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

June 17, 2016 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Study Type

Observational

Enrollment (Actual)

2396

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Alger, Algeria
      • Constantine, Algeria
      • Oran, Algeria
      • Setif, Algeria
      • Tizi-Ouzou, Algeria
  • Austria
      • Graz, Austria
      • Innsbruck, Austria
  • Croatia
      • Zagreb, Croatia
  • Denmark
      • Holstebro N/A, Denmark
      • Odense, Denmark
  • Estonia
      • Tallinn N/A, Estonia
      • Tartu, Estonia
  • France
      • Avignon Cedex 9, France
      • Blois Cedex, France
      • Bordeaux Cedex, France
      • Brest Cedex 2, France
      • Clermont Ferrand Cedex 2, France
      • Le Mans Cedex 9, France
      • Montpellier, France
      • Nantes N/A, France
      • Nîmes, France
      • Nîmes Cedex 9, France
      • Perpignan Cedex, France
      • Pontoise, France
      • Rennes, France
      • St Brieuc Cedex 1, France
      • Troyes Cedex, France
  • Germany
      • 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
      • Hannover, Germany
      • Hildesheim, Germany
      • Hof, Germany
      • Kaiserslautern, Germany
      • Lübeck, Germany
      • Mainz, Germany
      • Mayen, Germany
      • Mutlangen, Germany
      • München, Germany
      • Naunhof, Germany
      • Neunkirchen, Germany
      • Nürnberg, Germany
      • Olpe, Germany
      • Ostfildern, Germany
      • Rostock, Germany
      • Rotenburg, Germany
      • Saarbrÿcken, Germany
      • Stuttgart, Germany
      • Weiden, Germany
      • Würzburg, Germany
  • Greece
      • Athens, Greece
      • Larissa, Greece
      • Thessalonikis, Greece
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Pécs N/A, Hungary
      • Szeged, Hungary
      • Szombathely, Hungary
  • Israel
      • Haifa, Israel
      • Kfar Saba, Israel
      • Petah-Tikva, Israel
      • Ramat Gan, Israel
  • Latvia
      • Riga, Latvia
  • Lithuania
      • Klaipeda, Lithuania
      • Vilnius, Lithuania
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of
  • Poland
      • Bialystok, Poland
      • Brzozow, Poland
      • Bytom, Poland
      • Chorzow, Poland
      • Gdansk, Poland
      • Gorzow Wielkopolski, Poland
      • Katowice, Poland
      • Legnica, Poland
      • Lublin, Poland
      • Opole, Poland
      • Poznan, Poland
      • Rzeszow, Poland
      • Slupsk, Poland
      • Warszawa, Poland
      • Warszawa Poland, Poland
      • Wroclaw, Poland
      • Zamosc, Poland
  • Portugal
      • Ponta Delgada, Portugal
      • Porto, Portugal
  • Russian Federation
      • Kolomna, Russian Federation
      • Krasnodar, Russian Federation
      • Krasnogorsk, Russian Federation
      • Moscow, Russian Federation
      • Podolsk, Russian Federation
      • Saint Petersburg, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Samara, Russian Federation
      • Saransk, Russian Federation
      • Tula, Russian Federation
      • Ulyanovsk, Russian Federation
      • Volgograd, Russian Federation
      • Vologda, Russian Federation
  • Slovenia
      • Ljubljana, Slovenia
  • South Africa
      • Bloemfontein, South Africa
      • Cape Town, South Africa
      • Durban, South Africa
      • Johannesburg, South Africa
  • Spain
      • Alicante, Spain
      • Barcelona, Spain
      • Caceres, Spain
      • Ciudad Real, Spain
      • Cádiz, Spain
      • Guadalajara, Spain
      • Jaen, Spain
      • Leon, Spain
      • Madrid, Spain
      • Marbella, Spain
      • Murcia, Spain
      • Palma De Mallorca, Spain
      • Salamanca N/A, Spain
      • San Sebastian, Spain
      • Sevilla, Spain
      • Talavera De La Reina, Toledo, Spain
      • Tarragona, Spain
      • Zaragoza, Spain
  • Turkey
      • Adana, Turkey
      • Ankara, Turkey
      • Antalya, Turkey
      • Bursa, Turkey
      • Istanbul, Turkey
      • Izmir, Turkey
      • Kayseri, Turkey
      • Samsun, Turkey
  • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Any MMY treatment Any line of treatment for MMY
Other: Any MMY treatment
Any line of treatment for MMY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Description of current treatment regimens for MMY.
Time Frame: Every 3 months from baseline to 3 years after last patient recruited
Every 3 months from baseline to 3 years after last patient recruited

Secondary Outcome Measures

Outcome Measure
Time Frame
Utilisation of current treatment regimens for MMY
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Every 3 months from baseline to 3 years after last patient recruited
Every 3 months from baseline to 3 years after last patient recruited

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutica N.V., Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (Estimate)

November 16, 2010

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017410

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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