Efficacy of vitamin D supplementation in deficient multiple myeloma patients
- Conditions
- multiple myelomahypovitaminosis Dperipheral neuropathy
- Registration Number
- NL-OMON22930
- Lead Sponsor
- Prof. dr. E.N. van RoonHospital Pharmacist – Clinical PharmacologistMedical Centre LeeuwardenDepartment of Clinical Pharmacy & Pharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Subjects are (newly) diagnosed with smoldering or symptomatic multiple myeloma
Subjects must be over 18 years of age
Exclusion Criteria
Contraindications for the use of vitamin D:
- Hypersensitivity to the active substance(s) or to any of the excipients
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy of a predefined vitamin D dosing regimen in obtaining an adequate serum 25-hydroxyvitamin D level in multiple myeloma patients. The main endpoint is the difference in vitamin D levels at the beginning and end of the study.
- Secondary Outcome Measures
Name Time Method Secondary study parameters are:<br /><br>- to determine the efficacy of vitamin D supplementation on the prevalence and severity of peripheral neuropathy in multiple myeloma patients;<br /><br>- to determine differences between the effect of vitamin D supplementation on the prevalence and severity of PN for patients with or without MM treatment <br /><br>- to determine differences between the effect of vitamin D supplementation on the prevalence and severity of PN for each individual drug used for MM. Drugs that can be used: bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide and vincristine<br /><br>- to detect the influence of several variables (age, gender, cumulative dose, type of treatment, race, the use of alcohol, and the presence of diabetes mellitus) on the chance of successfully increasing the vitamin D serum concentration.