A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma
Inclusion Criteria
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