VELCADEXA: A National, Multi-Center, Open-Label Study of Pretransplant Induction With Alternating VELCADE and Dexamethasone (VEL/Dex) in Younger (< 65 Yrs) Untreated Multiple Myeloma Patients.
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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bladé Joan, Dr
HOSPITAL CLÍNIC BARCELONA
Spain: Ministry of Health