NCT00436059

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

Enrollment Period

2.4 years

First QC Date

February 15, 2007

Last Update Submit

July 7, 2009

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Changes in bone markers during treatment

Secondary Outcomes (1)

  • Changes in osteolysis during treatment

Interventions

bortezomibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously untreated multiple myeloma

You may not qualify if:

  • Use of bisfosfonates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Odense

Odense, Odense, 5000, Denmark

Location

Vejle Hospital

Vejle, Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Torben Plesner, MD

    Vejle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 16, 2007

Study Start

February 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations

DK(2)