Fig. 1: Study design and treatment disposition. | Leukemia

Fig. 1: Study design and treatment disposition.

From: A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma

Fig. 1

QnW every n week. *Randomization to Arms 1–3 was stratified according to whether or not patients had received prior treatment with pomalidomide and/or carfilzomib. Analysis of the pharmacokinetic parameters of patients treated at 10 mg/kg Q2W in the expansion cohort of the Phase 1 study demonstrated a high level of variability in exposure and non-linear clearance, suggesting that a higher dose and more intense “loading” schedule may be required to reach the desired therapeutic concentration faster. Therefore, Arm 4 was included, which evaluated a dose and schedule of 20 mg/kg QW for 1 cycle followed by 20 mg/kg Q2W. At study cut-off, December 9, 2016.

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