Aflibercept for Relapsed Multiple Myeloma

Conditions:Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:18 - Any
Start Date:January 2007
End Date:April 2011

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A Phase 2 Study of Aflibercept for the Treatment of Relapsed or Refractory Multiple Myeloma

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.


I. To evaluate the safety and efficacy of VEGF Trap (aflibercept) in patients with relapsed
or refractory, stage II or III multiple myeloma (MM).

II. To perform correlative studies in order to evaluate the angiogenic properties of tissue
from patients during the course of treatment with VEGF Trap.

OUTLINE: This is a multicenter study.

Patients receive aflibercept intravenously (IV) over 1 hour on day 1. Treatment repeats
every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed for 60 days and then periodically

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

- 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

- 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

- 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
We found this trial at
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
New York, NY
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
Bronx, NY
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
Manhasset, NY
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1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
Bronx, NY
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630 W 168th St
New York, New York
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
New York, NY
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
New York, NY
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