NCT06504524 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: COMPLETED
Registry last update: 2025-06-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis

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outcome · POSTED

OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis

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outcome · POSTED

Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis

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outcome · POSTED

PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis

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outcome · POSTED

Time to Next Treatment (TTNT): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis

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outcome · POSTED

TTNT: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis

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outcome · POSTED

Time to Treatment Discontinuation (TTD): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis

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outcome · POSTED

TTD: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sampling Method: NON_PROBABILITY_SAMPLE
sex: ALL
std Ages: ADULT
OLDER_ADULT
study Population: Patients treated with elranatamab will come from the MagnetisMM-3 trial. Patients treated with the standard-of-care therapies according to G-BA's definition will come from real-world data sources.

Treatment arms and interventions

arm Groups

description
Patient cohort treated with elranatamab, coming form clinical trial Magnetis MM-3 trial
intervention Names
Drug: Elranatamab
label
Elranatamab
description
Patients treated with the standard-of-care therapies according to G-BA's definition will come from real-world data sources
intervention Names
Drug: Standard of Care
label
Standard-of-care

interventions

arm Group Labels
Elranatamab
description
BCMA-CD3 bispecific antibody
name
Elranatamab
other Names
Elrexfio (brand name)
type
DRUG
arm Group Labels
Standard-of-care
description
control arm
name
Standard of Care
type
DRUG

Study design

observational Model: COHORT
time Perspective: RETROSPECTIVE

Enrollment

count: 633
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
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.
measure
Time to Next Treatment (TTNT): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
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)
description
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.
measure
TTNT: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
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)
description
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.
measure
Time to Treatment Discontinuation (TTD): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
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)
description
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.
measure
TTD: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
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)

primary Outcomes

description
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.
measure
Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis
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)
description
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.
measure
OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
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)

secondary Outcomes

description
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.
measure
Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
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)
description
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.
measure
PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
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)

Full study description

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.

Source references