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Efficacy Study of CYT997 in Multiple Myeloma
This study is currently recruiting participants.
Verified by Cytopia Research Pty Ltd, January 2009
Sponsored by: Cytopia Research Pty Ltd
Information provided by: Cytopia Research Pty Ltd
ClinicalTrials.gov Identifier: NCT00664378
  Purpose

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.


Condition Intervention Phase
Relapsed and Refractory Multiple Myeloma
Drug: CYT997
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Prospective, Single-Arm, Two-Stage, Open-Label Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma

Further study details as provided by Cytopia Research Pty Ltd:

Primary Outcome Measures:
  • To determine the overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma [ Time Frame: Every three week cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Continuous ] [ Designated as safety issue: No ]
  • Number of cycles required to achieve maximum response [ Time Frame: Continuous ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Until 30 days after last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: January 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Experimental
CYT997
Drug: CYT997
Intravenous infusion (24h); 202mg/m2 on days 1 and 8 of a 21 day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of multiple myeloma per 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
  • 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 creatinin 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 diarrhoea despite optimal medication and those with any history of acute gastrointestinal bleeding
  • Patients with a baseline prolongation of the QTc interval of 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:

LVEF < 45% as determined by 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 (bifasicular block); angina pectoris ≤ 3 months prior to starting study drug; acute MI ≤ 3 months prior to starting study drug; or other clinically significant heart disease (e.g., 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00664378

Contacts
Contact: Katie Boast, RN +61392763751 k.boast@alfred.org.au

Locations
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Andrew Spencer, MD            
Sponsors and Collaborators
Cytopia Research Pty Ltd
Investigators
Study Chair: Andrew Spencer, MD The Alfred
  More Information

Responsible Party: Cytopia Research Pty Ltd ( Dr Gregg Smith, Director: Drug Development )
Study ID Numbers: CCL07001
Study First Received: April 18, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00664378  
Health Authority: United States: Food and Drug Administration;   Australia: Therapeutic Goods Administration

Keywords provided by Cytopia Research Pty Ltd:
Multiple myeloma, relapsed, refractory

Study placed in the following topic categories:
Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009