Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
Neurofilament light chain, NFL, Proteasome inhibitor, Chemotherapy-induced peripheral neuropathy
Brief summary
Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy.
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.
Interventions
None listed
Sponsors
Aarhus University Hospital
Sygehus Lillebaelt
University of Southern Denmark
Odense University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of plasma neurofilament light chain | Baseline (before treatment initiation) | Plasma neurofilament light chain before treatment with bortezomib. (Cycle length can vary). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Denmark
Outcome results
None listed