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Variability and Uncertainty A sensitivity analysis was conducted on the criteria for identifying cohort 2

2.6 Patients 2.6.1 Patient selection and study design Patients were enrolled in a prospective, investigator-initiated, non-randomized, multicenter, open-label study designed to evaluate in part A the safety and efficacy of DARA monotherapy in individuals with relapsed/refractory MM (RRMM) ( PB and BM samples from patients treated with DARA monotherapy in part A of the clinical study were collected at baseline, prior to initiation of DARA monotherapy, and at the time of DARA treatment failure (defined as disease progression [PD] during the first cycle of treatment, less than minimal response after the second treatment cycle, or less than partial response [PR] after the third treatment cycle), or in case of PD after an initial response (PR or better) for evaluation of adenosine (ADO) and inosine (INO) levels