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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elranatamab; Drug: Standard of Care

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.

• Study Type: Observational
• Enrollment (Actual): 633

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Pfizer
• United States
  • New York
    • New York, New York, United States, 10001
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elranatamab; Patient cohort treated with elranatamab, coming form clinical trial Magnetis MM-3 trial	Drug: Elranatamab; BCMA-CD3 bispecific antibody; Other Names: Elrexfio (brand name)
Standard-of-care; Patients treated with the standard-of-care therapies according to G-BA's definition will come from real-world data sources	Drug: Standard of Care; control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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: 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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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: 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.	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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: 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.	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)
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.	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: 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.	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Myeloma; relapsed Multiple Myeloma; refractory Multiple Myeloma; PF-06863135; BCMA; bispecific; bispecific antibody; BCMA-CD3 bispecific; Elranatamab; MagnetisMM-3; External Control Arm
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: C1071035; NCT06504524 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No