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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]

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

Condition category

Condition code

Cancer

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]

Treatment: Drugs

Comparator / control treatment

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Overall response, defined as the best response on treatment assessed using modified M protein/ European Bone Marrow Transplant criteria.

Timepoint [1]

Response will be assessed every 2 months.

Secondary outcome [1]

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]

Response will be assessed every 2 months.

Secondary outcome [2]

Overall survival, defined as the time from commencement of treatment to the date of death from any cause.

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/06/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Janssen-Cilag

Country [1]

Australia

Primary sponsor type

Hospital

Name

Peter MacCallum Cancer Centre

Address

Country

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre

Ethics committee address [1]

East Melbourne

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/03/2006

Ethics approval number [1]

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

Prof HM Prince

Address

Peter MacCallum Cancer Centre
12 St Andrews Place, East Melbourne - 3002, VIC

Country

Australia

Phone

+61 3 9656 1111

Fax

+ 61 3 9656 1408

[email protected]

Contact person for public queries

Name

Prof HM Prince

Address

DHMO, 5th Floor, Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, VIC 8006

Country

Australia

Phone

03 9656 1700

Fax

03 9656 1408

[email protected]

Contact person for scientific queries

Name

Dr Simon Harrison

Address

DHMO 5th Floor Peter MacCallum Cancer Centre Locked Bag 1 A'Beckett Street Melbourne Victoria 8006

Country

Australia

Phone

03 9656 1111

Fax

03 9656 1408

[email protected]

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

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Documents added automatically

No additional documents have been identified.

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