Status:
COMPLETED
A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER)
Lead Sponsor:
Genentech, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, blinded, placebo-controlled, multicenter, Phase II study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patie...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Previously diagnosed with multiple myeloma
- Relapsed or refractory multiple myeloma with disease progression following one to three prior treatment regimens
- Measurable multiple myeloma disease
Exclusion
- Grade ≥ 2 peripheral neuropathy
- Use of corticosteroids within 21 days prior to Day 1
- Use of other anti-myeloma therapy within 21 days prior to Day 1
- Intolerance to bortezomib or compounds containing boron
- Life expectancy of \< 12 weeks
- Current, recent, or planned participation in an experimental drug study
- Active malignancy other than multiple myeloma within 5 years before screening
- Prior treatment with bevacizumab
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)
- Decreased left ventricular function at study entry
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to Day 1
- Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, including placement of a vascular access device within 7 days prior to Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture (for pathologic bone fractures consistent with multiple myeloma, patients may be eligible if no treatment is planned)
- Albuminuria
- Known hypersensitivity to any component of bevacizumab
- Pregnancy (positive pregnancy test) or lactation
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00473590
Start Date
June 1 2007
End Date
November 1 2009
Last Update
June 14 2017
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