Serum Vitamin D Levels and Peripheral Neuropathy Among Multiple Myeloma Patients

NCT01697839 | Completed

• 1 other identifier: X05392
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Myeloma; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Skeletal related event

  Day 1

Other Outcomes (1)

• Markers of depression

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
• Age ≥18 years at the time of signing the informed consent form
• Able to adhere to the study visit schedule and other protocol requirements

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oncotherapeutics: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (3)

Beaver Medical Group

Highland, California, 92346, United States

Location

James R. Berenson M.D., Inc.

West Hollywood, California, 90069, United States

Location

Illinois Cancer Specialists

Hinsdale, Illinois, 60521, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, white blood cells, red blood cells

MeSH Terms

Conditions

Multiple Myeloma; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• James R. Berenson, M.D.

  Oncotherapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: October 2, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (3)