An observational study in Multiple Myeloma, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Weeks and older. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Pfizer · Observational
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 514 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients treated with elranatamab will come from the MagnetisMM-3 trial. Patients treated with the standard-of-care therapies will come from real-world data sources.
Exclusion Criteria:
Patients treated with elranatamab from the MagnetisMM-3 trial
Drug: Elranatamab
Patients treated with standard-of-care therapies from real-world data sources
Drug: Standard of care
BCMA-CD3 bispecific antibody
Standard of care
Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis
PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed progressive disease (PD) per IMWG criteria or death due to any cause, whichever occurred first; b) RWD COTA: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>=25% (Percent) from the lowest response value in any 1 or more of the criteria: serum protein electrophoresis (SPEP) with an absolute increase \>0.5 gram/deciliter (g/dL); 24-hour(h) urine protein electrophoresis (UPEP) with an absolute increase \>200 microgram (mg)/24 h; in participants without measurable serum and urine M-protein, the absolute increase of \>10 mg/dL in the difference between involved and uninvolved free light chain (FLC) levels; or an absolute bone marrow plasma cell \>10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months.
Time frame: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)
PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW)
PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first; b) COTA: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>=25% from the lowest response value in any 1 or more of the criteria: SPEP with an absolute increase \>0.5 g/dL; 24-hour UPEP with an absolute increase \>200 mg/24 h; in participants without measurable serum and urine M-protein, the absolute increase of \>10 mg/dL in the difference between involved and uninvolved FLC levels; or an absolute bone marrow plasma cell percentage \>10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Participants without an event were censored at date of last adequate disease assessment or the data cut-off. Kaplan Meier method was used.
Time frame: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)
PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis
PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by \>= 0.5 g/dL; serum M-protein \>= 1 g/dL if the lowest M component was \>= 5 g/dL; an absolute increase in urine M-protein by UPEP by \>=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of \>10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months.
Time frame: C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months)
PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis
PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by \>= 0.5 g/dL; serum M-protein \>= 1 g/dL if the lowest M component was \>= 5 g/dL; an absolute increase in urine M-protein by UPEP by \>=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of \>10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Kaplan Meier Method was used for analysis.
Time frame: C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months)
Overall Survival (OS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; b) COTA Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
Time frame: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); COTA: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 64.3 months)
OS: Study C1071003 Cohort A Versus RWD COTA Cohort- Using IPTW Analysis
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; b) COTA Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
Time frame: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); COTA: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 64.3 months)
OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; B) Flatiron Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
Time frame: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); Flatiron: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 66.9 months)
OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; B) Flatiron Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
Time frame: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); Flatiron: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 66.9 months)
This retrospective cohort study used participant level data from study C1071003 (NCT04649359), and external control arms identified from real world data (RWD) sources.
| Milestone | C1071003 Cohort A | RWD: COTA | RWD: Flatiron Health |
|---|---|---|---|
| Started | 123 | 239 | 152 |
| Completed | 123 | 239 | 152 |
| Not completed | 0 | 0 | 0 |
PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed progressive disease (PD) per IMWG criteria or death due to any cause, whichever occurred first; b) RWD COTA: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>=25% (Percent) from the lowest response value in any 1 or more of the criteria: serum protein electrophoresis (SPEP) with an absolute increase \>0.5 gram/deciliter (g/dL); 24-hour(h) urine protein electrophoresis (UPEP) with an absolute increase \>200 microgram (mg)/24 h; in participants without measurable serum and urine M-protein, the absolute increase of \>10 mg/dL in the difference between involved and uninvolved free light chain (FLC) levels; or an absolute bone marrow plasma cell \>10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months.
| Months | C1071003 Cohort A | RWD: COTA |
|---|---|---|
| Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis | NA (NA to NA) | 4.70 (3.09 to 5.98) |
PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first; b) COTA: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>=25% from the lowest response value in any 1 or more of the criteria: SPEP with an absolute increase \>0.5 g/dL; 24-hour UPEP with an absolute increase \>200 mg/24 h; in participants without measurable serum and urine M-protein, the absolute increase of \>10 mg/dL in the difference between involved and uninvolved FLC levels; or an absolute bone marrow plasma cell percentage \>10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Participants without an event were censored at date of last adequate disease assessment or the data cut-off. Kaplan Meier method was used.
| Months | C1071003 Cohort A | RWD: COTA |
|---|---|---|
| PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW) | NA (NA to NA) | 5.26 (3.25 to 6.28) |
PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by \>= 0.5 g/dL; serum M-protein \>= 1 g/dL if the lowest M component was \>= 5 g/dL; an absolute increase in urine M-protein by UPEP by \>=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of \>10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months.
| Months | C1071003 Cohort A | RWD: Flatiron Health |
|---|---|---|
| PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis | NA (NA to NA) | 3.71 (3.02 to 7.13) |
PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of \>= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by \>= 0.5 g/dL; serum M-protein \>= 1 g/dL if the lowest M component was \>= 5 g/dL; an absolute increase in urine M-protein by UPEP by \>=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of \>10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Kaplan Meier Method was used for analysis.
| Months | C1071003 Cohort A | RWD: Flatiron Health |
|---|---|---|
| PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis | NA (NA to NA) | 2.79 (1.87 to 5.59) |
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; b) COTA Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
| Months | C1071003 Cohort A | RWD: COTA |
|---|---|---|
| Overall Survival (OS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis | NA (NA to NA) | 11.24 (9.36 to 14.75) |
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; b) COTA Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
| Months | C1071003 Cohort A | RWD: COTA |
|---|---|---|
| OS: Study C1071003 Cohort A Versus RWD COTA Cohort- Using IPTW Analysis | NA (NA to NA) | 11.24 (8.51 to 14.29) |
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; B) Flatiron Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
| Months | C1071003 Cohort A | RWD: Flatiron Health |
|---|---|---|
| OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis | NA (NA to NA) | 11.24 (7.75 to 13.21) |
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; B) Flatiron Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
| Months | C1071003 Cohort A | RWD: Flatiron Health |
|---|---|---|
| OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis | NA (NA to NA) | 11.24 (6.31 to 15.41) |
Collected over All-cause mortality: During observation period of approximately 15 months for C1071003, 64.3 months for RWD: COTA and 66.9 months for RWD: Flatiron Health; Serious adverse events and other adverse events: not applicable as adverse event data was not collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| C1071003 Cohort A | 55/123 (44.7%) | — | — |
| RWD: COTA | 171/239 (71.5%) | — | — |
| RWD: Flatiron Health | 90/152 (59.2%) | — | — |
Eligible participants whose data was included for observation in this study.
| Age, Continuous(Years) | C1071003 Cohort A | RWD: COTA | RWD: Flatiron Health | Total |
|---|---|---|---|---|
| Mean | 67.1 ± 9.4 | 68.0 ± 9.4 | 69.5 ± 10.0 | 68.2 ± 9.6 |
| Sex: Female, Male(Participants) | C1071003 Cohort A | RWD: COTA | RWD: Flatiron Health | Total |
|---|---|---|---|---|
| Female | 55 | 109 | 72 | 236 |
| Male | 68 | 130 | 80 | 278 |
| Race/Ethnicity, Customized(Participants) | C1071003 Cohort A | RWD: COTA | RWD: Flatiron Health | Total |
|---|---|---|---|---|
| White | 72 | 175 | 102 | 349 |
| Non-white | 51 | 64 | 50 | 165 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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