A Study to Assess Disease Burden, in Terms of Health-related Quality of Life and Direct Healthcare Costs, in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Autologous Stem Cell Transplant (ASCT) in Spain
NCT ID: NCT02946333
Last Updated: 2022-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
355 participants
OBSERVATIONAL
2016-12-25
2022-10-31
Brief Summary
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Detailed Description
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1. Recruitment period: data collection at the baseline visit, every 4 months +/- 15 days in the first year (month 4, 8 and 12) and every 6 months +/- 1 month in the second year (month 18 and 24).
2. Follow-up period: (study will end at 4 years following enrolment of the first patient)
* From month 24 until up to 4 years from enrolment of the first patient, follow-ups will be performed with semi-annual data collections coinciding with the patient's routine clinical practice visits.
* In case of progression, suspension or unexpected termination of treatment (for example due to toxicity), or death, a data collection coinciding with the visit in which any of the cases presented occurs will be performed.
* If a new line of treatment is started, the follow-up model will be started with the same frequency of follow-ups described in point 1 above (month 4, 8, 12, 18 and 24 and semi-annually according to routine clinical practice until up to 4 years from enrolment of the first patient in the study).
3. Observation period: Following this 4-year period, an additional 5-year follow-up will be performed only to evaluate the onset of second primary malignant neoplasms. This follow-up during the 5-year observational period will be performed semi-annually (± 1 month) according to routine clinical practice at each site.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient with MM who are not candidates for ASCT
Patients with newly diagnosed MM who are not candidates for ASCT and who are going to start drug treatment for the study disease and patient who is capable of understanding and filling in the study questionnaires At least 450 patients will be enrolled in a 2-year period. Patients must meet all of the inclusion criteria and none of the exclusion criteria and must have previously granted their informed consent in writing.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient with newly diagnosed multiple myeloma (MM) according to IMWG criteria who are not candidates for ASCT and who start treatment for the study disease.
* Patient who is capable of understanding and filling in the study questionnaires.
* Patient who has granted his or her informed consent in writing.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Giselle Lostaunau, Senior Medical Advisor MM
Role: STUDY_DIRECTOR
Celgene
Locations
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Hospital Punta de Europa
Algeciras, Andalusia, Spain
Hospital de Antequera
Antequera, Andalusia, Spain
Hospital Reina Sofía
Córdoba, Andalusia, Spain
Hospital Huercal Olvera
Huercal Olvera, Andalusia, Spain
Hospital General Jaén
Jaén, Andalusia, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Andalusia, Spain
Clinico Univ. Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Carlos Haya
Málaga, Andalusia, Spain
Hospital de Costa del Sol
Málaga, Andalusia, Spain
Hospital de Motril
Motril, Andalusia, Spain
Hospital Valle de los Pedroches Pozoblanco
Pozoblanco, Andalusia, Spain
Hospital Puerto Real
Puerto Real, Andalusia, Spain
Hospital de Macarena
Seville, Andalusia, Spain
Hospital Miguel Servet
Zaragoza, Aragon, Spain
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Hospital ICO Durán y Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
ICO Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Basurto
Bilbao, Basque Country, Spain
Hospital de Galadakao
Usansolo, Basque Country, Spain
Hospital de Txagorritxu
Vitoria-Gasteiz, Basque Country, Spain
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital Clínico de Valladolid
Valladolid, Castille and León, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Vall Hebrón
Barcelona, Catalonia, Spain
Hospital General de Granollers
Granollers, Catalonia, Spain
Hospital Arnau Vilanova de Lleida
Lleida, Catalonia, Spain
Fundació Althaia
Manresa, Catalonia, Spain
Parc Taulí
Sabadell, Catalonia, Spain
Mutua Terrassa
Terrassa, Catalonia, Spain
Complejo Hospitalario Llerena-Zafra
Llerena, Extremadura, Spain
Hospital de Mérida
Mérida, Extremadura, Spain
Complexo Hospitalario Universitario de A Coruña
A Coruña, Galicia, Spain
Hospital Lucus Augustí
Lugo, Galicia, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, Spain
Complexo Hospitalario de Pontevedra
Pontevedra, Galicia, Spain
Complexo Hospitalario Universitario de Vigo
Vigo, Galicia, Spain
Hospital Universitario Canarias
Santa Cruz de Tenerife, Islas Canaria, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital de la Princesa
Madrid, Madrid, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Quirón
Pozuelo de Alarcón, Madrid, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
Complejo Hospitalario de Navarra
Navarra, Navarre, Spain
Complejo Hospitalario Navarra
Pamplona, Navarre, Spain
Hospital de La Ribera
Alzira, Valencia, Spain
Hospital General Castellón
Castellon, Valencia, Spain
Hospital Arnau Vilanova Valencia
Valencia, Valencia, Spain
Hospital Doctor Peset
Valencia, Valencia, Spain
Hospital La Fe Valencia
Valencia, Valencia, Spain
Hospital La Ribera
Valencia, Valencia, Spain
Complejo Hospitalario de Ávila
Ávila, , Spain
Hospital Infanta Leonor
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
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References
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Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.
Other Identifiers
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CEL-MIE-2016-01
Identifier Type: -
Identifier Source: org_study_id
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