Clinical and Sociodemographic Characterization of Multiple Myeloma Participants With Symptomatic Relapse and/or Refractory Disease in Spain (CharisMMa Study)
NCT ID: NCT03188536
Last Updated: 2020-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
282 participants
OBSERVATIONAL
2017-07-26
2019-01-30
Brief Summary
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Detailed Description
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The study will look into sociodemographic data, current clinical and therapeutic data, clinical data relative to the latest relapse and clinical data at diagnosis and previous relapses will be collected.
The study will enroll approximately 350 patients.
This multi-center trial will be conducted in a total of 30 public sites in Spain. The overall time to collect data will be approximately 1 year from June 2017 to May 2018.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Multiple Myeloma (MM) Participants
Adult participants with a diagnosis of MM who received at least one previous treatment line (standard care of treatment) and experienced symptomatic relapse and/or refractory disease in the previous 6 months, who were followed-up at the time of the study visit. No intervention was administered in this study.
No Intervention
As it was an observational study, no intervention was administered in this study.
Interventions
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No Intervention
As it was an observational study, no intervention was administered in this study.
Eligibility Criteria
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Inclusion Criteria
* Have experienced symptomatic relapse and/or refractory disease in the 6 months before the study.
* Has continued in follow-up at the time of the study visit.
* Is currently treated in the site who have clinical records available.
* Is capable of understanding and completing the questions in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), and EORTC Multiple Myeloma Module (QLQ-MY20) questionnaires.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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H Universitario Puerta del Mar
Cadiz, Andalusia, Spain
H Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Juan Ramon Jimenez
Huelva, Andalusia, Spain
H Jerez
Jerez de la Frontera, Andalusia, Spain
Hospital Costa del Sol
Marbella, Andalusia, Spain
H. Nuestra Senora de Valme
Seville, Andalusia, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, Spain
H Son Espases
Palma, Balearic Islands, Spain
Hospital Son Llatzer
Palma, Balearic Islands, Spain
H de Donosti
Donostia / San Sebastian, Basque Country, Spain
Hospital de Txagorritxu
Vitoria-Gasteiz, Basque Country, Spain
H U Canarias
San Cristóbal de La Laguna, Canary Islands, Spain
H Marques de Valdecilla
Santander, Cantabria, Spain
Hospital de Burgos
Burgos, Castille and León, Spain
Hospital de Leon
León, Castille and León, Spain
Hospital de Salamanca
Salamanca, Castille and León, Spain
Complejo Asistencial de Segovia
Segovia, Castille and León, Spain
H U de Guadalajara
Guadalajara, Castille-La Mancha, Spain
Complejo Hospitalario Toledo
Toledo, Castille-La Mancha, Spain
Hospital Clinico de Barcelona
Barcelona, Catalonia, Spain
Hospital Doctor Trueta ICO Girona
Girona, Catalonia, Spain
ICO Bellvitge
L'Hospitalet de Llobregat, Catalonia, Spain
H Universitari de Tarragona Joan XXIII
Tarragona, Catalonia, Spain
Hospital Lucus Agusti
Lugo, Galicia, Spain
H Clinico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
H Universitario de Cabuenes
Gijón, Principality of Asturias, Spain
H Infanta Leonor
Madrid, , Spain
H 12 de Octubre
Madrid, , Spain
H Clinico de Valencia
Valencia, , Spain
Countries
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References
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Dachs LR, Gaisan CM, Bustamante G, Lopez SG, Garcia EG, Persona EP, Gonzalez-Calle V, Auzmendi MS, Perez JMA, Gonzalez Montes Y, Rios Tamayo R, de Miguel Llorente D, Bernal LP, Mayol AS, Caro CC, Grande M, Fernandez-Nistal A, Naves A, Miguel EMOS. Assessment of the psychometric properties of the Spanish version of EORTC QLQ-MY20 and evaluation of health-related quality of Life outcomes in patients with relapsed and/or refractory multiple myeloma in the real-world setting in Spain: results from the CharisMMa study. Leuk Lymphoma. 2023 Nov-Dec;64(11):1847-1856. doi: 10.1080/10428194.2023.2240922. Epub 2023 Aug 4.
Ocio EM, Montes-Gaisan C, Bustamante G, Garzon S, Gonzalez E, Perez-Persona E, Gonzalez-Calle V, Sirvent M, Arguinano JM, Gonzalez Y, Rios R, de Miguel D, Grande M, Fernandez-Nistal A, Naves A, Rosinol L. Real-World Health Care Services Utilization Associated With the Management of Patients With Relapsed and Refractory Multiple Myeloma in Spain: The CharisMMa Study. Clin Lymphoma Myeloma Leuk. 2023 Oct;23(10):e341-e347. doi: 10.1016/j.clml.2023.07.006. Epub 2023 Jul 15.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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TAK-MMR-2017-01
Identifier Type: REGISTRY
Identifier Source: secondary_id
RRMM-5012
Identifier Type: -
Identifier Source: org_study_id
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