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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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 patients with relapsed or refractory multiple myeloma.

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

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Bevacizumab; Bortezomib

Criteria

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