Prediction of Getting Peripheral Neuropathy in Patients Treated With Bortezomib? (NFL-BIOPAIN)

Odense University Hospital

Status: Completed

Conditions: Chemotherapy-induced Peripheral Neuropathy

Study type: Observational

Funder types: Other

Identifiers

NCT05781425

AKF-401

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Multiple Myeloma patients

Description:

Treatment naïve multiple myeloma patients. There is no intervention.