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A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER) - NCT00473590-53226B(Clinical Trial 169962)



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City:  Wauwatosa
State:  
WI
Zip Code: 53226
Conditions: Multiple Myeloma
Purpose: 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 patients with relapsed or refractory multiple myeloma.
Study summary:
Criteria: Inclusion Criteria: - Age ≥ 18 years - 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 Criteria: - 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 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
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Data Source: ClinicalTrials.gov
Date Processed: February 16, 2010
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