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

NCT ID: NCT01241396

Last Updated: 2016-06-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2396 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-11-30

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

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: CASE_ONLY

Study Groups

001

Any MMY treatment Any line of treatment for MMY

Any MMY treatment

Intervention Type: OTHER

Any line of treatment for MMY

Interventions

Any MMY treatment

Any line of treatment for MMY

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V.

Locations

Algiers, , Algeria

Constantine, , Algeria

Oran, , Algeria

Sétif, , Algeria

Tizi Ouzou, , Algeria

Graz, , Austria

Innsbruck, , Austria

Zagreb, , Croatia

Holstebro, , Denmark

Odense, , Denmark

Tallinn, , Estonia

Tartu, , Estonia

Avignon, , France

Blois, , France

Bordeaux, , France

Brest, , France

Clermont-Ferrand, , France

Le Mans, , France

Montpellier, , France

Nantes, , France

Nîmes, , France

Perpignan, , France

Pontoise, , France

Rennes, , France

Saint-Brieuc, , France

Troyes, , France

Amberg, , Germany

Aschaffenburg, , Germany

Augsburg, , Germany

Bad Soden, , Germany

Bamberg, , Germany

Berlin, , Germany

Bielefeld, , Germany

Bonn, , Germany

Borken, , Germany

Bottrop, , Germany

Bremerhaven, , Germany

Coburg, , Germany

Dresden, , Germany

Goslar, , Germany

Hamburg, , Germany

Hamm, , Germany

Hanover, , Germany

Hildesheim, , Germany

Hof, , Germany

Kaiserslautern, , Germany

Lübeck, , Germany

Mainz, , Germany

Mayen, , Germany

Mutlangen, , Germany

München, , Germany

Naunhof, , Germany

Neunkirchen, , Germany

Nuremberg, , Germany

Olpe, , Germany

Ostfildern, , Germany

Rostock, , Germany

Rotenburg (Wümme), , Germany

Saarbrÿcken, , Germany

Stuttgart, , Germany

Weiden, , Germany

Würzburg, , Germany

Athens, , Greece

Larissa, , Greece

Thessalonikis, , Greece

Budapest, , Hungary

Debrecen, , Hungary

Pécs, , Hungary

Szeged, , Hungary

Szombathely, , Hungary

Haifa, , Israel

Kfar Saba, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Riga, , Latvia

Klaipėda, , Lithuania

Vilnius, , Lithuania

Skopje, , North Macedonia

Bialystok, , Poland

Brzozów, , Poland

Bytom, , Poland

Chorzów, , Poland

Gdansk, , Poland

Gorzów Wielkopolski, , Poland

Katowice, , Poland

Legnica, , Poland

Lublin, , Poland

Opole, , Poland

Poznan, , Poland

Rzeszów, , Poland

Słupsk, , Poland

Warsaw, , Poland

Warszawa Poland, , Poland

Wroclaw, , Poland

Zamość, , Poland

Ponta Delgada, , Portugal

Porto, , Portugal

Kolomna, , Russia

Krasnodar, , Russia

Krasnogorsk, , Russia

Moscow, , Russia

Podolsk, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Saransk, , Russia

Tula, , Russia

Ulyanovsk, , Russia

Volgograd, , Russia

Vologda, , Russia

Ljubljana, , Slovenia

Bloemfontein, , South Africa

Cape Town, , South Africa

Durban, , South Africa

Johannesburg, , South Africa

Alicante, , Spain

Barcelona, , Spain

Cadiz, , Spain

Cáceres, , Spain

Ciudad Real, , Spain

Donostia / San Sebastian, , Spain

Guadalajara, , Spain

Jaén, , Spain

León, , Spain

Madrid, , Spain

Marbella, , Spain

Murcia, , Spain

Palma de Mallorca, , Spain

Salamanca, , Spain

Seville, , Spain

Talavera de La Reina, Toledo, , Spain

Tarragona, , Spain

Zaragoza, , Spain

Adana, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Antalya, , Turkey (Türkiye)

Bursa, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Kayseri, , Turkey (Türkiye)

Samsun, , Turkey (Türkiye)

Cherkassy, , Ukraine

Dnipro, , Ukraine

Donetsk, , Ukraine

Ivano-Frankivsk, , Ukraine

Kharkiv, , Ukraine

Kherson, , Ukraine

Khmelnitskiy, , Ukraine

Kiev, , Ukraine

Lutsk, , Ukraine

Lviv, , Ukraine

Mykolayiv, , Ukraine

Odesa, , Ukraine

Poltava, , Ukraine

Simferopol, , Ukraine

Ternopil, , Ukraine

Uzhhorod, , Ukraine

Vinnitsa, , Ukraine

Zaporizhzhya, , Ukraine

Zhytomyr, , Ukraine

Countries

Algeria; Austria; Croatia; Denmark; Estonia; France; Germany; Greece; Hungary; Israel; Latvia; Lithuania; North Macedonia; Poland; Portugal; Russia; Slovenia; South Africa; Spain; Turkey (Türkiye); Ukraine

Other Identifiers

CR017410

Identifier Type: -

Identifier Source: org_study_id