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Completed

NCT Number: NCT05781425

Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Blood Diseases - Aarhus University Hospital, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Level of plasma neurofilament light chain

    Time frame: Baseline (before treatment initiation)

    Plasma neurofilament light chain before treatment with bortezomib. (Cycle length can vary).

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

Secondary outcomes

  1. 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.

    Plasma neurofilament light chain relative to the cumulative dose of bortezomib in patients.

  2. 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.

    Using questionnaire Chemotherapy-induced peripheral neuropathy 20 (CIPN20), grading

  3. 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.

    Using Common Terminology Criteria for Adverse Events (CTCAE) version 5, grading 1-5 with 1 being the mildest case and 5 being the worst.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Sygehus Lillebaelt
  • University of Southern Denmark

Registry information

Official study title

Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy

Acronym: NFL-BIOPAIN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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