Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480363
Status:
COMPLETED
Last Update Posted:
2013-07-31
First Post:
2007-05-28
Brief Title:
QUIREDEX Revlimid Lenalidomide and Dexamethasone ReDex Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
QUIREDEX A National Open-Label Multicenter Randomized Phase III Study of Revlimid Lenalidomide and Dexamethasone ReDex Treatment Versus Observation in Patients With Smoldering Multiple Myeloma With High Risk of Progression
Status:
COMPLETED
Status Verified Date:
2013-07
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:
QUIREDEX
Brief Summary:
The primary objective is to evaluate when Revlimid and Dexamethasone treatment extend the time to progression to symptomatic MM in patients with smoldering MM The second one is to evaluate the efficacy of the treatment in response rate terms Otherwise this study wants to evaluate the safety and tolerability of the treatment
Detailed Description:
A total of up to 120 patients diagnosed of smoldering Multiple Myeloma with high risk of progression to symptomatic MM will be included
Patients will be stratified according its diagnosis date and randomized 1 to 1 to receive Revlimid and Dexamethasone Group A in 9 treatment cycles and maintenance with lower doses until progression or No treatment and observation until progression Group B
The patients will be evaluated at scheduled visits in up to three study periods Pre-treatment Treatment and Follow up
The Pre-treatment includes Screening and baseline visits After providing informed consent patients will be evaluated for study eligibility and then Patients will be stratified and randomized 11 to Group A or Group B
During Treatment Period patients will be evaluated once a month Once the treatment period has finished a maintenance treatment with low doses of Revlimid and Dexamethasone will be carry out in Group A During this period we will evaluate response progression-free survival and global survival every two months
Patients will be stratified according its diagnosis date and randomized 1 to 1 to receive Revlimid and Dexamethasone Group A in 9 treatment cycles and maintenance with lower doses until progression or No treatment and observation until progression Group B
The patients will be evaluated at scheduled visits in up to three study periods Pre-treatment Treatment and Follow up
The Pre-treatment includes Screening and baseline visits After providing informed consent patients will be evaluated for study eligibility and then Patients will be stratified and randomized 11 to Group A or Group B
During Treatment Period patients will be evaluated once a month Once the treatment period has finished a maintenance treatment with low doses of Revlimid and Dexamethasone will be carry out in Group A During this period we will evaluate response progression-free survival and global survival every two months
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 |
|---|---|---|---|
| QUIREDEX | None | None | None |