A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma as Compared With Standard of Care Therapies

May 19, 2025 updated by: Pfizer

Comparative Effectiveness of Elranatamab in Clinical Study C1071003 Versus Physician's Choice of Treatment (PCT) 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 a real-world data source, 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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame
Progression-free survival
Time Frame: From the index therapy start until progression or death due to any cause, whichever occurs first, assessed up to 6 years
From the index therapy start until progression or death due to any cause, whichever occurs first, assessed up to 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall surival
Time Frame: From the index therapy start until death due to any cause assessed up to 6 years
From the index therapy start until death due to any cause assessed up to 6 years
Duration of response
Time Frame: From the first documentation of objective response until progression or death due to any cause, whichever occurs first, assessed up to 6 years
From the first documentation of objective response until progression or death due to any cause, whichever occurs first, assessed up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2024

Primary Completion (Actual)

March 3, 2025

Study Completion (Actual)

March 3, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

September 6, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1071043

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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