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

NCT06504524 | Completed Results FDA Drug

• 2 other identifiers: C1071035NCT06504524
• Study Type: observational
• Target: 633
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of the study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). MM is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). 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. SOC are treatments that are accepted by medical experts as a proper treatment for a certain type of disease and that are widely used by doctors in real world. For people receiving elranatamab, the study doctors will use data from the other clinical trial (MagnetisMM-3). The study doctors will also use data from multiplemany real-world sources (TherapyMonitor MM Germany and Flatiron Health), for SOC in clinical practice. This study does not seek any participants for enrollment. The study doctors will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the study doctors 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; External Control Arm

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS): C1071003 Cohort A Versus TM-MM Database Using Inverse Probability of Treatment Weights (IPTW) Analysis

  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.

  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)

• OS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis

  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.

  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)

Secondary Outcomes (2)

• Progression Free Survival (PFS): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis

  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)

• PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis

  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)

Other Outcomes (4)

• Time to Next Treatment (TTNT): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis

  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)

• TTNT: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis

  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)

• Time to Treatment Discontinuation (TTD): C1071003 Cohort A Versus TM-MM Database Using IPTW Analysis

  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)

Study Arms (2)

Elranatamab

Patient cohort treated with elranatamab, coming form clinical trial Magnetis MM-3 trial

Drug: Elranatamab

Standard-of-care

Patients treated with the standard-of-care therapies according to G-BA's definition will come from real-world data sources

Drug: Standard of Care

Interventions

Elranatamab DRUG

BCMA-CD3 bispecific antibody

Also known as: Elrexfio (brand name)

Elranatamab

Standard of Care DRUG

control arm

Standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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 according to G-BA's definition 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 according to G-BA's definition of standard of care 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
• st treatment following TCR eligibility not according to G-BA's definition of standard of care

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer

New York, New York, 10001, United States

Location

Pfizer

Berlin, Germany

Location

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

There were some limitations of the study resulting in poor overlap between study arms suggesting that groups are not well comparable in terms of the observed confounding characteristics used for adjustment. This should be taken into consideration when interpreting results.

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 24, 2024
• First Posted: July 16, 2024
• Study Start: September 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); US (1)