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

Study ID
STU 082012-034

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
James Pond
214-648-7030
blake.pond@utsouthwestern.edu

Principal Investigator
Larry Anderson

Summary

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.

This study will include 3 cohorts of patients receiving one of the following classes of treatment for Multiple Myeloma:
* iMiDs (n-330) *
* Proteasome inhibitors (n-330)*
* Combination novel therapies (an iMiD plus a proteasome inibitor) (n-340)*

*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 in north america and the european union, 15 of those patients will be recruited at uTSW and Parkland Health and Hospital System. This will occur during an approximate 36-month timeframe, and each patient will be followed up for up to 3 years.

Participant Eligibility


* Patients diagnosed with relapsed or refractory Multiple Myeloma (MM) who have received at least one prior line of therapy for MM

* Age of 18 years (or legal age of consent) or older at time of entry into the study

* Have documented progression from a prior line of therapy

* Patients who have initiated treatment with one of the following therapies within 90 days before consent for this study OR in the case where treatme 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:
x IMiD*
x Proteasome inhibitor*
x 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.