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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: October 15, 2014
Last verified: October 2014

November 12, 2010
October 15, 2014
October 2010
October 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01241396 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.

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

Observational
Observational Model: Case-Only
Not Provided
Not Provided
Probability Sample

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.

Multiple Myeloma
Other: Any MMY treatment
Any line of treatment for MMY
001
Any MMY treatment Any line of treatment for MMY
Intervention: Other: Any MMY treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2399
October 2014
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Austria,   Croatia,   Denmark,   Estonia,   France,   Germany,   Hungary,   Israel,   Latvia,   Lithuania,   Macedonia, The Former Yugoslav Republic of,   Poland,   Portugal,   Russian Federation,   Slovenia,   South Africa,   Spain,   Turkey,   Ukraine
 
NCT01241396
CR017410
No
Janssen Pharmaceutica N.V., Belgium
Janssen Pharmaceutica N.V., Belgium
Not Provided
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
Janssen Pharmaceutica N.V., Belgium
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP