A Prospective, Single-Arm, Two-Stage, Open-Label, Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma

YM BioSciences Australia Pty Ltd0 个研究点目标入组 24 人开始时间: 2007年11月14日最近更新: 2020年1月13日

试验速览

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•Diagnosis of multiple myeloma as per WHO (World Health Organisation) criteria.
•Age 18 years or greater.
•Patients must have received at least one but no more than 3 prior lines of myeloma therapy.
•Patients must have failed to respond to the most recently administered anti-myeloma therapy or have demonstrably progressive disease by accepted clinical criteria.
•Patients must have a life expectancy of at least 3 months.
•ECOG (Eastern Co-operative Oncology Group) performance status <3.
•Patients must be willing and able to given informed, written consent.
•Patients must agree to use adequate contraceptive measures if indicated.

•Patients with monoclonal gammopathy of undetermined significance.
•Known or suspective hypersensitivity to CYT997.
•Patient with uncontrolled intercurrent illness.
•Patients who are pregnant or lactating.
•Patient who have received other investigational agents within the preceding three weeks prior to starting therapy.
•Patients with heart-attack or stroke within the preceding 6 months; unstable angina pectoris; history of diabetic retinopathy or major surgery in the preceding 30 days will be excluded.
•Patients with a baseline prolongation of the QTc interval (QT interval corrected for heart rate) >450 msec.
•Patients with impaired cardiac function or clinically significant cardiac disease.
•Patients currently receiving treatment with medications known to prolong the QTc interval.

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