Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02387879
Status:
UNKNOWN
Last Update Posted:
2019-09-26
First Post:
2015-02-05
Brief Title:
A Non-interventionalObservational Post Authorization Study of Patients With Multiple Myeloma Treated With Lenalidomide TR
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Non-interventional Multi-center Observational Post Authorization Safety Study of Patients With RelapseRefractory Multiple Myeloma Treated With Lenalidomide in Turkey
Status:
UNKNOWN
Status Verified Date:
2019-09
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:
None
Brief Summary:
CC-5013-PASS-TRA non-interventional multi-center observational post authorization safety study of patients with relapsedrefractory multiple myeloma treated with Lenalidomide in Turkey
The study is anticipated to last for approximately 8 years Recruitment period will continue until 500 subjects have commenced the third cycle of treatment with lenalidomide
The study is anticipated to last for approximately 8 years Recruitment period will continue until 500 subjects have commenced the third cycle of treatment with lenalidomide
Detailed Description:
Objectives
- Primary To characterize and determine the incidence of adverse events of special interest in subjects treated with Lenalidomide in real life setting in given indication
- Secondary
1 To observe the basic adverse event management approaches of physicians
2 To evaluate the effectiveness of Lenalidomide in given indication and to evaluate the prescription line
3 To monitor the reasons of patients noncompliance with lenalidomide usage recommended in Patient Information Leaflet
Subjects will be recruited from approximately 36 hematologyoncology sites in Turkey In all cases the decision to treat the patient will be made prior to the decision to enter the subject into the study All subjects enrolled will be prospectively followed up for up to 36 months where feasible following the end of observed treatment period This 36 month observation period will start from end of treatment The observation follow up period will end 36 months after the end of lenalidomide or background observed treatment period or at time of death withdrawal of consent or loss to follow up Following completion of treatment subjects will be followed up after 30 days and then every 6 months to assess status
Patients who are eligible and signed a consent form will be recruited consecutively Subjects who temporarily discontinue treatment for any reason for more than 30 days will be withdrawn from treatment observation but will be observed for safety for up to 36 months from the end of treatment If the reason for discontinuation for subjects is due to an adverse event the follow up of the adverse event will not be time limited and will continue until resolution or stabilization or when in the opinion of the investigator no additional useful information can be obtained from the event or the subject withdraws their consent to any more data being collected Subjects will discontinue from the study if they switch to another treatment No intervention will be performed to physician Treatment will be according to physicians regular clinical practice
All treatments will be prescribed by the treating investigator in accordance with regular clinical practice
All assessments will be made according to the regular clinical practice of the treating investigator Therefore if a parameter is requested on the case report form CRF but the investigators normal practice is not to carry out such an assessment then the field will not be completed
Statistical Analysis
Data from all subjects who receive at least one dose of treatment will be included in the safety analysis
Adverse events will be classified using the MedDRA classification system The severity of the toxicities will be graded according to the NCI CTCAE V 403 whenever possible
Adverse event frequency will be tabulated by body system and MedDRA term In the by subject analysis a subject having the same event more than once will be counted only once Adverse events will be summarized by worst NCI CTCAE V 403 grade
Adverse events leading to death or to discontinuation from treatment study-drug-related events and serious adverse events will be listed separately
The Kaplan-Meier procedures will be used to characterize time to onset and time to resolution for adverse events of special interest Multivariate logistic regression will be used to determine the demographic and baseline characteristics most predictive of developing adverse events of interest A forward selection stepwise procedure will be used to identify the subset of relevant factors
Summary tables will also be provided for clinically relevant subgroups Analyses will be undertaken to explore the course of neuropathy for subjects who have pre-existing neuropathy at baseline Specifically cross-tabulations will be used to summarize changes in severity observed during lenalidomide treatment and summary statistics will be provided for other relevant variables
- Primary To characterize and determine the incidence of adverse events of special interest in subjects treated with Lenalidomide in real life setting in given indication
- Secondary
1 To observe the basic adverse event management approaches of physicians
2 To evaluate the effectiveness of Lenalidomide in given indication and to evaluate the prescription line
3 To monitor the reasons of patients noncompliance with lenalidomide usage recommended in Patient Information Leaflet
Subjects will be recruited from approximately 36 hematologyoncology sites in Turkey In all cases the decision to treat the patient will be made prior to the decision to enter the subject into the study All subjects enrolled will be prospectively followed up for up to 36 months where feasible following the end of observed treatment period This 36 month observation period will start from end of treatment The observation follow up period will end 36 months after the end of lenalidomide or background observed treatment period or at time of death withdrawal of consent or loss to follow up Following completion of treatment subjects will be followed up after 30 days and then every 6 months to assess status
Patients who are eligible and signed a consent form will be recruited consecutively Subjects who temporarily discontinue treatment for any reason for more than 30 days will be withdrawn from treatment observation but will be observed for safety for up to 36 months from the end of treatment If the reason for discontinuation for subjects is due to an adverse event the follow up of the adverse event will not be time limited and will continue until resolution or stabilization or when in the opinion of the investigator no additional useful information can be obtained from the event or the subject withdraws their consent to any more data being collected Subjects will discontinue from the study if they switch to another treatment No intervention will be performed to physician Treatment will be according to physicians regular clinical practice
All treatments will be prescribed by the treating investigator in accordance with regular clinical practice
All assessments will be made according to the regular clinical practice of the treating investigator Therefore if a parameter is requested on the case report form CRF but the investigators normal practice is not to carry out such an assessment then the field will not be completed
Statistical Analysis
Data from all subjects who receive at least one dose of treatment will be included in the safety analysis
Adverse events will be classified using the MedDRA classification system The severity of the toxicities will be graded according to the NCI CTCAE V 403 whenever possible
Adverse event frequency will be tabulated by body system and MedDRA term In the by subject analysis a subject having the same event more than once will be counted only once Adverse events will be summarized by worst NCI CTCAE V 403 grade
Adverse events leading to death or to discontinuation from treatment study-drug-related events and serious adverse events will be listed separately
The Kaplan-Meier procedures will be used to characterize time to onset and time to resolution for adverse events of special interest Multivariate logistic regression will be used to determine the demographic and baseline characteristics most predictive of developing adverse events of interest A forward selection stepwise procedure will be used to identify the subset of relevant factors
Summary tables will also be provided for clinically relevant subgroups Analyses will be undertaken to explore the course of neuropathy for subjects who have pre-existing neuropathy at baseline Specifically cross-tabulations will be used to summarize changes in severity observed during lenalidomide treatment and summary statistics will be provided for other relevant variables
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