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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Sygehus Lillebaelt | OTHER |
| University of Southern Denmark | OTHER |
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Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Myeloma patients | Treatment naïve multiple myeloma patients. There is no intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Level of plasma neurofilament relative to cumulative dose of bortezomib | Plasma neurofilament light chain relative to the cumulative dose of bortezomib in patients. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Per Damkier | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood Diseases - Aarhus University Hospital | Aarhus | Denmark | ||||
| Department of Hematology - Odense University Hospital |
Individual participant data cannot be shared due to general data protection regulation (GDPR).
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| ID | Term |
|---|---|
| C537987 | Charcot-Marie-Tooth disease, Type 1F |
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| 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) |
Using questionnaire Chemotherapy-induced peripheral neuropathy 20 (CIPN20), grading |
| 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 | Using Common Terminology Criteria for Adverse Events (CTCAE) version 5, grading 1-5 with 1 being the mildest case and 5 being the worst. | From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year. |
| Odense |
| 5000 |
| Denmark |