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NCT02976272: SENSIB
Neurotoxic Effect of Bortezomib Treatment in Patient With Myeloma Multiple
trial testing bortezomib in Multiple Myeloma in 60 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 7 June 2016 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 January 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- bortezomib (bortezomib) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
- Bortezomib Regimen — all drugs for Bortezomib Regimen →
- Adult — all drugs for Adult →
Sponsor
University Hospital, Clermont-Ferrand
Who can join
18 and older, any sex, with Multiple Myeloma or Bortezomib Regimen. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Crosstalk between hypoxic cellular micro-environment and the immune system: a potential therapeutic target for infectious diseases.
Akinsulie OC, Shahzad S, Ogunleye SC, Oladapo IP, et al · · 2023 · cited 11× · PMID 37600803 · DOI 10.3389/fimmu.2023.1224102
Verify or expand the search:
- PubMed search for NCT02976272
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other University Hospital, Clermont-Ferrand trials
Trials by the same sponsor.
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- NCT07330856 — Evaluation of Treatments for Dry or Productive Cough · Phase 4 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02976272 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Clermont-Ferrand
- Last refreshed: 1 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02976272.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing