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

NCT ID: NCT00436059

Last Updated: 2009-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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bortezomib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previously untreated multiple myeloma

Exclusion Criteria

* Use of bisfosfonates
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Vejle Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Torben Plesner, MD

Role: PRINCIPAL_INVESTIGATOR

Vejle Hospital

Locations

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University Hospital Odense

Odense, Odense, Denmark

Site Status

Vejle Hospital

Vejle, Vejle, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2006/175

Identifier Type: -

Identifier Source: org_study_id

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