Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232934
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2005-10-04
Brief Title:
Melphalan Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients
Sponsor:
Gruppo Italiano per lo Studio del Mieloma Multiplo
Organization:
Gruppo Italiano per lo Studio del Mieloma Multiplo
Study Overview
Official Title:
Phase III Prospective Open Label Multicenter Randomized Trial of Melphalan Prednisone and Thalidomide Versus Melphalan and Prednisone as First Line Therapy in Myeloma Patients Aged 65
Status:
COMPLETED
Status Verified Date:
2018-08
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:
The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma
Detailed Description:
Intermittent courses of Melphalan and Prednisone MP have been the first line therapy in multiple myeloma for many years
Advances in systemic and supportive therapy increased remission rates and overall survival but multiple myeloma still remains an incurable haematological malignancy Several preliminary studies demonstrate the efficacy of thalidomide in refractory and relapsed multiple myeloma with an overall response rate of 30 to 60
Due to its activity Thalidomide will be evaluated in association with MP in a randomized study for newly diagnosed myeloma patients not eligible for high-dose chemotherapy
Advances in systemic and supportive therapy increased remission rates and overall survival but multiple myeloma still remains an incurable haematological malignancy Several preliminary studies demonstrate the efficacy of thalidomide in refractory and relapsed multiple myeloma with an overall response rate of 30 to 60
Due to its activity Thalidomide will be evaluated in association with MP in a randomized study for newly diagnosed myeloma patients not eligible for high-dose chemotherapy
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