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

18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC)

Outcome Time Frame:

on day 1 at the first cycle, and 12-24 weeks

Safety Issue:


Principal Investigator

Janssen Korea, Ltd. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd.


Korea: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

November 2009

Related Keywords:

  • Multiple Myeloma
  • Osteoblst effect
  • Velcade
  • Proteasome inhibitor
  • Bortezomib
  • Multjple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell