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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
100-300 mg capsule taken by mouth once daily.
University of Miami
Miami, Florida, United States
Progression-free Survival (PFS)
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).
Time frame: Up to five years
Overall Survival (OS)
OS is defined as the elapsed time from start of treatment until death or date of censoring.
Time frame: Up to five years
Response Rate (RR)
Response rate is defined as the percentage of participants whose cancer shrinks or disappears after treatment.
Time frame: Up to five years
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Treatment emergent adverse events will be assessed by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0.
Time frame: Up to five years
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