Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?

Study Overview
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Brief Summary
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Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy.

Detailed Description
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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.

Official Title
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Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy

Conditions
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Chemotherapy-induced Peripheral Neuropathy

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Myeloma patients<br>Treatment naïve multiple myeloma patients. There is no intervention. | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NFL, Neurofilament light chain, Proteasome inhibitor, Chemotherapy-induced peripheral neuropathy