A Phase 2 interventional study of Velcade/Dexamethasone in Multiple Myeloma, sponsored by PETHEMA Foundation. Completed at 10 sites in Spain. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2009-09-18.
Sponsored by PETHEMA Foundation · Phase 2, Interventional, and Treatment
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
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 40 is close to the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →PETHEMA Foundation is the lead sponsor of 104 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours.
For poor or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligosecretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine by immunofixation.
Platelet count ≥ 50x109/L, hemoglobin ≥ 8 g/dl and absolute neutrophil count (ANC) ≥ 1.0x109/L; Corrected serum calcium \<14mg/dl. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. Total bilirubin: ≤1.5 x the upper limit of normal. Serum creatinine value ≤ 2mg/dl
Exclusion Criteria:
Velcade 1,3 mg/m2 on days 1, 4, 8 and 11
Response rate
Time frame: 6 months
Compare the efficacy of velcade and dexamethasone with chemotherapy combination VBMCP/VBAD
Time frame: 1 year
Evaluate the quality of progenitors cells after treatment with Velcade and dexamethasone
Time frame: 6 months
Compare the complete response rate after high dose therapy in patients treated with velcade and dexamethasone or VBMCP/VBAD
Time frame: 6 months
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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PETHEMA Foundation