Relapsed and Refractory Multiple Myeloma
Conditions
Keywords
Multiple myeloma, relapsed, refractory
Brief summary
This is a clinical research study that is designed to test the safety of CYT997 when given to patients with multiple myeloma and to test if CYT997 has any activity against that cancer.
Interventions
DRUGCYT997
Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of multiple myeloma per International Working Group (IWG) criteria * Have received at least 1 but no more than 4 prior lines of therapy * Have failed to respond to the most recently administered anti-myeloma therapy * Have a life expectancy of at least 3 months * Eastern Cooperative Oncology Group (ECOG) performance status \< 3 * At registration absolute neutrophil count \> 1x10\^9/L and platelet count \> 50 x 10\^9/L unsupported * At registration bilirubin less than 1.5 x upper limit of normal and transaminases less than 2 x upper limit of normal and serum creatinine less than 0.19 mmol/L * Written informed consent * Must agree to adequate contraceptive measure if indicated
Exclusion criteria
* Patients with monoclonal gammopathy of undetermined significance * Known or suspected hypersensitivity to CYT997 * Patient with uncontrolled intercurrent illness * Active infections or other illnesses that precludes chemotherapy administration or patient compliance. * Pregnant or lactating women. * Patients who have received any other investigational agents in the last 3 weeks prior to the start of treatment. * Patients with the following conditions will be excluded: * myocardial infarction or stroke within 6 months * unstable angina pectoris or acute ischemic changes on ECG * history of diabetic retinopathy * symptomatic peripheral arterial disease * major surgery in the last 30 days * Patients with uncontrolled diarrhea despite optimal medication and those with any history of acute gastrointestinal bleeding * Patients with a baseline prolongation of the QTc interval of Common Terminology Criteria (CTC) Grade 1 (QTc \> 0.45-0.47 sec) or greater * Patients with impaired cardiac function or clinically significant cardiac diseases, including any one of the following: * left ventricular ejection fraction (LVEF) \< 45% as determined by multigated acquisition (MUGA) scan or echocardiogram; * complete left bundle branch block; * obligate use of a cardiac pacemaker; * congenital long QT syndrome; * history or presence of ventricular tachyarrhythmia; * presence of unstable atrial fibrillation (ventricular response \> 100 bpm). -Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma | Baseline to study completion | The overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma once every 3 week cycle |
Secondary
| Measure | Time frame |
|---|---|
| Number of cycles required to achieve maximum response | Baseline to study completion |
| Overall survival | Baseline to study completion |
| Safety and tolerability | Baseline to study completion |
| Time to disease progression | Baseline to study completion |
Countries
Australia
Outcome results
None listed