Phase 2
Completed N=2
Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Source: ClinicalTrials.gov NCT02507336 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Progression-free Survival (PFS) — NA years
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
NA | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Response Rate (RR) |
NA | — |
| SECONDARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events |
NA | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02507336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.