Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?

NCT05781425 | Completed

• 1 other identifier: AKF-401
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Neurofilament light chain; NFL; Proteasome inhibitor; Chemotherapy-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (10)

• Level of plasma neurofilament light chain

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

  Baseline (before treatment initiation)

• Level of plasma neurofilament light chain

  Plasma neurofilament light chain during treatment with bortezomib.

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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

  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

  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

  From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.

Study Arms (1)

Multiple Myeloma patients

Treatment naïve multiple myeloma patients. There is no intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital: collaborator
• Sygehus Lillebaelt: collaborator
• University of Southern Denmark: collaborator

Study Sites (2)

Blood Diseases - Aarhus University Hospital

Aarhus, Denmark

Location

Department of Hematology - Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Charcot-Marie-Tooth disease, Type 1F

Study Officials

• Per Damkier

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 23, 2023
• Study Start: May 12, 2023
• Primary Completion: April 24, 2025
• Study Completion: July 29, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)