The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)

This study has been completed.
Sponsor:
Collaborator:
Odense University Hospital
Information provided by:
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT00436059
First received: February 15, 2007
Last updated: July 7, 2009
Last verified: July 2009
  Purpose

The primary objective of the the study is to investigate the changes in bone remodeling during Velcade treatment.


Condition Intervention Phase
Multiple Myeloma
Drug: bortezomib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Changes in bone markers during treatment

Secondary Outcome Measures:
  • Changes in osteolysis during treatment

Estimated Enrollment: 20
Study Start Date: February 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

20 patients will be included in the study over a 2 year period. Before, during and after treatment we will measure NTX-I, CTX-I, CTX-MMP, bALP, DKK-1, PINP, TRAcP and PTH. NTX, CTX and CTX-MMP are measured to estimate bone degradation. TRAcP is measured to estimate the activity of the osteoclasts. bALP and DKK-1 is measured to evaluate the activity of the osteoblasts and PINP is measured as a marker of new bone formation. PTH is measured in order to evaluate if the positive effects that is observed in bone formation in relations to velcade treatment is due to the pulsative way velcade is administered.

The effect of the velcade treatment will be evaluated by x-ray, bone marrow and m-component.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously untreated multiple myeloma

Exclusion Criteria:

  • Use of bisfosfonates
  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: NCT00436059

Locations
Denmark
University Hospital Odense
Odense, Denmark, 5000
Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
Odense University Hospital
Investigators
Principal Investigator: Torben Plesner, MD Vejle Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00436059     History of Changes
Other Study ID Numbers: 2006/175
Study First Received: February 15, 2007
Last Updated: July 7, 2009
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Bone Marrow Neoplasms
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
Hematologic Neoplasms
Neoplasms by Site
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 30, 2014