Neurotoxic Effect of Bortezomib Treatment in Patient With Myeloma Multiple

NCT02976272 | Unknown

• 2 other identifiers: CHU-02912015-A01172-47
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Multiple Myeloma; Bortezomib Regimen; Adult

Keywords

Bortezomib regimen; patients with multiple myeloma

Outcome Measures

Primary Outcomes (3)

• Thermal sensory thresholds of sensitivity to hot measured using a thermode (Medoc TSA-II Abioz Technologies)

  at day 1

• Sensory thresholds of patients will be measured using a thermode (Medoc TSA-II Abioz Technologies)

  at day 1

• Thermal sensory thresholds will be reviewed at the thenar eminence of 2 hands

  at day 1

Secondary Outcomes (8)

• Sensitivity to heat, cold and vibration (will be measured using a thermode)

  at day 1

• Pain induced by hot and cold (will be measured using a thermode)

  at day 1

• Neuropathic symptoms (DN4 questionnaires)

  at day 1

• Neuropathic symptoms (QLQ CIPN20 NPSI questionnaires)

  at day 1

• Neuropathic pain (NRS) measured using a thermode (Medoc TSA-II Abioz Technologies)

  at day 1

Study Arms (1)

patients with myeloma multiple

Other: bortezomib

Interventions

bortezomib OTHER

patients with myeloma multiple

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 with myeloma multiple

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Laboratoires Takeda: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

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

• Carine CHALETEIX

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

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

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 29, 2016
• Study Start: June 7, 2016
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: July 1, 2019

Record last verified: 2016-11

Locations

FR (1)