The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
18 Years
N/A
Both
Multiple Myeloma
Trial Information
The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
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.
Inclusion Criteria:
- Previously untreated multiple myeloma
Exclusion Criteria:
- Use of bisfosfonates
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Changes in bone markers during treatment
Principal Investigator
Torben Plesner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vejle Hospital
Authority:
Denmark: Danish Medicines Agency
Study ID:
2006/175
NCT ID:
NCT00436059
Start Date:
February 2007
Completion Date:
July 2009
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Bone Marrow Neoplasms
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