Trial Information

Screening of Cathepsin G Levels in Multiple Myeloma Patients Receiving Treatment With Thalidomide/Lenalidomide Within the ECOG Trials E1A00 and E4A03

OBJECTIVES:

Primary

- To analyze the mechanism of development of thalidomide/lenalidomide-induced venous
thromboembolism (VTE) in patients with multiple myeloma treated on clinical trial
ECOG-E4A03 or E-E1A00.

- To determine the intensity, dynamics, and specificity of cathepsin G (CG) upregulation
in response to thalidomide and lenalidomide treatment.

- To determine the specificity and threshold levels of CG for induction of platelet
aggregation in response to thalidomide and lenalidomide and the resulting risk for VTE
development.

OUTLINE: Blood samples obtained before, during, and after treatment with thalidomide or
lenalidomide from patients previously enrolled on clinical trial ECOG-E4A03 or E-E1A00 are
analyzed to determine the total content of cathepsin G (CG) via ELISA; to determine mRNA
levels of CG via RT-PCR; and for platelet aggregation studies. Blood samples are collected
from healthy volunteers for platelet preparation.