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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Sex
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
Not applicable
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2011
Sample size
Target
Accrual to date
Final
5
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00664378