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.
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
- Group C: All other patients enrolled in 20030165 who expired or experienced disease
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.
1. Enrolled on the 20030165 clinical trial.
2. Ability to understand and willingness to sign a written informed consent document.
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
3. Psychiatric illness/condition likely in the judgment of the PI to limit compliance
with clinical study requirements.