This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible/deferred multiple myeloma.
Participants must be at least 18 years of age
Newly diagnosed multiple myeloma, with monoclonal plasma cells in the bone marrow ≥10% or a biopsy proven plasmacytoma and either CRAB criteria or biomarker of malignancy
Serum monoclonal protein ≥0.5 g/dL. For IgA monoclonal protein, total IgA >500 mg/dL is allowable.
Urine monoclonal protein ≥200 mg/24 hours
Prior or current systemic therapy for any plasma cell disorder. An exception is emergency use of corticosteroids (equivalent to dexamethasone 40 mg daily for four days). After discussion with the principal investigator. one cycle of standard of care myeloma therapy (without anti-CD38 monoclonal antibody) is permissible to allow for stabilization of disease, during screening/prior to enrollment.
Pregnancy, currently breastfeeding, or planned breastfeeding.
Participant plans to father a child while enrolled in the study or within 100 days after last dose of study treatment.
Basal or squamous cell carcinoma of the skin
Massachusetts General Hospital
Lead sponsor
Pfizer
Collaborator