Efficacy Study of CYT997 in Multiple Myeloma

Relapsed and Refractory Multiple Myeloma Clinical Trial

Official title:

A Prospective, Single-arm, Two-stage, Open-label Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00664378
• Other study ID #: CCL07001
• Status: Terminated
• Phase: Phase 2
• Start date: January 2008
• Est. completion date: February 2011

Study information

• Verified date: April 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed and Refractory Multiple Myeloma

Intervention

Drug:
• CYT997
Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma	The overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma once every 3 week cycle	Baseline to study completion
Secondary	Number of cycles required to achieve maximum response		Baseline to study completion
Secondary	Overall survival		Baseline to study completion
Secondary	Safety and tolerability		Baseline to study completion
Secondary	Time to disease progression		Baseline to study completion