At a glance
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A Multicenter, Open-Label Phase II Study of SyB L-0501 in Patients With Relapsed/Refractory Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating SyB L-0501 for Relapsed/Refractory Multiple Myeloma. Completed, enrolled 17 participants across 14 sites.
Detailed Summary
The purpose of this study is to determine the antitumor efficacy and safety of bendamustine (SyB L-0501: 90 mg/m\^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory multiple myeloma.
Study Details
Timeline
Interventions
The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.