Ignite Creation Date:
2024-05-06 @ 3:58 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02415413
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-09-10
First Post:
2015-03-29
Brief Title:
Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
A Phase II Multicenter Study of Carfilzomib Lenalidomide and Dexamethasone KRd as Induction Therapy Followed by High-dose Therapy With Melphalan and Autologous Peripheral Blood Stem Cell Transplantation Consolidation With KRd and Maintenance With Lenalidomide and Dexamethasone in Patients 70 Years Old With Smoldering Multiple Myeloma SMM With High Risk of Progression to Symptomatic Myeloma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-09
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:
Patients included in the study will receive induction treatment during 6 months followed by receive high-dose therapy followed by peripheral blood stem cell transplantation
Approximately 3 months after peripheral blood stem cell transplantation patients will receive consolidation treatment during 2 months
Subsequently patients will start maintenance treatment during 24 months Therefore the total duration of the treatment will be approximately 36 months
Approximately 3 months after peripheral blood stem cell transplantation patients will receive consolidation treatment during 2 months
Subsequently patients will start maintenance treatment during 24 months Therefore the total duration of the treatment will be approximately 36 months
Detailed Description:
This clinical trial is a multicenter Phase II study designed to evaluate the efficacy and toxicity of an intensive therapeutic approach in 90 patients with asymptomatic high risk multiple myeloma SMM
1 - Patients will receive an induction treatment consisting of 6 cycles of carfilzomib lenalidomide and low-dose dexamethasone KRd patients will receive carfilzomib 20-36 mgm2 IV on days 1 2 8 9 15 and 16 with oral lenalidomide 25 mg daily on days 1-21 subsequently there will be a rest period of a week from day 22 to day 27 Moreover oral dexamethasone 40mg daily will be administered weekly days 1 8 15 and 22
2 - Following the induction treatment patients will receive high-dose 200 mgm2 melphalan-based treatment administered via the intravenous route followed by peripheral blood stem cell transplantation HDT-ASCT
3 - The consolidation treatment will consist of 2 cycles of KRd with the same doses and scheduled of the induction treatment
4 - Maintenance treatment all patients without progression to symptomatic multiple myeloma or toxicity requiring discontinuation of the trial will receive maintenance treatment during 24 cycles
This maintenance treatment comprises the administration of lenalidomide 10mg on days 1-21 followed by a rest period of 1 week with the weekly administration of dexamethasone 20mg
Treatment will be administrated until the end of the maintenance although patients will continue in the trial
If biological progression is observed following the discontinuation of the treatment lenalidomide and dexamethasone will be reinstituted in order to control the disease again Lenalidomide 10 mg will be administrated on days 1-21 combined with dexamethasone 20mg on days 1 8 15 and 22 All patients will be monitored for asymptomatic disease progression and to collect data regarding on overall survival OS
1 - Patients will receive an induction treatment consisting of 6 cycles of carfilzomib lenalidomide and low-dose dexamethasone KRd patients will receive carfilzomib 20-36 mgm2 IV on days 1 2 8 9 15 and 16 with oral lenalidomide 25 mg daily on days 1-21 subsequently there will be a rest period of a week from day 22 to day 27 Moreover oral dexamethasone 40mg daily will be administered weekly days 1 8 15 and 22
2 - Following the induction treatment patients will receive high-dose 200 mgm2 melphalan-based treatment administered via the intravenous route followed by peripheral blood stem cell transplantation HDT-ASCT
3 - The consolidation treatment will consist of 2 cycles of KRd with the same doses and scheduled of the induction treatment
4 - Maintenance treatment all patients without progression to symptomatic multiple myeloma or toxicity requiring discontinuation of the trial will receive maintenance treatment during 24 cycles
This maintenance treatment comprises the administration of lenalidomide 10mg on days 1-21 followed by a rest period of 1 week with the weekly administration of dexamethasone 20mg
Treatment will be administrated until the end of the maintenance although patients will continue in the trial
If biological progression is observed following the discontinuation of the treatment lenalidomide and dexamethasone will be reinstituted in order to control the disease again Lenalidomide 10 mg will be administrated on days 1-21 combined with dexamethasone 20mg on days 1 8 15 and 22 All patients will be monitored for asymptomatic disease progression and to collect data regarding on overall survival OS
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