Trial Outcomes & Findings for A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma (NCT NCT05932290)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

514 participants

Primary outcome timeframe

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)

Results posted on

2024-10-29

Participant Flow

This retrospective cohort study used participant level data from study C1071003 (NCT04649359), and external control arms identified from real world data (RWD) sources.

Participant milestones

Participant milestones
Measure	C1071003 Cohort A Eligible participants with triple-class refractory multiple myeloma (TCR MM), who were B-cell maturation antigen (BCMA) naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA Eligible participants with TCR MM who were treated with standard of care (SOC) therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.	RWD: Flatiron Health Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from Flatiron Health database were included. This arm served as external control arm.
Overall Study STARTED	123	239	152
Overall Study COMPLETED	123	239	152
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C1071003 Cohort A n=123 Participants Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA n=239 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.	RWD: Flatiron Health n=152 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from Flatiron Health database were included. This arm served as external control arm.	Total n=514 Participants Total of all reporting groups
Age, Continuous	67.1 Years STANDARD_DEVIATION 9.4 • n=5 Participants	68.0 Years STANDARD_DEVIATION 9.4 • n=7 Participants	69.5 Years STANDARD_DEVIATION 10.0 • n=5 Participants	68.2 Years STANDARD_DEVIATION 9.6 • n=4 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	109 Participants n=7 Participants	72 Participants n=5 Participants	236 Participants n=4 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	130 Participants n=7 Participants	80 Participants n=5 Participants	278 Participants n=4 Participants
Race/Ethnicity, Customized White	72 Participants n=5 Participants	175 Participants n=7 Participants	102 Participants n=5 Participants	349 Participants n=4 Participants
Race/Ethnicity, Customized Non-white	51 Participants n=5 Participants	64 Participants n=7 Participants	50 Participants n=5 Participants	165 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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)

Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. Kaplan Meier method was used for analysis. Participants without an event were censored at the date of last adequate disease assessment or the data cut-off.

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.

Outcome measures

Outcome measures
Measure	C1071003 Cohort A n=123 Participants Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA n=239 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis	NA Months Median and 95% CI was not estimated because of insufficient number of participants with the event.	4.70 Months Interval 3.09 to 5.98

PRIMARY outcome

Timeframe: 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)

Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets, hence "Number of Participants Analyzed" (N) are different from participant flow and baseline section.

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.

Outcome measures

Outcome measures
Measure	C1071003 Cohort A n=113 Participants Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA n=235 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW)	NA Months Median and 95% CI was not estimated because of insufficient number of participants with the event.	5.26 Months Interval 3.25 to 6.28

PRIMARY outcome

Timeframe: 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)

Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. Kaplan Meier Method was used for analysis. Participants without an event were censored at date of last adequate disease assessment or the data cut-off.

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.

Outcome measures

Outcome measures
Measure	C1071003 Cohort A n=123 Participants Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA n=152 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis	NA Months Median and 95% CI was not estimated because of insufficient number of participants with the event.	3.71 Months Interval 3.02 to 7.13

PRIMARY outcome

Timeframe: 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)

Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. IPTW analysis: eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets and "N" are different from participant and baseline section. Participants without an event were censored at date of last adequate disease assessment or the data cut-off.

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.

Outcome measures

Outcome measures
Measure	C1071003 Cohort A n=113 Participants Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA n=150 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis	NA Months Median and 95% CI was not estimated because of insufficient number of participants with the event.	2.79 Months Interval 1.87 to 5.59

SECONDARY outcome

Timeframe: 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)

Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study.

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.

Outcome measures

Outcome measures
Measure	C1071003 Cohort A n=123 Participants Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA n=239 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
Overall Survival (OS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis	NA Months Median and 95% CI was not estimated because of insufficient number of participants with the event.	11.24 Months Interval 9.36 to 14.75

SECONDARY outcome

Timeframe: 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)

Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets and "Number of Participants Analyzed" are different from participant flow and baseline section.

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.

Outcome measures

Outcome measures
Measure	C1071003 Cohort A n=113 Participants Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA n=235 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
OS: Study C1071003 Cohort A Versus RWD COTA Cohort- Using IPTW Analysis	NA Months Median and 95% CI was not estimated because of insufficient number of participants with the event.	11.24 Months Interval 8.51 to 14.29

SECONDARY outcome

Timeframe: 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)

Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study.

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.

Outcome measures

Outcome measures
Measure	C1071003 Cohort A n=123 Participants Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA n=152 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis	NA Months Median and 95% CI was not estimated because of insufficient number of participants with the event.	11.24 Months Interval 7.75 to 13.21

SECONDARY outcome

Timeframe: 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)

Population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets and "Number of Participants Analyzed" are different from participant flow and baseline section.

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.

Outcome measures

Outcome measures
Measure	C1071003 Cohort A n=113 Participants Eligible participants with TCR MM, who were BCMA naïve, who were enrolled between 2 February 2021 to 07 January 2022 and who were treated with elranatamab in study C1071003 were included.	RWD: COTA n=150 Participants Eligible participants with TCR MM who were treated with SOC therapies in real world clinical practice setting, identified from COTA database were included. This arm served as external control arm.
OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis	NA Months Median and 95% CI was not estimated because of insufficient number of participants with the event.	11.24 Months Interval 6.31 to 15.41

Adverse Events

C1071003 Cohort A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 55 deaths

RWD: COTA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 171 deaths

RWD: Flatiron Health

Serious events: 0 serious events

Other events: 0 other events

Deaths: 90 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER