Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00412919




Registration number
NCT00412919
Ethics application status
Date submitted
17/12/2006
Date registered
19/12/2006
Date last updated
16/12/2013

Titles & IDs
Public title
Study of Azacitidine to Treat Relapsed or Refractory Multiple Myeloma
Scientific title
A Prospective, Single-Arm, 2-Stage, Open-label, Phase II Trial of Azacitidine in Relapsed and Refractory Multiple Myeloma.
Secondary ID [1] 0 0
AH213/06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Azacitidine

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

Outcomes
Primary outcome [1] 0 0
Overall response rate
Timepoint [1] 0 0
Secondary outcome [1] 0 0
time to progression
Timepoint [1] 0 0
Secondary outcome [2] 0 0
duration of response
Timepoint [2] 0 0
Secondary outcome [3] 0 0
number of cycles of azacitidine required to first achieve a response
Timepoint [3] 0 0
Secondary outcome [4] 0 0
progression free survival
Timepoint [4] 0 0
Secondary outcome [5] 0 0
safety
Timepoint [5] 0 0
Secondary outcome [6] 0 0
tolerability
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
- diagnosis of MM as per IMWG criteria

- age greater than 17 years

- have received at least 2 but no more than 4 prior lines of therapy

- have failed to respond to the most recently administered anti-MM therapy or have
demonstrably progressive disease as defined by accepted standard criteria

- have a life expectancy of at least 3 months

- ECOG performance status < 3

- at registration haematological values within the following limits:

1. absolute neutrophil count (ANC) > 1.0 x 109/L

2. platelet count > 50 x 109/L unsupported

- At registration biochemical values within the following limits

1. Bilirubin < 1.5 x upper limit of normal (ULN) and transaminases < 2 x ULN unless
considered secondary to hepatic myelomatous infiltration

2. Serum creatinine < 0.19mMol/L

- Written informed consent

- Must agree to use adequate contraceptive measures if indicated. Specifically, women of
childbearing potential (WOCBP) may participate provided they meet the following
conditions:

1. Agree to use at least 2 effective contraceptive methods throughout the study and
for 30 days following the study

2. Have a negative serum pregnancy test within 24 hours of commencing on study
medication

3. Male participants with female partners that are WOCBP must agree to use 2
effective contraceptive methods throughout the study and for 30 days following
the study
Minimum age
17 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 (MGUS) or
indolent/smouldering MM

- Known or suspected hypersensitivity to AZA or mannitol

- Patients whose general condition makes them unsuitable for intensive treatment e.g.
significant cardiac or pulmonary disease

- Active infections or other illnesses that precludes chemotherapy administration or
patient compliance

- Active viral infection with known human immunodeficiency virus (HIV) or viral
hepatitis type B or C

- Pregnant or lactating women

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
7
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
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II trial evaluating the overall response rate, safety and tolerability to
azacitidine in patients with relapsed or refractory multiple myeloma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00412919
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Spencer, Assoc. Prof
Address 0 0
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/ct2/show/NCT00412919