Last updated 5 days ago
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)
492 patients around the world
Available in Spain, Argentina, United States
Pfizer
14Research sites
492Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Hospital Universitario Austral - Pilar
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Hospital Italiano de La Plata
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Universidad Federal de São Paulo - Unifesp
Recruiting
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Mãe de Deus Hospital
Recruiting
Hospital Mãe de Deus - Porto Alegre
Recruiting
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Recruiting
Instituto do Coração do HCFMUSP
Recruiting
Clinica São Germano
Recruiting
StudyMagnetisMM-32
SponsorPfizer
Study typeInterventional
Conditions
Multiple myeloma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06152575
