N/A N=633

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

Multiple Myeloma

Bottom Line

View on ClinicalTrials.gov: NCT06504524 ↗

Enrolled (actual)

633

Serious AEs

—

Results posted

Jun 2025

Primary outcome: Primary: Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis — 13.27; 14.29 Months — p==0.615

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Elranatamab (Drug); Standard of Care (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis	13.27; 14.29	=0.615
PRIMARY OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis	14.62; 18.99	=0.4429
SECONDARY Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis	13.01; 9.00	=0.120
SECONDARY PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis	10.58; 6.01	=0.0011 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06504524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.