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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT01241396
First received: November 12, 2010
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Other: Any MMY treatment
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: An Observational Study of the Treatment of Multiple Myeloma in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:
  • Description of current treatment regimens for MMY. [ Time Frame: Every 3 months from baseline to 3 years after last patient recruited ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Utilisation of current treatment regimens for MMY [ Time Frame: Every 3 months from baseline to 3 years after last patient recruited ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety profile of current treatment regimens for MMY [ Time Frame: Every 3 months from baseline to 3 years after last patient recruited ] [ Designated as safety issue: No ]
  • The effectiveness of current treatment regimens for MMY [ Time Frame: Every 3 months from baseline to 3 years after last patient recruited ] [ Designated as safety issue: No ]

Enrollment: 2382
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
Any MMY treatment Any line of treatment for MMY
Other: Any MMY treatment
Any line of treatment for MMY

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241396

  Hide Study Locations
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
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
Samara, Russian Federation
Saransk, Russian Federation
St Petersburg, 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
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT01241396     History of Changes
Other Study ID Numbers: CR017410
Study First Received: November 12, 2010
Last Updated: May 30, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Hungary: Scientific and Research Ethics Committee of the Medical Research Council

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Multiple Myeloma
observational
survey
non-interventional
international
epidemiology
treatment
routine clinical practice
retrospective
prospective

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2014