Skin Biopsies in Chemotherapy-Induced Neuropathy

This study has been completed.
Information provided by (Responsible Party):
Joost LM Jongen, Erasmus Medical Center Identifier:
First received: August 10, 2009
Last updated: December 23, 2014
Last verified: December 2014

Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose and quantify using conventional electromyography. Determining intra-epidermal nerve fiber density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more sensitive and more specific ancillary investigation to establish the diagnosis of small fiber neuropathy. In this study the investigators aim to establish the sensitivity of IENFD measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.

Multiple Myeloma
Peripheral Neuropathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Skin Biopsies in Chemotherapy-induced Neuropathy

Resource links provided by NLM:

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • intraepidermal nerve fiber density/pain intensity [ Time Frame: one timepoint, i.e. date of skin biopsy ] [ Designated as safety issue: No ]
    correlation between intraepidermal nerve fiber density and pain intensity

Biospecimen Retention:   Samples Without DNA

skin biopsy

Enrollment: 26
Study Start Date: November 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Patients with multiple myeloma


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

Patients with multiple myeloma receiving bortezomib in a large university hospital


Inclusion Criteria:

  • Patients with multiple myeloma receiving bortezomib

Exclusion Criteria:

  • Patients not able to provide informed consent
  • Patients with coagulation disturbances or immunocompromised patients
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Please refer to this study by its identifier: NCT00956033

Erasmus MC, Centrumlocatie en Daniel den Hoed
Rotterdam, Zuid-Holland, Netherlands, 3000CA
Sponsors and Collaborators
Erasmus Medical Center
Principal Investigator: Joost L Jongen Erasmus MC
  More Information

Additional Information:
No publications provided

Responsible Party: Joost LM Jongen, J.L.M. Jongen, MD, PhD, Erasmus Medical Center Identifier: NCT00956033     History of Changes
Other Study ID Numbers: MEC2008-305
Study First Received: August 10, 2009
Last Updated: December 23, 2014
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Erasmus Medical Center:
Peripheral Neuropathy

Additional relevant MeSH terms:
Multiple Myeloma
Peripheral Nervous System Diseases
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Nervous System Diseases
Neuromuscular Diseases
Vascular Diseases processed this record on October 08, 2015