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Trial registered on ANZCTR


Registration number
ACTRN12606000180516
Ethics application status
Approved
Date submitted
15/05/2006
Date registered
16/05/2006
Date last updated
24/01/2013
Type of registration
Prospectively registered

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 to improve time to progression
Secondary ID [1] 261 0
Peter MacCallum Cancer Centre: 05/69
Universal Trial Number (UTN)
Trial acronym
Bomer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 1153 0
Condition category
Condition code
Cancer 1234 1234 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.Induction
Up to eight (8) cycles with 3-week treatment cycles: bortezomib (1.3 mg/m2 as a single bolus IV on days 1, 4, 8, 11) and dexamethasone 20 mg PO once daily on the day of bortezomib injection and the day thereafter (days 1, 2, 4, 5, 8, 9, 11, and 12) followed by a 10 day break between doses of bortezomib (days 12 through 21).
2.Consolidation
Up to three (3) cycles with 5-week treatment cycles bortezomib (1.3 mg/m2 as a single bolus IV on days 1, 8, 15, 22) and dexamethasone 20 mg PO once daily on the day of bortezomib injection and the day thereafter (days 1, 2, 8, 9, 15, 16, 21, 22) followed by a 13 day break between doses of bortezomib (days 23 through 35).
3.Maintenance
Only patients with progressive disease will not be eligible for maintenance therapy.
Patients who achieve a maximum ‘response’ to bortezomib of one of stable disease (SD), partial response (PR) or complete response (CR) will receive maintenance therapy.
Patients with PR or SD will undergo the entire Induction/Consolidation treatment program outlined above and then move onto maintenance. Patients who achieve a CR must receive 2 further cycles of Induction therapy once CR is documented, and then they will move onto maintenance therapy.
Bortezomib 1.3g/m2 as a single dose every 2 weeks with dexamethasone 20 mg PO once daily on the day of bortezomib injection and the day thereafter (day 1,2). This will continue until disease progression.
Intervention code [1] 1040 0
Treatment: Drugs
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1672 0
Overall response, defined as the best response on treatment assessed using modified M protein/ European Bone Marrow Transplant criteria.
Timepoint [1] 1672 0
Response will be assessed every 2 months.
Secondary outcome [1] 2995 0
Time to progression, defined as the time from commencement of treatment to the date of first evidence of progressive disease using modified M protein/ European Bone Marrow Transplant criteria.
Timepoint [1] 2995 0
Response will be assessed every 2 months.
Secondary outcome [2] 2996 0
Overall survival, defined as the time from commencement of treatment to the date of death from any cause.
Timepoint [2] 2996 0
at time of event

Eligibility
Key inclusion criteria
1.Patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second or third line therapy. 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.2. Patient is of a legally consenting age, as defined by local regulations.3. Patient is, in the investigator’s opinion, willing and able to comply with the protocol requirements.4. 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.5. Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.6. Male patient agrees to use an acceptable method for contraception for the duration of the study.7. Patient has measurable disease8. Patient has a Karnofsky performance status =60%.9. Patient has a life-expectancy >3 months.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Primary Dexamethasone resistancePatients are defined as being refractory to treatment with high-dose dexamethasone if they achieved less than a partial response, or developed progressive disease within 6 months of discontinuing dexamethasone, or dexamethasone was discontinued because of =Grade 3 dexamethasone-related toxicity.oHigh-dose dexamethasone therapy is defined as >500mg dexamethasone or equivalent over a 10-week period, whether administered alone or as part of the VAD regimen.2.Prior therapy with Bortezomib3.Prior severe allergic reactions to Bortezomib (Velcade), Boron or Mannitol4. Neuropathy > Grade 2.

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)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 1351 0
Commercial sector/Industry
Name [1] 1351 0
Janssen-Cilag
Address [1] 1351 0
1-5 Khartoum Road

Macquarie Park, NSW, 2113



Country [1] 1351 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2702 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 2702 0
East Melbourne
Ethics committee country [1] 2702 0
Australia
Date submitted for ethics approval [1] 2702 0
Approval date [1] 2702 0
16/03/2006
Ethics approval number [1] 2702 0
05/69

Summary
Brief summary
Velcade is a new drug, which is being developed for the treatment of patients with a variety of cancers. In studies to date, it has been shown to be useful in the treatment of patients with advanced multiple myeloma whose myeloma has progressed after standard drug treatment. Approximately one third of them have had a response to treatment, which has lasted for approximately 12 months. It has been associated with improvement in symptoms from the disease including improvements in blood counts, fewer blood transfusions and in a lessening of bone pain. There is some evidence that more patients respond to Velcade when it is given together with a steroid drug, Dexamethasone, which is commonly used in the treatment of Myeloma, and you may have received in the past. Only a small number of patients have been treated with Velcade and Dexamethasone from the beginning of therapy. However, many more have had Dexamethasone added later if they have failed to respond to Velcade on its own.
Velcade is approved in the USA and Europe by the Food and Drug Administration (FDA) for the treatment of patients with myeloma. However, Velcade is not approved in Australia and therefore its use in this study is considered experimental.
This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients who respond to Velcade in the controlled setting of a clinical trial. This study is specifically designed for patients who have received at least one kind of standard treatment in the past and are now in need of further therapy because their disease has relapsed. The second aim of this study is to see whether treating patients with Velcade and Dexamethasone for a longer period of time extends the time that the myeloma is under control. This is known as maintenance treatment.
Approximately 100 patients will participate around Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36029 0
Prof HM Prince
Address 36029 0
Peter MacCallum Cancer Centre
12 St Andrews Place, East Melbourne - 3002, VIC
Country 36029 0
Australia
Phone 36029 0
+61 3 9656 1111
Fax 36029 0
+ 61 3 9656 1408
Email 36029 0
Miles.Prince@petermac.org
Contact person for public queries
Name 10229 0
Prof Prof HM Prince
Address 10229 0
DHMO, 5th Floor, Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, VIC 8006
Country 10229 0
Australia
Phone 10229 0
03 9656 1700
Fax 10229 0
03 9656 1408
Email 10229 0
Miles.Prince@petermac.org
Contact person for scientific queries
Name 1157 0
Dr Dr Simon Harrison
Address 1157 0
DHMO 5th Floor Peter MacCallum Cancer Centre Locked Bag 1 A'Beckett Street Melbourne Victoria 8006
Country 1157 0
Australia
Phone 1157 0
03 9656 1111
Fax 1157 0
03 9656 1408
Email 1157 0
Simon.Harrison@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary