Clinical trial · Observational
Neurotoxic Effect of Bortezomib Treatment in Patient With Myeloma Multiple
Assessment of Sensory Disorders Associated With Peripheral Neuropathy Induced by Bortezomib: Prospective Comparative Study
- 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)
Chemotherapy-induced peripheral neuropathies (CIPN) remain a problem in oncology because no "gold standard" treatment exists to prevent or treat the CIPN. Therefore, oncologists reduce or stop the chemotherapy doses to limit degradation of the quality of life of patients with CIPN. Bortezomib is relatively understudied while neurotoxicity remains a limiting factor for treatment. Since 2012, the FDA and the EMA validated by the administration of bortezomib subcutaneously (SC) instead of intravenous (IV) in order to limit neurotoxicity. However, a retrospective study reported that the prevalence of neuropathy induced by bortezomib after SC administration remains high and equivalent to IV route. No studies have quantitatively and qualitatively evaluated the sensory disorders in peripheral neuropathies induced by bortezomib after SC administration. On the other hand, the QLQ-CIPN20 questionnaire (EORTC) evaluating the intensity of sensory, motor and autonomic disorders associated with CIPN has never been tested in this population. The objective of this study is twofold: (i) psychophysical evaluation of neuropathic disorders by studying the thermal and vibratory detection thresholds and thermal nociceptive thresholds and (ii) quantitative and qualitative assessment of neuropathic disorders by the QLQ-CIPN20 and related comorbidities in a population of neuropathic patients treated with bortezomib (n = 15), compared to control patients treated with bortezomib but non-neuropathic (n = 45).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult | — | UNRESOLVED | — |
| Bortezomib Regimen | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- patients with myeloma multiple
- interventionNames
- Other: bortezomib
Primary outcomes (3)
- measure
- Thermal sensory thresholds of sensitivity to hot measured using a thermode (Medoc TSA-II Abioz Technologies)
- timeFrame
- at day 1
- measure
- Sensory thresholds of patients will be measured using a thermode (Medoc TSA-II Abioz Technologies)
- timeFrame
- at day 1
- measure
- Thermal sensory thresholds will be reviewed at the thenar eminence of 2 hands
- timeFrame
- at day 1
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Multiple myeloma diagnosis. * Patient undergoing or who received bortezomib-based chemotherapy in first-line (VTD protocol, MPV or VD). Case Group: peripheral sensory neuropathy * Neuropathy ≥ grade 2 (grade 2-3) from NCI-CTCAE Control group: asymptomatic * Neuropathy of grade \<2 (grade 0-1) from NCI-CTCAE Exclusion Criteria: * Age \<18 years. * Treatment history by neurotoxic chemotherapy (taxanes, platinum salts, bortezomib, thalidomide, eribulin) before the current treatment. * Existing treatment: opioids, tricyclic antidepressants, pregabalin, gabapentin, duloxetine or AEDs. * Drinking: Male \> 3 and Woman \> 2 units per day. * Peripheral neuropathies history or known neuropathic pain * Progressive neurological disease. * Patient enrolled in a clinical study evaluating a preventive or curative treatment of chemotherapy-induced peripheral neuropathy.
References
Publications (0)
Data not yet available