N/A
N=508
A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT05565391 ↗Enrolled (actual)
508
Serious AEs
—
Results posted
Apr 2024
Primary outcome: Primary: Objective Response Rate (ORR)-Unweighted Analysis — 61.0; 31.3; 30.3 Percentage of participants — p=<.0001
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
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR)-Unweighted Analysis |
61.0; 31.3; 30.3 | <.0001 sig |
| PRIMARY Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis |
75.7; 34.2 | <.0001 sig |
| PRIMARY Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis |
56.0; 31.3 | 0.0447 sig |
| SECONDARY Time to Response (TTR)-Unweighted Analysis |
1.22; 1.38; 1.87 | 0.4241 |
| SECONDARY Time to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis |
1.25; 1.18 | 0.7682 |
| SECONDARY Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis |
1.15; 1.87 | 0.0326 sig |
| SECONDARY Duration of Response (DOR)-Unweighted Analysis |
NA; 4.37; 7.16 | <.0001 sig |
| SECONDARY Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis |
NA; 4.37 | <.0001 sig |
| SECONDARY Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis |
NA; 7.16 | <.0001 sig |
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, we will use data from the phase 2 clinical trial (MagnetisMM-3). We will also use data from two real-world databases, representing the SOC in clinical practice. This study does not seek any participants for enrollment. We will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help us 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 (NCT05565391). 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.