|- candidate number||24704|
|- NTR Number||NTR5990|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-jul-2016|
|- Secondary IDs||RTPO 985 |
|- Public Title||Vitamin D and neuralgia in multiple myeloma|
|- Scientific Title||Vitamin D status and peripheral neuropathy in multiple myeloma patients.|
|- hypothesis||Decreased levels of vitamin D is associated with the occurence of peripheral neuropathy in multiple myeloma patients.|
|- Healt Condition(s) or Problem(s) studied||Neuropathy , Multiple myeloma, Vitamin D|
|- Inclusion criteria||Patients with smoldering or symptomatic multiple myeloma|
Patients 18 years or older
Able to give informed consent
|- Exclusion criteria||None|
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||26-sep-2016|
|- planned closingdate||27-jan-2017|
|- Target number of participants||120|
|- Interventions||- Blood samples will be drawn to determine 25-hydroxyvitamin D levels.|
- All patients will complete the self-assessment survey ICPNQ and when necessary the VAS score, to distinguish different PN grades in MM patients.
|- Primary outcome||The correlation between PN and the vitamin D status in MM patients.|
|- Secondary outcome||- to evaluate the influence of vitamin D on the severity of PN|
- to determine the correspondence of the ICPNQ results and patientsí records.
- the number of patients with low 25-hydroxyvitamin D serum levels
- to search for differences in incidence of PN for each drug
|- Timepoints||Vitamin D levels and neuropathy grading will be determined at one timepoint.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Berdien Oortgiesen|
|- CONTACT for SCIENTIFIC QUERIES|| Berdien Oortgiesen|
|- Sponsor/Initiator ||Medical Center Leeuwarden |
(Source(s) of Monetary or Material Support)
|Wetenschapsfonds MCL, Leeuwarden, The Netherlands|
|- Brief summary||Vitamin D status and peripheral neuropathy in multiple myeloma patients
Background: 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.
Objectives: 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. 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).
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 population: Patients with smoldering or symptomatic multiple myeloma in the Medical Centre
Leeuwarden are included in the study. Patients must be over 18 years of age and must be able to
give informed consent.
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.
|- Main changes (audit trail)|
|- RECORD||28-jul-2016 - 29-sep-2016|