Multiple Myeloma
Conditions
Brief summary
This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). 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 used in real-world clinical practice. For people receiving elranatamab, the investigators will use data from the phase 2 clinical trial (MagnetisMM-3). The investigators will also use data from a real-world data source, representing the SOC in clinical practice. This study does not seek any participants for enrollment. The investigators will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the investigators to know how well elranatamab can be used for RRMM treatment.
Interventions
DRUGElranatamab
BCMA-CD3 bispecific antibody
DRUGStandard of care
Standard of care
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | From the index therapy start until progression or death due to any cause, whichever occurs first, assessed up to 6 years |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response | From the first documentation of objective response until progression or death due to any cause, whichever occurs first, assessed up to 6 years |
| Overall surival | From the index therapy start until death due to any cause assessed up to 6 years |
Countries
United States
Outcome results
None listed