Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561854
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Study Comparing Therapy for Advanced Relapsedrefractory Multiple Myeloma with and Without Dexamethasone
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Free Regimen of Dexamethasone As Initial Therapy for Advanced Relapsedrefractory Multiple Myeloma an Open-label Randomized Non-inferiority Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FREEDOM
Brief Summary:
Patients with relapsedrefractory symptomatic multiple myeloma who meet all inclusion criteria will be randomized 11 to receive either standard of care chemotherapy IKEMA or ICARIA and dexamethasone until disease progression dexamethasone arm arm A or standard of care chemotherapy IKEMA or ICARIA and dexamethasone with dexamethasone discontinuation from the 3rd cycle of treatment after 8 weeks dexamethasone-free arm arm B
In most centers IKEMA and ICARIA schema can be adapted according to the standard of care in each center Choice between the ICARIA and IKEMA schema is at the discretion of the investigator in compliance with each drugs SmPC but must be performed before randomisation for the purpose of stratification
In most centers IKEMA and ICARIA schema can be adapted according to the standard of care in each center Choice between the ICARIA and IKEMA schema is at the discretion of the investigator in compliance with each drugs SmPC but must be performed before randomisation for the purpose of stratification
Detailed Description:
Patients with relapsedrefractory symptomatic multiple myeloma who meet all inclusion criteria will be randomized 11 to receive either standard of care chemotherapy IKEMA or ICARIA and dexamethasone until disease progression dexamethasone arm arm A or standard of care chemotherapy IKEMA or ICARIA and dexamethasone with dexamethasone discontinuation from the 3rd cycle of treatment after 8 weeks dexamethasone-free arm arm B
In most centers IKEMA and ICARIA schema are as follow but can be adapted according to the standard of care in each center Choice between the ICARIA and IKEMA schema is at the discretion of the investigator in compliance with each drugs SmPC but must be performed before randomisation for the purpose of stratification
1 ICARIA schema
dexamethasone 40mg 20mg for 75yr on day 1 8 15 22 of each cycle plus
isatuximab 10mgkg on day 1 8 15 22 in C1 subsequently on day 1 15 plus
pomalidomide 4mg on days 1-21 of 28-day cycle
2 IKEMA schema
dexamethasone 20 mg on day 1-2 day 8-9 day 15-16 and day 22-23 of each cycle
isatuximab 10 mgkg on day 1 8 15 22 in C1 then Q2W
carfilzomib 20 mgm² on day 1-2 56 mgm² day 8-9 day 15-16 in C1 56 mgm² on day 1-2 day 8-9 day 15-16 all subsequent cycles
In the dexamethasone arm standard of care
Dexamethasone will be given on each cycle
In the dexamethasone-free arm experimental arm
Dexamethasone will be only given on cycle 1 and cycle 2 Supportive care will be administered according to each participating centers usual practice in both arms The aim of the current protocol is to investigate whether administration of dexamethasone for a very limited period 2 cycles combined with standard treatment for relapsedrefractory MM is not inferior to the continuous administration of the combination until disease progression In this study some patients may have a similar OS while receiving a shorter duration of dexamethasone treatment This study may allow delivery of a shorter duration of dexamethasone for the treatment of relapsed MM
The foreseeable risks are those of an earlier relapse in patients receiving a short duration of dexamethasone 8 weeks compared to the situation where they would have received the dexamethasone until disease progression
In most centers IKEMA and ICARIA schema are as follow but can be adapted according to the standard of care in each center Choice between the ICARIA and IKEMA schema is at the discretion of the investigator in compliance with each drugs SmPC but must be performed before randomisation for the purpose of stratification
1 ICARIA schema
dexamethasone 40mg 20mg for 75yr on day 1 8 15 22 of each cycle plus
isatuximab 10mgkg on day 1 8 15 22 in C1 subsequently on day 1 15 plus
pomalidomide 4mg on days 1-21 of 28-day cycle
2 IKEMA schema
dexamethasone 20 mg on day 1-2 day 8-9 day 15-16 and day 22-23 of each cycle
isatuximab 10 mgkg on day 1 8 15 22 in C1 then Q2W
carfilzomib 20 mgm² on day 1-2 56 mgm² day 8-9 day 15-16 in C1 56 mgm² on day 1-2 day 8-9 day 15-16 all subsequent cycles
In the dexamethasone arm standard of care
Dexamethasone will be given on each cycle
In the dexamethasone-free arm experimental arm
Dexamethasone will be only given on cycle 1 and cycle 2 Supportive care will be administered according to each participating centers usual practice in both arms The aim of the current protocol is to investigate whether administration of dexamethasone for a very limited period 2 cycles combined with standard treatment for relapsedrefractory MM is not inferior to the continuous administration of the combination until disease progression In this study some patients may have a similar OS while receiving a shorter duration of dexamethasone treatment This study may allow delivery of a shorter duration of dexamethasone for the treatment of relapsed MM
The foreseeable risks are those of an earlier relapse in patients receiving a short duration of dexamethasone 8 weeks compared to the situation where they would have received the dexamethasone until disease progression
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