Serum Vitamin D Levels and Peripheral Neuropathy Among Multiple Myeloma Patients

NCT ID: NCT01697839

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-08-31

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.

Conditions

Multiple Myeloma; Peripheral Neuropathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Oncotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James R. Berenson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oncotherapeutics

Locations

Beaver Medical Group

Highland, California, United States

James R. Berenson M.D., Inc.

West Hollywood, California, United States

Illinois Cancer Specialists

Hinsdale, Illinois, United States

Countries

United States

Other Identifiers

X05392

Identifier Type: -

Identifier Source: org_study_id