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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 Model: Case-Only, Time Perspective: Prospective
Janssen Korea, Ltd., Korea
Published on BioPortfolio: 2014-07-23T21:11:32-0400
The purpose of this study is to test the safety and effectiveness of a drug called bortezomib when administered to patients with multiple myeloma who have previously responded to a bortezo...
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Expanded Access Protocol (EAP) to Provide Bortezomib to Patients With Multiple Myeloma Who Have Received at Least 2 Previous Lines of Therapy and Are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma
The purpose of this study is to provide bortezomib to patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory or have relapse after their l...
This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule...
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Multiple myeloma is a hematologic malignancy that is unable to be cured and has significant impact throughout the world. Front line treatment has shifted but ultimately has landed on a bortezomib-base...
Multiple myeloma is a hematologic malignancy affecting bone marrow derived plasma cells. Current therapies are not able to eradicate the disease and most patients become refractory to the treatment. L...
A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.
An asymptomatic and slow-growing PLASMA CELL dyscrasia characterized by presence of MYELOMA PROTEINS and clonal bone marrow plasma cells without end-organ damage (e.g., renal impairment). It is distinguished from MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE by a much higher risk of progression to symptomatic MULTIPLE MYELOMA.
A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...