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Completed

NCT Number: NCT06504524

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer, Berlin, Germany

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About this study

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:

  • Online check during data entry (incomplete and non-plausible data entries trigger an error message)
  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elranatamab

Drug

BCMA-CD3 bispecific antibody

Other names: Elrexfio (brand name)

Standard of care

Drug

control arm

Primary outcomes

  1. 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)

    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.

  2. 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)

    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 outcomes

  1. 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)

    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.

  2. 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)

    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 outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. 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)

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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