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

This study is ongoing, but not recruiting participants.

First Received: February 15, 2007 Last Updated: February 19, 2009 History of Changes

Sponsors and Collaborators:	Vejle Hospital Odense University Hospital
Information provided by:	Vejle Hospital
ClinicalTrials.gov Identifier:	NCT00436059

Purpose

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

Condition	Intervention	Phase
Multiple Myeloma	Drug: bortezomib	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:

Changes in bone markers during treatment

Secondary Outcome Measures:

Changes in osteolysis during treatment

Estimated Enrollment:	20
Study Start Date:	February 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously untreated multiple myeloma

Exclusion Criteria:

Use of bisfosfonates

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436059

Locations

Denmark
University Hospital Odense
Odense, Denmark, 5000
Vejle Hospital
Vejle, Denmark, 7100

Sponsors and Collaborators

Vejle Hospital

Odense University Hospital

Investigators

Principal Investigator:

Torben Plesner, MD

Vejle Hospital

More Information

No publications provided

Study ID Numbers:	2006/175
Study First Received:	February 15, 2007
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00436059 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency

Study placed in the following topic categories:

Immunoproliferative Disorders
Hematologic Neoplasms
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Bone Marrow Neoplasms

Paraproteinemias
Hemostatic Disorders
Protease Inhibitors
Multiple Myeloma
Hemorrhagic Disorders
Bone Marrow Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Hematologic Neoplasms
Molecular Mechanisms of Pharmacological Action
Blood Protein Disorders
Antineoplastic Agents
Paraproteinemias
Hemostatic Disorders
Hemorrhagic Disorders
Neoplasms by Site
Therapeutic Uses
Cardiovascular Diseases
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases

Hematologic Diseases
Bortezomib
Vascular Diseases
Bone Marrow Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Multiple Myeloma
Protease Inhibitors
Neoplasms
Lymphoproliferative Disorders
Bone Marrow Diseases
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009