Clinical trial NCT05781425: Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?
Official title: Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Neurofilament light chain
NFL
Proteasome inhibitor
Chemotherapy-induced peripheral neuropathy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Sygehus Lillebaelt
name: University of Southern Denmark
First posted: 2023-03-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of plasma neurofilament light chain
timeFrame: Baseline (before treatment initiation)
measure: Level of plasma neurofilament light chain
timeFrame: Between day 8 and 15 in cycle 1 (each cycle is often between 3-6 weeks)
measure: Level of plasma neurofilament light chain
timeFrame: Day 1 in cycle 2 (each cycle is often between 3-6 weeks)
measure: Level of plasma neurofilament light chain
timeFrame: Day 1 in cycle 3 (each cycle is often between 3-6 weeks)
measure: Level of plasma neurofilament light chain
timeFrame: Day 1 in cycle 4 (each cycle is often between 3-6 weeks)
measure: Level of plasma neurofilament light chain
timeFrame: Day 1 in cycle 5 (each cycle is often between 3-6 weeks)
measure: Level of plasma neurofilament light chain
timeFrame: Day 1 in cycle 6 (each cycle is often between 3-6 weeks)
measure: Level of plasma neurofilament light chain
timeFrame: Day 1 in cycle 7 (each cycle is often between 3-6 weeks)
measure: Level of plasma neurofilament light chain
timeFrame: Day 1 in cycle 8 (each cycle is often between 3-6 weeks)
measure: Level of plasma neurofilament light chain
timeFrame: Day 1 in cycle 9 (each cycle is often between 3-6 weeks)
Secondary outcomes:
measure: Level of plasma neurofilament relative to cumulative dose of bortezomib
timeFrame: From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.
measure: Degree of peripheral neuropathy
timeFrame: From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.
measure: Degree of peripheral neuropathy
timeFrame: From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Blood Diseases - Aarhus University Hospital
city: Odense
country: Denmark
facility: Department of Hematology - Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Per Damkier
role: PRINCIPAL_INVESTIGATOR
References: