Serum Vitamin D Levels and Peripheral Neuropathy Among Multiple Myeloma Patients

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697839
• Other study ID #: X05392
• Status: Completed
• Phase: N/A
• First received: August 24, 2012
• Last updated: March 2, 2018
• Start date: June 2012
• Est. completion date: August 2015

Study information

• Verified date: March 2018
• Source: Oncotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Locations

Country	Name	City	State
United States	Beaver Medical Group	Highland	California
United States	Illinois Cancer Specialists	Hinsdale	Illinois
United States	James R. Berenson M.D., Inc.	West Hollywood	California

Sponsors (2)

Lead Sponsor	Collaborator
Oncotherapeutics	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Markers of depression	Correlation between vitamin D levels and markers of depression for MM patients	Day 1
Primary	Serum vitamin D levels	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	Day 1
Secondary	Skeletal related event	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	Day 1