Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504524
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
A Study to Compare the Effects of Elranatamab PF 06863135 Versus Standard of Care SOC in Patients With Multiple Myeloma MM in Germany and US
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Effectiveness of Elranatamab PF 06863135 in Clinical Study C1071003 Versus Standard of Care SOC in a Real-World RW External Control Arm of Patients With Triple-Class Refractory TCR Multiple Myeloma MM From TherapyMonitor MM Germany
Status:
COMPLETED
Status Verified Date:
2024-07
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:
None
Brief Summary:
The purpose of the study is to understand how well elranatamab PF-06863135 may be used for relapsed refractory multiple myeloma RRMM MM is a type of cancer that begins in plasma cells white blood cells that produce antibodies Sometimes MM might improve at first but then gets resistant to the treatment and starts growing again known as relapsed refractory
This study medicine will be compared with standard-of-care SOC therapies SOC are treatments that are accepted by medical experts as a proper treatment for a certain type of disease and that are widely used by doctors in real world
For people receiving elranatamab the study doctors will use data from the other clinical trial MagnetisMM-3 The study doctors will also use data from multiplemany real-world sources TherapyMonitor MM Germany and Flatiron Health for SOC in clinical practice This study does not seek any participants for enrollment
The study doctors will compare the experiences of people receiving elranatamab to people receiving SOC therapies This way it will help the study doctors to know how well elranatamab can be used for RRMM treatment
This study medicine will be compared with standard-of-care SOC therapies SOC are treatments that are accepted by medical experts as a proper treatment for a certain type of disease and that are widely used by doctors in real world
For people receiving elranatamab the study doctors will use data from the other clinical trial MagnetisMM-3 The study doctors will also use data from multiplemany real-world sources TherapyMonitor MM Germany and Flatiron Health for SOC in clinical practice This study does not seek any participants for enrollment
The study doctors will compare the experiences of people receiving elranatamab to people receiving SOC therapies This way it will help the study doctors to know how well elranatamab can be used for RRMM treatment
Detailed Description:
This study aims to contextualize the outcomes of Study C1071003 by comparing a priori specified clinical effectiveness of patients treated with elranatamab using patient-level data from study C1071003 vs RW external control of patients with TCE MM treated with SOC therapies from the TM-MM Germany dataset and from the Flatiron Health database The study is an extension of studies C1071024 and C1071031 with more recent data and an alternative set of therapies included in the ECA following the G-BAs definition of the appropriate comparator therapy and with an alternative data base focusing on German patients Effectiveness will be measured by Overall Survival Progression-free Survival with no differentiation between primary and secondary endpoints To further reduce the potential for bias appropriate comparative effectiveness methods and statistical techniques will be utilized propensity score weightingmatching methods and multivariable regression If appropriate multiple imputation by chained equations will be performed No formal sample size estimations have been performed for this observational study
All patients who meet the inclusionexclusion criteria of the external control arm will be included in the analyses
This is a retrospective study so issues of quality control at study sites eg data queries do not apply Analyses are programmed according to the specifications in the protocol Statistical programming code and summary output will be reviewed by the study team including a biostatistician for accuracy and completeness Final deliverables will be reviewed and verified by a second independent analyst All quality checks will be documented
For the secondary data collected by the TM-MM Germany project the completeness and plausibility checks have been carried out in three stages during the generation of the dataset include
1 Online check during data entry incomplete and non-plausible data entries trigger an error message
2 Central individual review after completion of data entry by the TNXO team of clinical monitors in-complete or non-plausible data entry triggers a query process
3 Central review of data sets by the TNXO team of data analysts to find and exclude any duplicated patients
After the duplicate records are excluded only complete and plausible records are included in the database Once the TM-MM dataset is provided by TNXO to Cytel and Pfizer approves data access for Study C1071003 the study data management will adhere to pre-defined process guidelines which mainly consist of data validation based on computer-assisted checking of variablesvalues In the RW dataset patients with any implausiblecounter-intuitive data will be excluded from the sample during the selection of the study population or for the analysis of specific outcomes as applicable The study team will maintain adequate and accurate records to enable the conduct of the study to be fully documented
The Flatiron databases are compliant with both the spirit and the letter of the Health Insurance Portability and Accountability Act of 1996 HIPAA The databases meet the criteria for a limited-use dataset and contain none of the data elements prohibited by HIPAA for limited-use datasets
All patients who meet the inclusionexclusion criteria of the external control arm will be included in the analyses
This is a retrospective study so issues of quality control at study sites eg data queries do not apply Analyses are programmed according to the specifications in the protocol Statistical programming code and summary output will be reviewed by the study team including a biostatistician for accuracy and completeness Final deliverables will be reviewed and verified by a second independent analyst All quality checks will be documented
For the secondary data collected by the TM-MM Germany project the completeness and plausibility checks have been carried out in three stages during the generation of the dataset include
1 Online check during data entry incomplete and non-plausible data entries trigger an error message
2 Central individual review after completion of data entry by the TNXO team of clinical monitors in-complete or non-plausible data entry triggers a query process
3 Central review of data sets by the TNXO team of data analysts to find and exclude any duplicated patients
After the duplicate records are excluded only complete and plausible records are included in the database Once the TM-MM dataset is provided by TNXO to Cytel and Pfizer approves data access for Study C1071003 the study data management will adhere to pre-defined process guidelines which mainly consist of data validation based on computer-assisted checking of variablesvalues In the RW dataset patients with any implausiblecounter-intuitive data will be excluded from the sample during the selection of the study population or for the analysis of specific outcomes as applicable The study team will maintain adequate and accurate records to enable the conduct of the study to be fully documented
The Flatiron databases are compliant with both the spirit and the letter of the Health Insurance Portability and Accountability Act of 1996 HIPAA The databases meet the criteria for a limited-use dataset and contain none of the data elements prohibited by HIPAA for limited-use datasets
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