A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma
A Phase II Trial of Bevacizumab in Patients With Relapsed or Refractory Multiple Myeloma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of multiple myeloma by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with relapsed or refractory multiple myeloma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive bevacizumab IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are obtained for correlative studies at baseline, after course 2, and at 12 weeks. Samples are analyzed for interleukin-6, Flt-1, and VEGF levels.
After completion of study therapy, patients are followed every 3-6 months for up to 3 years.
DISEASE CHARACTERISTICS:
Diagnosis of relapsed or refractory multiple myeloma
Measurable or evaluable disease as defined by ≥ 1 of the following:
No concurrent amyloidosis
PATIENT CHARACTERISTICS:
ECOG performance status (PS) 0 or 1
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:
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
No other concurrent investigational therapy
No other concurrent systemic antineoplastic therapy including, but not limited to, the following:
Concurrent bisphosphonates allowed