Clinical trial · Observational
A Retreatment Study With Bortezomib for Multiple Myeloma
An Observational, Prospective Analysis of Retreatment With Bortezomib for Multiple Myeloma
- 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 study is to monitor such factors as a past history, a previous history of drug use, the degree of response to initial treatment, the frequency of previous therapies, age, Eastern Cooperative Oncology Group (ECOG) performance status, which is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for re-treatment and the pattern of treatment in patients with multiple myeloma who were re-treated with injectable bortezomib.
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
- To monitor such factors as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, the concomitant drugs that are used for re-treatment and the pattern of treatment.
- timeFrame
- 6-12 months
Secondary outcomes (2)
- measure
- Adverse events
- timeFrame
- at the end of every 3 week cycle
- measure
- Overall response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with multiple myeloma * Patients who were treated with bortezomib monotherapy or bortezomib combination therapy * Patients who relapsed after \>= six months interval since last dose of bortezomib * Patients who had a treatment response of higher than partial remission (PR) to the previous bortezomib therapy * Patients who were fully aware of the objectives and essential procedures of the current trial and then submitted a written informed consent declaring that they will voluntarily participate in the current trial Exclusion Criteria: * The current presence of or a past history of hypersensitivity to bortezomib or its constituents * Severe hepatic dysfunction (AST or ALT at first use\>= x 5 upper normal) * Pregnant women
References
Publications (0)
Data not yet available