Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-12

Study Completion Date

2025-07-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Myeloma patients

Treatment naïve multiple myeloma patients. There is no intervention.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No