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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01026701
First Posted: December 4, 2009
Last Update Posted: April 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
December 3, 2009
December 4, 2009
April 28, 2014
March 2008
November 2009   (Final data collection date for primary outcome measure)
bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC) [ Time Frame: on day 1 at the first cycle, and 12-24 weeks ]
bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC) [ Time Frame: before bortezomib 1st cycle injection and after the use of 4th, end of bortezomib injection ]
Complete list of historical versions of study NCT01026701 on ClinicalTrials.gov Archive Site
  • CR rate [ Time Frame: at the end of every 3 week cycle ]
  • Overall response rate [ Time Frame: at the end of every 3 week cyclet ]
  • Correlation between primary endpoints and response rate [ Time Frame: 12 -24 weeks ]
  • NRS pain score [ Time Frame: at the end of every 3 week cycle ]
  • Adverse events [ Time Frame: at the end of every 3 week cycle ]
  • CR rate [ Time Frame: after the use of 4th cycle and end of bortezomib treatment ]
  • Overall response rate [ Time Frame: after the use of 4th cycle and end of bortezomib treatment ]
  • Correlation between primary endpoints and response rate [ Time Frame: after the use of 4th cycle and end of bortezomib treatment ]
  • NRS pain score [ Time Frame: every cycle ]
  • Adverse events [ Time Frame: every cycle ]
Not Provided
Not Provided
 
Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Multiple Myeloma
Drug: bortezomib
injection into a vein 1.3 mg/m2 twice a week for 21 days
001
bortezomib injection into a vein 1.3 mg/m2 twice a week for 21 days
Intervention: Drug: bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
November 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01026701
CR015067
26866138MMY4036
BORKOR5020
Yes
Not Provided
Not Provided
Janssen Korea, Ltd., Korea
Janssen Korea, Ltd., Korea
Not Provided
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
Janssen Korea, Ltd., Korea
April 2014