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

NCT03344328 | Completed

• 1 other identifier: CHU-359
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chemotherapy Induced Peripheral Neuropathy; Multiple Myeloma

Keywords

Chemotherapy; Bortezomib; Multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Prevalence of peripheral neuropathy

  Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20 ; EORTC- European Organisation for Research and Treatment of Cancer). The questionnaire is divided in 3 subscales: sensory, motor and vegetative. Severity scores summed from 0 to 100. A high score will correspond to the worst symptoms. * Sensory score CIPN20 ≤ 6 = grade 0 NCI-CTCAE * Sensory score CIPN20 \> 6 and \< 30 = grade 1 NCI-CTCAE * Sensory score CIPN20 ≥ 30 and \< 80 = grade 2-3 NCI-CTCAE * Sensory score CIPN20 ≥ 80 = grade 4 NCI-CTCAE.

  at day 1

Secondary Outcomes (5)

• Chronic pain

  at day 1

• Screening of neuropathic pain

  at day 1

• Anxiety and Depression Score

  at day 1

• Hearing disorders

  at day 1

• Health -related quality of life related to chemotherapy treatment.

  at day 1

Interventions

Bortezomib DRUG

The algorithm (computer query) will identify all patients who received bortezomib-based chemotherapy for the multiple myeloma indication between 2008 and 2016. All the questionnaires used are validated in the scientific literature.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients previously treated with bortezomib for multiple myeloma between 2008 and 2016 at Clermont-Ferrand University Hospital

You may qualify if:

• \- Patients previously treated with bortezomib for multiple myeloma between 2008 and 2016 at Clermont-Ferrand University Hospital.
• Oral non-opposition of participation in the study

You may not qualify if:

• Patient unable to understand or answer questionnaires.
• Age \< 18 years.
• Neurological pathologies (e. g. Parkinson's syndrome, stroke, fibromyalgia, etc.).
• Legal incapacity (person deprived of liberty or under guardianship).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

• Giraudet F, Selvy M, Kerckhove N, Pereira B, Barreau F, Nguyen D, Busserolles J, Cabrespine A, Chaleteix C, Soubrier M, Bay JO, Lemal R, Balayssac D. Relation between auditory difficulties and bortezomib-induced peripheral neuropathy in multiple myeloma: a single-center cross-sectional study. Eur Arch Otorhinolaryngol. 2022 Apr;279(4):2197-2201. doi: 10.1007/s00405-021-07234-1. Epub 2022 Jan 31.

  PMID: 35098333 DERIVED

• Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.

  PMID: 33218965 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David BALAYSSAC

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: November 17, 2017
• Study Start: January 15, 2019
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: November 12, 2020

Record last verified: 2019-06

Locations

FR (1)