Serum Vitamin D Levels and Peripheral Neuropathy Among Multiple Myeloma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Oncotherapeutics
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Oncotherapeutics
ClinicalTrials.gov Identifier:
NCT01697839
First received: August 24, 2012
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition
Multiple Myeloma
Peripheral Neuropathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Oncotherapeutics:

Primary Outcome Measures:
  • Serum vitamin D levels [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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:
  • Skeletal related event [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Markers of depression [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Correlation between vitamin D levels and markers of depression for MM patients


Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 110
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697839

Locations
United States, California
James R. Berenson M.D., Inc. Recruiting
West Hollywood, California, United States, 90069
Contact: Regina Swift, R.N    310-623-1222    rswift@berensononcology.com   
Contact: James R. Berenson, M.D.    (310) 623-1222    jberenson@berensononcology.com   
Sponsors and Collaborators
Oncotherapeutics
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: James R. Berenson, M.D. Oncotherapeutics
  More Information

No publications provided

Responsible Party: Oncotherapeutics
ClinicalTrials.gov Identifier: NCT01697839     History of Changes
Other Study ID Numbers: X05392
Study First Received: August 24, 2012
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014