Overview
Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2023-11-01
2023-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of MiamiTreatments:
Thalidomide
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.