Observational Study of the Effects Intravenous Bortezomib Has on Osteoblast (Cell That is Responsible for Bone Formation) Activity in Multiple Myeloma Patients.
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Multiple Myeloma |
Drug: bortezomib |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Observational Study of Osteoblast Activity in Velcade�(Bortezomib) IV Treated Multiple Myeloma Patients. |
- bone metabolism markers (DKK-1, sRANKL, OPG, sRANKL/OPG,bALP, OC) [ Time Frame: on day 1 at the first cycle, and 12-24 weeks ] [ Designated as safety issue: No ]
- CR rate [ Time Frame: at the end of every 3 week cycle ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: at the end of every 3 week cyclet ] [ Designated as safety issue: No ]
- Correlation between primary endpoints and response rate [ Time Frame: 12 -24 weeks ] [ Designated as safety issue: No ]
- NRS pain score [ Time Frame: at the end of every 3 week cycle ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: at the end of every 3 week cycle ] [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | March 2008 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Medical Director, Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT01026701 History of Changes |
| Other Study ID Numbers: | CR015067, 26866138MMY4036, BORKOR5020 |
| Study First Received: | December 3, 2009 |
| Last Updated: | January 14, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Osteoblst effect Velcade Proteasome inhibitor Bortezomib Multjple Myeloma |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013