Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib? (NFL-BIOPAIN)

Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy

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

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced 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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Per Damkier, ph.d.; Phone Number: 0045 26113790; Email: Per.Damkier@rsyd.dk

Study Locations

• Denmark
  • Aarhus, Denmark
    • Recruiting
    • Blood Diseases - Aarhus University Hospital
    • Contact: Mette Katrine Nygaard, MD
  • Odense, Denmark, 5000
    • Recruiting
    • Department of Hematology - Odense University Hospital
    • Contact: Thomas Lund, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Must be at least 18 years of age, must understand and speak Danish, must have multiple myeloma and be a candidate for treatment with bortezomib and must not be at candidate for cell transplantation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Multiple Myeloma patients; Treatment naïve multiple myeloma patients. There is no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of plasma neurofilament light chain	Plasma neurofilament light chain before treatment with bortezomib. (Cycle length can vary).	Baseline (before treatment initiation)
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)
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)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Aarhus University Hospital; University of Southern Denmark; Sygehus Lillebaelt
• Investigators: Principal Investigator: Per Damkier, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Neurofilament light chain; Chemotherapy-induced peripheral neuropathy; Proteasome inhibitor; NFL
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: AKF-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data cannot be shared due to general data protection regulation (GDPR).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No