Studying Blood Samples From Patients With Multiple Myeloma Who Were Treated With Thalidomide or Lenalidomide
NCT ID: NCT00899080
Last Updated: 2017-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2008-07-04
2008-08-04
Brief Summary
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PURPOSE: This research study is looking at blood samples from patients with multiple myeloma who were treated with thalidomide or lenalidomide.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Interventions
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gene expression analysis
reverse transcriptase-polymerase chain reaction
immunoenzyme technique
laboratory biomarker analysis
platelet aggregation test
Eligibility Criteria
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Inclusion Criteria
* 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
120 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Suzanne Lentzsch, MD, PhD
Role: STUDY_CHAIR
University of Pittsburgh
Other Identifiers
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ECOG-E4A03T2
Identifier Type: -
Identifier Source: secondary_id
CDR0000600320
Identifier Type: -
Identifier Source: org_study_id
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