Efficacy Study of CYT997 in Multiple Myeloma

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

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.

Study Overview

• Status: Terminated
• Conditions: Relapsed and Refractory Multiple Myeloma
• Intervention / Treatment: Drug: CYT997

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I; CYT997	Drug: CYT997; Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Overall survival	Baseline to study completion
Number of cycles required to achieve maximum response	Baseline to study completion
Safety and tolerability	Baseline to study completion
Time to disease progression	Baseline to study completion

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Principal Investigator: Andrew Spencer, Assoc Prof., Myeloma Research Group, The Alfred Hospital, Melbourne

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Multiple myeloma, relapsed, refractory
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CCL07001