Aflibercept for Relapsed Multiple Myeloma

Stopped early · Phase 2

Conditions studied: Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

This phase II trial is studying the side effects and how well aflibercept works in treating patients with stage II or stage III multiple myeloma that has relapsed or not responded to previous treatment. Aflibercept may be able to carry cancer-killing substances directly to multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood flow to the cancer.

Key facts

Study ID

NCT00437034

Run by

National Cancer Institute (NCI)

People needed

6

Starts

2007-01-01

Expected to finish

2011-04-01

Last updated by the study team

2021-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• North Shore University Hospital — Manhasset, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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