Studying Blood Samples From Patients With Multiple Myeloma Who Were Treated With Thalidomide or Lenalidomide

Eastern Cooperative Oncology Group33 enrolled

Overview

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at blood samples from patients with multiple myeloma who were treated with thalidomide or lenalidomide.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Interventions

gene expression analysisGENETIC

reverse transcriptase-polymerase chain reactionGENETIC

immunoenzyme techniqueOTHER

laboratory biomarker analysis

Eligibility

Sex: ALLMax age: 120 YearsHealthy volunteers:

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Diagnosed with multiple myeloma and treated with thalidomide or lenalidomide on clinical trial ECOG-E4A03 or E-E1A00 * Healthy volunteer PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Outcomes

Primary Outcomes

Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels

Time frame: 1 month

Secondary Outcomes

Mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE)

Time frame: 1 month

Intensity, dynamics, and specificity of CG upregulation in response to thalidomide and lenalidomide treatment

Time frame: 1 month

Specificity and threshold levels of CG for induction of platelet aggregation in response to thalidomide and lenalidomide and the resulting risk for VTE development

Time frame: 1 month

Data from ClinicalTrials.gov

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