Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396045
Status:
COMPLETED
Last Update Posted:
2006-11-30
First Post:
2006-11-02
Brief Title:
Melphalan Prednisone and CC-5013 Revlimid as Induction Therapy in Multiple Myeloma
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
A Multicenter Open Label Study of Oral Melphalan Prednisone and CC-5013 Revlimid MPR as Induction Therapy in Elderly Newly Diagnosed Multiple Myeloma Patients
Status:
COMPLETED
Status Verified Date:
2006-11
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 evaluate the safety and efficacy of the association of MelphalanPrednisoneRevlimid MPR as induction treatment for newly diagnosed myeloma patients over age 65 or those under 65 years who refuse or are not eligible for high dose therapy This association might further increase the response rate achieved by the standard oral MP regimen
Detailed Description:
In Multiple Myeloma patients the standard treatment is the oral combination of Melphalan and Prednisone MP This approach induces a partial response PR rate of approximately 50 and a complete remission CR rate of 1-5 with a median remission duration of 18-20 months and a median overall survival of 3 years
Recently the combination of oral MP plus thalidomide increased response rate to 80 and complete remission rate to 20 marked cytoreduction is the first step toward a sustained remission period
CC-5013 Revlimid is a thalidomide analogue 50000 times more potent than thalidomide in inhibiting TNF-alfa secretion a potent growth factor for myeloma cells Revlimid represents a novel class of anti-cancer drugs it is active in patients with multiple myeloma who are refractory to conventional and high-dose chemotherapy with a response rate of approximately 30 The association Revlimid plus dexamethasone further increases the response rate induced by Revlimid by an additional 30
This study will evaluate the safety and efficacy of the association of MelphalanPrednisoneRevlimid MPR as induction treatment for newly diagnosed myeloma patients over age 65 or those under 65 years who refuse or are not eligible for high dose therapy This association might further increase the response rate achieved by the standard oral MP regimen
In the first part of the study phase I component different doses of oral Melphalan 018-025 mgKg associated with Prednisone MP will be combined with escalating doses of Revlimid from 5 mgday and administered together This phase will define the MTD of the association In the second part of the study phase II component 30 patients will be treated with MPR at doses defined from phase I component to verify data of response and toxicity
Recently the combination of oral MP plus thalidomide increased response rate to 80 and complete remission rate to 20 marked cytoreduction is the first step toward a sustained remission period
CC-5013 Revlimid is a thalidomide analogue 50000 times more potent than thalidomide in inhibiting TNF-alfa secretion a potent growth factor for myeloma cells Revlimid represents a novel class of anti-cancer drugs it is active in patients with multiple myeloma who are refractory to conventional and high-dose chemotherapy with a response rate of approximately 30 The association Revlimid plus dexamethasone further increases the response rate induced by Revlimid by an additional 30
This study will evaluate the safety and efficacy of the association of MelphalanPrednisoneRevlimid MPR as induction treatment for newly diagnosed myeloma patients over age 65 or those under 65 years who refuse or are not eligible for high dose therapy This association might further increase the response rate achieved by the standard oral MP regimen
In the first part of the study phase I component different doses of oral Melphalan 018-025 mgKg associated with Prednisone MP will be combined with escalating doses of Revlimid from 5 mgday and administered together This phase will define the MTD of the association In the second part of the study phase II component 30 patients will be treated with MPR at doses defined from phase I component to verify data of response and toxicity
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MPR | None | None | None |