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

NCT ID: NCT05565391

Last Updated: 2024-05-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

508 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2022-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Elranatamab

Patients treated with elranatamab from the MagnetisMM-3 trial

Elranatamab

Intervention Type DRUG

BCMA-CD3 bispecific antibody

Standard of care

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

Standard of care

Intervention Type DRUG

Standard of care

Interventions

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Elranatamab

BCMA-CD3 bispecific antibody

Intervention Type DRUG

Standard of care

Standard of care

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C1071024

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

Other Identifiers

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C1071024

Identifier Type: -

Identifier Source: org_study_id

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