The BELAMI trial is an open label, multicenter, phase 2 study for patients with MM who relapsed following BCMA-directed CAR-T cells or bispecific antibodies with a Phase Ib Safety run-in.
The primary hypothesis of this study is that a combination of ADC targeting BCMA and CELMoD will be efficient for these patients.
Subjects who are ≥ 18 years of age
Participant has a histologically or cytologically confirmed diagnosis of MM as defined by IMWG criteria
Participant has Eastern Cooperative Oncology Group (ECOG) performance status of score of 0, 1, or 2
Participant is considered transplant ineligible or for participants with a history of autologous stem cell transplant (ASCT), ASCT was >100 days before initiating study treatment
Patients under guardianship or curators
Patients with insufficient proficiency in French to understand the study information
Prior treatment with an anti-BCMA targeted therapy within 90 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs.
A known intolerance or immediate or delayed hypersensitivity to drugs chemically related to Belantamab mafodontin or Mezigdomide or any of of the components of the study treatment.