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


Phase 2
18 Years
N/A
Not Enrolling
Both
Relapsed and Refractory Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma

Outcome Description:

The overall response rate to CYT997 when used to treat patients with relapsed or refractory multiple myeloma once every 3 week cycle

Outcome Time Frame:

Baseline to study completion

Safety Issue:

No

Principal Investigator

Andrew Spencer, Assoc Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Myeloma Research Group, The Alfred Hospital, Melbourne

Authority:

United States: Food and Drug Administration

Study ID:

CCL07001

NCT ID:

NCT00664378

Start Date:

January 2008

Completion Date:

February 2011

Related Keywords:

  • Relapsed and Refractory Multiple Myeloma
  • Multiple myeloma, relapsed, refractory
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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