A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER)

A Randomized, Blinded, Placebo-Controlled, Multicenter, Phase II Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

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.

Inclusion Criteria:

• 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 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 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