Clinical trial · Observational
Retrospective Survey of Re-treatment With Bortezomib
Retrospective Evaluation of Re-Treatment With Bortezomib in Subjects With First Relapse After Bortezomib First-Line Therapy
- 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)
The purpose of this retrospective study is to collect information about patients who received bortezomib as their first chemotherapy and who responded well to it, but who relapsed afterwards and were treated again with bortezomib a second time after a treatment-free period of at least 6 months. During this non-interventional study (this means that no drug is being tested in this study) the safety and effectiveness (whether it works or not) of bortezomib re-treatment will be evaluated in patients with multiple myeloma. Only data already mentioned in your clinical file will be collected. About 100 adult patients will take part in the study
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Cancer | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib retreatment due to relapse | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- bortezomib retreatment
- description
- bortezomib retreatment due to relapse Patients who received bortezomib-containing chemotherapy as first-line treatment for MM experienced partial response or better and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months
- interventionNames
- Other: bortezomib retreatment due to relapse
Primary outcomes (1)
- measure
- overall response after retreatment
- timeFrame
- Day 1
- description
- overall response after retreatment will be assessed from initial diagnosis to the time of data collection
Secondary outcomes (6)
- measure
- number of medical care encounters
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has a current diagnosis/was diagnosed with MM or secretory MM * Was previously treated with bortezomib-containing chemotherapy * Responded to bortezomib as first-line treatment * Has been re-treated with bortezomib (at least 3 cycles) due to relapse of the disease (following the first bortezomib treatment), after a treatment-free interruption of at least 6 months * Completed bortezomib re-treatment at least 2 months ago Exclusion Criteria: * Was a pregnant or breastfeeding woman while receiving either first-line or second-line treatment with Velcade Has received bortezomib-containing chemotherapy for the first time following a first relapse or later * Has participated in a clinical trial in which bortezomib was used as second-line treatment following a relapse after response to Velcade as first-line chemotherapy, and the study data are not publicly available at the time of inclusion in the current study * Has received bortezomib as first-line therapy and was re-treated with bortezomib after first relapse in the VISTA clinical trial
References
Publications (0)
Data not yet available