Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?

Sponsor
Odense University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05781425
Collaborator
Aarhus University Hospital (Other), Sygehus Lillebaelt (Other), University of Southern Denmark (Other)
20
9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Level of plasma neurofilament light chain [Baseline (before treatment initiation)]

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

    2. Level of plasma neurofilament light chain [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 [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 [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 [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 [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 [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 [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 [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 [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 Outcome Measures

    1. Level of plasma neurofilament relative to cumulative dose of bortezomib [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Per Damkier, Odense University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT05781425
    Other Study ID Numbers:
    • AKF-401
    First Posted:
    Mar 23, 2023
    Last Update Posted:
    Mar 27, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Odense University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 27, 2023