Multiple Myeloma
Conditions
Keywords
Myeloma, Multiple Myeloma, relapsed Multiple Myeloma, refractory Multiple Myeloma, PF-06863135, BCMA, bispecific, bispecific antibody, BCMA-CD3 bispecific, Elranatamab, MagnetisMM-3, External Control Arm
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.
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-BA's 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 weighting/matching 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 inclusion/exclusion 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, e.g., 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 variables/values. In the RW dataset, patients with any implausible/counter-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.
Interventions
DRUGElranatamab
BCMA-CD3 bispecific antibody
DRUGStandard of Care
control arm
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years and older at index date Diagnosis of MM Measurable disease according to IMWG criteria ECOG performance status ≤2 Refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 treatment (ie, triple-class refractory \[TCR\]) At least 1 treatment according to G-BA's definition of standard of care following their TCR eligibility
Exclusion criteria
Acute plasma cell leukemia Amyloidosis Smoldering MM Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD) Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ Administration with an investigational drug within 30 days prior to index 1st treatment following TCR eligibility not according to G-BA's definition of standard of care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis | C1071003: First dose to death due to any cause or censoring whichever occurred first (maximum [max] follow-up of 2.09 years [Y]); TM-MM Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 4.22Y) | OS: A) C1071003 Cohort A: OS was defined as time from the date of the first dose of elranatamab until death due to any cause. Participants were censored at loss to or end of follow-up. B) TM-MM Database: OS was defined as time from initiation of SOC until death due to any cause. Participants were censored at loss to follow-up or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months. |
| OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | C1071003: First dose to death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y) | OS: A) C1071003 Cohort A: OS was defined as time from the date of the first dose of elranatamab until death due to any cause. Participants were censored at loss to or end of follow-up. B) Flatiron Health Database: OS was defined as time from initiation of SOC until death due to any cause. Participants were censored at loss to follow-up or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis | C1071003: First dose to PD or death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); TM-MM Database: SOC to PD or death due to any cause or censoring whichever occurred first (max follow-up of 4.22Y) | PFS: A) C1071003 Cohort A: time from date of first dose of elranatamab until confirmed progressive disease (PD) per IMWG criteria or death due to any cause, whichever occurred first. Participants censored at loss to or end of follow-up. B) TM-MM Database: time from SOC to either date of progression or death due to any cause. Participants censored at loss to follow-up or end of study period. PD per IMWG criteria: increase of \>=25% from lowest response value in any 1 or more of the criteria: serum protein electrophoresis test (SPEP) with absolute increase \>0.5 g/dL; 24-hour urine protein electrophoresis (UPEP) with absolute increase \>200 mg/24 h; in participants without measurable serum & urine M-protein, absolute increase of \>10 mg/dL in difference between involved & uninvolved free light chains (FLC) level; or absolute bone marrow plasma cell percentage \>10%. Kaplan Meier method used for analysis. Retrospective data evaluated in this observational study for approximately 9 months. |
| PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | C1071003: First dose to PD or death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to PD or death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y) | PFS: A) C1071003 Cohort A: time from date of first dose of elranatamab until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. Participants censored at loss to or end of follow-up. B) Flatiron Health Database: time from SOC to either date of progression or death due to any cause. Participants censored at loss to follow-up or end of study period. PD per IMWG criteria: increase of \>=25% from lowest response value in any 1 or more of the criteria: SPEP with absolute increase \>0.5 g/dL; 24-hour UPEP with absolute increase \>200 mg/24 h; in participants without measurable serum and urine M-protein, absolute increase of \>10 mg/dL in difference between involved and uninvolved FLC level; or absolute bone marrow plasma cell percentage \>10%. Kaplan Meier method used for analysis. Retrospective data evaluated in this observational study for approximately 9 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Next Treatment (TTNT): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis | C1071003: Date of first dose to start of next treatment line or censoring whichever occurred first (max follow-up of 2.09Y); TM-MM Database: SOC to start of next treatment line or censoring whichever occurred first (max follow-up of 4.22Y) | TTNT: A) C1071003 Cohort A: time from date of first dose of elranatamab to initiation of the next treatment line. Participants were censored at death, loss to or end of follow-up. B) TM-MM Database: time from SOC to start of the next treatment line. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months. |
| TTNT: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | C1071003: Date of first dose to start of next treatment line or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to start of next treatment line or censoring whichever occurred first (max follow-up of 6.45Y) | TTNT: A) C1071003 Cohort A: time from date of first dose of elranatamab to initiation of the next treatment line. Participants were censored at death, loss to or end of follow-up. B) Flatiron Health Database: time from SOC to start of the next treatment line. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months. |
| Time to Treatment Discontinuation (TTD): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis | C1071003: Date of first dose to discontinuation or censoring whichever occurred first (max follow-up of 2.09Y); TM-MM Database: SOC to discontinuation of SOC or censoring whichever occurred first (max follow-up of 4.22Y) | TTD: A) C1071003 Cohort A: time from the date of first dose of elranatamab to discontinuation. Participants were censored at death, loss to or end of follow-up. B) TM-MM Database: time from initiation of SOC to discontinuation (end) of the SOC. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months. |
| TTD: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | C1071003: Date of first dose to discontinuation or censoring whichever occurred first (maximum of 2.09Y); Flatiron Health Database: SOC to discontinuation of SOC or censoring whichever occurred first (maximum of 6.45Y) | TTD: a) C1071003 Cohort A: time from the date of first dose of elranatamab to discontinuation. Participants were censored at death, loss to or end of follow-up. B) Flatiron Health Database: time from initiation of the SOC to discontinuation (end) of the SOC. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months. |
Countries
Germany, United States
Participant flow
Recruitment details
Data of eligible participants with triple class refractory (TCR) multiple myeloma (MM) treated with elranatamab \[data utilized form clinical trial C1071003\] or standard of care treatment (SOC) \[data utilized from real world data (RWD) sources Therapy Monitor MM (TM-MM) Germany dataset and the Flatiron Health database\] was collected.
Pre-assignment details
Available data from eligible participants was evaluated in approximately 9 months (study start date: 01-September-2023 to study completion date: 31-May-2024) of this retrospective, observational study as per its objectives.
Participants by arm
| Arm | Count |
|---|---|
| C1071003 Cohort A Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included. | 118 |
| RWD: TM-MM Database Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm. | 277 |
| RWD: Flatiron Health Database Eligible participants with TCR-MM who initiated SOC treatment and were identified from Flatiron Health database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm. | 238 |
| Total | 633 |
Baseline characteristics
| Characteristic | Total | C1071003 Cohort A | RWD: TM-MM Database | RWD: Flatiron Health Database |
|---|---|---|---|---|
| Age, Customized Age 65-74 years | 279 Participants | 55 Participants | 134 Participants | 90 Participants |
| Age, Customized Age <65 years | 145 Participants | 41 Participants | 33 Participants | 71 Participants |
| Age, Customized Age >=75 years | 209 Participants | 22 Participants | 110 Participants | 77 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Sex: Female, Male Female | 278 Participants | 53 Participants | 107 Participants | 118 Participants |
| Sex: Female, Male Male | 355 Participants | 65 Participants | 170 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 54 / 118 | 128 / 277 | 150 / 238 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
OS: A) C1071003 Cohort A: OS was defined as time from the date of the first dose of elranatamab until death due to any cause. Participants were censored at loss to or end of follow-up. B) Flatiron Health Database: OS was defined as time from initiation of SOC until death due to any cause. Participants were censored at loss to follow-up or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Time frame: C1071003: First dose to death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y)
Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| C1071003 Cohort A | OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | 14.62 Months |
| RWD: TM-MM Database | OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | 18.99 Months |
p-value: =0.442995% CI: [0.85, 1.64]Regression, Cox
Primary
Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis
OS: A) C1071003 Cohort A: OS was defined as time from the date of the first dose of elranatamab until death due to any cause. Participants were censored at loss to or end of follow-up. B) TM-MM Database: OS was defined as time from initiation of SOC until death due to any cause. Participants were censored at loss to follow-up or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Time frame: C1071003: First dose to death due to any cause or censoring whichever occurred first (maximum [max] follow-up of 2.09 years [Y]); TM-MM Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 4.22Y)
Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| C1071003 Cohort A | Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis | 13.27 Months |
| RWD: TM-MM Database | Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis | 14.29 Months |
p-value: =0.61595% CI: [0.705, 1.804]Regression, Cox
Secondary
PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
PFS: A) C1071003 Cohort A: time from date of first dose of elranatamab until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. Participants censored at loss to or end of follow-up. B) Flatiron Health Database: time from SOC to either date of progression or death due to any cause. Participants censored at loss to follow-up or end of study period. PD per IMWG criteria: increase of \>=25% from lowest response value in any 1 or more of the criteria: SPEP with absolute increase \>0.5 g/dL; 24-hour UPEP with absolute increase \>200 mg/24 h; in participants without measurable serum and urine M-protein, absolute increase of \>10 mg/dL in difference between involved and uninvolved FLC level; or absolute bone marrow plasma cell percentage \>10%. Kaplan Meier method used for analysis. Retrospective data evaluated in this observational study for approximately 9 months.
Time frame: C1071003: First dose to PD or death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to PD or death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y)
Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| C1071003 Cohort A | PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | 10.58 Months |
| RWD: TM-MM Database | PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | 6.01 Months |
p-value: =0.001195% CI: [0.38, 0.71]Regression, Cox
Secondary
Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
PFS: A) C1071003 Cohort A: time from date of first dose of elranatamab until confirmed progressive disease (PD) per IMWG criteria or death due to any cause, whichever occurred first. Participants censored at loss to or end of follow-up. B) TM-MM Database: time from SOC to either date of progression or death due to any cause. Participants censored at loss to follow-up or end of study period. PD per IMWG criteria: increase of \>=25% from lowest response value in any 1 or more of the criteria: serum protein electrophoresis test (SPEP) with absolute increase \>0.5 g/dL; 24-hour urine protein electrophoresis (UPEP) with absolute increase \>200 mg/24 h; in participants without measurable serum & urine M-protein, absolute increase of \>10 mg/dL in difference between involved & uninvolved free light chains (FLC) level; or absolute bone marrow plasma cell percentage \>10%. Kaplan Meier method used for analysis. Retrospective data evaluated in this observational study for approximately 9 months.
Time frame: C1071003: First dose to PD or death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); TM-MM Database: SOC to PD or death due to any cause or censoring whichever occurred first (max follow-up of 4.22Y)
Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| C1071003 Cohort A | Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis | 13.01 Months |
| RWD: TM-MM Database | Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis | 9.00 Months |
p-value: =0.1295% CI: [0.39, 1.115]Regression, Cox
Other Pre-specified
Time to Next Treatment (TTNT): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
TTNT: A) C1071003 Cohort A: time from date of first dose of elranatamab to initiation of the next treatment line. Participants were censored at death, loss to or end of follow-up. B) TM-MM Database: time from SOC to start of the next treatment line. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Time frame: C1071003: Date of first dose to start of next treatment line or censoring whichever occurred first (max follow-up of 2.09Y); TM-MM Database: SOC to start of next treatment line or censoring whichever occurred first (max follow-up of 4.22Y)
Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| C1071003 Cohort A | Time to Next Treatment (TTNT): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis | NA Months |
| RWD: TM-MM Database | Time to Next Treatment (TTNT): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis | 12.06 Months |
p-value: =0.50395% CI: [0.337, 1.71]Regression, Cox
Other Pre-specified
Time to Treatment Discontinuation (TTD): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
TTD: A) C1071003 Cohort A: time from the date of first dose of elranatamab to discontinuation. Participants were censored at death, loss to or end of follow-up. B) TM-MM Database: time from initiation of SOC to discontinuation (end) of the SOC. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Time frame: C1071003: Date of first dose to discontinuation or censoring whichever occurred first (max follow-up of 2.09Y); TM-MM Database: SOC to discontinuation of SOC or censoring whichever occurred first (max follow-up of 4.22Y)
Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| C1071003 Cohort A | Time to Treatment Discontinuation (TTD): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis | 2.46 Months |
| RWD: TM-MM Database | Time to Treatment Discontinuation (TTD): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis | 5.59 Months |
p-value: =0.70695% CI: [0.587, 1.436]Regression, Cox
Other Pre-specified
TTD: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
TTD: a) C1071003 Cohort A: time from the date of first dose of elranatamab to discontinuation. Participants were censored at death, loss to or end of follow-up. B) Flatiron Health Database: time from initiation of the SOC to discontinuation (end) of the SOC. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Time frame: C1071003: Date of first dose to discontinuation or censoring whichever occurred first (maximum of 2.09Y); Flatiron Health Database: SOC to discontinuation of SOC or censoring whichever occurred first (maximum of 6.45Y)
Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| C1071003 Cohort A | TTD: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | 6.87 Months |
| RWD: TM-MM Database | TTD: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | 5.32 Months |
p-value: =0.018295% CI: [0.52, 0.88]Regression, Cox
Other Pre-specified
TTNT: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
TTNT: A) C1071003 Cohort A: time from date of first dose of elranatamab to initiation of the next treatment line. Participants were censored at death, loss to or end of follow-up. B) Flatiron Health Database: time from SOC to start of the next treatment line. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Time frame: C1071003: Date of first dose to start of next treatment line or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to start of next treatment line or censoring whichever occurred first (max follow-up of 6.45Y)
Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| C1071003 Cohort A | TTNT: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | NA Months |
| RWD: TM-MM Database | TTNT: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis | 7.39 Months |
p-value: <0.000195% CI: [0.26, 0.57]Regression, Cox