Clinical trial NCT01241396: 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
Official title: An Observational Study of the Treatment of Multiple Myeloma in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
observational
survey
non-interventional
international
epidemiology
treatment
routine clinical practice
retrospective
prospective
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 2396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Description of current treatment regimens for MMY.
timeFrame: Every 3 months from baseline to 3 years after last patient recruited
Secondary outcomes:
measure: Utilisation of current treatment regimens for MMY
timeFrame: Every 3 months from baseline to 3 years after last patient recruited
measure: Quality of life and health economic parameters associated with MMY treatment regimens
timeFrame: Every 3 months from baseline to 3 years after last patient recruited
measure: Safety profile of current treatment regimens for MMY
timeFrame: Every 3 months from baseline to 3 years after last patient recruited
measure: The effectiveness of current treatment regimens for MMY
timeFrame: Every 3 months from baseline to 3 years after last patient recruited
Other outcomes:
Locations:
city: Alger
country: Algeria
city: Constantine
country: Algeria
city: Oran
country: Algeria
city: Setif
country: Algeria
city: Tizi-Ouzou
country: Algeria
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Zagreb
country: Croatia
city: Holstebro N/A
country: Denmark
city: Odense
country: Denmark
city: Tallinn N/A
country: Estonia
city: Tartu
country: Estonia
city: Avignon Cedex 9
country: France
city: Blois Cedex
country: France
city: Bordeaux Cedex
country: France
city: Brest Cedex 2
country: France
city: Clermont Ferrand Cedex 2
country: France
city: Le Mans Cedex 9
country: France
city: Montpellier
country: France
city: Nantes N/A
country: France
city: Nîmes Cedex 9
country: France
city: Nîmes
country: France
city: Perpignan Cedex
country: France
city: Pontoise
country: France
city: Rennes
country: France
city: St Brieuc Cedex 1
country: France
city: Troyes Cedex
country: France
city: Amberg
country: Germany
city: Aschaffenburg
country: Germany
city: Augsburg
country: Germany
city: Bad Soden
country: Germany
city: Bamberg
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Bonn
country: Germany
city: Borken
country: Germany
city: Bottrop
country: Germany
city: Bremerhaven
country: Germany
city: Coburg
country: Germany
city: Dresden
country: Germany
city: Goslar
country: Germany
city: Hamburg
country: Germany
city: Hamm
country: Germany
city: Hannover
country: Germany
city: Hildesheim
country: Germany
city: Hof
country: Germany
city: Kaiserslautern
country: Germany
city: Lübeck
country: Germany
city: Mainz
country: Germany
city: Mayen
country: Germany
city: Mutlangen
country: Germany
city: München
country: Germany
city: Naunhof
country: Germany
city: Neunkirchen
country: Germany
city: Nürnberg
country: Germany
city: Olpe
country: Germany
city: Ostfildern
country: Germany
city: Rostock
country: Germany
city: Rotenburg
country: Germany
city: Saarbrÿcken
country: Germany
city: Stuttgart
country: Germany
city: Weiden
country: Germany
city: Würzburg
country: Germany
city: Athens
country: Greece
city: Larissa
country: Greece
city: Thessalonikis
country: Greece
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pécs N/A
country: Hungary
city: Szeged
country: Hungary
city: Szombathely
country: Hungary
city: Haifa
country: Israel
city: Kfar Saba
country: Israel
city: Petah-Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Riga
country: Latvia
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Bialystok
country: Poland
city: Brzozow
country: Poland
city: Bytom
country: Poland
city: Chorzow
country: Poland
city: Gdansk
country: Poland
city: Gorzow Wielkopolski
country: Poland
city: Katowice
country: Poland
city: Legnica
country: Poland
city: Lublin
country: Poland
city: Opole
country: Poland
city: Poznan
country: Poland
city: Rzeszow
country: Poland
city: Slupsk
country: Poland
city: Warszawa Poland
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zamosc
country: Poland
city: Ponta Delgada
country: Portugal
city: Porto
country: Portugal
city: Kolomna
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnogorsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Podolsk
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Saransk
country: Russian Federation
city: Tula
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Vologda
country: Russian Federation
city: Ljubljana
country: Slovenia
city: Bloemfontein
country: South Africa
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Caceres
country: Spain
city: Ciudad Real
country: Spain
city: Cádiz
country: Spain
city: Guadalajara
country: Spain
city: Jaen
country: Spain
city: Leon
country: Spain
city: Madrid
country: Spain
city: Marbella
country: Spain
city: Murcia
country: Spain
city: Palma De Mallorca
country: Spain
city: Salamanca N/A
country: Spain
city: San Sebastian
country: Spain
city: Sevilla
country: Spain
city: Talavera De La Reina, Toledo
country: Spain
city: Tarragona
country: Spain
city: Zaragoza
country: Spain
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Bursa
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kayseri
country: Turkey
city: Samsun
country: Turkey
city: Cherkassy
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Khmelnitskiy
country: Ukraine
city: Kiev
country: Ukraine
city: Lutsk
country: Ukraine
city: Lviv
country: Ukraine
city: Nikolaev
country: Ukraine
city: Odessa
country: Ukraine
city: Poltava
country: Ukraine
city: Simferopol
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Zhytomyr
country: Ukraine
Study officials:
affiliation: Janssen Pharmaceutica N.V.
name: Janssen Pharmaceutica N.V. Clinical Trial
role: STUDY_DIRECTOR
References: