Aflibercept for Relapsed Multiple Myeloma

Inclusion Criteria

• •Histologically or cytologically confirmed multiple myeloma
• •* Stage II or III disease according to Salmon-Durie staging criteria
• •Relapsed or refractory disease
• •Progressive disease
• •Measurable disease, defined by ≥ 1 of the following criteria:
• •* Serum M protein ≥ 1.0 g/dL by serum protein electrophoresis
• •* Free light chain measurement \> 200 mg/dL
• •* Urinary M protein excretion ≥ 200 mg/24 hours
• •Must have received ≥ 2 prior therapies\* for multiple myeloma that meet the following criteria:
• •* Antimyeloma therapeutic regimen consisting of ≥ 1 complete course of single-agent or combination-agent therapy, or a planned series of treatments (e.g., 3-4 courses of induction therapy followed by a stem cell harvest procedure followed by conditioning high-dose therapy supported by stem cell transplantation)
• •* Antimyeloma regimen is discontinued because of the development of resistant disease or severe therapy-related toxicity
• •* Individual antimyeloma regimen will be considered to have been discontinued when all agents of the regimen have been permanently stopped
• •* A prior regimen will not be considered to have been discontinued for the modification of drug doses, or if less than all the agents of a combination regimen have been discontinued, or if the regimen has been halted temporarily for the development of a plateau phase of myeloma
• •* Maintenance therapy will not be considered an additional regimen
• •* If new agents are added to an existing regimen, presumably because of tumor resistance, the old regimen will be considered to have ended and a new regimen to have started
• •No evidence of central nervous system (CNS) disease, including primary brain tumor or brain metastasis
• •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
• •Life expectancy \> 12 weeks
• •White blood cell (WBC) ≥ 3,000/mm\^3
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 75,000/mm\^3
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN
• •Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
• •No albuminuria only
• •* Urine protein: creatinine ratio \< 1 OR 24-hour urine protein with an albumin level \< 500 mg
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy