None listed
Conditions
Brief summary
Laboratory studies indicate that CYT997 is able to potently inhibit myeloma cells from patients with this condition. Given these favourable "test tube" findings, Cytopia has decided to investigate whether CYT997, when given to patients with multiple myeloma, can improve their condition and extend survival from the disease. The effect of CYT997 in patients will be determined from analysis of blood plasma and bone marrow samples and comparison to accepted clinical standards for response in multiple myeloma.
Interventions
CYT997 is administered as a 24-hour intravenous infusion at a dose of 202mg/m2 on days 1 and 8 of a 21 day cycle for up to three cycles
Sponsors
YM BioSciences Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed