The primary objective of this study is to determine the efficacy of vitamin D supplementation on the severity of PN in patients with multiple myeloma.
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The efficacy of vitamin D supplementation on the severity of PN in vitamin
D-deficient MM patients with grade 2 or 3 PN. The main endpoint is the percent
change in the number of patients whose PN decreases with at least 1 grade.
Secondary outcome
Secondary objectives are to assess an optimal dosing regimen of vitamin D
supplementation in MM patients and to search for differences in the effect of
vitamin D on PN for each drug.
Background summary
Randomized controlled trials have shown that the introduction of the novel
agents bortezomib, thalidomide and lenalidomide have improved response rates,
progression-free survival and overall survival. However, chemotherapy-induced
peripheral neuropathy (CIPN), especially when using bortezomib, is a common
adverse event. In addition, several studies have found that up to 54% of MM
patients have peripheral neuropathy (PN) at diagnosis, indicating that the
disease itself can also induce PN. PN decreases quality of life and requires
dose adjustment, delay or premature termination of the treatment, resulting in
a negative influence on time to progression and survival. Vitamin D was found
to reduce polyneuropathy in diabetes mellitus type 2 patients and a possible
mechanism was found in animal trials, where the investigators found an increase
of nerve growth factor in diabetic rats after supplementation of vitamin D.
Recently, it was found that vitamin D deficient MM patients were more likely to
have severe CIPN (>grade 2) of both motor and sensory PN and in this study we
want to investigate the effect of vitamin D supplementation in MM patients on
the occurrence and severity of PN.
Study objective
The primary objective of this study is to determine the efficacy of vitamin D
supplementation on the severity of PN in patients with multiple myeloma.
Study design
Patients will be randomized in two groups. Patients in group 1 receive vitamin
D supplementation and patients in group 2 will not. The 25-hydroxyvitamin D
serum levels of patients in group 1 will be measured after two months, to
ascertain a vitamin D level * 75 nmol/l. When necessary, dose adjustments can
be made to accomplish an accurate level. After 6 months, vitamin D levels will
be determined in all patients. In addition, each patient will complete the
self-assessment questionnaire ICPNQ and VAS score after two months and at end
of follow-up after six months.
Intervention
Patients in group 1 receive vitamin D-supplements for six months. In addition,
every patient will complete the ICPNQ Questionnaire and VAS score after 2 and 6
months to determine neuropathy grading.
Study burden and risks
Preventing CIPN is of great importance for the continuation of chemotherapy and
the prolonged exposure presumably results in a higher survival rate and an
improved quality of life. As blood sampling is performed frequently in myeloma
patients and the questionnaire can be filled in within minutes, the burden for
the patients is minimal. Patients do need to take an extra vitamin supplement
on top of the other drugs needed for treatment. However, vitamin D in doses in
this study is reported a safe intervention without adverse drug reactions.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
Patients with multiple myeloma with grade 2/3 peripheral neuropathy and a 25-hydroxyvitamin D level <75 nmol/l.
Exclusion criteria
Contraindications for the use of vitamin D and/or patients who are already using any formulation of vitamin D
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002343-42-NL |
| CCMO | NL57872.099.16 |