Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00335348
• Date of registration: 07/06/2006
• Prospective Registration: No
• Primary sponsor: Peter MacCallum Cancer Centre, Australia
• 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
• Date of first enrolment: June 2006
• Target sample size: 101
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00335348
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Simon Harrison, MB, BS., PhD
• Affiliation: Peter MacCallum Cancer Centre, Australia

• Name: Miles Prince, MD
• Affiliation: Peter MacCallum Cancer Centre, Melbourne, Australia.

Key inclusion & exclusion criteria

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consent may be withdrawn by the patient at any time without prejudice to their future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.

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: Dexamethasone

Drug: Bortezomib

Primary Outcome(s)

Overall Response Rate, defined as the best response on treatment assessed using the EBMT criteria [Time Frame: 2 years]

Secondary Outcome(s)

Overall survival, defined as the time from commencement of treatment to the date of death from any cause. [Time Frame: 2years]

Time To Progression, defined as the time from commencement of treatment to the date of first evidence of progressive disease. [Time Frame: 2 years]

Secondary ID(s)

ACTRN (pending)

05/69

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen-Cilag Ltd.