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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. juni 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2396

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Algeriet
      • Alger, Algeriet
      • Constantine, Algeriet
      • Oran, Algeriet
      • Setif, Algeriet
      • Tizi-Ouzou, Algeriet
  • Danmark
      • Holstebro N/A, Danmark
      • Odense, Danmark
  • Den Russiske Føderation
      • Kolomna, Den Russiske Føderation
      • Krasnodar, Den Russiske Føderation
      • Krasnogorsk, Den Russiske Føderation
      • Moscow, Den Russiske Føderation
      • Podolsk, Den Russiske Føderation
      • Saint Petersburg, Den Russiske Føderation
      • Saint-Petersburg, Den Russiske Føderation
      • Samara, Den Russiske Føderation
      • Saransk, Den Russiske Føderation
      • Tula, Den Russiske Føderation
      • Ulyanovsk, Den Russiske Føderation
      • Volgograd, Den Russiske Føderation
      • Vologda, Den Russiske Føderation
  • Estland
      • Tallinn N/A, Estland
      • Tartu, Estland
  • Frankrig
      • Avignon Cedex 9, Frankrig
      • Blois Cedex, Frankrig
      • Bordeaux Cedex, Frankrig
      • Brest Cedex 2, Frankrig
      • Clermont Ferrand Cedex 2, Frankrig
      • Le Mans Cedex 9, Frankrig
      • Montpellier, Frankrig
      • Nantes N/A, Frankrig
      • Nîmes, Frankrig
      • Nîmes Cedex 9, Frankrig
      • Perpignan Cedex, Frankrig
      • Pontoise, Frankrig
      • Rennes, Frankrig
      • St Brieuc Cedex 1, Frankrig
      • Troyes Cedex, Frankrig
  • Grækenland
      • Athens, Grækenland
      • Larissa, Grækenland
      • Thessalonikis, Grækenland
  • Israel
      • Haifa, Israel
      • Kfar Saba, Israel
      • Petah-Tikva, Israel
      • Ramat Gan, Israel
  • Kalkun
      • Adana, Kalkun
      • Ankara, Kalkun
      • Antalya, Kalkun
      • Bursa, Kalkun
      • Istanbul, Kalkun
      • Izmir, Kalkun
      • Kayseri, Kalkun
      • Samsun, Kalkun
  • Kroatien
      • Zagreb, Kroatien
  • Letland
      • Riga, Letland
  • Litauen
      • Klaipeda, Litauen
      • Vilnius, Litauen
  • Makedonien, Den Tidligere Jugoslaviske Republik
      • Skopje, Makedonien, Den Tidligere Jugoslaviske Republik
  • Polen
      • Bialystok, Polen
      • Brzozow, Polen
      • Bytom, Polen
      • Chorzow, Polen
      • Gdansk, Polen
      • Gorzow Wielkopolski, Polen
      • Katowice, Polen
      • Legnica, Polen
      • Lublin, Polen
      • Opole, Polen
      • Poznan, Polen
      • Rzeszow, Polen
      • Slupsk, Polen
      • Warszawa, Polen
      • Warszawa Poland, Polen
      • Wroclaw, Polen
      • Zamosc, Polen
  • Portugal
      • Ponta Delgada, Portugal
      • Porto, Portugal
  • Slovenien
      • Ljubljana, Slovenien
  • Spanien
      • Alicante, Spanien
      • Barcelona, Spanien
      • Caceres, Spanien
      • Ciudad Real, Spanien
      • Cádiz, Spanien
      • Guadalajara, Spanien
      • Jaen, Spanien
      • Leon, Spanien
      • Madrid, Spanien
      • Marbella, Spanien
      • Murcia, Spanien
      • Palma De Mallorca, Spanien
      • Salamanca N/A, Spanien
      • San Sebastian, Spanien
      • Sevilla, Spanien
      • Talavera De La Reina, Toledo, Spanien
      • Tarragona, Spanien
      • Zaragoza, Spanien
  • Sydafrika
      • Bloemfontein, Sydafrika
      • Cape Town, Sydafrika
      • Durban, Sydafrika
      • Johannesburg, Sydafrika
  • Tyskland
      • Amberg, Tyskland
      • Aschaffenburg, Tyskland
      • Augsburg, Tyskland
      • Bad Soden, Tyskland
      • Bamberg, Tyskland
      • Berlin, Tyskland
      • Bielefeld, Tyskland
      • Bonn, Tyskland
      • Borken, Tyskland
      • Bottrop, Tyskland
      • Bremerhaven, Tyskland
      • Coburg, Tyskland
      • Dresden, Tyskland
      • Goslar, Tyskland
      • Hamburg, Tyskland
      • Hamm, Tyskland
      • Hannover, Tyskland
      • Hildesheim, Tyskland
      • Hof, Tyskland
      • Kaiserslautern, Tyskland
      • Lübeck, Tyskland
      • Mainz, Tyskland
      • Mayen, Tyskland
      • Mutlangen, Tyskland
      • München, Tyskland
      • Naunhof, Tyskland
      • Neunkirchen, Tyskland
      • Nürnberg, Tyskland
      • Olpe, Tyskland
      • Ostfildern, Tyskland
      • Rostock, Tyskland
      • Rotenburg, Tyskland
      • Saarbrÿcken, Tyskland
      • Stuttgart, Tyskland
      • Weiden, Tyskland
      • Würzburg, Tyskland
  • Ukraine
      • Cherkassy, Ukraine
      • Dnepropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kherson, Ukraine
      • Khmelnitskiy, Ukraine
      • Kiev, Ukraine
      • Lutsk, Ukraine
      • Lviv, Ukraine
      • Nikolaev, Ukraine
      • Odessa, Ukraine
      • Poltava, Ukraine
      • Simferopol, Ukraine
      • Ternopil, Ukraine
      • Uzhgorod, Ukraine
      • Vinnitsa, Ukraine
      • Zaporizhzhya, Ukraine
      • Zhytomyr, Ukraine
  • Ungarn
      • Budapest, Ungarn
      • Debrecen, Ungarn
      • Pécs N/A, Ungarn
      • Szeged, Ungarn
      • Szombathely, Ungarn
  • Østrig
      • Graz, Østrig
      • Innsbruck, Østrig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
001
Any MMY treatment Any line of treatment for MMY
Andet: Any MMY treatment
Any line of treatment for MMY

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Description of current treatment regimens for MMY.
Tidsramme: Every 3 months from baseline to 3 years after last patient recruited
Every 3 months from baseline to 3 years after last patient recruited

Sekundære resultatmål

Resultatmål
Tidsramme
Utilisation of current treatment regimens for MMY
Tidsramme: Every 3 months from baseline to 3 years after last patient recruited
Every 3 months from baseline to 3 years after last patient recruited
Quality of life and health economic parameters associated with MMY treatment regimens
Tidsramme: Every 3 months from baseline to 3 years after last patient recruited
Every 3 months from baseline to 3 years after last patient recruited
Safety profile of current treatment regimens for MMY
Tidsramme: Every 3 months from baseline to 3 years after last patient recruited
Every 3 months from baseline to 3 years after last patient recruited
The effectiveness of current treatment regimens for MMY
Tidsramme: Every 3 months from baseline to 3 years after last patient recruited
Every 3 months from baseline to 3 years after last patient recruited

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Pharmaceutica N.V., Belgium

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2010

Primær færdiggørelse (Faktiske)

1. november 2014

Studieafslutning (Faktiske)

1. november 2014

Datoer for studieregistrering

Først indsendt

12. november 2010

Først indsendt, der opfyldte QC-kriterier

12. november 2010

Først opslået (Skøn)

16. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR017410

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Myelomatose

Kliniske forsøg med Any MMY treatment

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Norway

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner