Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy.
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
20
Blood Diseases - Aarhus University Hospital
Aarhus, Denmark
Department of Hematology - Odense University Hospital
Odense, Denmark
Level of plasma neurofilament light chain
Plasma neurofilament light chain before treatment with bortezomib. (Cycle length can vary).
Time frame: Baseline (before treatment initiation)
Level of plasma neurofilament light chain
Plasma neurofilament light chain during treatment with bortezomib.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Day 1 in cycle 6 (each cycle is often between 3-6 weeks)
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Level of plasma neurofilament light chain
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Time frame: 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).
Time frame: 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).
Time frame: Day 1 in cycle 9 (each cycle is often between 3-6 weeks)
Level of plasma neurofilament relative to cumulative dose of bortezomib
Plasma neurofilament light chain relative to the cumulative dose of bortezomib in patients.
Time frame: 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
Time frame: 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.
Time frame: From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.