Trial Outcomes & Findings for A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany and US (NCT NCT06504524)
NCT ID: NCT06504524
Last Updated: 2025-06-27
Results Overview
OS: A) C1071003 Cohort A: OS was defined as time from the date of the first dose of elranatamab until death due to any cause. Participants were censored at loss to or end of follow-up. B) TM-MM Database: OS was defined as time from initiation of SOC until death due to any cause. Participants were censored at loss to follow-up or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
COMPLETED
633 participants
C1071003: First dose to death due to any cause or censoring whichever occurred first (maximum [max] follow-up of 2.09 years [Y]); TM-MM Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 4.22Y)
2025-06-27
Participant Flow
Data of eligible participants with triple class refractory (TCR) multiple myeloma (MM) treated with elranatamab \[data utilized form clinical trial C1071003\] or standard of care treatment (SOC) \[data utilized from real world data (RWD) sources Therapy Monitor MM (TM-MM) Germany dataset and the Flatiron Health database\] was collected.
Available data from eligible participants was evaluated in approximately 9 months (study start date: 01-September-2023 to study completion date: 31-May-2024) of this retrospective, observational study as per its objectives.
Participant milestones
| Measure |
C1071003 Cohort A
Eligible participants with TCR-MM, who were B-cell maturation antigen (BCMA) naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
RWD: Flatiron Health Database
Eligible participants with TCR-MM who initiated SOC treatment and were identified from Flatiron Health database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
118
|
277
|
238
|
|
Overall Study
COMPLETED
|
118
|
277
|
238
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
C1071003 Cohort A
n=118 Participants
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
n=277 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
RWD: Flatiron Health Database
n=238 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from Flatiron Health database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
Total
n=633 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age · <65 years
|
41 Participants
n=118 Participants
|
33 Participants
n=277 Participants
|
71 Participants
n=238 Participants
|
145 Participants
n=633 Participants
|
|
Age, Customized
Age · 65-74 years
|
55 Participants
n=118 Participants
|
134 Participants
n=277 Participants
|
90 Participants
n=238 Participants
|
279 Participants
n=633 Participants
|
|
Age, Customized
Age · >=75 years
|
22 Participants
n=118 Participants
|
110 Participants
n=277 Participants
|
77 Participants
n=238 Participants
|
209 Participants
n=633 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=118 Participants
|
107 Participants
n=277 Participants
|
118 Participants
n=238 Participants
|
278 Participants
n=633 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=118 Participants
|
170 Participants
n=277 Participants
|
120 Participants
n=238 Participants
|
355 Participants
n=633 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: C1071003: First dose to death due to any cause or censoring whichever occurred first (maximum [max] follow-up of 2.09 years [Y]); TM-MM Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 4.22Y)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.
OS: A) C1071003 Cohort A: OS was defined as time from the date of the first dose of elranatamab until death due to any cause. Participants were censored at loss to or end of follow-up. B) TM-MM Database: OS was defined as time from initiation of SOC until death due to any cause. Participants were censored at loss to follow-up or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Outcome measures
| Measure |
C1071003 Cohort A
n=118 Participants
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
n=277 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
|---|---|---|
|
Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis
|
13.27 Months
Interval 9.59 to
Upper limit of 95% confidence interval (CI) could not be estimated due to insufficient number of participants with events.
|
14.29 Months
Interval 12.98 to 24.08
|
PRIMARY outcome
Timeframe: C1071003: First dose to death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y)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.
OS: A) C1071003 Cohort A: OS was defined as time from the date of the first dose of elranatamab until death due to any cause. Participants were censored at loss to or end of follow-up. B) Flatiron Health Database: OS was defined as time from initiation of SOC until death due to any cause. Participants were censored at loss to follow-up or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Outcome measures
| Measure |
C1071003 Cohort A
n=118 Participants
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
n=238 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
|---|---|---|
|
OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
|
14.62 Months
Interval 9.59 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
18.99 Months
Interval 13.14 to 24.74
|
SECONDARY outcome
Timeframe: C1071003: First dose to PD or death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); TM-MM Database: SOC to PD or death due to any cause or censoring whichever occurred first (max follow-up of 4.22Y)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.
PFS: A) C1071003 Cohort A: time from date of first dose of elranatamab until confirmed progressive disease (PD) per IMWG criteria or death due to any cause, whichever occurred first. Participants censored at loss to or end of follow-up. B) TM-MM Database: time from SOC to either date of progression or death due to any cause. Participants censored at loss to follow-up or end of study period. PD per IMWG criteria: increase of \>=25% from lowest response value in any 1 or more of the criteria: serum protein electrophoresis test (SPEP) with absolute increase \>0.5 g/dL; 24-hour urine protein electrophoresis (UPEP) with absolute increase \>200 mg/24 h; in participants without measurable serum \& urine M-protein, absolute increase of \>10 mg/dL in difference between involved \& uninvolved free light chains (FLC) level; or absolute bone marrow plasma cell percentage \>10%. Kaplan Meier method used for analysis. Retrospective data evaluated in this observational study for approximately 9 months.
Outcome measures
| Measure |
C1071003 Cohort A
n=118 Participants
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
n=277 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
|---|---|---|
|
Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
|
13.01 Months
Interval 7.66 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
9.00 Months
Interval 7.2 to 11.63
|
SECONDARY outcome
Timeframe: C1071003: First dose to PD or death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to PD or death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y)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.
PFS: A) C1071003 Cohort A: time from date of first dose of elranatamab until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. Participants censored at loss to or end of follow-up. B) Flatiron Health Database: time from SOC to either date of progression or death due to any cause. Participants censored at loss to follow-up or end of study period. PD per IMWG criteria: increase of \>=25% from lowest response value in any 1 or more of the criteria: SPEP with absolute increase \>0.5 g/dL; 24-hour UPEP with absolute increase \>200 mg/24 h; in participants without measurable serum and urine M-protein, absolute increase of \>10 mg/dL in difference between involved and uninvolved FLC level; or absolute bone marrow plasma cell percentage \>10%. Kaplan Meier method used for analysis. Retrospective data evaluated in this observational study for approximately 9 months.
Outcome measures
| Measure |
C1071003 Cohort A
n=118 Participants
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
n=238 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
|---|---|---|
|
PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
|
10.58 Months
Interval 3.42 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
6.01 Months
Interval 4.53 to 7.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: C1071003: Date of first dose to start of next treatment line or censoring whichever occurred first (max follow-up of 2.09Y); TM-MM Database: SOC to start of next treatment line or censoring whichever occurred first (max follow-up of 4.22Y)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.
TTNT: A) C1071003 Cohort A: time from date of first dose of elranatamab to initiation of the next treatment line. Participants were censored at death, loss to or end of follow-up. B) TM-MM Database: time from SOC to start of the next treatment line. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Outcome measures
| Measure |
C1071003 Cohort A
n=118 Participants
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
n=277 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
|---|---|---|
|
Time to Next Treatment (TTNT): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
|
NA Months
Interval 4.01 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
12.06 Months
Interval 11.47 to 14.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: C1071003: Date of first dose to start of next treatment line or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to start of next treatment line or censoring whichever occurred first (max follow-up of 6.45Y)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.
TTNT: A) C1071003 Cohort A: time from date of first dose of elranatamab to initiation of the next treatment line. Participants were censored at death, loss to or end of follow-up. B) Flatiron Health Database: time from SOC to start of the next treatment line. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Outcome measures
| Measure |
C1071003 Cohort A
n=118 Participants
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
n=238 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
|---|---|---|
|
TTNT: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
|
NA Months
Interval 14.06 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
7.39 Months
Interval 6.24 to 9.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: C1071003: Date of first dose to discontinuation or censoring whichever occurred first (max follow-up of 2.09Y); TM-MM Database: SOC to discontinuation of SOC or censoring whichever occurred first (max follow-up of 4.22Y)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.
TTD: A) C1071003 Cohort A: time from the date of first dose of elranatamab to discontinuation. Participants were censored at death, loss to or end of follow-up. B) TM-MM Database: time from initiation of SOC to discontinuation (end) of the SOC. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Outcome measures
| Measure |
C1071003 Cohort A
n=118 Participants
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
n=277 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
|---|---|---|
|
Time to Treatment Discontinuation (TTD): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis
|
2.46 Months
Interval 2.04 to 10.19
|
5.59 Months
Interval 4.99 to 7.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: C1071003: Date of first dose to discontinuation or censoring whichever occurred first (maximum of 2.09Y); Flatiron Health Database: SOC to discontinuation of SOC or censoring whichever occurred first (maximum of 6.45Y)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.
TTD: a) C1071003 Cohort A: time from the date of first dose of elranatamab to discontinuation. Participants were censored at death, loss to or end of follow-up. B) Flatiron Health Database: time from initiation of the SOC to discontinuation (end) of the SOC. Participants were censored at loss to follow-up, death, or end of the study period. Kaplan Meier method was used for analysis. Retrospective data was evaluated in this observational study for approximately 9 months.
Outcome measures
| Measure |
C1071003 Cohort A
n=118 Participants
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
|
RWD: TM-MM Database
n=238 Participants
Eligible participants with TCR-MM who initiated SOC treatment and were identified from TM-MM database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
|
|---|---|---|
|
TTD: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis
|
6.87 Months
Interval 2.56 to 10.41
|
5.32 Months
Interval 4.17 to 6.64
|
Adverse Events
C1071003 Cohort A
RWD: TM-MM Database
RWD: Flatiron Health Database
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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 publications 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