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The primary efficacy objective of this study is to study the efficacy in terms of response rate to alternating bortezomib/dexamethasone regimen
Multiple Myeloma is a plasma cell disorder characterized by an uncontrolled proliferation of bone marrow plasma cells leading to skeletal destruction with bone pain, anemia, renal failure, hypercalcemia, recurrent bacterial infections and extramedullary plasmacytomas. It accounts for 1% of all malignancies and slightly more than 10% of hematologic malignancies, with an annual incidence of about four per 100.000. Although this disease is incurable with a median survival of about 3 years, remarkable treatment advances have been recently made, including high-dose therapy followed by stem cell rescue and, particularly, the introduction of novel promising agents with new mechanisms of action.
Data from pre-clinical and clinical studies conducted to date support the continued development of VELCADE for the treatment of Multiple Myeloma. Standard chemotherapy remains as the gold standard for induction before HDT/SCT treatment in younger multiple myeloma patients (<65 years). Since VELCADE has a mechanism of action different from chemotherapy and dexamethasone and is considered to be efficacious in Multiple Myeloma, its introduction in induction regimens may contribute to increase the response rate and eventually survival of these patients that represent half of myeloma population.
Since VBMCP/VBAD is considered to be the gold standard for Multiple Myeloma patients <65 years as induction regimen prior HDT/SCT, the results of VEL/DEX will be compared with those obtained in 100 patients treated with VBMCP/VBAD chemotherapy in our last GEM protocol (Spanish Myeloma Group) for patients <65 years (closed in Dec 2004
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clínica Universitaria de Navarra
Published on BioPortfolio: 2014-08-27T03:41:54-0400
The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.
This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to prov...
The purpose of this phase 3 study is to determine if subcutaneous velcade is non-inferior to intravenous velcade when administered in combination with low-dose dexamethasone in chinese ref...
This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients with who respond to Velcade. The second aim of this study is to see whether...
The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamid...
The immunostimulatory monoclonal antibody elotuzumab plus lenalidomide and dexamethasone has been shown to be effective in patients with relapsed or refractory multiple myeloma. The immunomodulatory a...
Recombinant human endostatin (rhES) can inhibit multiple myeloma, while its clinical efficacy in treating relapsed refractory multiple myeloma (RRMM) has not been assessed. One hundred eleven RRMM pat...
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...
Osteolytic bone disease is one of the most debilitating manifestations of multiple myeloma (MM). Bortezomib is a proteasome inhibitor that shows both anticancer and bone anabolic properties and is bei...
Novel efficacious treatments with long-term tolerability are needed for transplant-ineligible, newly diagnosed multiple myeloma (NDMM) patients. This phase 2 study evaluated the safety and efficacy of...
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.
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.
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...