Last updated on September 2018

Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

Brief description of study

This is a non-interventional observational study aimed at understanding the real world effectiveness of novel agents used in treating multiple myeloma and their impact on patient-reported outcomes. This study will collect information that is already in medical records regarding treatment and diagnostic procedures. Patients are asked to complete questionnaires for patient-reported outcome measures.

Detailed Study Description

This is a prospective, multi-regional, observational cohort study with up to 3 years of follow up per patient. During the entire observational period (from the first patient first visit to the last patient last visit), vital status will be collected every 6 months on all patients, including those who complete the 3-year follow up prior to study conclusion. The study will include 3 cohorts of patients receiving one of the following classes of treatments for MM:

  • IMiDs
  • Proteasome inhibitors
  • Combination novel therapies (an IMiD plus a proteasome inhibitor)
  • Additional use of corticosteroids and/or cytotoxic agents (eg, alkylating agents) is permitted for all 3 cohorts.

Medicines that are prescribed in a manner that is consistent with the terms of the approved marketing authorization or in line with the current standard of practice of the participating physician will be allowed.

Note : Treatment with the current regimen:

i. must have been initiated within 90 days before consent for this study OR ii. in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before consent for this study must be provided, and treatment must be initiated within 30 days after consent.

Enrollment of approximately 1000 patients will occur during an approximate 36-month timeframe, and each patient will be followed for up to 3 years.

Clinical Study Identifier: NCT01838512

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Local Institution

Shreveport, LA United States
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Recruitment Status: Open

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