Efficacy of vitamin D supplementation in deficient multiple myeloma patients

Efficacy of a predefined vitamin D dosing regimen in vitamin D-deficient multiple myeloma patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22930

Enrollment

100

Registered

2017-11-22

Start date

2017-12-10

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma hypovitaminosis D peripheral neuropathy

Interventions

Patients receive vitamin D-supplements for six months and will receive a vitamin D loading dose (may be repeated after two months). In addition, every patient will complete the ICPNQ Questionnaire and

Eligibility

Inclusion criteria

Inclusion criteria: Subjects are (newly) diagnosed with smoldering or symptomatic multiple myeloma Subjects must be over 18 years of age Subjects must be able to give informed consent Subjects with a 25-hydroxyvitamin D level <75 nmol/l

Exclusion criteria

Exclusion criteria: Contraindications for the use of vitamin D: - Hypersensitivity to the active substance(s) or to any of the excipients - Hypercalcaemia and/or hypercalciuria - Nephrolithiasis and/or nephrocalcinosis - Serious renal impairment - Hypervitaminosis D - Pseudohypoparathyroidism

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary study parameters are: - to determine the efficacy of vitamin D supplementation on the prevalence and severity of peripheral neuropathy in multiple myeloma patients; - to determine differences between the effect of vitamin D supplementation on the prevalence and severity of PN for patients with or without MM treatment - 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 - 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.	—

Measure

Time frame

Secondary study parameters are: - to determine the efficacy of vitamin D supplementation on the prevalence and severity of peripheral neuropathy in multiple myeloma patients; - to determine differences between the effect of vitamin D supplementation on the prevalence and severity of PN for patients with or without MM treatment - 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 - 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.

—

Contacts

Public ContactBerdien Oortgiesen

Medisch Centrum Leeuwarden

Berdien.Oortgiesen@znb.nlTel: 058- 286 1918

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)