N/A
N=514
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT05932290 ↗Enrolled (actual)
514
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis — NA; 4.70 Months — p=<.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Elranatamab (Drug); Standard of care (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis |
NA; 4.70 | <.0001 sig |
| PRIMARY PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW) |
NA; 5.26 | .0003 sig |
| PRIMARY PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis |
NA; 3.71 | — |
| PRIMARY PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis |
NA; 2.79 | — |
| SECONDARY Overall Survival (OS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis |
NA; 11.24 | .0062 sig |
| SECONDARY OS: Study C1071003 Cohort A Versus RWD COTA Cohort- Using IPTW Analysis |
NA; 11.24 | .0032 sig |
| SECONDARY OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis |
NA; 11.24 | — |
| SECONDARY OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis |
NA; 11.24 | — |
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 multiple real-world sources, 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.
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 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
Data sourced from ClinicalTrials.gov (NCT05932290). 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.