Predicting peripheral neuropathy risk in patients treated with bortezomib
Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy
This study is trying to see if measuring a specific protein in the blood can help predict the risk of nerve damage in people with multiple myeloma who are being treated with bortezomib.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Trial ID | NCT05781425 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the risk of developing chemotherapy-induced peripheral neuropathy in patients with multiple myeloma undergoing treatment with bortezomib. It aims to enroll 20 patients who will have blood samples drawn before treatment and during their treatment cycles to measure levels of neurofilament light chain (NFL). The primary goal is to correlate NFL levels during treatment with baseline levels, while a secondary goal is to assess the relationship between NFL levels and the cumulative dose of bortezomib. Participants will follow their standard treatment regimen while contributing to this research.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with multiple myeloma who are starting bortezomib treatment and are not candidates for transplantation.
Not a fit: Patients with other underlying cancer diseases, previous neurotoxic chemotherapy, or known polyneuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at higher risk for peripheral neuropathy, allowing for better management and prevention strategies.
How similar studies have performed: While this approach is focused on a specific patient population, similar studies have shown promise in predicting chemotherapy-related side effects using biomarkers.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarhus and 1 other locations
- Blood Diseases - Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Department of Hematology - Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Per Damkier — Odense University Hospital
- Study coordinator: Per Damkier, ph.d.
- Email: Per.Damkier@rsyd.dk
- Phone: 26113790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.