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NCT00436059 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00436059
Other study ID # 2006/175
Secondary ID
Status Completed
Phase Phase 2
First received February 15, 2007
Last updated July 7, 2009
Start date February 2007
Est. completion date July 2009

Study information
Verified date July 2009
Source Vejle Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Previously untreated multiple myeloma

Exclusion Criteria:

- Use of bisfosfonates

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• bortezomib

Locations
Country Name City State
Denmark University Hospital Odense Odense
Denmark Vejle Hospital Vejle

Sponsors (2)
Lead Sponsor Collaborator
Vejle Hospital Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in bone markers during treatment
Secondary Changes in osteolysis during treatment
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