Efficacy Study of CYT997 in Multiple Myeloma

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

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 exclusion criteria;

• clinically significant resting bradycardia (< 50 bpm);

• right bundle branch block + left anterior hemiblock (bifascicular block);

• angina pectoris ≤ 3 months prior to starting study drug;

• acute myocardial infarction (MI) ≤ 3 months prior to starting study drug; or

• other clinically significant heart disease (e.g., congestive heart failure (CHF), uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).

• Patients currently receiving treatment with medications known to prolong the QTc interval and/or to induce Torsades de Pointes arrhythmia.