapable of personally giving their consent including adults under guardianship","ALL","18 Years","70 Years",{"count":172,"type":173},204,"ESTIMATED","INTERVENTIONAL",[176],"NA","This is a prospective, multicentre, phase III, randomised, controlled intervention study.\n\nTwo groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).\n\nEach patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).\n\n\\- PASCA interventional group\n\nFor both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary.\n\n\\- Control group\n\nFor the 7 complications of interest (primary objective) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management.\n\n=\\> For all patients, regardless of group\n\nAll patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications:\n\n* Visit No.1 (T1), 1-2 months after the autologous haematopoietic stem cell transplantation (aHSCT), corresponding to the patient's visit to his or her Multiple Myeloma (MM) monitoring consultation and\u002For the start of his or her consolidation treatment.\n* Visit No.2 (T2), 4 months after aHSCT, corresponding to a patient's visit for the end of consolidation treatment;\n* Visit No.3 (T3), 14 months after the last aHSCT, corresponding to a visit by the patient during his or her maintenance treatment;\n* Visit No.4 (T4), 24 months after the last aHSCT, corresponding to a visit by the patient for a MM monitoring consultation.",[179,180],"Multiple Myeloma","Complication",[179,182,183,184,185,186],"Complications","Detection","Intervention","Autologous stem cell transplant","Randomized controlled trials","2026-06-09",{"date":189,"type":190},"2026-06-11","ACTUAL",{"date":192,"type":190},"2024-01-19",{"date":194,"type":173},"2029-09-14",{"name":5,"class":6},6]