Status:
RECRUITING
MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
Lead Sponsor:
Pfizer
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is s...
Eligibility Criteria
Inclusion
- Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
- Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
- Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
- Have clinical laboratory values within the specified range.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
- Not pregnant or breastfeeding and willing to use contraception.
Exclusion
- Smoldering multiple myeloma.
- Plasma cell leukemia.
- Amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
- Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
- Any active, uncontrolled bacterial, fungal, or viral infection.
- Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
- Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
- Unable to receive investigator's choice therapy.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT06152575
Start Date
February 8 2024
End Date
December 30 2027
Last Update
January 7 2026
Active Locations (273)
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1
Infirmary Cancer Care
Mobile, Alabama, United States, 36607
2
Western Regional Medical Center, Inc. dba. City of Hope Phoenix
Goodyear, Arizona, United States, 85338
3
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
4
Community Cancer Institute
Clovis, California, United States, 93611