Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

082405

ACTR Number:

ACTRN12607000584437

Trial Status:

Registered

Date Submitted:

13/11/2007

Date Registered:

14/11/2007

Page 1

Public title:

A Prospective, Single-Arm, Two-Stage, Open-Label, Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma

ANZCTR registration title:

A Prospective, Single-Arm, Two-Stage, Open-Label, Phase II Trial of CYT997 in Relapsed and Refractory Multiple Myeloma

Secondary ID:

UTN:

Trial acronym:

Page 2
Health condition(s) or problem(s) studied:
Relapsed or refractory multiple myeloma

Blood	Haematological diseases
Condition category:	Condition code:

Page 3

Description of intervention(s) / exposure:

CYT997 is administered as a 24-hour intravenous infusion at a dose of 202mg/m2 on days 1 and 8 of a 21 day cycle for up to three cycles

Intervention code:

Treatment: drugs

Comparator / control treatment:

There is no control group in this study.

Control group:

Uncontrolled

Page 4
Primary outcome:	Overall response rate
Timepoint:	Response will be measured after each cycle (ie every three weeks).
Secondary outcome 1:	Time to progression (TTP)
Timepoint:	Progression will be measured each cycle (ie every three weeks).
Secondary outcome 2:	Number of cycles of CYT997 required to achieve maximal response.
Timepoint:	Response will be measured each cycle (ie every three weeks). The number of cycles required to attain maximal response will be determined on an ongoing basis by comparison with data collected during treatment for that patient.
Secondary outcome 3:	Overall survival.
Timepoint:	Overall survival will be measured on an ongoing basis during the study and whilst the patient remains on CYT997 therapy.
Secondary outcome 4:	Safety and tolerability
Timepoint:	Safety and tolerability will be assessed on an ongoing basis during the patients' participation in the trial.

Page 5

Key inclusion criteria:

Diagnosis of multiple myeloma as per WHO (World Health Organisation) criteria.
Age 18 years or greater.
Patients must have received at least one but no more than 3 prior lines of myeloma therapy.
Patients must have failed to respond to the most recently administered anti-myeloma therapy or have demonstrably progressive disease by accepted clinical criteria.
Patients must have a life expectancy of at least 3 months.
ECOG (Eastern Co-operative Oncology Group) performance status <3.
Patients must be willing and able to given informed, written consent.
Patients must agree to use adequate contraceptive measures if indicated.

Minimum Age:

18 Years

Maximum Age:

N/A

Gender:

Both males and females

Healthy volunteers?

Key exclusion criteria:

Patients with monoclonal gammopathy of undetermined significance. Known or suspective hypersensitivity to CYT997. Patient with uncontrolled intercurrent illness. Patients who are pregnant or lactating. Patient who have received other investigational agents within the preceding three weeks prior to starting therapy. Patients with heart-attack or stroke within the preceding 6 months; unstable angina pectoris; history of diabetic retinopathy or major surgery in the preceding 30 days will be excluded. Patients with a baseline prolongation of the QTc interval (QT interval corrected for heart rate) >450 msec. Patients with impaired cardiac function or clinically significant cardiac disease. Patients currently receiving treatment with medications known to prolong the QTc interval.

Page 6

Study type:

Interventional

Purpose of the study:

Treatment

Allocation to intervention:

Nonrandomised trial

Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):

Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):

Masking / blinding:

Open (masking not used)

Assignment:

Single group

Other design features (specify):

Type of endpoint(s):

Safety/efficacy

Page 7

Phase

Phase 2

Anticipated or actual date of first participant enrolement:

1/12/2007

Target sample size:

Recruitment status:

Open to recruitment

Page 8

Funding source:

Commercial sector/Industry

Name:

Cytopia Research Pty Ltd

Address:

Level 2, 499 St Kilda Road, Melbourne VIC 3004

Country:

Australia

Primary sponsor:

Commercial sector/Industry

Name:

Cytopia Research Pty Ltd

Address:

Level 2, 499 St Kilda Road, Melbourne VIC 3004

Country:

Australia

Secondary sponsor:

None

Name:

Address:

Country:

Other collaborator:

Page 9

Has the study received approval from at least one ethics committee?

Yes

Ethics Committee name:

Alfred Hospital Ethics Committee

Address:

Alfred Hospital Commercial Road MELBOURNE VIC

Country:

Australia

Date of approval:

HREC Number:

EC00315

Countries of recruitment:

Australia

Postcode:

3004

Brief summary:

Laboratory studies indicate that CYT997 is able to potently inhibit myeloma cells from patients with this condition. Given these favourable "test tube" findings, Cytopia has decided to investigate whether CYT997, when given to patients with multiple myeloma, can improve their condition and extend survival from the disease. The effect of CYT997 in patients will be determined from analysis of blood plasma and bone marrow samples and comparison to accepted clinical standards for response in multiple myeloma.

Trial website:

Presentations / publication list:

Page 10

Contact person for public queries

Name:

Dr Gregg Smith

Address:

Level 2, 499 St Kilda Road, Melbourne VIC 3004

Country:

Australia

Tel:

(03) 9926 0444

Fax:

Email:

gregg.smith@cytopia.com.au

Contact person for scientific queries

Name:

Dr Gregg Smith

Address:

Level 2, 499 St Kilda Road, Melbourne VIC 3004

Country:

Australia

Tel:

(03) 9926 0444

Fax:

Email:

gregg.smith@cytopia.com.au

Contact person responsible for updating information

Name:

Dr Gregg Smith

Address:

Level 2, 499 St Kilda Road, Melbourne VIC 3004

Country:

Australia

Tel:

(03) 9926 0444

Fax:

Email:

Trial Details

Page 1

Page 2

Page 3

Page 4

Page 5

Page 6

Page 7

Page 8

Page 9

Page 10