Efficacy of vitamin D supplementation in multiple myeloma patients.

Efficacy of a predefined vitamin D dosing regimen in vitamin D-insufficient multiple myeloma patients. - Efficacy of vitamin D supplementation in multiple myeloma patients.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005110-58-NL

Enrollment

Registered

2018-05-14

Start date

2018-06-14

Completion date

Unknown

Last updated

2018-06-25

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

Conditions

Hypovitaminosis D

Interventions

Trade Name: Cholecalciferol Mylan 800 IU tablets Product Name: Cholecalciferol Mylan 800 IE tablets Pharmaceutical Form: Tablet Trade Name: D-Cura 100.000 IU oral solution Pharmaceutical Form: Oral s

Eligibility

Sex/Gender

All

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29

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. The use of vitamin D tablets or multivitamin tablets containing vitamin D

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to determine the efficacy of a predefined vitamin D dosing regimen on the prevalence of vitamin D insufficiency in MM patients. ;Secondary Objective: Secondary objectives are 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; to determine the efficacy of vitamin D supplementation on the prevalence and severity of PN in MM patients; to determine differences between the effect of vitamin D supplementation on the prevalence and severity of PN for each subgroup: treatment and different drugs used for MM (drugs that can be used are bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide and vincristine).;Primary end point(s): The main endpoint is the proportion of patients with an adequate vitamin D level (> 75 nmol/L) after 6 months.;Timepoint(s) of evaluation of this end point: After 6 months	—

Measure

Time frame

Main Objective: The primary objective of this study is to determine the efficacy of a predefined vitamin D dosing regimen on the prevalence of vitamin D insufficiency in MM patients. ;Secondary Objective: Secondary objectives are 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; to determine the efficacy of vitamin D supplementation on the prevalence and severity of PN in MM patients; to determine differences between the effect of vitamin D supplementation on the prevalence and severity of PN for each subgroup: treatment and different drugs used for MM (drugs that can be used are bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide and vincristine).;Primary end point(s): The main endpoint is the proportion of patients with an adequate vitamin D level (> 75 nmol/L) after 6 months.;Timepoint(s) of evaluation of this end point: After 6 months

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are 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; the efficacy of vitamin D supplementation on the prevalence and severity of PN in vitamin D-deficient MM patients; differences between the effect of vitamin D supplementation on the prevalence and severity of PN for each subgroup: treatment and different drugs used for MM (drugs that can be used are bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide and vincristine);Timepoint(s) of evaluation of this end point: After 6 months	—

Measure

Time frame

Secondary end point(s): Secondary endpoints are 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; the efficacy of vitamin D supplementation on the prevalence and severity of PN in vitamin D-deficient MM patients; differences between the effect of vitamin D supplementation on the prevalence and severity of PN for each subgroup: treatment and different drugs used for MM (drugs that can be used are bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide and vincristine);Timepoint(s) of evaluation of this end point: After 6 months

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Countries

Netherlands

Contacts

Public ContactBerdien Oortgiesen

Medical Centre Leeuwarden

00310582861918

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026