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

NCT05932290 | Completed Results FDA Drug

• 1 other identifier: C1071031
• Study Type: observational
• Target: 514
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Multiple Myeloma

Keywords

Myeloma; Multiple Myeloma; relapsed Multiple Myeloma; refractory Multiple Myeloma; PF-06863135; BCMA; bispecific; bispecific antibody; BCMA-CD3 bispecific; Elranatamab; MagnetisMM-3

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Overall Survival (OS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis

  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

  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

  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

  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)

Study Arms (2)

Elranatamab

Patients treated with elranatamab from the MagnetisMM-3 trial

Drug: Elranatamab

Standard of care

Patients treated with standard-of-care therapies from real-world data sources

Drug: Standard of care

Interventions

Elranatamab DRUG

BCMA-CD3 bispecific antibody

Elranatamab

Standard of care DRUG

Standard of care

Standard of care

Eligibility Criteria

• Age: 18 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Publications (1)

• Costa LJ, LeBlanc TW, Tesch H, Sonneveld P, Kyle RP, Sinyavskaya L, Hlavacek P, Meche A, Ren J, Schepart A, Aydin D, Nador G, DiBonaventura MD. Elranatamab efficacy in MagnetisMM-3 compared with real-world control arms in triple-class refractory multiple myeloma. Future Oncol. 2024;20(17):1175-1189. doi: 10.2217/fon-2023-0995. Epub 2024 Feb 28.

  PMID: 38415370 DERIVED

Related Links

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

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

IMWG: International Myeloma Working Group

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 6, 2023
• Study Start: June 1, 2023
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)