Clinical trial NCT01697839: Serum Vitamin D Levels and Peripheral Neuropathy Among Multiple Myeloma Patients
Official title: Correlation Between Serum Vitamin D Levels and the Incidence of Peripheral Neuropathy Among Multiple Myeloma Patients Who Have Previously Received Treatment With Bortezomib or Thalidomide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Peripheral Neuropathy
Lead sponsor: Oncotherapeutics
Sponsor class: INDUSTRY
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2012-10-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: This is a prospective study investigating the relationship between vitamin D and peripheral neuropathy (PN) among multiple myeloma (MM) patients treated with either bortezomib or thalidomide. The study consists of a screening period of up to 14 days, followed by a single assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic pain, and markers of depression. Patient charts will also be utilized to assess the frequency of skeletal-related events.

Detailed description: Approximately 10% of myeloma patients present at diagnosis with clinical neuropathy although studies reveal as many as 1/3 may have abnormal electrophysiological examinations. Baseline neuropathic abnormal findings are exacerbated by many myeloma treatments, especially bortezomib, thalidomide, and to a lesser extent lenalidomide. Several studies suggest that vitamin D supplementation may help reduce the symptoms of neuropathy.In this prospective study, we will investigate the relationship between vitamin D and PN among MM patients treated with either bortezomib or thalidomide. The study consists of a screening period of up to 14 days, followed by a single assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic pain, and markers of depression. Patient charts will also be utilized to assess the frequency of skeletal-related events.

Eligibility criteria: Inclusion Criteria:

* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
* Prior diagnosis of multiple myeloma based on standard criteria (Durie 1986)
* Received consecutive, prior treatment for MM with a regimen consisting of at least 16 consecutive weeks of bortezomib or 16 consecutive weeks of thalidomide prior to the Day of Assessment
* The 16 weeks of consecutive treatment must have included at least one of the following doses and schedules:

  * Bortezomib: ≥ 1.0 mg/m² dosed 3 or more times per each 4-week period
  * Thalidomide: ≥ 50 mg/day dosed daily
* The qualifying regimen may include both bortezomib and thalidomide. However, the above inclusion requirements need only be satisfied by either one of the agents.
* Age ≥18 years at the time of signing the informed consent form
* Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

* Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome (Bardwick 1980)
* Plasma cell leukemia
* Primary amyloidosis
* Vitamin D level assessment occurring within the 12 months preceding the Day of Assessment
* Vitamin D non-dietary oral supplementation \> 1200 IU per day for \> 30 total days within the 12 month period preceding the Day of Assessment
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

Primary outcomes:
measure: Serum vitamin D levels
timeFrame: Day 1
Secondary outcomes:
measure: Skeletal related event
timeFrame: Day 1
Other outcomes:
measure: Markers of depression
timeFrame: Day 1
Locations:
city: Highland
country: United States
facility: Beaver Medical Group
state: California
city: West Hollywood
country: United States
facility: James R. Berenson M.D., Inc.
state: California
city: Hinsdale
country: United States
facility: Illinois Cancer Specialists
state: Illinois
Study officials:
affiliation: Oncotherapeutics
name: James R. Berenson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: