A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bevacizumab; Bortezomib; placebo
Intervention description: 15 mg/kg administered by intravenous infusion; 1.3 mg/m^2 administered by intravenous bolus injection; Intravenous repeating dose
Intervention MeSH terms: Bevacizumab; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Avastin; AMBER; Myeloma; Velcade

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.
    

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