Last updated 8 days ago
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
944 patients around the world
Available in Argentina, Brazil, Spain
Pfizer
21Research sites
944Patients 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 IMWG criteria (Rajkumar et al, 2014).Measurable disease based on IMWG criteria as defined by at least 1 of the following:Serum M-protein ≥0.5 g/dL.Urinary M-protein excretion ≥200 mg/24 hours.Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.ECOG performance status ≤2.Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.Not pregnant and willing to use contraception.
- Smoldering multiple myeloma.Plasma cell leukemia.Amyloidosis.POEMS Syndrome.Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.Previous treatment with a BCMA-directed therapy.Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.Live attenuated vaccine within 4 weeks of the first dose of study intervention.Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
Sites
Sanatorio de la Mujer - Rosario
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
Hospital Italiano de La Plata
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Centro de Internación e Investigación Clínica FUNDALEU
Recruiting
Clinica São Germano
Recruiting
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
Recruiting
Hospital Mãe de Deus - Porto Alegre
Recruiting
Instituto de Educação, Pesquisa e Gestão em Saúde
Recruiting
Hospital Japonês Santa Cruz
Recruiting
StudyMAGNETISMM-5
SponsorPfizer
Study typeInterventional
Conditions
Multiple myeloma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05020236
