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

Active, not recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Elranatamab; Drug: Standard of care

• Registration Number: NCT06592222
• Lead Sponsor: Pfizer

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 clinica...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-08-08
• Study Start: 2024-08-26
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elranatamab	Elranatamab	Patients treated with elranatamab from the MagnetisMM-3 trial
Standard of care	Standard of care	Patients treated with standard-of-care therapies from real-world data sources

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer; 🇺🇸 New York, New York, United States