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

Vejle Hospital

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT00436059

2006/175

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously untreated multiple myeloma

Exclusion criteria

• Use of bisfosfonates

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)