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

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.

Full Title of Study: “Screening of Cathepsin G Levels in Multiple Myeloma Patients Receiving Treatment With Thalidomide/Lenalidomide Within the ECOG Trials E1A00 and E4A03”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 4, 2008

Detailed Description

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.

Interventions

  • Genetic: gene expression analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: immunoenzyme technique
  • Other: laboratory biomarker analysis
  • Other: platelet aggregation test

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels
    • Time Frame: 1 month

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eastern Cooperative Oncology Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Suzanne Lentzsch, MD, PhD, Study Chair, University of Pittsburgh

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