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VELCADEXA: Velcade and Dexamethasone in Multiple Myeloma

2014-08-27 03:41:54 | BioPortfolio

Summary

The primary efficacy objective of this study is to study the efficacy in terms of response rate to alternating bortezomib/dexamethasone regimen

Description

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

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

Velcade/Dexamethasone

Location

Clínica Universitaria de Navarra
Pamplona
Navarra
Spain

Status

Completed

Source

PETHEMA Foundation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:54-0400

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Medical and Biotech [MESH] Definitions

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.

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