Ignite Creation Date:
2024-05-06 @ 7:38 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02575144
Status:
UNKNOWN
Last Update Posted:
2022-02-01
First Post:
2015-10-12
Brief Title:
GEM-CLARIDEX Ld vs BiRd
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
GEM-CLARIDEX Lenalidomide and Dexamethasone Ld Versus Clarithromycin Lenalidomide Revlimid Dexamethasone BiRd as Initial Therapy in Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
GEM-CLARIDEX
Brief Summary:
This phase III study open-label randomized study investigating lenalidomide and dexamethasone with and without biaxin in subjects with newly diagnosed previously untreated MM Eligible subjects will be randomized in a 11 ratio to receive a regimen consisting of either biaxin lenalidomide and low-dose dexamethasone BiRd arm or lenalidomide and low-dose dexamethasone Rd arm 306 patients will be included 50 in Spain 153 and 50 in the USA 153
Detailed Description:
BiRd Arm
Subjects on the BiRD arm will receive clarithromycin Revlimid lenalidomide and dexamethasone in 28-day cycles Dosing is as follows
Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle If a dose of clarithromycin is missed it should be taken as soon as possible on the same day If it is missed for the entire day it should not be made up Vomited doses will not be made up
Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle for patients with a calculated creatinine clearance of 60 ccmin Patients with a calculated creatinine clearance of 60 ccmin will receive 15 mgs PO daily on days 1-21 of a 28 cycle If a dose of lenalidomide is missed it should be taken as soon as possible on the same day If it is missed for the entire day it should not be made up Vomited doses will not be made up
Dexamethasone 40mg PO will be given on days 1 8 15 22 of a 28-day cycle Missed or vomited doses will not be made up If subject cannot tolerate oral dexamethasone it will be given intravenously
Rd Arm
Subjects on the Rd arm will receive Revlimid and dexamethasone in 28-day cycles Dosing is as follows
Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle for patients with a calculated creatinine clearance of 60 ccmin Patients with a calculated clearance of 60 ccmin will receive 15 mgs PO daily on days 1-21 of a28 cycle If a dose of lenalidomide is missed it should be taken as soon as possible on the same day If it is missed for the entire day it should not be made up Vomited doses will not be made up
Dexamethasone 40mg PO will be given on days 1 8 15 22 of a 28-day cycle Missed or vomited doses will not be made up If subject cannot tolerate oral dexamethasone it will be given intravenously
Correlative studies Relative dose intensity Projected total dose per cycle of each component of assigned drug will be divided by the actual dose received and a ratio will be assessed for each cycle delivered
MRD Minimal residual disease testing will be performed in subjects who achieve complete response MRD testing may be performed either by flow cytometry or polymerase chain reaction PCR whichever is more readily available at the study institution
Subjects will continue their randomized treatment assignment until disease progression or unacceptable toxicity whichever occurs first In case toxicity precludes dosing of one agent ie dexamethasone clarithromycin lenalidomide treatment regimen will continue with the remaining agents Subjects unable to receive ALL the components of the assigned treatment arms will be removed from study after reasonable attempts to dose reduce and manage side effects Subjects can also be removed from study at investigators discretion or if they withdraw consent At completion or early discontinuation of treatment subjects will be followed for 30 additional days or up to the initiation of subsequent treatment whichever occurs first after which they will be off the active treatment phase of the study Long-term follow-up for disease status and survival will proceed until the subject has withdrawn consent is lost to follow-up or has died
Subjects on the BiRD arm will receive clarithromycin Revlimid lenalidomide and dexamethasone in 28-day cycles Dosing is as follows
Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle If a dose of clarithromycin is missed it should be taken as soon as possible on the same day If it is missed for the entire day it should not be made up Vomited doses will not be made up
Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle for patients with a calculated creatinine clearance of 60 ccmin Patients with a calculated creatinine clearance of 60 ccmin will receive 15 mgs PO daily on days 1-21 of a 28 cycle If a dose of lenalidomide is missed it should be taken as soon as possible on the same day If it is missed for the entire day it should not be made up Vomited doses will not be made up
Dexamethasone 40mg PO will be given on days 1 8 15 22 of a 28-day cycle Missed or vomited doses will not be made up If subject cannot tolerate oral dexamethasone it will be given intravenously
Rd Arm
Subjects on the Rd arm will receive Revlimid and dexamethasone in 28-day cycles Dosing is as follows
Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle for patients with a calculated creatinine clearance of 60 ccmin Patients with a calculated clearance of 60 ccmin will receive 15 mgs PO daily on days 1-21 of a28 cycle If a dose of lenalidomide is missed it should be taken as soon as possible on the same day If it is missed for the entire day it should not be made up Vomited doses will not be made up
Dexamethasone 40mg PO will be given on days 1 8 15 22 of a 28-day cycle Missed or vomited doses will not be made up If subject cannot tolerate oral dexamethasone it will be given intravenously
Correlative studies Relative dose intensity Projected total dose per cycle of each component of assigned drug will be divided by the actual dose received and a ratio will be assessed for each cycle delivered
MRD Minimal residual disease testing will be performed in subjects who achieve complete response MRD testing may be performed either by flow cytometry or polymerase chain reaction PCR whichever is more readily available at the study institution
Subjects will continue their randomized treatment assignment until disease progression or unacceptable toxicity whichever occurs first In case toxicity precludes dosing of one agent ie dexamethasone clarithromycin lenalidomide treatment regimen will continue with the remaining agents Subjects unable to receive ALL the components of the assigned treatment arms will be removed from study after reasonable attempts to dose reduce and manage side effects Subjects can also be removed from study at investigators discretion or if they withdraw consent At completion or early discontinuation of treatment subjects will be followed for 30 additional days or up to the initiation of subsequent treatment whichever occurs first after which they will be off the active treatment phase of the study Long-term follow-up for disease status and survival will proceed until the subject has withdrawn consent is lost to follow-up or has died
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