Chemotherapy-induced Peripheral NeuropathyNFL-BIOPAINNCT05781425
Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 12 May 2023to 29 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Blood Diseases - Aarhus University Hospital
Aarhus
Department of Hematology - Odense University Hospital
Odense, 5000
About this study
Official title: 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.
Read the 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.
- Keywords
- Neurofilament light chain, NFL, Proteasome inhibitor, Chemotherapy-induced peripheral neuropathy
- Medical subject headings
- Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma patients | Treatment naïve multiple myeloma patients. There is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of plasma neurofilament light chain
Plasma neurofilament light chain before treatment with bortezomib. (Cycle length can vary).
Measured: Baseline (before treatment initiation)
Level of plasma neurofilament light chain
Plasma neurofilament light chain during treatment with bortezomib.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 1 in cycle 9 (each cycle is often between 3-6 weeks)
Secondary outcomes (3)
Level of plasma neurofilament relative to cumulative dose of bortezomib
Plasma neurofilament light chain relative to the cumulative dose of bortezomib in patients.
Measured: 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
Measured: 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.
Measured: From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start12 May 2023
- Primary completion24 Apr 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Sygehus Lillebaelt, University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Per Damkier, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781425
- Sponsor's protocol ID
- AKF-401
- Acronym
- NFL-BIOPAIN
- Status last verified
- Jul 2025
- First submitted
- 15 Feb 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data cannot be shared due to general data protection regulation (GDPR).
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05781425
- Acronym / sponsor ID
- NFL-BIOPAIN / AKF-401
- Keywords
- Neurofilament light chain, NFL, Proteasome inhibitor, Chemotherapy-induced peripheral neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Sygehus Lillebaelt, University of Southern Denmark
- Study start
- 12 May 2023 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma patients | – | –Treatment naïve multiple myeloma patients. There is no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of plasma neurofilament light chain
Time frame: Baseline (before treatment initiation)
Plasma neurofilament light chain before treatment with bortezomib. (Cycle length can vary).
Level of plasma neurofilament light chain
Time frame: Between day 8 and 15 in cycle 1 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib.
Level of plasma neurofilament light chain
Time frame: Day 1 in cycle 2 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Level of plasma neurofilament light chain
Time frame: Day 1 in cycle 3 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Level of plasma neurofilament light chain
Time frame: Day 1 in cycle 4 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Level of plasma neurofilament light chain
Time frame: Day 1 in cycle 5 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Level of plasma neurofilament light chain
Time frame: Day 1 in cycle 6 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Level of plasma neurofilament light chain
Time frame: Day 1 in cycle 7 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Level of plasma neurofilament light chain
Time frame: Day 1 in cycle 8 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
Level of plasma neurofilament light chain
Time frame: Day 1 in cycle 9 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
3 secondary outcomes
Level of plasma neurofilament relative to cumulative dose of bortezomib
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data cannot be shared due to general data protection regulation (GDPR).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Damkier principal investigator
Odense University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of plasma neurofilament light chain (time frame: Baseline (before treatment initiation)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.