Serum Vitamin D Levels and Peripheral Neuropathy Among Multiple Myeloma Patients

Completed

• Conditions: Peripheral Neuropathy; Multiple Myeloma

• Registration Number: NCT01697839
• Lead Sponsor: Oncotherapeutics

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum vitamin D levels	Day 1	Correlation of serum vitamin D levels to the incidence and severity of anti-myeloma treatment-induced PN/ neuropathic pain among MM patients previously exposed to bortezomib and/or thalidomide

Secondary Outcome Measures

Name	Time	Method
Skeletal related event	Day 1	Correlation between vitamin D levels and skeletal-related events (pathologic fracture, spinal cord compression or collapse, or surgery or radiotherapy to bone) among MM patients

Trial Locations

Locations (3)

Beaver Medical Group; 🇺🇸 Highland, California, United States

Illinois Cancer Specialists; 🇺🇸 Hinsdale, Illinois, United States

James R. Berenson M.D., Inc.; 🇺🇸 West Hollywood, California, United States