Multiple Myeloma, Peripheral Neuropathy
Conditions
Brief summary
This is a prospective study investigating the relationship between vitamin D and peripheral neuropathy (PN) among multiple myeloma (MM) patients treated with either bortezomib or thalidomide. The study consists of a screening period of up to 14 days, followed by a single assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic pain, and markers of depression. Patient charts will also be utilized to assess the frequency of skeletal-related events.
Detailed description
Approximately 10% of myeloma patients present at diagnosis with clinical neuropathy although studies reveal as many as 1/3 may have abnormal electrophysiological examinations. Baseline neuropathic abnormal findings are exacerbated by many myeloma treatments, especially bortezomib, thalidomide, and to a lesser extent lenalidomide. Several studies suggest that vitamin D supplementation may help reduce the symptoms of neuropathy.In this prospective study, we will investigate the relationship between vitamin D and PN among MM patients treated with either bortezomib or thalidomide. The study consists of a screening period of up to 14 days, followed by a single assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic pain, and markers of depression. Patient charts will also be utilized to assess the frequency of skeletal-related events.
Interventions
None listed
Sponsors
Millennium Pharmaceuticals, Inc.
Oncotherapeutics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Prior diagnosis of multiple myeloma based on standard criteria (Durie 1986) * Received consecutive, prior treatment for MM with a regimen consisting of at least 16 consecutive weeks of bortezomib or 16 consecutive weeks of thalidomide prior to the Day of Assessment * The 16 weeks of consecutive treatment must have included at least one of the following doses and schedules: * Bortezomib: ≥ 1.0 mg/m² dosed 3 or more times per each 4-week period * Thalidomide: ≥ 50 mg/day dosed daily * The qualifying regimen may include both bortezomib and thalidomide. However, the above inclusion requirements need only be satisfied by either one of the agents. * Age ≥18 years at the time of signing the informed consent form * Able to adhere to the study visit schedule and other protocol requirements
Exclusion criteria
* Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome (Bardwick 1980) * Plasma cell leukemia * Primary amyloidosis * Vitamin D level assessment occurring within the 12 months preceding the Day of Assessment * Vitamin D non-dietary oral supplementation \> 1200 IU per day for \> 30 total days within the 12 month period preceding the Day of Assessment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum vitamin D levels | Day 1 | Correlation of serum vitamin D levels to the incidence and severity of anti-myeloma treatment-induced PN/ neuropathic pain among MM patients previously exposed to bortezomib and/or thalidomide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal related event | Day 1 | Correlation between vitamin D levels and skeletal-related events (pathologic fracture, spinal cord compression or collapse, or surgery or radiotherapy to bone) among MM patients |
Other
| Measure | Time frame | Description |
|---|---|---|
| Markers of depression | Day 1 | Correlation between vitamin D levels and markers of depression for MM patients |
Countries
United States
Outcome results
None listed