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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00664378




Registration number
NCT00664378
Ethics application status
Date submitted
18/04/2008
Date registered
22/04/2008
Date last updated
8/06/2018

Titles & IDs
Public title
Efficacy Study of CYT997 in Multiple Myeloma
Scientific title
A Prospective, Single-arm, Two-stage, Open-label Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma
Secondary ID [1] 0 0
CCL07001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed and Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CYT997

Experimental: I - CYT997


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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline to study completion
Secondary outcome [1] 0 0
Number of cycles required to achieve maximum response
Timepoint [1] 0 0
Baseline to study completion
Secondary outcome [2] 0 0
Overall survival
Timepoint [2] 0 0
Baseline to study completion
Secondary outcome [3] 0 0
Safety and tolerability
Timepoint [3] 0 0
Baseline to study completion
Secondary outcome [4] 0 0
Time to disease progression
Timepoint [4] 0 0
Baseline to study completion

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00664378
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Spencer, Assoc Prof.
Address 0 0
Myeloma Research Group, The Alfred Hospital, Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00664378