Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— NFL-BIOPAIN  

Official title:

Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781425
• Other study ID #: AKF-401
• Status: Recruiting
• Start date: May 12, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Odense University Hospital
• Contact: Per Damkier, ph.d.
• Phone: 26113790
• Email: Per.Damkier[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
Denmark	Blood Diseases - Aarhus University Hospital	Aarhus
Denmark	Department of Hematology - Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital, Sygehus Lillebaelt, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain before treatment with bortezomib. (Cycle length can vary).	Baseline (before treatment initiation)
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain during treatment with bortezomib.	Between day 8 and 15 in cycle 1 (each cycle is often between 3-6 weeks)
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).	Day 1 in cycle 2 (each cycle is often between 3-6 weeks)
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).	Day 1 in cycle 3 (each cycle is often between 3-6 weeks)
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).	Day 1 in cycle 4 (each cycle is often between 3-6 weeks)
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).	Day 1 in cycle 5 (each cycle is often between 3-6 weeks)
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).	Day 1 in cycle 6 (each cycle is often between 3-6 weeks)
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).	Day 1 in cycle 7 (each cycle is often between 3-6 weeks)
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).	Day 1 in cycle 8 (each cycle is often between 3-6 weeks)
Primary	Level of plasma neurofilament light chain	Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).	Day 1 in cycle 9 (each cycle is often between 3-6 weeks)
Secondary	Level of plasma neurofilament relative to cumulative dose of bortezomib	Plasma neurofilament light chain relative to the cumulative dose of bortezomib in patients.	From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.
Secondary	Degree of peripheral neuropathy	Using questionnaire Chemotherapy-induced peripheral neuropathy 20 (CIPN20), grading	From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.
Secondary	Degree of peripheral neuropathy	Using Common Terminology Criteria for Adverse Events (CTCAE) version 5, grading 1-5 with 1 being the mildest case and 5 being the worst.	From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.