Clinical trial · Observational
Bortezomib (Velcade) - Regulatory Post Marketing Surveillance (PMS)
Velcade - Regulatory Post Marketing Surveillance (PMS)
NCT01005628CI-TRIAL-00009506completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
After the KFDA (Korea Food and Drug Administration) approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 001
- description
- bortezomib Injection into a vein 1.3 mg/m2 twice a week for 21 days
- interventionNames
- Drug: bortezomib
Primary outcomes (1)
- measure
- The data on AE (Adverse event) incidence, such as whether AEs occurred, types of AEs, and incidence of AEs by type
- timeFrame
- every cycles or every 3 weeks
Secondary outcomes (1)
- measure
- The overall response rate (complete remission rate+partal remission rate) will be measured according to the EBMT or IMWG criteria.
- timeFrame
- every cycle or every 3 weeks and end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma Exclusion Criteria: * Patients who are hypersensitive to the bortezomib or any component of the bortezomib or with a history of the hypersensitivity * Patients with severe hepatic impairment * Pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.