Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?

Recruiting

• Conditions: Chemotherapy-induced Peripheral Neuropathy

• Registration Number: NCT05781425
• Lead Sponsor: Odense University Hospital

Brief Summary

Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy.

Detailed Description

The study aims to include 20 patients with multiple myeloma that are initiating bortezomib treatment. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 9 cycles.

Blood is dawn before treatment initiation and approximately once per cycle in order to measure neurofilament light chain (NFL) before and during treatment. The primary outcome is to relate the level of NFL during treatment with the level at baseline and as a secondary outcome to relate the level of NFL to the cumulative dose of bortezomib.

Study Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-23
• Study Start: 2023-05-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Above 18 years of age
• Must speak and understand Danish
• Must be able to and willing to give informed consent
• Diagnosed with myeloma and in need for treatment
• Must not be a candidate for transplantation and must be a candidate for bortezomib treatment.
• Must not previously have been treated with proteasome inhibitors
• Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 3

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Exclusion Criteria

• Other underlying cancer disease - with exception of a) basal cell carcinoma, b) healed carcinoma in situ cervicis uteri, c) other cancer disease with minimal risk of recurrence or d) prostate cancer with low glean score
• Previous treatment with neurotoxic chemotherapy
• Known polyneuropathy or at diagnosis have polyneuropathy degree 1 with pain or degree 2 without pain.
• Simultaneous amyloidosis/POEMS syndrome
• Patients who have received chemotherapy previously and patients with diabetes, HIV and neurodegenerative diseases.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of plasma neurofilament light chain	Day 1 in cycle 9 (each cycle is often between 3-6 weeks)	Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).

Secondary Outcome Measures

Name	Time	Method
Level of plasma neurofilament relative to cumulative dose of bortezomib	From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.	Plasma neurofilament light chain relative to the cumulative dose of bortezomib in patients.
Degree of peripheral neuropathy	From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.	Using Common Terminology Criteria for Adverse Events (CTCAE) version 5, grading 1-5 with 1 being the mildest case and 5 being the worst.

Trial Locations

Locations (2)

Blood Diseases - Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Hematology - Odense University Hospital; 🇩🇰 Odense, Denmark