The primary objective of this study is to determine the correlation between the 25-hydroxyvitamin D serum levels and 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 relationship between the occurrence of PN and the vitamin D status in MM
patients. The main endpoint is the number of patients with neuropathy and the
difference in neuropathy grading between patient groups with or without
accurate vitamin D levels.
Secondary outcome
Secondary objectives are to evaluate the influence of different vitamin D
levels on the severity of PN; to search for differences in prevalence of PN for
each drug; to determine the correspondence of the ICPNQ results and patients'
records and to gain insight in the number of patients with inadequate
25-hydroxyvitamin D serum levels (< 75 nmol/l).
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. In this study we want
to confirm the relationship of vitamin D status and the occurrence and severity
of PN in MM patients.
Study objective
The primary objective of this study is to determine the correlation between the
25-hydroxyvitamin D serum levels and PN in patients with multiple myeloma.
Study design
This is an observational study. Blood samples will be drawn to determine
vitamin D levels and the ICPNQ Questionnaire, a validated questionnaire to
distinguish different PN grades in MM patients will be completed. VAS scores
will be used to grade the intensity of PN.
Study burden and risks
Preventing CIPN is of great importance for the continuation of chemotherapy and
a prolonged exposure will presumably result in a higher survival rate and an
improved quality of life. When this study confirms the relationship between
vitamin D and neuropathy, new opportunities for the prevention of PN may arise.
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.
Henri Dunantweg 2
Leeuwarden 9034 AD
NL
Henri Dunantweg 2
Leeuwarden 9034 AD
NL
Listed location countries
Age
Inclusion criteria
* Subjects are (newly) diagnosed with smoldering or symptomatic MM
* Subjects must be over 18 years of age
* Subjects must be able to give informed consent
Exclusion criteria
None
Design
Recruitment
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 |
|---|---|
| CCMO | NL58290.099.16 |