Long-term Follow-up and/or Continued Thalidomide (THALOMID®) Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Enrolled on the 20030165 clinical trial.
- •Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria
- •Patients who were discontinued from 20030165 for any reason prior to the completion of protocol-specified treatment (e.g. withdrawal of consent).
- •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.
- •Psychiatric illness/condition likely in the judgment of the PI to limit compliance with clinical study requirements.
Arms & Interventions
Group A - CR+Thalidomide
Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. Patients in Group A will receive daily oral thalidomide (THALOMID®) as per standard of care and THALOMID® REMS™ guidelines. Patients will continue with thalidomide (THALOMID®) as per standard of care guidelines, until progression of disease, discontinuation due to toxicity, death or study withdrawal. Patients will receive annual clinical/laboratory evaluations.
Intervention: Thalidomide (Drug)
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: Up to five years
PFS is defined as the length of time, during and after treatment, until documented disease progression or death (by any cause, in the absence of progression).
Secondary Outcomes
- Overall Survival (OS)(Up to five years)
- Response Rate (RR)(Up to five years)
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events(Up to five years)
Investigators
Izidore Lossos, MD
Professor
University of Miami