A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Standard of care
Drug: Elranatamab

Registration Number: NCT05565391

Lead Sponsor: Pfizer

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, 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 508

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	Patients treated with standard-of-care therapies from real-world data sources
Elranatamab	Elranatamab	Patients treated with elranatamab from the MagnetisMM-3 trial

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)-Unweighted Analysis	From index date until first documentation of progression, death, or the start of new anticancer therapy (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)	ORR was the percentage of participants with objective response (OR) per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, OR was partial response (PR) or better (stringent complete response \[sCR\]+complete response \[CR\]+very good partial response \[VGPR\]+PR). For Study C1071003 and Flatiron Health, OR was PR or better (at least VGPR+PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. Clopper-Pearson two-sided 95% exact confidence intervals were estimated.
Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis	From index date until first documentation of progression, death, or the start of new anticancer therapy (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)	ORR was the percentage of participants with an OR per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, the OR was defined as PR or better (sCR + CR + VGPR + PR). For Study C1071003 and Flatiron Health, OR was defined as PR or better (at least VGPR + PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.
Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis	From index date until first documentation of progression, death, or the start of new anticancer therapy (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)	ORR was the percentage of participants with an OR per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, the OR was defined as PR or better (sCR + CR + VGPR + PR). For Study C1071003 and Flatiron Health, OR was defined as PR or better (at least VGPR + PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

Secondary Outcome Measures

Name	Time	Method
Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis	From index date to date of first documentation of OR (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)	TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.
Duration of Response (DOR)-Unweighted Analysis	From first documentation of OR until confirmed PD or death due to any cause or censoring date (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)	DOR was defined as the time from the first documentation of OR, until confirmed disease progression (PD) per IMWG criteria, or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; and urine M-protein \[absolute increase \>=200mg/24h\]).
Time to Response (TTR)-Unweighted Analysis	From index date to date of first documentation of OR (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)	TTR was defined as the time from the index date to the first documentation of OR. No censoring was performed. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria.
Time to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis	From index date to date of first documentation of OR (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)	TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.
Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis	From first documentation of OR until confirmed PD or death due to any cause or censoring date (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)	DOR was defined as the time from the first documentation of OR, until confirmed disease progression (PD) per IMWG criteria, or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; and urine M-protein \[absolute increase \>=200mg/24h\]). Median and 95% Confidence Interval (CI) reported in the descriptive section was determined using unweighted analysis.
Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis	From first documentation of OR until confirmed PD or death due to any cause or censoring date (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)	DOR was defined as the time from the first documentation of OR, until confirmed disease progression (PD) per IMWG criteria, or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; and urine M-protein \[absolute increase \>=200mg/24h\]). Median and 95% Confidence Interval (CI) reported in the descriptive section was determined using unweighted analysis.