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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma, Peripheral Neuropathy

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Trial Information

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


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not part of normal medical care, with the understanding that consent may be withdrawn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 four times per each 4-week period

- Thalidomide: ≥ 50 mg/day dosed daily

- The 16 weeks of qualifying treatment containing either thalidomide or bortezomib must
have occurred within the 24 weeks prior to the Day of Assessment. This means that the
last dose of qualifying treatment cannot occur more than 8 weeks (56 days) before the
day of assessment

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Serum 25 hydroxyvitamin D levels

Outcome Description:

Correlation of serum 25 hydroxyvitamin D levels to the incidence and severity of myeloma treatment induced PN/neuropathic pain among MM patients previously exposed to bortezomib and/or thalidomide

Outcome Time Frame:

Day 1

Safety Issue:

No

Principal Investigator

James R. Berenson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncotherapeutics

Authority:

United States: Institutional Review Board

Study ID:

X05392

NCT ID:

NCT01697839

Start Date:

June 2012

Completion Date:

September 2014

Related Keywords:

  • Multiple Myeloma
  • Peripheral Neuropathy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location

James R. Berenson M.D., Inc.West Hollywood, California  90069