VELCADEXA: Velcade and Dexamethasone in Multiple Myeloma

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


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

Study Design

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


Multiple Myeloma




Clínica Universitaria de Navarra




PETHEMA Foundation

Results (where available)

View Results


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

Clinical Trials [1795 Associated Clinical Trials listed on BioPortfolio]

Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.

Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma

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...

Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse

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...

Study of Subcutaneous and Intravenous Velcade in Combination With Dexamethasone in Chinese Subjects With Relapsed and Refractory Multiple Myeloma

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...

Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients

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...

PubMed Articles [5803 Associated PubMed Articles listed on BioPortfolio]

Elotuzumab and Dexamethasone for Relapsed or Refractory Multiple Myeloma Patients: A Retrospective Study.

To evaluate the efficacy and safety of elotuzumab and dexamethasone (Ed) for relapsed or refractory multiple myeloma (RRMM) patients.

Cost-effectiveness of lenalidomide in combination with dexamethasone compared to bortezomib in combination with dexamethasone for the second-line treatment of multiple myeloma in Chile.

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...

An Expanded Treatment Protocol of Panobinostat Plus Bortezomib and Dexamethasone in Patients With Previously Treated Myeloma.

Panobinostat was recently approved by the US Food and Drug Administration and European Commission in combination with bortezomib and dexamethasone for patients with multiple myeloma who have received...

Cyclophosphamide's addition in relapsed/refractory multiple myeloma patients with biochemical progression during lenalidomide-dexamethasone treatment.

The aim of this study was to evaluate the addition of Cyclophosphamide in relapsed-refractory Multiple Myeloma patients (RRMM) who experienced biochemical relapse or progression without CRAB, during t...

Proteasome inhibitor-based therapy for treatment of newly diagnosed multiple myeloma.

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...

Medical and Biotech [MESH] Definitions

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.

Class I human histocompatibility (HLA) antigens encoded by a small cluster of structural genes at the C locus on chromosome 6. They have significantly lower immunogenicity than the HLA-A and -B determinants and are therefore of minor importance in donor/recipient crossmatching. Their primary role is their high-risk association with certain disease manifestations (e.g., spondylarthritis, psoriasis, multiple myeloma).

More From BioPortfolio on "VELCADEXA: Velcade and Dexamethasone in Multiple Myeloma"

Quick Search


Relevant Topic

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...

Searches Linking to this Trial