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

Trial Information

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

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.