Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse

Phase 2

Completed

• Conditions: Multiple Myeloma; Cancer - Myeloma

• Registration Number: ACTRN12606000180516
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.5.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.

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

• Study Type: Interventional
• Study Design: Not specified