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
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Observational

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
    

Intervention name(s): Any MMY treatment
Intervention type(s): Other
Intervention description(s): Any line of treatment for MMY
Observational model: Case-Only
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.
      
Keywords: Multiple Myeloma; observational; survey; non-interventional; international; epidemiology; treatment; routine clinical practice; retrospective; prospective