Back to resultsThe Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Previously untreated multiple myeloma
Exclusion Criteria:
- Use of bisfosfonates
Sites / Locations
- University Hospital Odense
- Vejle Hospital
Outcomes
Primary Outcome Measures
Changes in bone markers during treatment
Secondary Outcome Measures
Changes in osteolysis during treatment
Full Information
NCT ID
NCT00436059
First Posted
February 15, 2007
Last Updated
July 7, 2009
Sponsor
Vejle Hospital
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00436059
Brief Title
The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
Official Title
The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vejle Hospital
Collaborators
Odense University Hospital
4. Oversight
5. Study Description
Brief Summary
The primary objective of the the study is to investigate the changes in bone remodeling during Velcade treatment.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bortezomib
Primary Outcome Measure Information:
Title
Changes in bone markers during treatment
Secondary Outcome Measure Information:
Title
Changes in osteolysis during treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previously untreated multiple myeloma
Exclusion Criteria:
Use of bisfosfonates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben Plesner, MD
Organizational Affiliation
Vejle Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Odense
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
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