Trial Outcomes & Findings for A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma (NCT NCT05565391)
NCT ID: NCT05565391
Last Updated: 2024-05-21
Results Overview
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.
COMPLETED
508 participants
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)
2024-05-21
Participant Flow
This retrospective cohort study included triple-class refractory (TCR) multiple myeloma (MM) participants who initiated elranatamab in study C1071003 (NCT04649359) and 2 cohorts of real-world (RW) TCR MM participants who initiated standard of care (SOC) treatment identified from Flatiron Health and COTA databases as external control arms for Study C1071003.
Index date was defined as the date of initiation of the first regimen after TCR MM eligibility. Only participants with an index date between 16-Nov-2015 and 31-Mar-2022 were selected. Participants were observed from the index date to the earliest of death, or the latest available participants record, whichever occurred first.
Participant milestones
| Measure |
Study C1071003 Cohort A
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Overall Study
STARTED
|
123
|
233
|
152
|
|
Overall Study
COMPLETED
|
123
|
233
|
152
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Study C1071003 Cohort A
n=123 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=233 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
n=152 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
Total
n=508 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
>18 years
|
123 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
508 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
234 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
72 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
51 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
164 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included.
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.
Outcome measures
| Measure |
Study C1071003 Cohort A
n=123 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=233 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
n=152 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Objective Response Rate (ORR)-Unweighted Analysis
|
61.0 Percentage of participants
Interval 51.8 to 69.6
|
31.3 Percentage of participants
Interval 25.4 to 37.7
|
30.3 Percentage of participants
Interval 23.1 to 38.2
|
PRIMARY outcome
Timeframe: 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)Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
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.
Outcome measures
| Measure |
Study C1071003 Cohort A
n=123 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=213 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis
|
75.7 Percentage of participants
Interval 65.6 to 87.4
|
34.2 Percentage of participants
Interval 27.2 to 43.0
|
—
|
PRIMARY outcome
Timeframe: 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)Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
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.
Outcome measures
| Measure |
Study C1071003 Cohort A
n=122 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=149 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis
|
56.0 Percentage of participants
Interval 41.1 to 76.2
|
31.3 Percentage of participants
Interval 19.4 to 50.4
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Study C1071003 Cohort A
n=75 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=73 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
n=46 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Time to Response (TTR)-Unweighted Analysis
|
1.22 Months
Interval 0.99 to 2.0
|
1.38 Months
Interval 0.82 to 2.79
|
1.87 Months
Interval 0.95 to 2.69
|
SECONDARY outcome
Timeframe: 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)Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers.
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.
Outcome measures
| Measure |
Study C1071003 Cohort A
n=76 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=68 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Time to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis
|
1.25 months
Interval 0.99 to 2.1
|
1.18 months
Interval 0.82 to 1.87
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants after application of IPTW method to raw numbers.
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.
Outcome measures
| Measure |
Study C1071003 Cohort A
n=74 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=43 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis
|
1.15 Months
Interval 0.99 to 2.0
|
1.87 Months
Interval 0.95 to 2.1
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
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 \[absolute increase \>=200mg/24h\]).
Outcome measures
| Measure |
Study C1071003 Cohort A
n=75 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=73 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
n=46 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Duration of Response (DOR)-Unweighted Analysis
|
NA Months
Interval 11.99 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
4.37 Months
Interval 2.86 to 8.05
|
7.16 Months
Interval 4.99 to 13.6
|
SECONDARY outcome
Timeframe: 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)Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Study C1071003 Cohort A
n=75 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=68 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis
|
NA Months
Interval 11.99 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
4.37 Months
Interval 2.86 to 8.05
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Study C1071003 Cohort A
n=74 Participants
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
|
COTA Cohort
n=43 Participants
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
|
Flatiron Health Cohort
Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from Flatiron Health database were included.
|
|---|---|---|---|
|
Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis
|
NA Months
Interval 11.99 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
7.16 Months
Interval 4.99 to 13.6
|
—
|
Adverse Events
Study C1071003 Cohort A
COTA Chohort
Flatiron Health Cohort
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