Efficacy Study of CYT997 in Multiple Myeloma

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	CYT997	CYT997

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall survival	Baseline to study completion
Time to disease progression	Baseline to study completion
Safety and tolerability	Baseline to study completion
Number of cycles required to achieve maximum response	Baseline to study completion