Multicenter, open label, phase II clinical trial evaluating the combination of elranatamab with mezigdomide and dexamethasone in patients with relapsed/refractory multiple myeloma

Relapsed/refractory multiple myeloma

MRD negativity rate defined as the percentage of participants who achieve MRD negativity at 10-5 by NGF in BM and ≥CR according to the IMWG criteria (APPENDIX 6)

Sustained MRD negativity at 10-5 at 24 months evaluated by NGF in BM, Percentage of patients converting to MRD negative at 10-5 at any time after ERI, evaluated by NGF in BM, Response rate, defined as the percentage of patients who achieve CR, VGPR, PR, MR, and SD as the best response to treatment based on confirmed response according to the IMWG criteria. ORR, defined as the percentage of subjects who achieve best response of partial response (PR) or better (PR, VGPR, or CR), based on confirmed response according to the IMWG criteria. TTR defined as the time from the date of elranatamab treatment initiation until the achievement of at least a PR, DoR, defined as the time from the achievement of at least a PR until the earliest date of documented disease progression by IMWG criteria. PFS, defined as the time from the date of elranatamab treatment initiation until the earliest date of documented disease progression by IMWG criteria or death due to any cause. OS, defined as the time from the date of elranatamab treatment initiation until the date of death due to any cause., The safety profile of the study combination will be assessed based on: - Incidence of AEs. - Percentage of patients discontinuing therapy due to AEs. - Percentage of patients requiring dose modifications due to AEs. - Incidence of SAEs. - Changes in laboratory analytes from the hematology and blood chemistry panel. - Incidence of deaths and primary cause of death. Treatment safety will be assessed from C1D1 until 4 weeks after EoT

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