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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT05565391

Collaborator

(none)

Enrollment

Location

1.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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, 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Elranatamab Drug: Standard of care

Study Design

Study Type:

Observational

Actual Enrollment :

1 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Comparative Effectiveness of Elranatamab (PF 06863135) in Clinical Study C1071003 Versus Standard of Care (SOC) in Real-World (RW) External Control Arms in Patients With Triple-Class Refractory (TCR) Multiple Myeloma (MM)

Actual Study Start Date :

Oct 3, 2022

Actual Primary Completion Date :

Nov 4, 2022

Actual Study Completion Date :

Nov 4, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Objective response rate [assessed over at least the first 9 months from index therapy start]
Objective response rate (International Myeloma Working Group [IMWG] response criteria)

Secondary Outcome Measures

Time to response [assessed over at least the first 9 months from index therapy start]
Time to response (IMWG response criteria)
Duration of response [assessed over at least the first 9 months from index therapy start]
Duration of response (IMWG response criteria)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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