Overview

Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165

Status:
Active, not recruiting
Trial end date:
2023-11-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Miami
Treatments:
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.