Aflibercept for Relapsed Multiple Myeloma

This is an interventional treatment trial for Stage II Multiple Myeloma Read More

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

Exclusion criteria:

• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No known history of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in the study
• No serious or nonhealing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 28 days
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• No clinically significant cardiovascular disease
• No prothrombin time (PT) or international normalized ratio (INR) > 1.5 (unless patient is on full-dose warfarin)
• No evidence of bleeding diathesis or coagulopathy
• No uncontrolled intercurrent illness that would limit compliance with study requirements, including ongoing or active infection
• No psychiatric illness or social situations that would limit study compliance
• No concurrent major surgery
• No concurrent immunosuppressive agents (including steroids)
• No other concurrent investigational agents