Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388635
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2006-10-16
Brief Title:
Velcade-Melphalan-Prednisone in Older Untreated Multiple Myeloma Patients
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
A National Multi-Center Open-Label Study of Velcade in Combination With Melphalan and Prednisone V-MP in Older Untreated Multiple Myeloma Patients
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol is planned as a multicentric national open-label trial designed to evaluate first optimal dose of Velcade Bortezomib in combination with melphalan and prednisone After optimal dose is known the second aim is evaluate safety and tolerance of V-MP plan in respond terms in a cohort of 60 patients Finally the entire results will be compared with those obtained from a series of 100 patients all of them over 70 years old diagnosed of Multiple Myeloma belonging to the GEM protocol finished in May 2003
Detailed Description:
Multiple Myeloma is a neoplastic disorder of the last maturation stage of B cell called plasmatic cell It represents the second most common haematological neoplasia after Non Hodgkin Lymphoma The annual incidence is over 4 cases per 100000 Multiple Myeloma is an invariably mortal disease When illness advances the reduction of infections resistance the intense bones destruction with bone pain pathological fractures and hypercalcemia anaemia renal failure and in a less frequency neurological complications and hyperviscosity provoke severe morbidity and mortality Five-year survival rate in patients with Multiple Myeloma treated with conventional chemotherapy is 29 There is an urgent need of new therapeutic agents for the treatment of this disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None