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


Active: Yes
Cancer Type: Multiple Myeloma NCT ID: NCT01838512
Trial Phases: Protocol IDs: CA204-008 (primary)
Eligibility: 18 Years and older, Male and Female Study Type: Other
Study Sponsor: Bristol-Myers Squibb
NCI Full Details: http://clinicaltrials.gov/show/NCT01838512

Summary

The purpose of this study is to assess the clinical effectiveness of all approved
multiple myeloma (MM) therapies in the newly-diagnosed (NDMM) and the relapsed/refractory
MM (RRMM) settings in real-world clinical practice.

Objectives

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.

Treatment Sites in Georgia

Pearlman Cancer Center at South Georgia Medical Center
2501 North Patterson Street
Valdosta, GA 31602
229-259-4628
www.sgmc.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.