Efficacy Study of CYT997 in Multiple Myeloma

NCT ID: NCT00664378

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-02-28

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.

Conditions

Relapsed and Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I

CYT997

Group Type: EXPERIMENTAL

CYT997

Intervention Type: DRUG

Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle

Interventions

CYT997

Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle

Intervention Type: DRUG

Eligibility 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;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Spencer, Assoc Prof.

Role: PRINCIPAL_INVESTIGATOR

Myeloma Research Group, The Alfred Hospital, Melbourne

Locations

The Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

CCL07001

Identifier Type: -

Identifier Source: org_study_id