Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter MacCallum Cancer Centre, Australia
• Collaborator: Janssen-Cilag Ltd.
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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