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Completed

NCT Number: NCT00436059

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

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

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Odense, Odense, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously untreated multiple myeloma

Exclusion criteria

  • Use of bisfosfonates

Treatment and study plan

bortezomib

Drug

Primary outcomes

  1. Changes in bone markers during treatment

Secondary outcomes

  1. Changes in osteolysis during treatment

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Collaborators

  • Odense University Hospital

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 16, 2007
Registry last updated
Jul 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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