Multiple Myeloma
Conditions
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.
Interventions
DRUGbortezomib
Sponsors
Odense University Hospital
Vejle Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously untreated multiple myeloma
Exclusion criteria
* Use of bisfosfonates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in bone markers during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in osteolysis during treatment | — |
Countries
Denmark
Outcome results
None listed