Expired Study
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Miami, Florida 33136


Purpose:

The study seeks to provide long-term follow-up and/or to offer continued maintenance thalidomide (THALOMID) therapy to those patients enrolled in 20030165. Patients will be followed until withdrawal of consent, or death.


Study summary:

The study is designed to provide long-term follow-up and/or to offer continued maintenance thalidomide (THALOMID®) therapy to those patients enrolled in 20030165. - Group A: Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. - Group B: Patients who achieved complete response (CR) in 20030165, but are not receiving maintenance Thalidomide. - Group C: All other patients enrolled in 20030165 who expired or experienced disease progression. Thalidomide (THALOMID®) will be administered as per standard of care guidelines to Group A; in compliance with Risk Evaluation and Mitigation Strategy (REMS™) program requirements. Patients in Group A, B and C will be followed until withdrawal of consent, or death. All other patients in Group C who expired on 20030165 will also be included in all analyses.


Criteria:

Inclusion Criteria: 1. Enrolled on the 20030165 clinical trial. 2. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who were discontinued from 20030165 for any reason prior to the completion of protocol-specified treatment (e.g. withdrawal of consent). 2. Uncontrolled, intercurrent serious illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or cardiac arrhythmia likely in the judgment of the PI to interfere with clinical study requirements. 3. Psychiatric illness/condition likely in the judgment of the PI to limit compliance with clinical study requirements.


NCT ID:

NCT02507336


Primary Contact:

Principal Investigator
Izidore Lossos, MD
University of Miami


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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