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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: immunoenzyme technique
* Other: laboratory biomarker analysis
* Other: platelet aggregation test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Other: immunoenzyme technique|nan|
|Other: laboratory biomarker analysis|nan|
|Other: platelet aggregation test|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE) |  | 1 month | 
| Intensity, dynamics, and specificity of CG upregulation in response to thalidomide and lenalidomide treatment |  | 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 |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma