Clinical trial of Elranatamab (PF-06863135) and Daratumumab in participants with relapsed/refractory multiple myeloma

THE OBJECTIVE OF PART 1 OF THIS CLINICAL TRIAL IS TO FIND THE BEST DOSE OF ELRANATAMAB WHEN ADMINISTERED IN COMBINATION WITH A SECOND DRUG, DARATUMUMAB. IN PART 2 OF THIS STUDY, THE SAFETY AND EFFICACY OF THE STUDY DRUG, ELRANATAMAB, WILL BE STUDIED IN PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RELAPSED OR ARE UNRESPONSIVE AFTER PREVIOUS TREATMENT. IN THIS PART 2 OF THE STUDY, IN ORDER TO EVALUATE DIFFERENT ADMINISTRATION REGIMENS, PARTICIPANTS WILL BE DIVIDED INTO 3 GROUPS: GROUP A, WHICH WILL RECEIVE INCREASING DOSES OF ELRANATAMAB; GROUP B, WHICH WILL RECEIVE ELRANATAMAB IN COMBINATION WITH DARATUMUMAB; AND GROUP C (CONTROL GROUP), WHICH WILL RECEIVE DARATUMUMAB WITH POMALIDOMIDE AND DEXAMETHASONE. DARATUMUMAB AND ELRANATAMAB ARE INVESTIGATIONAL DRUGS IN THIS STUDY BECAUSE THEY ARE NOT APPROVED FOR USE IN COMBINATION. BOTH ARE ADMINISTERED BY INJECTION UNDER THE SKIN. ULTIMATELY, THE MAIN OBJECTIVE OF THIS STUDY IS: PART 1: TO EVALUATE THE DOSE-LIMITING TOXICITIES (DLTS), SAFETY, AND TOLERABILITY OF ELRANATAMAB DARATUMUMAB TO SELECT A DRF3 FOR THE COMBINATION TO BE USED IN PART 2 OF THIS STUDY. PART 2: -COMPARE THE EFFICACY OF ELRANATAMAB (GROUP A) VERSUS DARATUMUMAB POMALIDOMIDE DEXAMETHASONE (GROUP C) AS MEASURED BY PFS. -COMPARE THE EFFICACY OF ELRANATAMAB DARATUMUMAB (GROUP B) VERSUS GROUP C AS MEASURED BY PFS.