AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
Adult
Measurable disease based on IMWG criteria as defined by at least 1 of the following: Serum M-protein greater than or equal to 0.5 g/dL; Urinary M-protein excretion greater than or equal to 200 mg/24 hours; Serum immunoglobulin FLC greater than or equal to 10 mg/dL (greater than or equal to 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (less than 0.26 or greater than 1.65) At least 1, but not more than 3, prior lines of anti-MM therapy including treatment with lenalidomide and a PI. A response of MR or better must have been achieved with any prior anti-MM therapy based on investigator assessment using IMWG criteria. ECOG performance status <2.
Treatment
Greeley Campus
Harmony Campus
Medical Center of the Rockies
Poudre Valley Hospital
Steven Schuster, MD
Protocol Number: 23-0848
More information available at ClinicalTrials.gov: NCT05020236
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