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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00335348




Registration number
NCT00335348
Ethics application status
Date submitted
7/06/2006
Date registered
9/06/2006
Date last updated
9/01/2013

Titles & IDs
Public title
Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse
Scientific title
Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse An Australian Myeloma Forum Multi-Centre Phase II Trial
Secondary ID [1] 0 0
ACTRN (pending)
Secondary ID [2] 0 0
05/69
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
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

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

Experimental: Bortezomib and Dexamethasone -


Treatment: Drugs: Bortezomib
Induction- 1.3mg/m2 IV days 1,4,8,11 every 3 weeks up to 8 cycles Consolidation- 1.3mg/m2 IV days 1,8,15,22 every 5 weeks up to 3 cycles Maintenance- 1.3mg/m2 IV days 1,15 every 4 weeks

Treatment: Drugs: Dexamethasone
Induction- 20mg orally days 1,2,4,5,8,9,11,12 every 3 weeks up to 8 cycles Consolidation- 20mg orally days 1,2,8,9,15,16,22,23 every 5 weeks up to 3 cycles Maintenance- 20mg orally days 1,2,15,16 every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate, defined as the best response on treatment assessed using the EBMT criteria
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Time To Progression, defined as the time from commencement of treatment to the date of first evidence of progressive disease.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Overall survival, defined as the time from commencement of treatment to the date of death from any cause.
Timepoint [2] 0 0
2years

Eligibility
Key inclusion criteria
- Patient was previously diagnosed with multiple myeloma based on standard criteria and
currently requires second or *third line therapy because of PD, defined as a 25%
increase in M-protein, or development of new or worsening of existing lytic bone
lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dL), or
relapse from CR.*Patients will only be eligible for bortezomib as 3rd line therapy if
they have received dexamethasone alone, thalidomide alone (or with corticosteroids) or
revlimid alone (or with corticosteroids) as one of the 2 prior therapies.

- Patient is of a legally consenting age, as defined by local regulations.

- Patient is, in the investigator's opinion, willing and able to comply with the
protocol requirements.

- Patient has given voluntary written informed consent before performance of any
study-related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the patient at any time without prejudice to their future
medical care.

- Female patient is either post-menopausal or surgically sterilized or willing to use an
acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.

- Male patient agrees to use an acceptable method for contraception for the duration of
the study.

- Patient has measurable disease

- Patient has a Karnofsky performance status =60%.

- Patient has a life-expectancy >3 months.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Primary Dexamethasone resistance

- Prior therapy with Bortezomib

- Prior severe allergic reactions to Bortezomib (Velcade), Boron or Mannitol

- Neuropathy > Grade 2 with pain by NCI-CTCAE criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2012
Sample size
Target
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
8006 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen-Cilag Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study has two main aims. The first is to assess whether Dexamethasone can increase the
number of patients with who respond to Velcade.

The second aim of this study is to see whether treating patients with relapsed multiple
myeloma with Velcade and Dexamethasone for a longer period of time extends the time that the
myeloma is under control.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00335348
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Miles Prince, MD
Address 0 0
Peter MacCallum Cancer Centre, Melbourne, Australia.
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/NCT00335348