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
Sponsor: Pfizer
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
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: 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 Endpoints
Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
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
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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