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

Multiple Myeloma Clinical Trial

Official title:

Comparative Effectiveness of Elranatamab (PF 06863135) in Clinical Study C1071003 Versus Standard of Care (SOC) in Real-World (RW) External Control Arms in Patients With Triple-Class Refractory (TCR) Multiple Myeloma (MM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05565391
• Other study ID #: C1071024
• Status: Completed
• Start date: October 3, 2022
• Est. completion date: November 4, 2022

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elranatamab
BCMA-CD3 bispecific antibody
• Standard of care
Standard of care

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)-Unweighted Analysis	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.	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)
Primary	Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis	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.	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)
Primary	Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis	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.	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)
Secondary	Time to Response (TTR)-Unweighted Analysis	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.	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)
Secondary	Time to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis	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.	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)
Secondary	Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis	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.	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)
Secondary	Duration of Response (DOR)-Unweighted Analysis	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]).	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)
Secondary	Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis	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.	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)
Secondary	Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis	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.	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)

External Links

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