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

Part of paid clinical trials in New York, New York.

Sponsor
Pfizer
Study ID
NCT06504524
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elranatamab — DRUG
    BCMA-CD3 bispecific antibody
  • Standard of Care — DRUG
    control arm

Study Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
May 2025
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
633 participants (actual)

Arms

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

Primary Outcome 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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
PfizerNew YorkNew York10001-

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By condition
Multiple myeloma
By specialty
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By research site
Pfizer· New York, NY

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