The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer) |
- Changes in bone markers during treatment
- Changes in osteolysis during treatment
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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 |
Inclusion Criteria:
- Previously untreated multiple myeloma
Exclusion Criteria:
- Use of bisfosfonates
Contacts and Locations| Denmark | |
| University Hospital Odense | |
| Odense, Denmark, 5000 | |
| Vejle Hospital | |
| Vejle, Denmark, 7100 | |
| Principal Investigator: | Torben Plesner, MD | Vejle Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00436059 History of Changes |
| Other Study ID Numbers: | 2006/175 |
| Study First Received: | February 15, 2007 |
| Last Updated: | July 7, 2009 |
| Health Authority: | Denmark: Danish Medicines Agency Denmark: The Regional Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Bone Marrow Neoplasms Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders |
Immunoproliferative Disorders Immune System Diseases Hematologic Neoplasms Neoplasms by Site Bone Marrow Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013