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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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