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.
Parallel
CAR-T cells
DrugCombination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA CAR-T cells (with or without bispecific antibodies)
BCMA bispecific
DrugCombination of Belantamab and Mezigdomide treatments with patients previously treated with anti-BCMA bispecific antibodies
Progression Free Survival
Defined as the duration from the start date of treatment to the date of either progressive disease, or death, whichever occurs first. Progressive disease will be evaluated as defined by 2016 International Myeloma Working Group (IMWG) response criteria, as data permits, and assessed by the investigator.
Overall response rate (ORR)
ORR, defined as CR or VGPR or PR, according to the IMWG criteria at the time of data cutoff
Percentage of patients achieving very good partial response (VGPR) or better, complete response (CR), and partial response (PR).
Percentage of VGPR or better, CR, VGPR, PR, Progression Disease defined according to the IMWG criteria at the time of data cutoff
Time to response (TTR)
Time to response
Duration of response (DOR)
Response duration
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This trial is not recruiting at the moment. You can still explore other options:
