Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.

April 24, 2014 updated by: Janssen Korea, Ltd., Korea

Observational Study of Osteoblast Activity in Velcade�(Bortezomib) IV Treated Multiple Myeloma Patients.

The purpose of this study is to measure the markers related to bone metabolism before and after the use of bortezomib injection in patients with multiple myeloma and to evaluate the effect bortezomib injection has on bone disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Among several symptoms in patients with multiple myeloma, the bone disease is one of the most common symptoms that approximately 80 percent of the patients experience. Multiple myeloma is different from other tumors in that several osteoclast activating factors (OAF) released from multiple myeloma cells resorb bone and, at the same time, activation of osteoblast is inhibited, leading to unbalance of breakdown and formation of bone. Activation of osteoclast and inhibition of osteoblast brings about bone fractures, osteoporosis, hypercalcemia, bone pain and spinal cord compression. Those symptoms are directly related to patients' quality of life. Therefore, they are the important therapeutic targets for multiple myeloma. Various types of bisphosphonate agents are used for the treatment of the bone disease in patients with multiple myeloma. This is a prospective (a study where the participants are identified and then followed forward in time), multi-center, Phase 4, observational study (studies that record specific events occurring without any intervention from the researcher) in order to analyze the change in bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC) before and after the use of bortezomib injection by using an enzyme-linked immunosorbent assay (ELISA) in serum. The adverse events will be assessed through the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE V3). The patients will receive bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days under usual clinical practice.

Study Type

Observational

Enrollment (Actual)

104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom agree to provide information will be included in Korea.

Description

Inclusion Criteria:

  • Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom agree to provide information will be included.

Exclusion Criteria:

  • Patients who are hypersensitive to the study drug or any component of the study drug or with a history of the hypersensitivity
  • Patients with severe hepatic impairment
  • Women who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days
Drug: bortezomib
injection into a vein 1.3 mg/m2 twice a week for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC)
Time Frame: on day 1 at the first cycle, and 12-24 weeks
on day 1 at the first cycle, and 12-24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
CR rate
Time Frame: at the end of every 3 week cycle
at the end of every 3 week cycle
Overall response rate
Time Frame: at the end of every 3 week cyclet
at the end of every 3 week cyclet
Correlation between primary endpoints and response rate
Time Frame: 12 -24 weeks
12 -24 weeks
NRS pain score
Time Frame: at the end of every 3 week cycle
at the end of every 3 week cycle
Adverse events
Time Frame: at the end of every 3 week cycle
at the end of every 3 week cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 3, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR015067
  • 26866138MMY4036
  • BORKOR5020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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