A Study to Record in an Observational Manner the Treatment of Multiple Myeloma as it is Being Done in Every Day Practice Without Providing Any Investigational Drug or Prescribing Any Procedure
17 de junio de 2016 actualizado por: Janssen Pharmaceutica N.V., Belgium
An Observational Study of the Treatment of Multiple Myeloma in Routine Clinical Practice
The primary objective of this observational study is to document and describe current treatment regimens and disease progression of patients with Multiple Myeloma (MMY).
The aim of this registry is to provide accurate, descriptive information on the way Multiple Myeloma is treated in routine clinical practice.
The registry will collect information related to the treatment received for Multiple Myeloma.
About 3000 patients will take part in the study in about 28 countries.
The registry will only collect information that is already in medical files regarding treatment.
Patients will not be required to actively do anything in addition to what would be done without participating in this registry, nor will there be any procedures or interventions that are not already part of the current treatment.
Descripción general del estudio
Descripción detallada
There is a lack of objective data relating to variation in treatment practices and resource utilisation for Multiple Myeloma (MMY) patients between countries.
This void continues to hamper attempts to create meaningful health economic models for MMY treatment and impedes understanding of the MMY clinical arena.
This non-interventional observational study is designed to address the problem by providing a definitive picture of routine treatment and resource utilisation practices for MMY patients at any stage of treatment, independent of drug(s) used and treatment line across the different countries taking part.
A non-interventional study design has been selected to facilitate data collection about routine clinical practice.
This study seeks to obtain an appropriate subset of the true population of patients with MMY throughout Europe Middle East and Africa.
Many concerns exist when attempting to develop an unbiased study sample, including biases regarding the selection of patients to be enrolled.
Therefore, a multi-staged site and patient selection model will be used to reduce biases associated with patient and site selection.
The study seeks to enroll at least 3,000 patients.
It will deliver a description of everyday treatment practice of MMY.
Additional retrospective medical reviews will also be performed to collect information regarding disease history.
The primary objective of the study is to document and describe current treatment regimens and disease progression of patients with MMY.
Secondary objectives of the study involve understanding the MMY patient population and its generalisability to all treated MMY patients.
Additional goals of the study are to document and compare: (a) utilisation of current treatment regimens for MMY; (b) quality of life and health economic parameters associated with MMY treatment regimens; (c) the safety profile of current treatment regimens for MMY and the impact on resource utilisation; (d) the effectiveness of current treatment regimens for MMY.
The study will collect prospective data on efficacy, outcomes, health economic and safety parameters for all patients whenever available.
The resulting database will allow future health economic, pharmaco-epidemiological, and outcomes research, and provide important data from the clinical arena.
At least 3000 patients will be recruited to this study.
As this is an observational study, the decision of patients to take part in this study will not have any impact on the care they are receiving.
All treatment decisions will be made at the discretion of the participating physicians.
Only data available from routine clinical practice will be collected.
There are two phases of data collection in this study: (a) at baseline, the patient's historical treatment and resource utilisation data, where possible stretching back to diagnosis, will be recorded via electronic data capture; (b) following the baseline visit, the patient will enter a prospective data collection phase where data will be collected at least every three months.
At each data collection point, all changes since the previous data collection point will be collected.
Prospective data collection will continue until the study is complete or the patient is withdrawn from the study.
Data will continue to be captured until three years after the last patient is recruited to the study.
Interim analyses will be conducted at least annually to update the current data.
To monitor the safety profile of MMY treatment related to a Johnson and Johnson product, any unwanted effects that occur during the MMY treatment will be recorded Observational Study - No investigational drug administered
Tipo de estudio
De observación
Inscripción (Actual)
2396
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Amberg, Alemania
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Aschaffenburg, Alemania
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Augsburg, Alemania
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Bad Soden, Alemania
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Bamberg, Alemania
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Berlin, Alemania
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Bielefeld, Alemania
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Bonn, Alemania
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Borken, Alemania
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Bottrop, Alemania
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Bremerhaven, Alemania
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Coburg, Alemania
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Dresden, Alemania
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Goslar, Alemania
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Hamburg, Alemania
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Hamm, Alemania
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Hannover, Alemania
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Hildesheim, Alemania
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Hof, Alemania
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Kaiserslautern, Alemania
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Lübeck, Alemania
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Mainz, Alemania
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Mayen, Alemania
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Mutlangen, Alemania
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München, Alemania
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Naunhof, Alemania
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Neunkirchen, Alemania
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Nürnberg, Alemania
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Olpe, Alemania
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Ostfildern, Alemania
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Rostock, Alemania
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Rotenburg, Alemania
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Saarbrÿcken, Alemania
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Stuttgart, Alemania
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Weiden, Alemania
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Würzburg, Alemania
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Alger, Argelia
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Constantine, Argelia
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Oran, Argelia
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Setif, Argelia
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Tizi-Ouzou, Argelia
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Graz, Austria
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Innsbruck, Austria
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Zagreb, Croacia
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Holstebro N/A, Dinamarca
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Odense, Dinamarca
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Ljubljana, Eslovenia
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Alicante, España
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Barcelona, España
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Caceres, España
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Ciudad Real, España
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Cádiz, España
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Guadalajara, España
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Jaen, España
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Leon, España
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Madrid, España
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Marbella, España
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Murcia, España
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Palma De Mallorca, España
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Salamanca N/A, España
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San Sebastian, España
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Sevilla, España
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Talavera De La Reina, Toledo, España
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Tarragona, España
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Zaragoza, España
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Tallinn N/A, Estonia
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Tartu, Estonia
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Kolomna, Federación Rusa
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Krasnodar, Federación Rusa
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Krasnogorsk, Federación Rusa
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Moscow, Federación Rusa
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Podolsk, Federación Rusa
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Saint Petersburg, Federación Rusa
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Saint-Petersburg, Federación Rusa
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Samara, Federación Rusa
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Saransk, Federación Rusa
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Tula, Federación Rusa
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Ulyanovsk, Federación Rusa
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Volgograd, Federación Rusa
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Vologda, Federación Rusa
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Avignon Cedex 9, Francia
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Blois Cedex, Francia
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Bordeaux Cedex, Francia
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Brest Cedex 2, Francia
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Clermont Ferrand Cedex 2, Francia
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Le Mans Cedex 9, Francia
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Montpellier, Francia
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Nantes N/A, Francia
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Nîmes, Francia
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Nîmes Cedex 9, Francia
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Perpignan Cedex, Francia
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Pontoise, Francia
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Rennes, Francia
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St Brieuc Cedex 1, Francia
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Troyes Cedex, Francia
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Athens, Grecia
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Larissa, Grecia
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Thessalonikis, Grecia
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Budapest, Hungría
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Debrecen, Hungría
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Pécs N/A, Hungría
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Szeged, Hungría
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Szombathely, Hungría
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Haifa, Israel
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Kfar Saba, Israel
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Petah-Tikva, Israel
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Ramat Gan, Israel
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Riga, Letonia
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Klaipeda, Lituania
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Vilnius, Lituania
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Skopje, Macedonia, la ex República Yugoslava de
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Adana, Pavo
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Ankara, Pavo
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Antalya, Pavo
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Bursa, Pavo
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Istanbul, Pavo
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Izmir, Pavo
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Kayseri, Pavo
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Samsun, Pavo
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Bialystok, Polonia
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Brzozow, Polonia
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Bytom, Polonia
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Chorzow, Polonia
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Gdansk, Polonia
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Gorzow Wielkopolski, Polonia
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Katowice, Polonia
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Legnica, Polonia
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Lublin, Polonia
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Opole, Polonia
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Poznan, Polonia
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Rzeszow, Polonia
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Slupsk, Polonia
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Warszawa, Polonia
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Warszawa Poland, Polonia
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Wroclaw, Polonia
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Zamosc, Polonia
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Ponta Delgada, Portugal
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Porto, Portugal
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Bloemfontein, Sudáfrica
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Cape Town, Sudáfrica
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Durban, Sudáfrica
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Johannesburg, Sudáfrica
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Cherkassy, Ucrania
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Dnepropetrovsk, Ucrania
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Donetsk, Ucrania
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Ivano-Frankivsk, Ucrania
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Kharkiv, Ucrania
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Kherson, Ucrania
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Khmelnitskiy, Ucrania
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Kiev, Ucrania
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Lutsk, Ucrania
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Lviv, Ucrania
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Nikolaev, Ucrania
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Odessa, Ucrania
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Poltava, Ucrania
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Simferopol, Ucrania
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Ternopil, Ucrania
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Uzhgorod, Ucrania
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Vinnitsa, Ucrania
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Zaporizhzhya, Ucrania
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Zhytomyr, Ucrania
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 99 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
The study will focus on enrolling consecutively, patients who are initiating any new line of therapy for Multiple Myeloma, regardless of the line of treatment.
Because this is a non-interventional study, intended to provide a picture of routine clinical practice, no guidance will be given on any aspect of treatment, patient clinical management or treatment dose selection.
Descripción
Inclusion Criteria:
- Requires commencement of a new line of treatment for MMY at any stage, regardless of type of therapy selected.
Exclusion Criteria:
- Patients currently participating in another investigational study or clinical trial.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Any MMY treatment Any line of treatment for MMY
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Any line of treatment for MMY
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Description of current treatment regimens for MMY.
Periodo de tiempo: Every 3 months from baseline to 3 years after last patient recruited
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Every 3 months from baseline to 3 years after last patient recruited
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Utilisation of current treatment regimens for MMY
Periodo de tiempo: Every 3 months from baseline to 3 years after last patient recruited
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Every 3 months from baseline to 3 years after last patient recruited
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Quality of life and health economic parameters associated with MMY treatment regimens
Periodo de tiempo: Every 3 months from baseline to 3 years after last patient recruited
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Every 3 months from baseline to 3 years after last patient recruited
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Safety profile of current treatment regimens for MMY
Periodo de tiempo: Every 3 months from baseline to 3 years after last patient recruited
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Every 3 months from baseline to 3 years after last patient recruited
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The effectiveness of current treatment regimens for MMY
Periodo de tiempo: Every 3 months from baseline to 3 years after last patient recruited
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Every 3 months from baseline to 3 years after last patient recruited
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2010
Finalización primaria (Actual)
1 de noviembre de 2014
Finalización del estudio (Actual)
1 de noviembre de 2014
Fechas de registro del estudio
Enviado por primera vez
12 de noviembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
12 de noviembre de 2010
Publicado por primera vez (Estimar)
16 de noviembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de junio de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2016
Última verificación
1 de junio de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
Otros números de identificación del estudio
- CR017410
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .