Bevacizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma Read More

DISEASE CHARACTERISTICS:

• Diagnosis of relapsed or refractory multiple myeloma

• Measurable or evaluable disease as defined by ≥ 1 of the following:

  • Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
  • Monoclonal protein ≥ 200 mg by 24-hour urine electrophoresis
  • Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
  • Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
• No concurrent amyloidosis

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0 or 1

  • ECOG PS 2 based on immobility from myeloma bone disease alone allowed at the discretion of treating physician
• Creatinine ≤ 2.0 mg/dL
• ANC ≥ 1,000/mm³
• Platelet count ≥ 75,000/mm³
• Hemoglobin ≥ 8.0 g/dL
• Proteinuria ≤ 1 g/dL by 24-hour urine collection (excluding monoclonal protein)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
• No bleeding diathesis
• No hypertension (defined as BP > 150/100 mm Hg)
• No active bleeding, healing or nonhealing wound, ulcer, or bone fracture (excluding fractures secondary to myeloma)

• No active ulcerative disease including, but not limited to, any of the following:

  • Peptic ulcer disease
  • Ulcerative esophagitis
  • Ulcerative colitis
  • Crohn's disease
• LVEF ≥ 50% by 2-dimensional ECHO or MUGA scan
• No NYHA class III or IV heart disease
• No other active malignancy except for nonmelanoma skin cancer or in situ cervical or breast cancer
• No active infection
• No other comorbidity that would interfere with study compliance
• No transient ischemic attack, cerebrovascular accident, or myocardial infarction within the past year
• No abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 6 months
• No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No more than 2 prior antimyeloma treatment courses, except for bisphosphonates
• No standard or experimental drug therapy, other than ongoing bisphosphonate treatment and/or epoetin alfa, within the past 28 days
• No experimental non-drug therapy within the past 28 days
• Palliative radiation therapy within the past 28 days allowed provided ≤ 3 sites of bone disease was irradiated
• No prior bevacizumab or other experimental antiangiogenic agents other than thalidomide or lenalidomide
• No minor surgical procedures, fine-needle aspiration, or core biopsies within the past 7 days
• No major surgical procedure or open biopsy within the past 28 days

• No concurrent corticosteroids

  • Chronic steroids ≤ 20 mg/day (prednisone equivalent) for disorders other than myeloma (i.e., adrenal insufficiency, rheumatoid arthritis) allowed
• No other concurrent investigational therapy

• No other concurrent systemic antineoplastic therapy including, but not limited to, the following:

  • Cytotoxic chemotherapy
  • Immunotherapy
  • Hormonal therapy
  • Monoclonal antibody therapy
• Concurrent bisphosphonates allowed