A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER) (AMBER)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Avastin, AMBER, Myeloma, Velcade
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Bortezomib + bevacizumab
Bortezomib + placebo
Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.