Last updated 16 days ago
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
760 patients around the world
Available in Spain, Brazil
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells
and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
Pfizer
7Research sites
760Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosisPart 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positiveHistory of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.Partial Response or better according to IMWG criteria at the time of randomizationMust have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.ECOG performance status ≤1Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1Not pregnant and willing to use contraception
- Plasma cell leukemiaAmyloidosis, Waldenström's macroglobulinemiaPOEMS syndromeKnown active CNS involvement or clinical signs of myelomatous meningeal involvementPrevious MM maintenance treatmentPrior treatment with BCMA targeted therapyAny other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situActive, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illnessPrevious administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Sites
Instituto de Educação, Pesquisa e Gestão em Saúde
Hospital Japonês Santa Cruz
Recruiting
Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
Ambulatório Américas Medical City
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Recruiting
Hospital Mãe de Deus - Porto Alegre
Recruiting
Hospital Amaral Carvalho
StudyMagnetisMM-7
SponsorPfizer
Conditions
Multiple myeloma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05317416
