Bevacizumab, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Stage II or III Multiple Myeloma

This is an interventional treatment trial for Multiple Myeloma in Relapse Read More

Inclusion Criteria:

• Histologically or cytologically confirmed symptomatic multiple myeloma:

  • Stage II or III disease
  • Relapsed or refractory disease after >= 2 courses of prior chemotherapy
• Measurable levels of monoclonal protein (M protein) > 1.0 g/dL by serum protein electrophoresis OR > 200 mg of monoclonal light chain by 24-hour urine protein electrophoresis
• Measurable bone disease, defined as >= 1 unidimensionally measurable lesion (longest diameter to be recorded) >= 20 mm with conventional techniques OR >= 10 mm with spiral CT scan (for patients with lytic bone disease)
• No known brain metastases

• ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100%

  • Patients with PS of 3 are eligible if it is due to pain that is likely to improve with treatment
• Life expectancy > 6 months
• No known HIV positivity
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No active infections requiring oral or intravenous antibiotics within the past week

• No proteinuria (i.e., albuminuria) > 1,000 mg/24 hours unless related to the diagnosis of multiple myeloma

  • Patients with light chain (i.e., "Bence-Jones") proteinuria are still eligible if the non-light chain component of protein is < 1,000 mg/24 hours
• No serious nonhealing wound or ulcer
• No blood pressure > 150/90 mm Hg (even with medication)
• No significant traumatic injury within the past 28 days
• No clinically significant peripheral vascular disease
• No evidence of bleeding diathesis or coagulopathy
• No unstable angina or myocardial infarction within the past 6 months
• No stroke within the past 6 months
• No New York Heart Association class III or IV heart failure
• No secondary malignancy within the past 2 years except squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix
• Hemoglobin > 9 g/dL (may be supported by transfusion or growth factors)
• WBC >= 2,000/mm^3
• Absolute neutrophil count >= 1,000/mm^3
• Platelet count >= 75,000/mm^3
• Bilirubin =< 2.5 mg/dL
• At least 4 weeks since prior chemotherapy or radiotherapy and recovered
• More than 7 days since prior minor surgical procedures, fine-needle aspirations, or core biopsies:

More than 24 hours since prior bone marrow biopsy or central veinous access placement

• More than 28 days since prior major surgical procedure or open biopsy
• At least 4 weeks since prior and no concurrent participation in another experimental drug study
• Prior autologous peripheral blood stem cell transplantation allowed
• No prior lenalidomide

• Concurrent full-dose anticoagulants allowed provided all of the following criteria are met:

  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • No thrombocytopenia requiring transfusion
  • Platelet count > 75,000/mm3
  • INR 2-3 and stable
• No concurrent major surgery
• No concurrent sargramostim (GM-CSF)
• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies
• AST and ALT =< 5 times upper limit of normal
• Creatinine < 2.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and 4 weeks after completion of study treatment
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide and/or bevacizumab or other agents used in the study