Clinical trial · Interventional
Evaluation of Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients
Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.
NCT00872352CI-TRIAL-00002183unknownPhase 3ClinicalTrials.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)
In the present study we are planning to study electrophysiological changes related to the dose and time of bortezomib administration in newly diagnosed patients with MM, during the first months of treatment and 6 months after ending. In addition a possible correlation between the incidence of BIPN and the subtype of myeloma and other risk factors will be investigated.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EMG | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- A dose-related neurotoxic effect of bortezomib will be determined through regression analysis with the change in TNSr as the dependent variable Bortezomib doses will use as independent variables.
- timeFrame
- 3 months
Secondary outcomes (1)
- measure
- To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age\> 18 * Patients with Multiple Myeloma stage II, III (Durie and Salmon staging) prior to Bortezomib Therapy * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Be willing and able to comply with the protocol treatment for the duration of the study * Patient's written informed consent Exclusion Criteria: * Multiple Myeloma on progression * Incidence of Relapsed or Refractory Myeloma * Patients with the existing neuropathy at the time of the diagnosis
References
Publications (0)
Data not yet available
No reference posted for this study.