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

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)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Elranatamab; Drug: Standard of care

• Study Type: Observational
• Enrollment (Actual): 514

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elranatamab; Patients treated with elranatamab from the MagnetisMM-3 trial	Drug: Elranatamab; BCMA-CD3 bispecific antibody
Standard of care; Patients treated with standard-of-care therapies from real-world data sources	Drug: Standard of care; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Myeloma; relapsed Multiple Myeloma; refractory Multiple Myeloma; PF-06863135; BCMA; bispecific; bispecific antibody; BCMA-CD3 bispecific; Elranatamab; MagnetisMM-3
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: C1071031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No