Efficacy Study of CYT997 in Multiple Myeloma

This study has been terminated.
(Difficulty enrolling patients)
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00664378
First received: April 18, 2008
Last updated: April 25, 2013
Last verified: April 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Single-arm, Two-stage, Open-label Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
    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:
  • Number of cycles required to achieve maximum response [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
  • Time to disease progression [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664378

Locations
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Andrew Spencer, Assoc Prof. Myeloma Research Group, The Alfred Hospital, Melbourne
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00664378     History of Changes
Other Study ID Numbers: CCL07001
Study First Received: April 18, 2008
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Gilead Sciences:
Multiple myeloma, relapsed, refractory

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014