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

NCT06592222 | Completed FDA Drug

• 1 other identifier: C1071043
• Study Type: observational
• Target: 4
• 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 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

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 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 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 Links

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

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; 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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: September 19, 2024
• Study Start: August 26, 2024
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)