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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026701
• Other study ID #: CR015067
• Secondary ID: 26866138MMY4036B
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2009
• Last updated: April 24, 2014
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: April 2014
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• bortezomib
injection into a vein 1.3 mg/m2 twice a week for 21 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC)		on day 1 at the first cycle, and 12-24 weeks	No
Secondary	CR rate		at the end of every 3 week cycle	No
Secondary	Overall response rate		at the end of every 3 week cyclet	No
Secondary	Correlation between primary endpoints and response rate		12 -24 weeks	No
Secondary	NRS pain score		at the end of every 3 week cycle	No
Secondary	Adverse events		at the end of every 3 week cycle	No