NCT03344328: PREVIB

Prevalence, Intensity and Consequences of Bortezomib-induced Neuropathic Disorders.

Completed Last updated 12 November 2020

What this trial tests

trial testing Bortezomib in Chemotherapy Induced Peripheral Neuropathy in 67 participants. Completed in 31 January 2020.

Timeline

15 January 2019

Primary endpoint
31 December 2019

31 January 2020

Quick facts

Lead sponsor	University Hospital, Clermont-Ferrand
Status	Completed
Study type	OBSERVATIONAL
Enrollment	67
Start date	15 January 2019
Primary completion	31 December 2019
Estimated completion	31 January 2020
Sites	1 location across France

Drugs / interventions tested

• Bortezomib (bortezomib) — full drug profile →

Conditions studied

• Chemotherapy Induced Peripheral Neuropathy — all drugs for Chemotherapy Induced Peripheral Neuropathy →
• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

University Hospital, Clermont-Ferrand

Who can join

18 and older, any sex, with Chemotherapy Induced Peripheral Neuropathy or Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cancer-induced peripheral neuropathies (CIPN) remain a real problem in oncology (Balayssac et al., 2011). These CIPN are induced by certain classes of anticancer drugs such as taxanes (paclitaxel and docetaxel), platinum salts (cisplatin and oxaliplatin), alkaloids of Madagascar periwinkle (vincristine), bortezomib, thalidomide and eribulin (Balayssac et al., 2011; Vahdat et al., 2013). These CIPN essentially translate into sensory disorders such as paresthesia, dysesthetics or numbness. More rarely, these CIPN may be associated with motor or vegetative disorders (Balayssac et al., 2011). According to the recent meta-analysis by Hershman et al., no treatment can be proposed as a "gold standard" for preventing or treating CIPN (Hershman et al., 2014). As a result, oncologists reduce or stop doses of neurotoxic anticancer drugs because patients with CIPN have a marked deterioration in quality of life and co-morbidities such as anxiety, depression and sleep disorders (Hong et al., 2014; Mols et al., 2014). Therefore, understanding the pathophysiology of CIPN is essential to propose new therapeutic strategies.

Among neurotoxic anticancer drugs, bortezomib remains relatively little studied in terms of pathophysiology compared to platinum salts or taxanes, while the neurotoxicity of bortezomib remains a limiting factor in treatment. Since 2012, the FDA and EMA have validated the administration of bortezomib subcutaneously instead of intravenously in order to limit the neurotoxicity of bortezomib (Minarik et al., 2015). Indeed, a large study (N=222) reported that subcutaneous administration of bortezomib allowed the same therapeutic efficacy to be maintained while improving the safety profile and in particular limiting peripheral neuropathies (CIPN all grades: 38% vs. 53%, p=0.044, grade\> 2: 24% vs. 41%, p=0.012 and grade\> 3: 6% vs. 16%, p=0.026) However, a recent retrospective study (N=446) reports that the prevalence of bortezomib-induced peripheral neuropathies after subcutaneous administration remains relatively high: all grade: 41%, grade\> 2: 18%, grade\> 3: 4%, and above all that this prevalence is not different between subcutaneous and intravenous routes (Minarik et al., 2015).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prevalence of Chemotherapy-Induced Peripheral Neuropathy in Multiple Myeloma Patients and its Impact on Quality of Life: A Single Center Cross-Sectional Study.
   Selvy M, Kerckhove N, Pereira B, Barreau F, et al · · 2021 · cited 37× · PMID 33967771 · DOI 10.3389/fphar.2021.637593
2. Relation between auditory difficulties and bortezomib-induced peripheral neuropathy in multiple myeloma: a single-center cross-sectional study.
   Giraudet F, Selvy M, Kerckhove N, Pereira B, et al · · 2022 · cited 4× · PMID 35098333 · DOI 10.1007/s00405-021-07234-1