Status:
COMPLETED
Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 pat...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00335348
Start Date
June 1 2006
End Date
July 1 2012
Last Update
January 9 2013
Active Locations (1)
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1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006