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

Phase 3

Completed

Conditions: Hypovitaminosis D
vitamin D insufficiency
10047635
10035227
10034606

Registration Number: NL-OMON46493

Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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 vitamin D level * 75 nmol/L.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The efficacy of a predefined vitamin D dosing regimen in obtaining an adequate<br /><br>vitamin D level in multiple myeloma patients. The main endpoint is the<br /><br>proportion of patients with an adequate vitamin D level (> 75 nmol/L) after 6<br /><br>months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are: to detect the influence of several variables<br /><br>(age, gender, cumulative dose, type of treatment, race, the use of alcohol and<br /><br>the presence of diabetes mellitus) on the chance of successfully increasing the<br /><br>vitamin D serum concentration; to determine the efficacy of vitamin D<br /><br>supplementation on the prevalence and severity of peripheral neuropathy in<br /><br>multiple myeloma patients; to determine differences between the effect of<br /><br>vitamin D supplementation on the prevalence and severity of PN for each<br /><br>subgroup: treatment, and individual drugs used for MM (drugs that can be used<br /><br>are bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide,<br /><br>panobinostat, pomalidomide, thalidomide and vincristine) </p><br>