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

Launched by PFIZER · Jul 15, 2024

Keywords

ClinConnect Summary

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...

Gender

ALL

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